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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-002442-37 | EudraCT Number | ||
| U1111-1211-9010 | Registry Identifier | ICTRP |
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Study was stopped after interim analysis for all 4 cohorts with results either not fulfilling the pre-planned interim analysis criteria or fulfilling the criteria but as per sponsor decision. It was not due to any safety concern
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Primary Objectives:
Phase 1
-To characterize the safety and tolerability of isatuximab in combination with cemiplimab in participants with relapsed and refractory classic Hodgkin's lymphoma (cHL), diffuse large B-cell lymphoma (DLBCL) or peripheral T-cell lymphoma (PTCL), and to confirm the recommended Phase 2 dose (RP2D).
Phase 2
Secondary Objectives:
The total study duration per participant was up to 28 months, including an up to 28-day screening period, an up to 96-week treatment period, and a 90-day safety follow up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A1: cHL: Isatuximab + Cemiplimab | Experimental | Classic Hodgkin's lymphoma (cHL), anti-programmed cell death protein 1/ligand 1 (PD-1/PD-L1) inhibitor naïve participants received isatuximab 10 milligrams per kilogram (mg/kg), intravenous (IV) infusion once a week (QW) in Cycle 1 and then every 2 weeks (Q2W) from Cycle 2 to Cycle 6 (each cycle of 28 days), and then every 3 weeks (Q3W) from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 milligrams (mg) Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until, unacceptable adverse events (AEs) or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of complete response [CR], whichever was longer) of delivery of investigational medicinal product(s) without documented progressive disease (PD), or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
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| Cohort A2: cHL: Isatuximab + Cemiplimab | Experimental | cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until, unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
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| Cohort B: DLBCL: Isatuximab + Cemiplimab | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| isatuximab SAR650984 | Drug | Pharmaceutical form: solution for infusion Route of administration: intravenous |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose Limiting Toxicities (DLTs) | DLTs: Adverse Events (AEs) occurring during 1st treatment cycle, unless due to disease progression or obviously unrelated cause which included: hematological abnormalities: Grade(G) 4 neutropenia(N) for 7 or more consecutive days, G3 to G4 N with fever (temperature greater than or equal to [>=] 38.5 degree Celsius on more than 1 occasion) or microbiologically/radiographically documented infection, G3 to G4 thrombocytopenia with clinically significant bleeding requiring clinical intervention or non-hematological abnormalities: G 4 non-hematologic AE, G>=2 uveitis, G3 non-hematological AE lasting greater than (>)3 days, delay in initiation of Cycle 2 >14 days due to treatment related laboratory abnormalities/AE. Any other AE that the study committee deemed to be dose-limiting, regardless of grade, was also considered as DLT. | Cycle 1 (28 days) |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), and Treatment-Emergent Serious Adverse Events (TESAEs) | An AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily have to have a causal relationship with the treatment. Serious adverse events (SAEs) were any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were defined as AEs that developed, worsened or became serious during the TEAE period (defined as the time from the first dose of study treatment up to 30 days after the last dose of study treatment). | From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: up to 103 weeks) |
| Number of Participants With Laboratory Abnormalities: Hematological Parameters | Hematological parameters assessed were anemia, white blood cell (WBC) decreased, platelet count decreased, lymphocyte count decreased, and neutrophil count decreased. Abnormality criteria was assessed as per the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 NCI-CTCAE v 5.0), where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Induced and Treatment Boosted Antidrug Antibodies (ADA) Against Isatuximab | ADA responses were categorized as treatment boosted ADA and treatment-induced ADA. Treatment boosted ADA was defined as pre-existing ADAs with a significant increase in the ADA titer during the study compared to the Baseline titer. Treatment-induced ADA was defined as ADA that developed at any time during the ADA on-study observation period in participants without pre-existing ADA. |
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Inclusion criteria:
Exclusion criteria:
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number :2500005 | Dijon | 21000 | France | |||
| Investigational Site Number :2500004 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36251503 | Background | Carlo-Stella C, Zinzani PL, Sureda A, Araujo L, Casasnovas O, Carpio C, Yeh SP, Bouabdallah K, Cartron G, Kim WS, Cordoba R, Koh Y, Re A, Alves D, Chamuleau M, Le Gouill S, Lopez-Guillermo A, Moreira I, van der Poel MWM, Abbadessa G, Meng R, Ji R, Lepine L, Saleem R, Ribrag V. A phase 1/2, open-label, multicenter study of isatuximab in combination with cemiplimab in patients with lymphoma. Hematol Oncol. 2023 Feb;41(1):108-119. doi: 10.1002/hon.3089. Epub 2022 Oct 31. |
| Label | URL |
|---|---|
| ACT15320 Plain Language Results Summary | View source |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Efficacy results observed in Cohorts B & C didn't fulfill preplanned interim analysis criteria allowing the study to move to Phase(Ph) 2 Stage 2 in these cohorts. Efficacy results observed in Cohorts A1 & A2 fulfilled preplanned interim analysis criteria in Stage 1 to move to Ph 2 Stage 2 in these cohorts. However, study was stopped for all cohorts per sponsor's decision. Participant flow, Baseline,outcome measures & safety data were prespecified to be analyzed on combined Ph 1 & 2 populations.
Study was conducted at 20 sites in 7 countries. A total of 58 participants were enrolled between 11 December 2018 and 27 August 2020 and received isatuximab in combination with cemiplimab. Study was planned to be conducted in 2 parts: Phase 1(safety run-in) and Phase 2 (efficacy/2-stage design).
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A1: cHL: Isatuximab + Cemiplimab | Classic Hodgkin's lymphoma (cHL), anti-programmed cell death protein 1/ligand 1 (PD-1/PD-L1) inhibitor naïve participants with received isatuximab 10 mg/kg, IV infusion once a week (QW) in Cycle 1 and then every 2 weeks (Q2W) from Cycle 2 to Cycle 6 (each cycle of 28 days), and then every 3 weeks (Q3W) from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable adverse events (AEs) or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of complete response [CR], whichever was longer) of delivery of investigational medicinal product(s) without documented progressive disease (PD), or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 15, 2020 | Aug 15, 2023 |
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Diffuse large B-cell lymphoma (DLBCL), anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30 until, unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
|
| Cohort C: PTCL: Isatuximab + Cemiplimab | Experimental | Peripheral T-cell lymphoma (PTCL), anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30 until, unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
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| cemiplimab REGN2810 | Drug | Pharmaceutical form: solution for infusion Route of administration: intravenous |
|
| From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: up to 103 weeks) |
| Number of Participants With Laboratory Abnormalities: Electrolytes | Electrolyte parameters assessed were hyponatremia, hypokalemia, hyperkalemia, hypocalcemia, hypercalcemia, hypoalbuminemia, hypoglycemia and hyperglycemia. Abnormal criteria was assessed as per the NCI-CTCAE v 5.0, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs. | From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: up to 103 weeks) |
| Number of Participants With Laboratory Abnormalities: Renal Parameters | Abnormal renal parameters assessed were glomerular filtration rate (GFR) by class, creatinine increased and hyperuricemia. GFR by class was assessed in categories:>=90 milliliter per minute per 1.73 meter square (mL/min/1.73m^2) (Normal), >=60 to <90 mL/min/1.73m^2 (Mild), >=30 to <60 mL/min/1.73m^2 (Moderate), >=15 to <30 mL/min/1.73m^2 (Severe), and <15 mL/min/1.73m^2 (End Stage Renal Disease). Abnormal criteria was assessed as per NCI-CTCAE v 5.0, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs. | From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: up to 103 weeks) |
| Number of Participants With Laboratory Abnormalities: Liver Function Parameters | Abnormal liver function parameters assessed were aspartate aminotransferase (AST) increased, alanine aminotransferase (ALT) increased, alkaline phosphatase (ALP) increased, blood bilirubin (BB) increased. Abnormal criteria was assessed as per NCI-CTCAE v 5.0, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs. | From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: up to 103 weeks) |
| Cohort A1: Percentage of Participants With Complete Response (CR) | Percentage of participants who had a CR as a best overall response (BOR) using the Lugano response criteria (LRC) 2014 (based on PET-CT and CT responses). Per LRC, CR based on PET-CT response was defined as complete metabolic response (MR) in lymph nodes and extralymphatic sites with a score of 1, 2, or 3 with or without residual mass, on 5-point scale (5PS), where, 1= no uptake above background; 2 = uptake <=mediastinum; 3 = uptake > mediastinum but <= liver; 4 = uptake moderately > liver; 5 = uptake markedly higher than liver and/or new lesions; no new lesions and no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. CR based on CT-response was defined as target nodes/nodal masses of lymph nodes, extralymphatic sites regressed to <=1.5 cm in longest dimension transverse diameter of lesion (LDi); absence of non-measured lesion; organ enlargement regressed to normal; no new lesions; normal bone marrow morphology; if indeterminate, immunohistochemistry negative. | From the date of randomization until disease progression or death or study cut-off date, whichever comes first (maximum duration: up to 103 weeks) |
| Cohort A2, B and C: Percentage of Participants With Objective Response (OR) | Percentage of participants who had a CR or partial response (PR) as BOR using LRC, 2014. Per LRC, CR (PET-CT): complete MR in lymph nodes and extralymphatic sites with a score of 1, 2, or 3 with or without residual mass; no new lesions and no evidence of FDG-avid disease. CR (CT-response): target nodes/nodal masses of lymph nodes, extralymphatic sites regressed to <=1.5cm LDi; absence of non-measured lesion; organ enlargement regressed to normal; no new lesions; normal bone marrow morphology. PR (PET-CT): partial MR in lymph nodes and extralymphatic sites; no new lesions and residual uptake higher than uptake. PR (Per CT): lymph nodes, extralymphatic sites>=50% decrease in sum of product of perpendicular diameters (SPD), extranodal sites; if lesion is too small to measure on CT,assign5mm*5mm as default; if no longer visible:0*0mm; Node>5mm*5mm but smaller than normal, use actual measurement; absent/regressed non-measured lesions; no increase; spleen regressed by>50% or no new lesions. | From the date of randomization until disease progression, or death or study cut-off date, whichever comes first (maximum duration: up to 103 weeks) |
| From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: up to 103 weeks) |
| Number of Participants With Treatment-Induced and Treatment Boosted Antidrug Antibodies (ADA) Against Cemiplimab | ADA responses were categorized as treatment boosted ADA and treatment-induced ADA. Treatment boosted ADA was defined as pre-existing ADAs with a significant increase in the ADA titer during the study compared to the Baseline titer. Treatment-induced ADA was defined as ADA that developed at any time during the ADA on-study observation period in participants without pre-existing ADA. | From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: up to 103 weeks) |
| Pharmacokinetics (PK) Parameter: Plasma Concentration of Isatuximab at End of Infusion (CEOI) | Ceoi is the plasma concentration observed at the end of intravenous infusion of isatuximab. | End of infusion (EOI up to 3 hours) on Day 2 of Cycle 1 |
| PK Parameter: Maximum Observed Plasma Concentration (Cmax) After the First Infusion of Isatuximab | Cmax was defined as the maximum plasma concentration observed after the first administration of drug. | At Start of infusion (SOI; 0 hour), before actual EOI (up to 3 hours), EOI+ 4 hours, 72 hours and 144 hours post-dose on Day 2 of Cycle 1 |
| PK Parameter: Time to Reach Cmax (Tmax) After the First Infusion of Isatuximab | Tmax was defined as the time to reach Cmax, after the intravenous infusion of isatuximab. | At SOI (0 hour), before actual EOI (up to 3 hours), EOI+ 4 hours, 72 hours and 144 hours post-dose on Day 2 of Cycle 1 |
| PK Parameter: Area Under the Plasma Concentration (AUClast) Versus Time Curve After the First Infusion of Isatuximab | AUClast was defined as area under the plasma concentration versus time curve calculated from time 0 to last quantifiable concentration, calculated for isatuximab. | At SOI (0 hour), before actual EOI (up to 3 hours), EOI+ 4 hours, 72 hours and 144 hours post-dose on Day 2 of Cycle 1 |
| PK Parameter: Last Concentration Observed Above the Lower Limit of Quantification (Clast) After the First Infusion of Isatuximab | Clast was defined as the last concentration of isatuximab observed above the lower limit of quantification. | At SOI (0 hour), before actual EOI (up to 3 hours), EOI+ 4 hours, 72 hours and 144 hours post-dose on Day 2 of Cycle 1 |
| PK Parameter: Time of Clast (Tlast) After the First Infusion of Isatuximab | Tlast was defined as the time of last concentration observed above the lower limit of quantification for isatuximab. | At SOI (0 hour), before actual EOI (up to 3 hours), EOI+ 4 hours, 72 hours and 144 hours post-dose on Day 2 of Cycle 1 |
| PK Parameter: Area Under the Concentration Versus Time Curve Over the Dosing Interval (AUC0-168 Hours) After the First Infusion of Isatuximab | AUC0-168 hours was defined as the area under the plasma concentration versus time curve from time 0 to 168 hours post dose calculated for isatuximab. Samples for this outcome measure were collected up to 144 hours post-dose. No sample was collected at 168 hours post-dose; and thus, the samples collected up to 144 hours post-dose were extrapolated to derive data for 168 hours post-dose. | At SOI (0 hour), before actual EOI (up to 3 hours), EOI+ 4 hours, 72 hours and 144 hours post-dose on Day 2 of Cycle 1 |
| PK Parameter: Area Under the Concentration Versus Time Curve Over the Dosing Interval (AUC0-144 Hours) After the First Infusion of Isatuximab | AUC0-144 hours was defined as the area under the plasma concentration versus time curve from time 0 to 144 hours post dose calculated for isatuximab. | At SOI (0 hour), before actual EOI (up to 3 hours), EOI+ 4 hours, 72 hours and 144 hours post-dose on Day 2 of Cycle 1 |
| PK Parameter: Plasma Trough Concentration (Ctrough) of Isatuximab | Ctrough was the plasma concentration of isatuximab observed just before treatment administration during repeated dosing. | Pre-infusion on Cycle1:Day 2, 8, 15, & 22, Cycle 2:Day 1 &15, Cycle 3:Day 1 &15, Cycle 4:Day 1 &15, Cycle 5 Day1,Cycle 6 Day1,Cycle 7 Day 1, Cycle 8 Day1, Cycle 9 Day1, Cycle 10 Day1, Cycle 11 Day1, Cycle14 Day1, Cycle 17 Day1, Cycle 20 Day1,Cycle 23 Day1 |
| PK Parameter: Serum Concentration of Cemiplimab at End of Infusion (CEOI) | Ceoi is the plasma concentration observed at the end of intravenous infusion of cemiplimab. | EOI (up to 30 minutes [min]) on Day 1 of Cycle 1 |
| PK Parameter: Maximum Observed Concentration (Cmax) After the First Infusion of Cemiplimab | Cmax was defined as the maximum concentration observed after the first administration. | At SOI (0 hour), before actual EOI (up to 30 min), EOI+4 hours, 96 hours, 168 hours, and 336 hours post-dose on Day 1 of Cycle 1 |
| PK Parameter: Time to Reach Cmax (Tmax) After the First Infusion of Cemiplimab | Tmax was defined as the time to reach Cmax after the intravenous infusion of cemiplimab. | At SOI (0 hour), before actual EOI (up to 30 min), EOI+4 hours, 96 hours, 168 hours, and 336 hours post-dose on Day 1 of Cycle 1 |
| PK Parameter: Area Under the Serum Concentration (AUClast) Versus Time Curve After the First Infusion of Cemiplimab | AUClast was defined as area under the serum concentration versus time curve calculated from time 0 to last quantifiable concentration calculated for cemiplimab. | At SOI (0 hour), before actual EOI (up to 30 min), EOI+4 hours, 96 hours, 168 hours, and 336 hours post-dose on Day 1 of Cycle 1 |
| PK Parameter: Last Concentration Observed Above the Lower Limit of Quantification (Clast) After the First Infusion of Cemiplimab | Clast was defined as the last concentration of cemiplimab observed above the lower limit of quantification. | At SOI (0 hour), before actual EOI (up to 30 min), EOI+4 hours, 96 hours, 168 hours, and 336 hours post-dose on Day 1 of Cycle 1 |
| PK Parameter: Time of Clast (Tlast) After the First Infusion of Cemiplimab | Tlast was defined as the time of last concentration observed above the lower limit of quantification for cemiplimab. | At SOI (0 hour), before actual EOI (up to 30 min), EOI+4 hours, 96 hours, 168 hours, and 336 hours post-dose on Day 1 of Cycle 1 |
| PK Parameter: Area Under the Serum Concentration Versus Time Curve Over the Dosing Interval (AUC0-336 Hours) After the First Infusion of Cemiplimab | AUC0-336 hours was defined as the area under the serum concentration versus time curve from time 0 to 336 hours post dose for cemiplimab. | At SOI (0 hour), before actual EOI (up to 30 min), EOI+4 hours, 96 hours, 168 hours, and 336 hours post-dose on Day 1 of Cycle 1 |
| PK Parameter: Serum Trough Concentration (Ctrough) of Cemiplimab | Ctrough was the serum concentration of cemiplimab observed just before treatment administration during repeated dosing. | Pre-infusion on Cycle 1:Day 1 & Day15,Cycle 2:Day 1 & Day 15,Cycle 3:Day 1 & Day 15,Cycle 4:Day 1 & Day15,Cycle 5 Day 1,Cycle 6 Day 1,Cycle7 Day1,Cycle 8 Day 1,Cycle 9 Day1,Cycle 10 Day1,Cycle11 Day1,Cycle14 Day 1,Cycle 17 Day1,Cycle20 Day 1,Cycle 23 Day1 |
| Percent Change From Baseline in Tumor Burden | Tumor burden change was defined as the best percent-change from baseline in a sum of product of lesion diameters (longest for non-nodal lesion, short axis for nodal lesions) for all target lesions. | Up to 103 weeks |
| Duration of Response (DOR) | Time (months) between date of first response to first date that recurrent or radiologically disease progression (PD) was documented, or date of death,whichever was 1st. In absence of PD or death before cut-off date or date of initiation of further anticancer treatment, DOR was censored at date of last valid response not showing PD performed prior to initiation of further anticancer treatment or cut-off date, whichever was earlier. PD(PET-CT): metabolic disease with score 4/5 with inc. in intensity of uptake for target nodes/nodal mass & new FDG-avid foci consistent with lymphoma. PD(CT):any 1 of following: cross product of longest transverse diameter of lesion(LDi) & perpendicular diameter (PPD) progression of nodes/nodal mass, abnormal node/lesion with LDi >1.5 cm, inc >=50% from PPD nadir & inc in LDi/ shortest axis perpendicular to LDi(SDi) from nadir 0.5 cm, regrowth of resolved lesions, new splenomegaly,progression of non-measured lesion, new/recurrent involvement of bone marrow. | From the date of first response until disease progression or death, or study cut-off date whichever occurred first (maximum duration: up to 103 weeks) |
| Percentage of Participants With Disease Control (DC) | DC defined as percentage of participants who achieved CR, PR or stable disease (SD) as per LRC, 2014. CR (PET-CT): complete MR in lymph nodes and extralymphatic sites; no new lesions and no evidence of FDG-avid disease. CR (CT): target nodes/nodal masses of lymph nodes, extralymphatic sites regressed to <=1.5cm LDi; absence of non-measured lesion; organ enlargement regressed to normal; no new lesions; normal bone marrow. PR (PET-CT): partial MR in lymph nodes and sites; no new lesions. PR (CT): lymph nodes, sites>=50% decrease in SPD, sites; if lesion is too small to measure on CT, assign 5mm*5mm; No longer visible:0*0mm; Node>5mm*5mm, use actual measurement; absent/regressed non-measured lesions; no increase; spleen regressed by>50% or no new lesions. SD (PET-CT):no metabolic response, target nodes score of 4/5 with no significant change & no new lesions; SD (CT): <50% dec in SPD, no increase in progression for. 5PS:1: non-measured lesions, organ enlargement & no new lesions. | From the date of first response until disease progression or death, or study cut-off date whichever occurred first (maximum duration: up to 103 weeks) |
| Progression Free Survival (PFS) | PFS: time (in months) from 1st study treatment administration to date of 1st documented radiographic progression or date of death from any cause, whichever occurs 1st. Per LRC, 2014 PD (per PET-CT): metabolic disease with score 4/5 with increase (inc) in intensity of uptake for individual target nodes/nodal mass & new FDG-avid foci consistent with lymphoma at interim/ end-of-treatment assessment for extra nodal lesions, new FDG-avid foci consistent with lymphoma rather; new/recurrent FDG-avid foci bone marrow. PD (per CT response): any 1 of following: cross product of longest transverse diameter of lesion (LDi) & perpendicular diameter (PPD) progression of nodes/nodal mass, abnormal node/lesion with LDi >1.5 cm, inc >=50% from PPD nadir & inc in LDi/ shortest axis perpendicular to LDi from nadir 0.5 cm for lesion <= 2 cm, regrowth of resolved lesions, new splenomegaly,progression of preexisting non measured lesion, new/recurrent involvement of bone marrow. | From the date of randomization until disease progression, or death or study cut-off date, whichever comes first (maximum duration: up to 103 weeks) |
| Cohort A1 and A2: Percentage of Participants With Objective Response | Percentage of participants who had a CR or PR as BOR using LRC, 2014 (based on PET-CT and CT responses). CR (per PET-CT): complete MR in lymph nodes and extra lymphatic sites with a score of 1, 2, or 3 with or without residual mass; no new lesions and no evidence of FDG-avid disease. CR (CT-response): target nodes/nodal masses of lymph nodes, extralymphatic sites regressed to <=1.5cm LDi; absence of non-measured lesion; organ enlargement regressed to normal; no new lesions; normal bone marrow morphology. PR (per PET-CT): partial MR in lymph nodes and extral ymphatic sites; no new lesions and residual uptake higher than uptake. PR (per CT): lymph nodes, extralymphatic sites >=50% decrease in SPD, extranodal sites; if lesion is too small to measure on CT, assign 5mm*5mm as default; if no longer visible:0*0mm; Node>5mm*5mm but smaller than normal, used actual measurement; absent/regressed non-measured lesions; no increase; spleen regressed by>50% or no new lesions. | From the date of randomization until disease progression, or death or study cut-off date, whichever comes first (maximum duration: up to 103 weeks) |
| Cohort A1 and A2: Percentage of Participants With Complete Response | Percentage of participants who had a CR as a BOR using the LRC, 2014 (based on PET-CT and CT responses). Per LRC, CR based on PET-CT was defined as complete MR in lymph nodes and extralymphatic sites with a score of 1, 2, or 3 with or without residual mass, on 5PS, where, 1= no uptake above background; 2 = uptake <=mediastinum; 3 = uptake > mediastinum but <= liver; 4 = uptake moderately > liver; 5 = uptake markedly higher than liver and/or new lesions; no new lesions and no evidence of FDG-avid disease in bone marrow. CR based on CT-response was defined as target nodes/nodal masses of lymph nodes, extralymphatic sites regressed to <=1.5 cm in longest dimension transverse diameter of lesion (LDi); absence of non-measured lesion; organ enlargement regressed to normal; no new lesions; normal bone marrow morphology; if indeterminate, immunohistochemistry negative. | From the date of randomization until disease progression, or death or study cut-off date, whichever comes first (maximum duration: up to 103 weeks) |
| Montpellier |
| 34295 |
| France |
| Investigational Site Number :2500002 | Nantes | 44093 | France |
| Investigational Site Number :2500007 | Pessac | 33600 | France |
| Investigational Site Number :2500001 | Villejuif | 94800 | France |
| Investigational Site Number :3800003 | Rozzano | Milano | 20089 | Italy |
| Investigational Site Number :3800002 | Bologna | 40138 | Italy |
| Investigational Site Number :3800006 | Brescia | 25123 | Italy |
| Investigational Site Number :5280002 | Amsterdam | 1081 HV | Netherlands |
| Investigational Site Number :5280001 | Maastricht | 6229 HX | Netherlands |
| Investigational Site Number :6200002 | Coimbra | 3000-075 | Portugal |
| Investigational Site Number :6200004 | Lisbon | 1649-035 | Portugal |
| Investigational Site Number :6200003 | Porto | 4200 | Portugal |
| Investigational Site Number :4100001 | Gangnam-gu | Seoul-teukbyeolsi | 06351 | South Korea |
| Investigational Site Number :4100002 | Seoul | Seoul-teukbyeolsi | 03080 | South Korea |
| Investigational Site Number :7240003 | Barcelona | Barcelona [Barcelona] | 08035 | Spain |
| Investigational Site Number :7240005 | Barcelona | Barcelona [Barcelona] | 08036 | Spain |
| Investigational Site Number :7240002 | L'Hospitalet de Llobregat | Barcelona [Barcelona] | 08908 | Spain |
| Investigational Site Number :7240004 | Madrid / Madrid | Madrid, Comunidad de | 28040 | Spain |
| Investigational Site Number :1580002 | Taichung | 40447 | Taiwan |
| FG001 | Cohort A2: cHL: Isatuximab + Cemiplimab | cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
| FG002 | Cohort B: DLBCL: Isatuximab + Cemiplimab | Diffuse large B-cell lymphoma (DLBCL), anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
| FG003 | Cohort C: PTCL: Isatuximab + Cemiplimab | Peripheral T-cell lymphoma (PTCL), anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
| COMPLETED | Participants who completed study treatment. |
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| NOT COMPLETED |
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Analysis was performed on all treated population which included all participants who signed the study informed consent and received at least 1 dose of the study treatment, either isatuximab or cemiplimab.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort A1: cHL: Isatuximab + Cemiplimab | cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
| BG001 | Cohort A2: cHL: Isatuximab + Cemiplimab | cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
| BG002 | Cohort B: DLBCL: Isatuximab + Cemiplimab | DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
| BG003 | Cohort C: PTCL: Isatuximab + Cemiplimab | PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
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| Primary | Number of Participants With Dose Limiting Toxicities (DLTs) | DLTs: Adverse Events (AEs) occurring during 1st treatment cycle, unless due to disease progression or obviously unrelated cause which included: hematological abnormalities: Grade(G) 4 neutropenia(N) for 7 or more consecutive days, G3 to G4 N with fever (temperature greater than or equal to [>=] 38.5 degree Celsius on more than 1 occasion) or microbiologically/radiographically documented infection, G3 to G4 thrombocytopenia with clinically significant bleeding requiring clinical intervention or non-hematological abnormalities: G 4 non-hematologic AE, G>=2 uveitis, G3 non-hematological AE lasting greater than (>)3 days, delay in initiation of Cycle 2 >14 days due to treatment related laboratory abnormalities/AE. Any other AE that the study committee deemed to be dose-limiting, regardless of grade, was also considered as DLT. | Analysis was performed on DLT evaluable population which included all participants who received the planned doses of isatuximab and cemiplimab during Cycle 1 and completed the DLT observation period after the first administration of the study drug. Here, "0" in the "overall number of participants analyzed" signifies that no participants were evaluable for DLTs in the Cohort A1 arm. | Posted | Count of Participants | Participants | Cycle 1 (28 days) |
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| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), and Treatment-Emergent Serious Adverse Events (TESAEs) | An AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily have to have a causal relationship with the treatment. Serious adverse events (SAEs) were any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were defined as AEs that developed, worsened or became serious during the TEAE period (defined as the time from the first dose of study treatment up to 30 days after the last dose of study treatment). | Analysis was performed on all treated population which included all participants who signed the informed consent and received at least 1 dose of the study treatment, either isatuximab or cemiplimab. | Posted | Count of Participants | Participants | From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: up to 103 weeks) |
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| Primary | Number of Participants With Laboratory Abnormalities: Hematological Parameters | Hematological parameters assessed were anemia, white blood cell (WBC) decreased, platelet count decreased, lymphocyte count decreased, and neutrophil count decreased. Abnormality criteria was assessed as per the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 NCI-CTCAE v 5.0), where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs. | Analysis was performed on all treated population. | Posted | Count of Participants | Participants | From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: up to 103 weeks) |
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| Primary | Number of Participants With Laboratory Abnormalities: Electrolytes | Electrolyte parameters assessed were hyponatremia, hypokalemia, hyperkalemia, hypocalcemia, hypercalcemia, hypoalbuminemia, hypoglycemia and hyperglycemia. Abnormal criteria was assessed as per the NCI-CTCAE v 5.0, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs. | Analysis was performed on all treated population. Here "number analyzed" signifies the participants with available data for each specified parameter. | Posted | Count of Participants | Participants | From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: up to 103 weeks) |
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| Primary | Number of Participants With Laboratory Abnormalities: Renal Parameters | Abnormal renal parameters assessed were glomerular filtration rate (GFR) by class, creatinine increased and hyperuricemia. GFR by class was assessed in categories:>=90 milliliter per minute per 1.73 meter square (mL/min/1.73m^2) (Normal), >=60 to <90 mL/min/1.73m^2 (Mild), >=30 to <60 mL/min/1.73m^2 (Moderate), >=15 to <30 mL/min/1.73m^2 (Severe), and <15 mL/min/1.73m^2 (End Stage Renal Disease). Abnormal criteria was assessed as per NCI-CTCAE v 5.0, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs. | Analysis was performed on all treated population. | Posted | Count of Participants | Participants | From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: up to 103 weeks) |
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| Primary | Number of Participants With Laboratory Abnormalities: Liver Function Parameters | Abnormal liver function parameters assessed were aspartate aminotransferase (AST) increased, alanine aminotransferase (ALT) increased, alkaline phosphatase (ALP) increased, blood bilirubin (BB) increased. Abnormal criteria was assessed as per NCI-CTCAE v 5.0, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs. | Analysis was performed on all treated population. | Posted | Count of Participants | Participants | From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: up to 103 weeks) |
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| Primary | Cohort A1: Percentage of Participants With Complete Response (CR) | Percentage of participants who had a CR as a best overall response (BOR) using the Lugano response criteria (LRC) 2014 (based on PET-CT and CT responses). Per LRC, CR based on PET-CT response was defined as complete metabolic response (MR) in lymph nodes and extralymphatic sites with a score of 1, 2, or 3 with or without residual mass, on 5-point scale (5PS), where, 1= no uptake above background; 2 = uptake <=mediastinum; 3 = uptake > mediastinum but <= liver; 4 = uptake moderately > liver; 5 = uptake markedly higher than liver and/or new lesions; no new lesions and no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. CR based on CT-response was defined as target nodes/nodal masses of lymph nodes, extralymphatic sites regressed to <=1.5 cm in longest dimension transverse diameter of lesion (LDi); absence of non-measured lesion; organ enlargement regressed to normal; no new lesions; normal bone marrow morphology; if indeterminate, immunohistochemistry negative. | Analysis was performed on all treated population. Data for this outcome measure was not planned to be collected and analyzed for Cohort B and C as pre-specified in protocol. | Posted | Number | percentage of participants | From the date of randomization until disease progression or death or study cut-off date, whichever comes first (maximum duration: up to 103 weeks) |
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| Primary | Cohort A2, B and C: Percentage of Participants With Objective Response (OR) | Percentage of participants who had a CR or partial response (PR) as BOR using LRC, 2014. Per LRC, CR (PET-CT): complete MR in lymph nodes and extralymphatic sites with a score of 1, 2, or 3 with or without residual mass; no new lesions and no evidence of FDG-avid disease. CR (CT-response): target nodes/nodal masses of lymph nodes, extralymphatic sites regressed to <=1.5cm LDi; absence of non-measured lesion; organ enlargement regressed to normal; no new lesions; normal bone marrow morphology. PR (PET-CT): partial MR in lymph nodes and extralymphatic sites; no new lesions and residual uptake higher than uptake. PR (Per CT): lymph nodes, extralymphatic sites>=50% decrease in sum of product of perpendicular diameters (SPD), extranodal sites; if lesion is too small to measure on CT,assign5mm*5mm as default; if no longer visible:0*0mm; Node>5mm*5mm but smaller than normal, use actual measurement; absent/regressed non-measured lesions; no increase; spleen regressed by>50% or no new lesions. | Analysis was performed on all treated population. | Posted | Number | 90% Confidence Interval | percentage of participants | From the date of randomization until disease progression, or death or study cut-off date, whichever comes first (maximum duration: up to 103 weeks) |
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| Secondary | Number of Participants With Treatment-Induced and Treatment Boosted Antidrug Antibodies (ADA) Against Isatuximab | ADA responses were categorized as treatment boosted ADA and treatment-induced ADA. Treatment boosted ADA was defined as pre-existing ADAs with a significant increase in the ADA titer during the study compared to the Baseline titer. Treatment-induced ADA was defined as ADA that developed at any time during the ADA on-study observation period in participants without pre-existing ADA. | Analysis was performed on Anti-drug antibody (ADA) evaluable population that included all participants who signed informed consent and received at least 1 dose of either isatuximab or cemiplimab, with at least 1 non-missing ADA result after the drug administration. Here, "overall number of participants" analyzed signifies the participants with available data for this outcome measure. | Posted | Count of Participants | Participants | From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: up to 103 weeks) |
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| Secondary | Number of Participants With Treatment-Induced and Treatment Boosted Antidrug Antibodies (ADA) Against Cemiplimab | ADA responses were categorized as treatment boosted ADA and treatment-induced ADA. Treatment boosted ADA was defined as pre-existing ADAs with a significant increase in the ADA titer during the study compared to the Baseline titer. Treatment-induced ADA was defined as ADA that developed at any time during the ADA on-study observation period in participants without pre-existing ADA. | Analysis was performed on ADA evaluable population. Here, "overall number of participants" analyzed signifies the participants with available data for this outcome measure. | Posted | Count of Participants | Participants | From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: up to 103 weeks) |
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| Secondary | Pharmacokinetics (PK) Parameter: Plasma Concentration of Isatuximab at End of Infusion (CEOI) | Ceoi is the plasma concentration observed at the end of intravenous infusion of isatuximab. | Analysis was performed on PK population (for isatuximab) which included participants who signed informed consent and received at least 1 dose of the drug with at least one reportable concentration after the study drug (isatuximab) administration. Here, "overall number of participants" analyzed signifies the participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | micrograms per milliliter (mcg/mL) | End of infusion (EOI up to 3 hours) on Day 2 of Cycle 1 |
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| Secondary | PK Parameter: Maximum Observed Plasma Concentration (Cmax) After the First Infusion of Isatuximab | Cmax was defined as the maximum plasma concentration observed after the first administration of drug. | Analysis was performed on PK population (for isatuximab). Here, "overall number of participants" analyzed signifies the participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | mcg/mL | At Start of infusion (SOI; 0 hour), before actual EOI (up to 3 hours), EOI+ 4 hours, 72 hours and 144 hours post-dose on Day 2 of Cycle 1 |
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| Secondary | PK Parameter: Time to Reach Cmax (Tmax) After the First Infusion of Isatuximab | Tmax was defined as the time to reach Cmax, after the intravenous infusion of isatuximab. | Analysis was performed on PK population (for isatuximab). Here, "overall number of participants" analyzed signifies the participants with available data for this outcome measure. | Posted | Median | Full Range | hours | At SOI (0 hour), before actual EOI (up to 3 hours), EOI+ 4 hours, 72 hours and 144 hours post-dose on Day 2 of Cycle 1 |
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| Secondary | PK Parameter: Area Under the Plasma Concentration (AUClast) Versus Time Curve After the First Infusion of Isatuximab | AUClast was defined as area under the plasma concentration versus time curve calculated from time 0 to last quantifiable concentration, calculated for isatuximab. | Analysis was performed on PK population (for isatuximab). Here, "overall number of participants" analyzed signifies the participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | hours*mcg/mL | At SOI (0 hour), before actual EOI (up to 3 hours), EOI+ 4 hours, 72 hours and 144 hours post-dose on Day 2 of Cycle 1 |
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| Secondary | PK Parameter: Last Concentration Observed Above the Lower Limit of Quantification (Clast) After the First Infusion of Isatuximab | Clast was defined as the last concentration of isatuximab observed above the lower limit of quantification. | Analysis was performed on PK population (for isatuximab). Here, "overall number of participants" analyzed signifies the participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | mcg/mL | At SOI (0 hour), before actual EOI (up to 3 hours), EOI+ 4 hours, 72 hours and 144 hours post-dose on Day 2 of Cycle 1 |
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| Secondary | PK Parameter: Time of Clast (Tlast) After the First Infusion of Isatuximab | Tlast was defined as the time of last concentration observed above the lower limit of quantification for isatuximab. | Analysis was performed on PK population (for isatuximab). Here, "overall number of participants" analyzed signifies the participants with available data for this outcome measure. | Posted | Median | Full Range | hours | At SOI (0 hour), before actual EOI (up to 3 hours), EOI+ 4 hours, 72 hours and 144 hours post-dose on Day 2 of Cycle 1 |
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| Secondary | PK Parameter: Area Under the Concentration Versus Time Curve Over the Dosing Interval (AUC0-168 Hours) After the First Infusion of Isatuximab | AUC0-168 hours was defined as the area under the plasma concentration versus time curve from time 0 to 168 hours post dose calculated for isatuximab. Samples for this outcome measure were collected up to 144 hours post-dose. No sample was collected at 168 hours post-dose; and thus, the samples collected up to 144 hours post-dose were extrapolated to derive data for 168 hours post-dose. | Analysis was performed on PK population (for isatuximab). Here, "overall number of participants" analyzed signifies the participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | hour*mcg/mL | At SOI (0 hour), before actual EOI (up to 3 hours), EOI+ 4 hours, 72 hours and 144 hours post-dose on Day 2 of Cycle 1 |
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| Secondary | PK Parameter: Area Under the Concentration Versus Time Curve Over the Dosing Interval (AUC0-144 Hours) After the First Infusion of Isatuximab | AUC0-144 hours was defined as the area under the plasma concentration versus time curve from time 0 to 144 hours post dose calculated for isatuximab. | Analysis was performed on PK population (for isatuximab). Here, "overall number of participants" analyzed signifies the participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | hours*mcg/mL | At SOI (0 hour), before actual EOI (up to 3 hours), EOI+ 4 hours, 72 hours and 144 hours post-dose on Day 2 of Cycle 1 |
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| Secondary | PK Parameter: Plasma Trough Concentration (Ctrough) of Isatuximab | Ctrough was the plasma concentration of isatuximab observed just before treatment administration during repeated dosing. | Analysis was performed on PK population (for isatuximab). Here, '0' in the number analyzed field signifies that none of the participants were available for the specified timepoints. | Posted | Mean | Standard Deviation | mcg/mL | Pre-infusion on Cycle1:Day 2, 8, 15, & 22, Cycle 2:Day 1 &15, Cycle 3:Day 1 &15, Cycle 4:Day 1 &15, Cycle 5 Day1,Cycle 6 Day1,Cycle 7 Day 1, Cycle 8 Day1, Cycle 9 Day1, Cycle 10 Day1, Cycle 11 Day1, Cycle14 Day1, Cycle 17 Day1, Cycle 20 Day1,Cycle 23 Day1 |
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| Secondary | PK Parameter: Serum Concentration of Cemiplimab at End of Infusion (CEOI) | Ceoi is the plasma concentration observed at the end of intravenous infusion of cemiplimab. | Analysis was performed on PK population (for Cemiplimab) which included all participants who signed informed consent and received at least 1 dose of the drug with at least one reportable concentration after the study drug (cemiplimab) administration. Here 'overall number of participants analyzed" signifies the participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | milligrams per milliliter (mg/mL) | EOI (up to 30 minutes [min]) on Day 1 of Cycle 1 |
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| Secondary | PK Parameter: Maximum Observed Concentration (Cmax) After the First Infusion of Cemiplimab | Cmax was defined as the maximum concentration observed after the first administration. | Analysis was performed on PK population (for Cemiplimab). Here, "overall number of participants" analyzed signifies the participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | mg/L | At SOI (0 hour), before actual EOI (up to 30 min), EOI+4 hours, 96 hours, 168 hours, and 336 hours post-dose on Day 1 of Cycle 1 |
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| Secondary | PK Parameter: Time to Reach Cmax (Tmax) After the First Infusion of Cemiplimab | Tmax was defined as the time to reach Cmax after the intravenous infusion of cemiplimab. | Analysis was performed on PK population (for Cemiplimab). Here, "overall number of participants" analyzed signifies the participants with available data for this outcome measure. | Posted | Median | Full Range | hours | At SOI (0 hour), before actual EOI (up to 30 min), EOI+4 hours, 96 hours, 168 hours, and 336 hours post-dose on Day 1 of Cycle 1 |
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| Secondary | PK Parameter: Area Under the Serum Concentration (AUClast) Versus Time Curve After the First Infusion of Cemiplimab | AUClast was defined as area under the serum concentration versus time curve calculated from time 0 to last quantifiable concentration calculated for cemiplimab. | Analysis was performed on PK population (for Cemiplimab). Here, "overall number of participants" analyzed signifies the participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | day*mg/mL | At SOI (0 hour), before actual EOI (up to 30 min), EOI+4 hours, 96 hours, 168 hours, and 336 hours post-dose on Day 1 of Cycle 1 |
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| Secondary | PK Parameter: Last Concentration Observed Above the Lower Limit of Quantification (Clast) After the First Infusion of Cemiplimab | Clast was defined as the last concentration of cemiplimab observed above the lower limit of quantification. | Analysis was performed on PK population (for Cemiplimab). Here, "overall number of participants" analyzed signifies the participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | mg/L | At SOI (0 hour), before actual EOI (up to 30 min), EOI+4 hours, 96 hours, 168 hours, and 336 hours post-dose on Day 1 of Cycle 1 |
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| Secondary | PK Parameter: Time of Clast (Tlast) After the First Infusion of Cemiplimab | Tlast was defined as the time of last concentration observed above the lower limit of quantification for cemiplimab. | Analysis was performed on PK population (for Cemiplimab). Here, "overall number of participants analyzed" signifies the participants with available data for this outcome measure. | Posted | Median | Full Range | hours | At SOI (0 hour), before actual EOI (up to 30 min), EOI+4 hours, 96 hours, 168 hours, and 336 hours post-dose on Day 1 of Cycle 1 |
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| Secondary | PK Parameter: Area Under the Serum Concentration Versus Time Curve Over the Dosing Interval (AUC0-336 Hours) After the First Infusion of Cemiplimab | AUC0-336 hours was defined as the area under the serum concentration versus time curve from time 0 to 336 hours post dose for cemiplimab. | Analysis was performed on PK population (for Cemiplimab). Here, "overall number of participants" analyzed signifies the participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | day*mg/mL | At SOI (0 hour), before actual EOI (up to 30 min), EOI+4 hours, 96 hours, 168 hours, and 336 hours post-dose on Day 1 of Cycle 1 |
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| Secondary | PK Parameter: Serum Trough Concentration (Ctrough) of Cemiplimab | Ctrough was the serum concentration of cemiplimab observed just before treatment administration during repeated dosing. | Analysis was performed on PK population (for Cemiplimab). Here, '0' in the number analyzed field signifies that none of the participants were available for the specified timepoint. | Posted | Mean | Standard Deviation | mg/mL | Pre-infusion on Cycle 1:Day 1 & Day15,Cycle 2:Day 1 & Day 15,Cycle 3:Day 1 & Day 15,Cycle 4:Day 1 & Day15,Cycle 5 Day 1,Cycle 6 Day 1,Cycle7 Day1,Cycle 8 Day 1,Cycle 9 Day1,Cycle 10 Day1,Cycle11 Day1,Cycle14 Day 1,Cycle 17 Day1,Cycle20 Day 1,Cycle 23 Day1 |
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| Secondary | Percent Change From Baseline in Tumor Burden | Tumor burden change was defined as the best percent-change from baseline in a sum of product of lesion diameters (longest for non-nodal lesion, short axis for nodal lesions) for all target lesions. | Analysis was performed on all treated population. Here, "overall number of participants" analyzed signifies the participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | percent change | Up to 103 weeks |
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| Secondary | Duration of Response (DOR) | Time (months) between date of first response to first date that recurrent or radiologically disease progression (PD) was documented, or date of death,whichever was 1st. In absence of PD or death before cut-off date or date of initiation of further anticancer treatment, DOR was censored at date of last valid response not showing PD performed prior to initiation of further anticancer treatment or cut-off date, whichever was earlier. PD(PET-CT): metabolic disease with score 4/5 with inc. in intensity of uptake for target nodes/nodal mass & new FDG-avid foci consistent with lymphoma. PD(CT):any 1 of following: cross product of longest transverse diameter of lesion(LDi) & perpendicular diameter (PPD) progression of nodes/nodal mass, abnormal node/lesion with LDi >1.5 cm, inc >=50% from PPD nadir & inc in LDi/ shortest axis perpendicular to LDi(SDi) from nadir 0.5 cm, regrowth of resolved lesions, new splenomegaly,progression of non-measured lesion, new/recurrent involvement of bone marrow. | Analysis was performed on participants who had a response. DOR was analyzed using Kaplan-Meier method. Here, "overall number of participants" analyzed signifies the participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | months | From the date of first response until disease progression or death, or study cut-off date whichever occurred first (maximum duration: up to 103 weeks) |
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| Secondary | Percentage of Participants With Disease Control (DC) | DC defined as percentage of participants who achieved CR, PR or stable disease (SD) as per LRC, 2014. CR (PET-CT): complete MR in lymph nodes and extralymphatic sites; no new lesions and no evidence of FDG-avid disease. CR (CT): target nodes/nodal masses of lymph nodes, extralymphatic sites regressed to <=1.5cm LDi; absence of non-measured lesion; organ enlargement regressed to normal; no new lesions; normal bone marrow. PR (PET-CT): partial MR in lymph nodes and sites; no new lesions. PR (CT): lymph nodes, sites>=50% decrease in SPD, sites; if lesion is too small to measure on CT, assign 5mm*5mm; No longer visible:0*0mm; Node>5mm*5mm, use actual measurement; absent/regressed non-measured lesions; no increase; spleen regressed by>50% or no new lesions. SD (PET-CT):no metabolic response, target nodes score of 4/5 with no significant change & no new lesions; SD (CT): <50% dec in SPD, no increase in progression for. 5PS:1: non-measured lesions, organ enlargement & no new lesions. | Analysis was performed on all treated population. | Posted | Number | 90% Confidence Interval | percentage of participants | From the date of first response until disease progression or death, or study cut-off date whichever occurred first (maximum duration: up to 103 weeks) |
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| Secondary | Progression Free Survival (PFS) | PFS: time (in months) from 1st study treatment administration to date of 1st documented radiographic progression or date of death from any cause, whichever occurs 1st. Per LRC, 2014 PD (per PET-CT): metabolic disease with score 4/5 with increase (inc) in intensity of uptake for individual target nodes/nodal mass & new FDG-avid foci consistent with lymphoma at interim/ end-of-treatment assessment for extra nodal lesions, new FDG-avid foci consistent with lymphoma rather; new/recurrent FDG-avid foci bone marrow. PD (per CT response): any 1 of following: cross product of longest transverse diameter of lesion (LDi) & perpendicular diameter (PPD) progression of nodes/nodal mass, abnormal node/lesion with LDi >1.5 cm, inc >=50% from PPD nadir & inc in LDi/ shortest axis perpendicular to LDi from nadir 0.5 cm for lesion <= 2 cm, regrowth of resolved lesions, new splenomegaly,progression of preexisting non measured lesion, new/recurrent involvement of bone marrow. | Analysis was performed on all treated population. PFS was analyzed using Kaplan-Meier method. | Posted | Median | 95% Confidence Interval | months | From the date of randomization until disease progression, or death or study cut-off date, whichever comes first (maximum duration: up to 103 weeks) |
| |||||||||||||||||||||||||||||||||
| Secondary | Cohort A1 and A2: Percentage of Participants With Objective Response | Percentage of participants who had a CR or PR as BOR using LRC, 2014 (based on PET-CT and CT responses). CR (per PET-CT): complete MR in lymph nodes and extra lymphatic sites with a score of 1, 2, or 3 with or without residual mass; no new lesions and no evidence of FDG-avid disease. CR (CT-response): target nodes/nodal masses of lymph nodes, extralymphatic sites regressed to <=1.5cm LDi; absence of non-measured lesion; organ enlargement regressed to normal; no new lesions; normal bone marrow morphology. PR (per PET-CT): partial MR in lymph nodes and extral ymphatic sites; no new lesions and residual uptake higher than uptake. PR (per CT): lymph nodes, extralymphatic sites >=50% decrease in SPD, extranodal sites; if lesion is too small to measure on CT, assign 5mm*5mm as default; if no longer visible:0*0mm; Node>5mm*5mm but smaller than normal, used actual measurement; absent/regressed non-measured lesions; no increase; spleen regressed by>50% or no new lesions. | Analysis was performed on all treated population. Data for cohort B and C are reported separately. | Posted | Number | 90% Confidence Interval | percentage of participants | From the date of randomization until disease progression, or death or study cut-off date, whichever comes first (maximum duration: up to 103 weeks) |
| |||||||||||||||||||||||||||||||||
| Secondary | Cohort A1 and A2: Percentage of Participants With Complete Response | Percentage of participants who had a CR as a BOR using the LRC, 2014 (based on PET-CT and CT responses). Per LRC, CR based on PET-CT was defined as complete MR in lymph nodes and extralymphatic sites with a score of 1, 2, or 3 with or without residual mass, on 5PS, where, 1= no uptake above background; 2 = uptake <=mediastinum; 3 = uptake > mediastinum but <= liver; 4 = uptake moderately > liver; 5 = uptake markedly higher than liver and/or new lesions; no new lesions and no evidence of FDG-avid disease in bone marrow. CR based on CT-response was defined as target nodes/nodal masses of lymph nodes, extralymphatic sites regressed to <=1.5 cm in longest dimension transverse diameter of lesion (LDi); absence of non-measured lesion; organ enlargement regressed to normal; no new lesions; normal bone marrow morphology; if indeterminate, immunohistochemistry negative. | Analysis was performed on all treated population. Data for this outcome measure was not planned to be collected and analyzed for Cohort B and C as pre-specified. | Posted | Number | percentage of participants | From the date of randomization until disease progression, or death or study cut-off date, whichever comes first (maximum duration: up to 103 weeks) |
|
From first dose of study drug up to 30 days after the last dose of study drug (maximum duration: up to 103 weeks)
Analysis was performed on all-treated population.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort A1: cHL: Isatuximab + Cemiplimab | cHL, PD-1/PD-L1 inhibitor naïve participants received isatuximab 10 mg/kg, IV infusion QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days), and then Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). | 4 | 18 | 3 | 18 | 16 | 18 |
| EG001 | Cohort A2: cHL: Isatuximab + Cemiplimab | cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). | 0 | 12 | 2 | 12 | 12 | 12 |
| EG002 | Cohort B: DLBCL: Isatuximab + Cemiplimab | DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). | 12 | 17 | 10 | 17 | 17 | 17 |
| EG003 | Cohort C: PTCL: Isatuximab + Cemiplimab | PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). | 6 | 11 | 7 | 11 | 10 | 11 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Epstein-Barr Virus Infection | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Herpes Zoster Disseminated | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Meningitis Aseptic | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Pneumonia Bacterial | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Pneumonia Haemophilus | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Pneumonia Respiratory Syncytial Viral | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Streptococcal Sepsis | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Urinary Tract Infection Bacterial | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Prostate Cancer Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 25.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDra 25.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDra 25.0 | Systematic Assessment |
| |
| Peripheral Sensorimotor Neuropathy | Nervous system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Visual Acuity Reduced | Eye disorders | MedDra 25.0 | Systematic Assessment |
| |
| Subclavian Vein Thrombosis | Vascular disorders | MedDra 25.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Intestinal Perforation | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Large Intestinal Obstruction | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Death | General disorders | MedDra 25.0 | Systematic Assessment |
| |
| Disease Progression | General disorders | MedDra 25.0 | Systematic Assessment |
| |
| Multiple Organ Dysfunction Syndrome | General disorders | MedDra 25.0 | Systematic Assessment |
| |
| Performance Status Decreased | General disorders | MedDra 25.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDra 25.0 | Systematic Assessment |
| |
| Platelet Count Decreased | Investigations | MedDra 25.0 | Systematic Assessment |
| |
| Infusion Related Reaction | Injury, poisoning and procedural complications | MedDra 25.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bacteraemia | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Bacterial Diarrhoea | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Device Related Infection | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Fungal Skin Infection | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Genital Herpes | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Herpes Simplex | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Lower Respiratory Tract Infection | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Oral Candidiasis | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Oral Herpes | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Pneumonia Staphylococcal | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Postoperative Wound Infection | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Stenotrophomonas Infection | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Tinea Cruris | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Tooth Infection | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Tracheobronchitis | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Trichophytosis | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Vascular Device Infection | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Viral Infection | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Viral Pharyngitis | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Tumour Associated Fever | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 25.0 | Systematic Assessment |
| |
| Tumour Haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 25.0 | Systematic Assessment |
| |
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Hypogammaglobulinaemia | Immune system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDra 25.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDra 25.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDra 25.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDra 25.0 | Systematic Assessment |
| |
| Nervousness | Psychiatric disorders | MedDra 25.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Memory Impairment | Nervous system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Radiculopathy | Nervous system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Sedation | Nervous system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Conjunctival Oedema | Eye disorders | MedDra 25.0 | Systematic Assessment |
| |
| Vision Blurred | Eye disorders | MedDra 25.0 | Systematic Assessment |
| |
| Deafness | Ear and labyrinth disorders | MedDra 25.0 | Systematic Assessment |
| |
| Ear Pruritus | Ear and labyrinth disorders | MedDra 25.0 | Systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | MedDra 25.0 | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDra 25.0 | Systematic Assessment |
| |
| Extrasystoles | Cardiac disorders | MedDra 25.0 | Systematic Assessment |
| |
| Sinus Tachycardia | Cardiac disorders | MedDra 25.0 | Systematic Assessment |
| |
| Supraventricular Tachycardia | Cardiac disorders | MedDra 25.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDra 25.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDra 25.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDra 25.0 | Systematic Assessment |
| |
| Lymphorrhoea | Vascular disorders | MedDra 25.0 | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDra 25.0 | Systematic Assessment |
| |
| Varicophlebitis | Vascular disorders | MedDra 25.0 | Systematic Assessment |
| |
| Catarrh | Respiratory, thoracic and mediastinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Dyspnoea Exertional | Respiratory, thoracic and mediastinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Interstitial Lung Disease | Respiratory, thoracic and mediastinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Nasal Discharge Discolouration | Respiratory, thoracic and mediastinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Productive Cough | Respiratory, thoracic and mediastinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Rhinitis Allergic | Respiratory, thoracic and mediastinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Abdominal Distension | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Aphthous Ulcer | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Epigastric Discomfort | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Oral Pain | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Rectal Haemorrhage | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Granulomatous Liver Disease | Hepatobiliary disorders | MedDra 25.0 | Systematic Assessment |
| |
| Butterfly Rash | Skin and subcutaneous tissue disorders | MedDra 25.0 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDra 25.0 | Systematic Assessment |
| |
| Dermatitis Atopic | Skin and subcutaneous tissue disorders | MedDra 25.0 | Systematic Assessment |
| |
| Drug Eruption | Skin and subcutaneous tissue disorders | MedDra 25.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDra 25.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDra 25.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDra 25.0 | Systematic Assessment |
| |
| Milia | Skin and subcutaneous tissue disorders | MedDra 25.0 | Systematic Assessment |
| |
| Night Sweats | Skin and subcutaneous tissue disorders | MedDra 25.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDra 25.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDra 25.0 | Systematic Assessment |
| |
| Rash Macular | Skin and subcutaneous tissue disorders | MedDra 25.0 | Systematic Assessment |
| |
| Rash Maculo-Papular | Skin and subcutaneous tissue disorders | MedDra 25.0 | Systematic Assessment |
| |
| Rash Papular | Skin and subcutaneous tissue disorders | MedDra 25.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDra 25.0 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDra 25.0 | Systematic Assessment |
| |
| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDra 25.0 | Systematic Assessment |
| |
| Flank Pain | Musculoskeletal and connective tissue disorders | MedDra 25.0 | Systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDra 25.0 | Systematic Assessment |
| |
| Muscle Tightness | Musculoskeletal and connective tissue disorders | MedDra 25.0 | Systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDra 25.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDra 25.0 | Systematic Assessment |
| |
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDra 25.0 | Systematic Assessment |
| |
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDra 25.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDra 25.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDra 25.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDra 25.0 | Systematic Assessment |
| |
| Haematospermia | Reproductive system and breast disorders | MedDra 25.0 | Systematic Assessment |
| |
| Hypertrophic Cardiomyopathy | Congenital, familial and genetic disorders | MedDra 25.0 | Systematic Assessment |
| |
| Administration Site Extravasation | General disorders | MedDra 25.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDra 25.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDra 25.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDra 25.0 | Systematic Assessment |
| |
| Generalised Oedema | General disorders | MedDra 25.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDra 25.0 | Systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | MedDra 25.0 | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDra 25.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDra 25.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDra 25.0 | Systematic Assessment |
| |
| Swelling Face | General disorders | MedDra 25.0 | Systematic Assessment |
| |
| Gamma-Glutamyltransferase Increased | Investigations | MedDra 25.0 | Systematic Assessment |
| |
| Platelet Count Decreased | Investigations | MedDra 25.0 | Systematic Assessment |
| |
| Weight Decreased | Investigations | MedDra 25.0 | Systematic Assessment |
| |
| Weight Increased | Investigations | MedDra 25.0 | Systematic Assessment |
| |
| Arthropod Bite | Injury, poisoning and procedural complications | MedDra 25.0 | Systematic Assessment |
| |
| Eye Injury | Injury, poisoning and procedural complications | MedDra 25.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDra 25.0 | Systematic Assessment |
| |
| Infusion Related Reaction | Injury, poisoning and procedural complications | MedDra 25.0 | Systematic Assessment |
| |
| Limb Traumatic Amputation | Injury, poisoning and procedural complications | MedDra 25.0 | Systematic Assessment |
| |
| Tibia Fracture | Injury, poisoning and procedural complications | MedDra 25.0 | Systematic Assessment |
|
The efficacy results observed in Cohorts B and C did not fulfill the pre-planned interim analysis criteria allowing the study to move to Phase 2 Stage 2 in these cohorts. The efficacy results observed in Cohort A1 and A2 fulfilled the pre-planned interim analysis criteria in Stage 1 to move to Phase 2 Stage 2 in these cohorts. However, the study was stopped for all the cohorts as per Sponsor's decision.
The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi Aventis Recherche & Développement | 800-633-1610 | 6# | Contact-US@sanofi.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 24, 2020 | Aug 15, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000599209 | isatuximab |
| C000627974 | cemiplimab |
Not provided
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG003 | Cohort C: PTCL: Isatuximab + Cemiplimab | PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
| OG001 | Cohort A2: cHL: Isatuximab + Cemiplimab | cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
| OG002 | Cohort B: DLBCL: Isatuximab + Cemiplimab | DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
| OG003 | Cohort C: PTCL: Isatuximab + Cemiplimab | PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
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cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
| OG002 | Cohort B: DLBCL: Isatuximab + Cemiplimab | DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion Q2W Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
| OG003 | Cohort C: PTCL: Isatuximab + Cemiplimab | PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
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cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
| OG002 | Cohort B: DLBCL: Isatuximab + Cemiplimab | DLBCL, anti PD-1/PD-L1 naïve participants with received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
| OG003 | Cohort C: PTCL: Isatuximab + Cemiplimab | PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
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| OG001 |
| Cohort A2: cHL: Isatuximab + Cemiplimab |
cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
| OG002 | Cohort B: DLBCL: Isatuximab + Cemiplimab | DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
| OG003 | Cohort C: PTCL: Isatuximab + Cemiplimab | PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
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|
cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks).
| OG002 | Cohort B: DLBCL: Isatuximab + Cemiplimab | DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
| OG003 | Cohort C: PTCL: Isatuximab + Cemiplimab | PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
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| OG001 | Cohort B: DLBCL: Isatuximab + Cemiplimab | DLBCL, anti PD-1/PD-L1 naïve participants with received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
| OG002 | Cohort C: PTCL: Isatuximab + Cemiplimab | PTCL, anti PD-1/PD-L1 naïve participants with received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
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| OG001 | Cohort A2: cHL: Isatuximab + Cemiplimab | cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
| OG002 | Cohort B: DLBCL: Isatuximab + Cemiplimab | DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
| OG003 | Cohort C: PTCL: Isatuximab + Cemiplimab | PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
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| Cohort A2: cHL: Isatuximab + Cemiplimab |
cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
| OG002 | Cohort B: DLBCL: Isatuximab + Cemiplimab | DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
| OG003 | Cohort C: PTCL: Isatuximab + Cemiplimab | PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
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| OG002 | Cohort B: DLBCL: Isatuximab | DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days), until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
| OG003 | Cohort C: PTCL: Isatuximab | PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days), until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
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| OG002 | Cohort B: DLBCL: Isatuximab | DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days), until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
| OG003 | Cohort C: PTCL: Isatuximab | PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days), until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
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| OG002 | Cohort B: DLBCL: Isatuximab | DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days), until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
| OG003 | Cohort C: PTCL: Isatuximab | PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days), until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
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| OG002 | Cohort B: DLBCL: Isatuximab | DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
| OG003 | Cohort C: PTCL: Isatuximab | PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days), until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
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| OG002 | Cohort B: DLBCL: Isatuximab | DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days), until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
| OG003 | Cohort C: PTCL: Isatuximab | PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days), until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
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| OG002 | Cohort B: DLBCL: Isatuximab | DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
| OG003 | Cohort C: PTCL: Isatuximab | PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days), until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
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cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
| OG002 | Cohort B: DLBCL: Isatuximab | DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days), until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
| OG003 | Cohort C: PTCL: Isatuximab | PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days), until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
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| OG002 | Cohort B: DLBCL: Isatuximab | DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days), until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
| OG003 | Cohort C: PTCL: Isatuximab | PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days), until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
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| OG002 | Cohort B: DLBCL: Isatuximab | DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
| OG003 | Cohort C: PTCL: Isatuximab | PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days), until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
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| OG002 | Cohort B: DLBCL: Cemiplimab | DLBCL, anti PD-1/PD-L1 naïve participants received cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
| OG003 | Cohort C: PTCL: Cemiplimab | PTCL, anti PD-1/PD-L1 naïve participants received cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 (each cycle of 28 days) and then 350 mg Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
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| OG002 | Cohort B: DLBCL: Cemiplimab | DLBCL, anti PD-1/PD-L1 naïve participants received cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 (each cycle of 28 days) and then 350 mg Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days), until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
| OG003 | Cohort C: PTCL: Cemiplimab | PTCL, anti PD-1/PD-L1 naïve participants received cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 (each cycle of 28 days) and then 350 mg Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days), until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
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| OG002 | Cohort B: DLBCL: Cemiplimab | DLBCL, anti PD-1/PD-L1 naïve participants received cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 (each cycle of 28 days) and then 350 mg Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
| OG003 | Cohort C: PTCL: Cemiplimab | PTCL, anti PD-1/PD-L1 naïve participants received cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 (each cycle of 28 days) and then 350 mg Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
|
|
| OG002 | Cohort B: DLBCL: Cemiplimab | DLBCL, anti PD-1/PD-L1 naïve participants received cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 (each cycle of 28 days) and then 350 mg Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
| OG003 | Cohort C: PTCL: Isatuximab + Cemiplimab | PTCL, anti PD-1/PD-L1 naïve participants received cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 (each cycle of 28 days) and then 350 mg Q3W from Cycle 7 to Cycle 30 (each cycle of 28 days) until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
|
|
| OG002 | Cohort B: DLBCL: Cemiplimab | DLBCL, anti PD-1/PD-L1 naïve participants received cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 (each cycle of 28 days) and then 350 mg Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
| OG003 | Cohort C: PTCL: Cemiplimab | PTCL, anti PD-1/PD-L1 naïve participants received cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 (each cycle of 28 days) and then 350 mg Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
|
|
| OG002 | Cohort B: DLBCL: Cemiplimab | DLBCL, anti PD-1/PD-L1 naïve participants received cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 (each cycle of 28 days) and then 350 mg Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
| OG003 | Cohort C: PTCL: Cemiplimab | PTCL, anti PD-1/PD-L1 naïve participants received cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 (each cycle of 28 days) and then 350 mg Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
|
|
| OG002 | Cohort B: DLBCL: Cemiplimab | DLBCL, anti PD-1/PD-L1 naïve participants received cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 (each cycle of 28 days) and then 350 mg Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
| OG003 | Cohort C: PTCL: Cemiplimab | PTCL, anti PD-1/PD-L1 naïve participants received cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 (each cycle of 28 days) and then 350 mg Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
|
|
| OG002 | Cohort B: DLBCL: Cemiplimab | DLBCL, anti PD-1/PD-L1 naïve participants received cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 (each cycle of 28 days) and then 350 mg Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
| OG003 | Cohort C: PTCL: Cemiplimab | PTCL, anti PD-1/PD-L1 naïve participants received cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 (each cycle of 28 days) and then 350 mg Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
|
|
| OG002 | Cohort B: DLBCL: Isatuximab + Cemiplimab | DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
| OG003 | Cohort C: PTCL: Isatuximab + Cemiplimab | PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
|
|
| OG001 | Cohort A2: cHL: Isatuximab + Cemiplimab | cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
| OG002 | Cohort B: DLBCL: Isatuximab + Cemiplimab | DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
| OG003 | Cohort C: PTCL: Isatuximab + Cemiplimab | PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
|
|
| OG001 | Cohort A2: cHL: Isatuximab + Cemiplimab | cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion Q2W from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
| OG002 | Cohort B: DLBCL: Isatuximab + Cemiplimab | DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion Q2W from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
| OG003 | Cohort C: PTCL: Isatuximab + Cemiplimab | PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion Q2W from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
|
|
| OG001 | Cohort A2: cHL: Isatuximab + Cemiplimab | cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
| OG002 | Cohort B: DLBCL: Isatuximab + Cemiplimab | DLBCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
| OG003 | Cohort C: PTCL: Isatuximab + Cemiplimab | PTCL, anti PD-1/PD-L1 naïve participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
|
|
| OG001 | Cohort A2: cHL: Isatuximab + Cemiplimab | cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
|
|
| OG001 | Cohort A2: cHL: Isatuximab + Cemiplimab | cHL, anti-PD-1/PD-L1 inhibitor progressor participants received isatuximab 10 mg/kg, IV infusion, QW in Cycle 1 and then Q2W from Cycle 2 to Cycle 6 (each cycle of 28 days) and Q3W from Cycle 7 to Cycle 30 (each cycle of 21 days) along with cemiplimab 250 mg Q2W, IV infusion from Cycle 1 to 6 and then 350 mg Q3W from Cycle 7 to Cycle 30, with optional radiotherapy until unacceptable AEs or participant's decision to stop the treatment, or at least 96 weeks (at least 48 weeks from initial signal of CR, whichever was longer) of delivery of investigational medicinal product(s) without documented PD, or study cut-off date, whichever occurs first (maximum duration: up to 103 weeks). |
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