Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2018-000390-67 | EudraCT Number | ||
| U1111-1202-0839 | Other Identifier | UTN |
Not provided
Not provided
Not provided
Study was stopped after interim analysis for 4 cohorts (HCC, SCCHN, EOC, and GBM) indicated that the results did not fulfill the preplanned interim analysis criteria to move to Phase 2 stage 2 in all 4 cohorts.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Primary Objectives:
Secondary Objectives:
The total study duration per participant was up to 28 months including up to 28 days screening period, up to 24 months treatment period, and a 3 month safety follow up period.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A: HCC: Isatuximab + Atezolizumab | Experimental | Participants with hepatocellular carcinoma (HCC) received atezolizumab 1200 milligrams, every 3 weeks (Q3W), intravenous (IV) infusion along with isatuximab 10 milligrams per kilogram (mg/kg), IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable adverse events (AE), participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 106 weeks). |
|
| Cohort B: SCCHN: Isatuximab + Atezolizumab | Experimental | Participants with squamous cell carcinoma of the head and neck (SCCHN) received atezolizumab 1200 milligrams,Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 108 weeks). |
|
| Cohort C: EOC: Isatuximab + Atezolizumab | Experimental | Participants with epithelial ovarian cancer (EOC) received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 61 weeks). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isatuximab SAR650984 | Drug | Pharmaceutical form: solution for infusion Route of administration: intravenous |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose Limiting Toxicities (DLTs) | DLTs: AEs occurring during 1st treatment cycle, unless due to disease progression/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 thrombocytopenia with clinically significant bleeding/ G4 thrombocytopenia. Non-hematological abnormalities: G >=2 Aspartate transaminase (AST)/ Alanine transaminase (ALT) elevation simultaneous with G >=2 total bilirubin elevation without initial findings of cholestasis or any other reason found, G4 non-hematologic AE, G3 to 4 cytokine release syndrome, 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 study committee deemed to be dose-limiting, regardless of grade, was also considered DLT. | Cycle 1 (21 days) |
| Recommended Phase 2 Dose (RP2D) | RP2D was the starting dose selected for Phase 2 part of the study. RP2D was the selected dose at which no more than 1 out of 6 participants (starting dose or dose level minus -1 [DL-1]) or 2 out of 12 participants (starting dose) experienced a DLT related to the investigational medicinal product. DLTs: Adverse Event (AE) occurring during 1st treatment cycle, unless due to disease progression/obviously unrelated cause included: hematological abnormalities: G4 N for 7/ more consecutive days, G3 to G4 N with fever, G3/G4 thrombocytopenia. Non-hematological abnormalities: G>=2 AST/ALT elevation simultaneous with G >=2 total bilirubin elevation without cholestasis or any other reason found, G4 non-hematologic AE, G3 to 4 cytokine release syndrome, G3 non-hematological AE lasting >3 days, delay in initiation of Cycle 2 >14 days due to treatment related laboratory abnormalities/AE. | Cycle 1 (21 days) |
| Maximum Tolerated Dose (MTD) | MTD was defined as the highest dose level at which no more than 1 out of 6 participants (starting dose or DL-1) or 2 out of 12 participants (starting dose) experienced a DLT related to the investigational medicinal product. DLTs: AE occurring during 1st treatment cycle, unless due to disease progression/obviously unrelated cause included: hematological abnormalities: G4 N for 7 or more consecutive days, G3 to G4 N with fever, G3 or G4 thrombocytopenia. Non-hematological abnormalities: G>=2 AST/ ALT elevation simultaneous with G >=2 total bilirubin elevation without cholestasis or any other reason found, G4 non-hematologic AE, G3 to 4 cytokine release syndrome, G3 non-hematological AE lasting >3 days, delay in initiation of Cycle 2 >14 days due to treatment related laboratory abnormalities or AEs. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Anti-drug Antibodies (ADA) Response 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 (including participants without pretreatment samples). |
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number :8400004 | Santa Monica | California | 90404 | United States | ||
| Investigational Site Number :8400007 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35987165 | Background | Simonelli M, Garralda E, Eskens F, Gil-Martin M, Yen CJ, Obermannova R, Chao Y, Lonardi S, Melichar B, Moreno V, Yu ML, Bongiovanni A, Calvo E, Rottey S, Machiels JP, Gonzalez-Martin A, Paz-Ares L, Chang CL, Mason W, Lin CC, Reardon DA, Vieito M, Santoro A, Meng R, Abbadessa G, Menas F, Lee H, Liu Q, Combeau C, Ternes N, Ziti-Ljajic S, Massard C. Isatuximab plus atezolizumab in patients with advanced solid tumors: results from a phase I/II, open-label, multicenter study. ESMO Open. 2022 Oct;7(5):100562. doi: 10.1016/j.esmoop.2022.100562. Epub 2022 Aug 18. |
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Study was stopped after performance of interim analysis for 4 cohorts (Cohort A [HCC], Cohort B [SCCHN], Cohort C [EOC] & Cohort D-1 [GBM]) indicated that efficacy results observed in each cohort did not fulfill the preplanned interim analysis criteria allowing the study to move to Phase 2 Stage 2 in these 4 cohorts. Participant flow, Baseline, outcome measures and safety data were analyzed on combined Phase 1 and 2 populations.
Study was conducted at 26 active sites in 8 countries. A total of 107 participants were enrolled between 06 August 2018 and 21 July 2020 and received isatuximab in combination with atezolizumab. Study was planned to be conducted in 2 parts: Phase 1 (safety run-in) and Phase 2 (efficacy with a 2-stage design).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A: Hepatocellular Carcinoma (HCC): Isatuximab + Atezolizumab | Participants with hepatocellular carcinoma (HCC) received atezolizumab 1200 milligrams (mg), every 3 weeks (Q3W), intravenous (IV) infusion along with isatuximab 10 milligrams per kilogram (mg/kg), IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable adverse events (AE), participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 106 weeks). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 23, 2020 | May 2, 2023 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Cohort D-1: GBM: Isatuximab + Atezolizumab | Experimental | Participants with glioblastoma multiforme (GBM) received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 54 weeks). |
|
|
| Atezolizumab | Drug | Pharmaceutical form: solution for infusion Route of administration: intravenous |
|
|
| Cycle 1 (21 days) |
| Percentage of Participants With Overall Response (OR): For HCC/SCCHN/EOC Cohorts | OR was defined as the percentage of participants with complete response (CR) and partial response (PR) as best overall response, assessed per RECIST 1.1 criteria. Best overall response was derived per RECIST 1.1 criteria using disease assessments performed from the first dose of treatment throughout the study excluding any assessments performed after the cut-off date or following the initiation of a further anticancer treatment. CR was defined as the disappearance of all target lesions, pathological lymph nodes (target/non-target)- reduction in short axis <10 mm; PR was defined as at least 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters. Disease progression was defined as at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum, sum with an absolute increase of diameter of at least 5 mm and appearance of >1 new lesion. | From randomization until disease progression, or death or study cut-off whichever occurred first (maximum duration of exposure: up to 108 weeks) |
| Probability of Participants With Progression Free Survival at 6 Months (PFS-6): GBM Cohort | PFS-6 was defined as the probability of participants alive without disease progression at 6 months as assessed by RANO criteria. Participants who didn't experience documented progression or death before analysis cut-off date or date of initiation of new anticancer treatment, PFS was censored at date of last valid disease assessment not showing progression performed prior to initiation of further anticancer treatment or analysis cut-off date, whichever was 1st. Per RANO criteria, progressive disease was defined as >=25% increase size of T1- gadolinium enhancing disease, or increased T2/FLAIR signal, or presence of new lesion, or worsening clinical status. PFS-6 was evaluated by Kaplan-Meier method. | From randomization until 6 months after the last participant's first treatment in the GBM Cohort D-1 |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent 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 Baseline up to 30 days after last study treatment administration (maximum duration of exposure: 106 weeks for Cohort A, 108 weeks for Cohort B, 61 weeks for Cohort C and 54 weeks for Cohort D-1) |
| Number of Participants With Hematological Abnormalities | Hematological parameters assessed were anemia, white blood cell (WBC) decreased, platelet count decreased, lymphocyte count decreased, and neutrophil count decreased. Parameters were assessed as per the National Cancer Institute Common Terminology Criteria for Adverse Experience version 4.03, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs. | From Baseline up to 30 days after last study treatment administration (maximum duration of exposure: 106 weeks for Cohort A, 108 weeks for Cohort B, 61 weeks for Cohort C and 54 weeks for Cohort D-1) |
| Number of Participants With Abnormal Electrolyte Parameters | Electrolyte parameters assessed were hyponatremia, hypernatremia, hypokalemia, hyperkalemia, hypocalcemia, hypercalcemia, hypoalbuminemia, hypoglycemia and hyperglycemia. Parameters were assessed as per the National Cancer Institute Common Terminology Criteria for Adverse Experience version 4.03, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs. | From Baseline up to 30 days after last study treatment administration (maximum duration of exposure: 106 weeks for Cohort A, 108 weeks for Cohort B, 61 weeks for Cohort C and 54 weeks for Cohort D-1) |
| Number of Participants With Renal Function Abnormalities | Abnormal renal parameters assessed were creatinine clearance (CrCl), creatinine increased and hyperuricemia. Creatinine clearance was assessed in categories: >=60 - less than (<) 90 milliliters per minute per 1.73 square meter (mL/min/1.73m^2), >=30 - <60 mL/min/1.73m^2, >=15 - <30 mL/min/1.73m^2 and <15 mL/min/1.73m^2. Parameters were assessed as per the National Cancer Institute Common Terminology Criteria for Adverse Experience version 4.03, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs. | From Baseline up to 30 days after last study treatment administration (maximum duration of exposure: 106 weeks for Cohort A, 108 weeks for Cohort B, 61 weeks for Cohort C and 54 weeks for Cohort D-1) |
| Number of Participants With Liver Abnormalities | Abnormal liver function parameters assessed were AST increased, ALT increased, alkaline phosphatase (ALP) increased, blood bilirubin (BB) increased. Parameters were assessed as per the National Cancer Institute Common Terminology Criteria for Adverse Experience version 4.03, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs. | From Baseline up to 30 days after last study treatment administration (maximum duration of exposure: 106 weeks for Cohort A, 108 weeks for Cohort B, 61 weeks for Cohort C and 54 weeks for Cohort D-1) |
| From Baseline up to 30 days after last study treatment administration (maximum duration of exposure:106 weeks for Cohort A, 108 weeks for Cohort B, 61 weeks for Cohort C and 54 weeks for Cohort D-1) |
| Number of Participants With Anti-drug Antibodies (ADA) Response Against Atezolizumab | 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 (including participants without pretreatment samples). | From Baseline up to 30 days after last study treatment administration (maximum duration of exposure: 106 weeks for Cohort A, 108 weeks for Cohort B, 61 weeks for Cohort C and 54 weeks for Cohort D-1) |
| Pharmacokinetics (PK): Maximum Concentration Observed (Cmax) After the First Infusion of Isatuximab | Cmax was defined as the maximum concentration observed after the first administration calculated using the noncompartmental analysis after the intravenous infusion of isatuximab. | At start of infusion (SOI), end of infusion (EOI), EOI+4 hours, 72 hours and 168 hours post-dose on Day 1 of Cycle 1 |
| Pharmacokinetics (PK): Concentration Observed at the End of Intravenous Infusion (Ceoi) of Isatuximab | Ceoi is the plasma concentration observed at the end of intravenous infusion of isatuximab. | At end of infusion on Cycle 1 Day 1 |
| Pharmacokinetics (PK): Time to Reach Cmax (Tmax) After First Infusion of Isatuximab | Tmax was defined as the time to reach Cmax, calculated using the non-compartmental analysis after the intravenous infusion of isatuximab. | At SOI, EOI, EOI+4 hours, 72 hours and 168 hours post-dose on Day 1 of Cycle 1 |
| Pharmacokinetics (PK): 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, EOI, EOI+4 hours, 72 hours and 168 hours post-dose on Day 1 of Cycle 1 |
| Pharmacokinetics (PK): Time of Clast (Tlast) After First Infusion of Isatuximab | Tlast was defined as the time of last concentration observed above the lower limit of quantification, calculated using the non-compartmental analysis after the intravenous infusion of isatuximab. | At SOI, EOI, EOI+4 hours, 72 hours and 168 hours post-dose on Day 1 of Cycle 1 |
| Pharmacokinetics (PK): Area Under the Plasma Concentration Time Curve From Time 0 to Last Quantifiable Concentration (AUClast) After First Infusion of Isatuximab | AUClast was defined as area under the plasma concentration versus time curve calculated from time 0 to last quantifiable concentration. AUClast was calculated using the non-compartmental analysis after the intravenous infusion of isatuximab. | At SOI, EOI, EOI+4 hours, 72 hours and 168 hours post-dose on Day 1 of Cycle 1 |
| Pharmacokinetics (PK): Area Under the Plasma Concentration Time Curve Over the Dosing Interval (AUC0-168h) After First Infusion of Isatuximab | AUC0-168h was defined as the area under the plasma concentration versus time curve from time 0 to 168 hours post dose calculated using non-compartmental analysis after first infusion of isatuximab. | At SOI, EOI, EOI+4 hours, 72 hours and 168 hours post-dose on Day 1 of Cycle 1 |
| Pharmacokinetics (PK): Trough Plasma Concentrations (Ctrough) of Isatuximab | Ctrough was the plasma concentration of isatuximab observed just before treatment administration during repeated dosing. | Pre-infusion on Cycle 1 Day 1, Cycle 1 Day 8 and Cycle 1 Day 15 |
| Plasma Concentration of Atezolizumab | Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 8 Day 1 and Cycle 16 Day 1 |
| Best Percent Change From Baseline in Tumor Burden | Best tumor burden change was defined as the best percent-change from baseline in a sum of the diameters (longest for non-nodal lesion, short axis for nodal lesions) for all target lesions. | From randomization until progression or death or study cut-off date whichever occurred first (maximum duration of exposure: up to 108 weeks) |
| Percentage of Participants With Disease Control (DC) >=6 Months | DC: percentage of participants with complete response (CR), partial response (PR) & stable disease (SD) rate. RANO criteria, CR: no change in size of T1-gadolinium-enhancing (T1-Gd+) disease, stable/ reduced (red) T2/FLAIR signal, no new lesion (NL), no corticosteroid use (CU) & stable/ red clinical status (CS); PR: >=50% change in size of T1-Gd+ disease, stable/red T2/FLAIR signal, no NL, stable/ red CU & stable/ improved CS (ICS). SD: <50% reduction to <25% increase (inc) size of T1-Gd+ disease, stable/red T2/FLAIR signal, no NL, stable/red CU & stable/ICS. Progressive disease (PD): >=25% inc size of T1-Gd+ disease/ inc T2/FLAIR signal/ presence of NL/ worsening CS. RECIST criteria: CR: Disappearance of target lesions. Reduction in short axis to <10 mm of lymph nodes; PR: 30% decrease in sum of diameters of target lesions; PD: 20% inc in sum of diameters of target lesions; SD: Neither sufficient shrinkage from baseline study to qualify for PR nor sufficient inc to qualify for PD. | From the date of first response to disease progression or death, or study cut-off whichever occurred first (maximum duration of exposure: up to 108 weeks) |
| Duration of Response (DOR) | Time from date of 1st response until date of first documented recurrent/progressive disease (PD) or death whichever occurred 1st. In absence of disease progression or death before analysis cut-off date or date of initiation of further anticancer treatment, DOR was censored at date of last valid response. RECIST 1.1 criteria was used for assessment in HCC/SCCHN/EOC Cohorts and RANO criteria for GBM Cohort. Per RECIST 1.1, CR: disappearance of all target lesions; PR: at least 30% decrease in sum of diameters of target lesions, PD: at least 20% increase in sum of diameters of target lesions. Per RANO criteria; CR: no change in size of T1-Gd+ disease, stable/reduced T2/FLAIR signal, no new lesion, no corticosteroid use, and stable/improved status; PR: >=50% change in size of T1-Gd+, stable/reduced T2/FLAIR signal, no new lesion, stable/reduced corticosteroid use, and stable/improved status. PD:>=25% increase size of T1-Gd+/increased T2/FLAIR signal/presence of new lesion/worsening status. | From the date of first response until disease progression or death, or study cut-off date whichever occurred first (maximum duration of exposure: up to 108 weeks) |
| Progression-free Survival (PFS) | PFS was defined as time (in months) from 1st study treatment administration to date of 1st documented radiographic progression or date of death from any cause, whichever was 1st. Participants who didn't experience progression or death before analysis cut-off date/date of initiation of new anticancer treatment, PFS was censored at date of last valid disease assessment not showing progression performed prior to initiation of further anticancer treatment or analysis cut-off date, whichever was 1st. RECIST 1.1 criteria was used for assessment in HCC/SCCHN/EOC Cohorts and RANO criteria for GBM Cohort. Per RECIST 1.1 criteria, PD: at least 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study. Appearance of 1 or more new lesions was also considered progression. Per RANO criteria, PD: >=25% increase in product of perpendicular diameters of any target lesion, or worsening neurologic status not explained by causes unrelated to tumor progression. | From date of first study treatment administration until disease progression or death or study cut-off whichever occurred first (maximum duration of exposure: up to 108 weeks) |
| Percentage of Participants With Response as Per Response Assessment for Neuro-Oncology (RANO) Criteria: GBM Cohort | Response rate for participants with GBM was defined as percentage of participants with CR & PR as best overall response (BOR), assessed by Investigators using RANO criteria. BOR was derived per RANO criteria using disease assessments performed from 1st dose of treatment through study excluding any assessments performed after cut-off date or following initiation of further anticancer treatment. Per RANO criteria; CR was defined as no change in size of T1-gadolinium-enhancing (T1-Gd+) disease, stable or reduced T2/FLAIR signal, no new lesion, no corticosteroid use, and stable or improved clinical status; PR was defined as >=50% change in size of T1-Gd+ disease, stable or reduced T2/FLAIR signal, no new lesion, stable or reduced corticosteroid use, and stable or improved clinical status. Progressive disease was defined as >=25% increase size of T1-Gd+ disease, or increased T2/FLAIR signal, or presence of new lesion, or worsening clinical status. | From randomization until progression, or death, or study cut-off whichever occurred first (maximum duration of exposure: 54 weeks for Cohort D-1) |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Investigational Site Number :8400002 | Houston | Texas | 77030 | United States |
| Investigational Site Number :0560001 | Brussels | 1200 | Belgium |
| Investigational Site Number :0560002 | Ghent | 9000 | Belgium |
| Investigational Site Number :1240001 | Toronto | Ontario | M5G 2M9 | Canada |
| Investigational Site Number :2030001 | Brno | 65653 | Czechia |
| Investigational Site Number :2030003 | Olomouc | 77900 | Czechia |
| Investigational Site Number :2030002 | Prague | 12808 | Czechia |
| Investigational Site Number :3800007 | Meldola | Forlì-Cesena | 47014 | Italy |
| Investigational Site Number :3800003 | Rozzano | Milano | 20089 | Italy |
| Investigational Site Number :3800009 | Milan | 20141 | Italy |
| Investigational Site Number :3800004 | Padova | 35128 | Italy |
| Investigational Site Number :5280001 | Rotterdam | 3015 CE | Netherlands |
| Investigational Site Number :7240001 | Barcelona | Barcelona [Barcelona] | 08035 | Spain |
| Investigational Site Number :7240006 | Hospitalet de Llobregat | Castille and León | 08908 | Spain |
| Investigational Site Number :7240004 | Madrid | Madrid, Comunidad de | 28050 | Spain |
| Investigational Site Number :7240003 | Madrid / Madrid | Madrid, Comunidad de | 28040 | Spain |
| Investigational Site Number :7240008 | Pamplona | Navarre | 31008 | Spain |
| Investigational Site Number :7240007 | Madrid | 28041 | Spain |
| Investigational Site Number :1580005 | Kaohsiung City | 807 | Taiwan |
| Investigational Site Number :1580002 | Tainan | 704 | Taiwan |
| Investigational Site Number :1580003 | Taipei | 104 | Taiwan |
| Investigational Site Number :1580006 | Taipei | 112 | Taiwan |
| Investigational Site Number :1580004 | Taipei | 114 | Taiwan |
| Investigational Site Number :1580001 | Taipei | Taiwan |
| FG001 | Cohort B: Squamous Cell Carcinoma of the Head and Neck (SCCHN): Isatuximab + Atezolizumab | Participants with squamous cell carcinoma of the head and neck (SCCHN) received atezolizumab 1200 milligrams,Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 108 weeks). |
| FG002 | Cohort C: Epithelial Ovarian Cancer (EOC): Isatuximab + Atezolizumab | Participants with epithelial ovarian cancer (EOC) received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 61 weeks). |
| FG003 | Cohort D-1: Glioblastoma Multiforme (GBM): Isatuximab + Atezolizumab | Participants with glioblastoma multiforme (GBM) received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 54 weeks). |
| COMPLETED | Participants who completed the study treatment duration. |
|
| NOT COMPLETED |
|
|
Analysis was performed on all-treated population that included all the participants who signed the study informed consent and received at least 1 dose of the study treatments, either isatuximab or atezolizumab.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort A: HCC: Isatuximab + Atezolizumab | Participants with HCC received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 106 weeks). |
| BG001 | Cohort B: SCCHN: Isatuximab + Atezolizumab | Participants with SCCHN received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 108 weeks). |
| BG002 | Cohort C: EOC: Isatuximab + Atezolizumab | Participants with EOC received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 61 weeks). |
| BG003 | Cohort D-1: GBM: Isatuximab + Atezolizumab | Participants with GBM received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure:54 weeks). |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Dose Limiting Toxicities (DLTs) | DLTs: AEs occurring during 1st treatment cycle, unless due to disease progression/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 thrombocytopenia with clinically significant bleeding/ G4 thrombocytopenia. Non-hematological abnormalities: G >=2 Aspartate transaminase (AST)/ Alanine transaminase (ALT) elevation simultaneous with G >=2 total bilirubin elevation without initial findings of cholestasis or any other reason found, G4 non-hematologic AE, G3 to 4 cytokine release syndrome, 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 study committee deemed to be dose-limiting, regardless of grade, was also considered DLT. | Analysis was performed on DLT evaluable population that included participants who received planned doses of isatuximab and atezolizumab during Cycle 1 and who completed the DLT observation period. | Posted | Count of Participants | Participants | Cycle 1 (21 days) |
|
|
| ||||||||||||||||||||||||||
| Primary | Recommended Phase 2 Dose (RP2D) | RP2D was the starting dose selected for Phase 2 part of the study. RP2D was the selected dose at which no more than 1 out of 6 participants (starting dose or dose level minus -1 [DL-1]) or 2 out of 12 participants (starting dose) experienced a DLT related to the investigational medicinal product. DLTs: Adverse Event (AE) occurring during 1st treatment cycle, unless due to disease progression/obviously unrelated cause included: hematological abnormalities: G4 N for 7/ more consecutive days, G3 to G4 N with fever, G3/G4 thrombocytopenia. Non-hematological abnormalities: G>=2 AST/ALT elevation simultaneous with G >=2 total bilirubin elevation without cholestasis or any other reason found, G4 non-hematologic AE, G3 to 4 cytokine release syndrome, G3 non-hematological AE lasting >3 days, delay in initiation of Cycle 2 >14 days due to treatment related laboratory abnormalities/AE. | Analysis was performed on DLT evaluable population. | Posted | Number | milligrams per kilogram (mg/kg) | Cycle 1 (21 days) |
| ||||||||||||||||||||||||||||
| Primary | Maximum Tolerated Dose (MTD) | MTD was defined as the highest dose level at which no more than 1 out of 6 participants (starting dose or DL-1) or 2 out of 12 participants (starting dose) experienced a DLT related to the investigational medicinal product. DLTs: AE occurring during 1st treatment cycle, unless due to disease progression/obviously unrelated cause included: hematological abnormalities: G4 N for 7 or more consecutive days, G3 to G4 N with fever, G3 or G4 thrombocytopenia. Non-hematological abnormalities: G>=2 AST/ ALT elevation simultaneous with G >=2 total bilirubin elevation without cholestasis or any other reason found, G4 non-hematologic AE, G3 to 4 cytokine release syndrome, G3 non-hematological AE lasting >3 days, delay in initiation of Cycle 2 >14 days due to treatment related laboratory abnormalities or AEs. | Analysis was performed on DLT evaluable population. | Posted | Number | mg/kg | Cycle 1 (21 days) |
|
| |||||||||||||||||||||||||||
| Primary | Percentage of Participants With Overall Response (OR): For HCC/SCCHN/EOC Cohorts | OR was defined as the percentage of participants with complete response (CR) and partial response (PR) as best overall response, assessed per RECIST 1.1 criteria. Best overall response was derived per RECIST 1.1 criteria using disease assessments performed from the first dose of treatment throughout the study excluding any assessments performed after the cut-off date or following the initiation of a further anticancer treatment. CR was defined as the disappearance of all target lesions, pathological lymph nodes (target/non-target)- reduction in short axis <10 mm; PR was defined as at least 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters. Disease progression was defined as at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum, sum with an absolute increase of diameter of at least 5 mm and appearance of >1 new lesion. | Analysis was performed on all-treated population. Data for this outcome measure was not planned to be collected and analyzed for GBM Cohort as pre-specified in protocol. | Posted | Number | 90% Confidence Interval | percentage of participants | From randomization until disease progression, or death or study cut-off whichever occurred first (maximum duration of exposure: up to 108 weeks) |
| |||||||||||||||||||||||||||
| Primary | Probability of Participants With Progression Free Survival at 6 Months (PFS-6): GBM Cohort | PFS-6 was defined as the probability of participants alive without disease progression at 6 months as assessed by RANO criteria. Participants who didn't experience documented progression or death before analysis cut-off date or date of initiation of new anticancer treatment, PFS was censored at date of last valid disease assessment not showing progression performed prior to initiation of further anticancer treatment or analysis cut-off date, whichever was 1st. Per RANO criteria, progressive disease was defined as >=25% increase size of T1- gadolinium enhancing disease, or increased T2/FLAIR signal, or presence of new lesion, or worsening clinical status. PFS-6 was evaluated by Kaplan-Meier method. | Analysis was performed on all-treated population. Data for this outcome measure was not planned to be collected and analyzed for Cohorts A: HCC, Cohort B: SCCHN and Cohort C: EOC as pre-specified in protocol. | Posted | Number | 95% Confidence Interval | probability of participants | From randomization until 6 months after the last participant's first treatment in the GBM Cohort D-1 |
| |||||||||||||||||||||||||||
| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent 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. | Posted | Count of Participants | Participants | From Baseline up to 30 days after last study treatment administration (maximum duration of exposure: 106 weeks for Cohort A, 108 weeks for Cohort B, 61 weeks for Cohort C and 54 weeks for Cohort D-1) |
| ||||||||||||||||||||||||||||
| Primary | Number of Participants With Hematological Abnormalities | Hematological parameters assessed were anemia, white blood cell (WBC) decreased, platelet count decreased, lymphocyte count decreased, and neutrophil count decreased. Parameters were assessed as per the National Cancer Institute Common Terminology Criteria for Adverse Experience version 4.03, 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, 'overall number of participants analyzed' signifies participants with available data for this outcome measure. | Posted | Count of Participants | Participants | From Baseline up to 30 days after last study treatment administration (maximum duration of exposure: 106 weeks for Cohort A, 108 weeks for Cohort B, 61 weeks for Cohort C and 54 weeks for Cohort D-1) |
| ||||||||||||||||||||||||||||
| Primary | Number of Participants With Abnormal Electrolyte Parameters | Electrolyte parameters assessed were hyponatremia, hypernatremia, hypokalemia, hyperkalemia, hypocalcemia, hypercalcemia, hypoalbuminemia, hypoglycemia and hyperglycemia. Parameters were assessed as per the National Cancer Institute Common Terminology Criteria for Adverse Experience version 4.03, 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 'overall number of participants analyzed' signifies participants with available data for this outcome measure. | Posted | Count of Participants | Participants | From Baseline up to 30 days after last study treatment administration (maximum duration of exposure: 106 weeks for Cohort A, 108 weeks for Cohort B, 61 weeks for Cohort C and 54 weeks for Cohort D-1) |
| ||||||||||||||||||||||||||||
| Primary | Number of Participants With Renal Function Abnormalities | Abnormal renal parameters assessed were creatinine clearance (CrCl), creatinine increased and hyperuricemia. Creatinine clearance was assessed in categories: >=60 - less than (<) 90 milliliters per minute per 1.73 square meter (mL/min/1.73m^2), >=30 - <60 mL/min/1.73m^2, >=15 - <30 mL/min/1.73m^2 and <15 mL/min/1.73m^2. Parameters were assessed as per the National Cancer Institute Common Terminology Criteria for Adverse Experience version 4.03, 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 'overall number of participants analyzed' signifies participants with available data for this outcome measure. | Posted | Count of Participants | Participants | From Baseline up to 30 days after last study treatment administration (maximum duration of exposure: 106 weeks for Cohort A, 108 weeks for Cohort B, 61 weeks for Cohort C and 54 weeks for Cohort D-1) |
| ||||||||||||||||||||||||||||
| Primary | Number of Participants With Liver Abnormalities | Abnormal liver function parameters assessed were AST increased, ALT increased, alkaline phosphatase (ALP) increased, blood bilirubin (BB) increased. Parameters were assessed as per the National Cancer Institute Common Terminology Criteria for Adverse Experience version 4.03, 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 'overall number of participants analyzed' signifies participants with available data for this outcome measure. | Posted | Count of Participants | Participants | From Baseline up to 30 days after last study treatment administration (maximum duration of exposure: 106 weeks for Cohort A, 108 weeks for Cohort B, 61 weeks for Cohort C and 54 weeks for Cohort D-1) |
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Anti-drug Antibodies (ADA) Response 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 (including participants without pretreatment samples). | Analysis was performed on ADA evaluable population which included all participants who received at least 1 dose of study treatment with at least 1 non-missing ADA result after the drug administration. Here 'overall number of participants analyzed' signifies participants with available data for this outcome measure. | Posted | Number | count of participants | From Baseline up to 30 days after last study treatment administration (maximum duration of exposure:106 weeks for Cohort A, 108 weeks for Cohort B, 61 weeks for Cohort C and 54 weeks for Cohort D-1) |
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Anti-drug Antibodies (ADA) Response Against Atezolizumab | 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 (including participants without pretreatment samples). | Analysis was performed on ADA evaluable population. Here 'overall number of participants analyzed' signifies participants with available data for this outcome measure. | Posted | Number | count of participants | From Baseline up to 30 days after last study treatment administration (maximum duration of exposure: 106 weeks for Cohort A, 108 weeks for Cohort B, 61 weeks for Cohort C and 54 weeks for Cohort D-1) |
| ||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics (PK): Maximum Concentration Observed (Cmax) After the First Infusion of Isatuximab | Cmax was defined as the maximum concentration observed after the first administration calculated using the noncompartmental analysis after the intravenous infusion of isatuximab. | Analysis was performed on PK population which included all participants who received at least 1 dose of the study treatment with at least one reportable concentration after the study drug administration. | Posted | Mean | Standard Deviation | micrograms per milliliter (mcg/mL) | At start of infusion (SOI), end of infusion (EOI), EOI+4 hours, 72 hours and 168 hours post-dose on Day 1 of Cycle 1 |
| |||||||||||||||||||||||||||
| Secondary | Pharmacokinetics (PK): Concentration Observed at the End of Intravenous Infusion (Ceoi) of Isatuximab | Ceoi is the plasma concentration observed at the end of intravenous infusion of isatuximab. | Analysis was performed on PK population. | Posted | Mean | Standard Deviation | mcg/mL | At end of infusion on Cycle 1 Day 1 |
| |||||||||||||||||||||||||||
| Secondary | Pharmacokinetics (PK): Time to Reach Cmax (Tmax) After First Infusion of Isatuximab | Tmax was defined as the time to reach Cmax, calculated using the non-compartmental analysis after the intravenous infusion of isatuximab. | Analysis was performed on PK population. | Posted | Median | Full Range | hours | At SOI, EOI, EOI+4 hours, 72 hours and 168 hours post-dose on Day 1 of Cycle 1 |
| |||||||||||||||||||||||||||
| Secondary | Pharmacokinetics (PK): 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. | Posted | Mean | Standard Deviation | mcg/mL | At SOI, EOI, EOI+4 hours, 72 hours and 168 hours post-dose on Day 1 of Cycle 1 |
| |||||||||||||||||||||||||||
| Secondary | Pharmacokinetics (PK): Time of Clast (Tlast) After First Infusion of Isatuximab | Tlast was defined as the time of last concentration observed above the lower limit of quantification, calculated using the non-compartmental analysis after the intravenous infusion of isatuximab. | Analysis was performed on PK population. | Posted | Median | Full Range | hours | At SOI, EOI, EOI+4 hours, 72 hours and 168 hours post-dose on Day 1 of Cycle 1 |
| |||||||||||||||||||||||||||
| Secondary | Pharmacokinetics (PK): Area Under the Plasma Concentration Time Curve From Time 0 to Last Quantifiable Concentration (AUClast) After First Infusion of Isatuximab | AUClast was defined as area under the plasma concentration versus time curve calculated from time 0 to last quantifiable concentration. AUClast was calculated using the non-compartmental analysis after the intravenous infusion of isatuximab. | Analysis was performed on PK population. | Posted | Mean | Standard Deviation | micrograms*hour/milliliter (mcg*h/mL) | At SOI, EOI, EOI+4 hours, 72 hours and 168 hours post-dose on Day 1 of Cycle 1 |
| |||||||||||||||||||||||||||
| Secondary | Pharmacokinetics (PK): Area Under the Plasma Concentration Time Curve Over the Dosing Interval (AUC0-168h) After First Infusion of Isatuximab | AUC0-168h was defined as the area under the plasma concentration versus time curve from time 0 to 168 hours post dose calculated using non-compartmental analysis after first infusion of isatuximab. | Analysis was performed on PK population. | Posted | Mean | Standard Deviation | mcg*h/mL | At SOI, EOI, EOI+4 hours, 72 hours and 168 hours post-dose on Day 1 of Cycle 1 |
| |||||||||||||||||||||||||||
| Secondary | Pharmacokinetics (PK): Trough Plasma Concentrations (Ctrough) of Isatuximab | Ctrough was the plasma concentration of isatuximab observed just before treatment administration during repeated dosing. | Analysis was performed on participants who received at least 1 dose of the study treatment with at least one reportable concentration after drug administration; and were ADA negative (i.e., participants without any treatment induced or treatment boosted ADA-positive sample during the treatment or follow-up observation period). Here 'Number analyzed' signifies participants with available data for each specified category. | Posted | Mean | Standard Deviation | mcg/mL | Pre-infusion on Cycle 1 Day 1, Cycle 1 Day 8 and Cycle 1 Day 15 |
| |||||||||||||||||||||||||||
| Secondary | Plasma Concentration of Atezolizumab | Data for the plasma concentration of atezolizumab is not reported because no sample was collected after study termination and analyzed as the study did not fulfil the predefined criteria for Atezolizumab PK analysis. | Posted | Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 8 Day 1 and Cycle 16 Day 1 |
| |||||||||||||||||||||||||||||||
| Secondary | Best Percent Change From Baseline in Tumor Burden | Best tumor burden change was defined as the best percent-change from baseline in a sum of the 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 participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | percent change | From randomization until progression or death or study cut-off date whichever occurred first (maximum duration of exposure: up to 108 weeks) |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Disease Control (DC) >=6 Months | DC: percentage of participants with complete response (CR), partial response (PR) & stable disease (SD) rate. RANO criteria, CR: no change in size of T1-gadolinium-enhancing (T1-Gd+) disease, stable/ reduced (red) T2/FLAIR signal, no new lesion (NL), no corticosteroid use (CU) & stable/ red clinical status (CS); PR: >=50% change in size of T1-Gd+ disease, stable/red T2/FLAIR signal, no NL, stable/ red CU & stable/ improved CS (ICS). SD: <50% reduction to <25% increase (inc) size of T1-Gd+ disease, stable/red T2/FLAIR signal, no NL, stable/red CU & stable/ICS. Progressive disease (PD): >=25% inc size of T1-Gd+ disease/ inc T2/FLAIR signal/ presence of NL/ worsening CS. RECIST criteria: CR: Disappearance of target lesions. Reduction in short axis to <10 mm of lymph nodes; PR: 30% decrease in sum of diameters of target lesions; PD: 20% inc in sum of diameters of target lesions; SD: Neither sufficient shrinkage from baseline study to qualify for PR nor sufficient inc to qualify for PD. | Analysis was performed on all-treated population. | Posted | Number | 90% Confidence Interval | percentage of participants | From the date of first response to disease progression or death, or study cut-off whichever occurred first (maximum duration of exposure: up to 108 weeks) |
| |||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) | Time from date of 1st response until date of first documented recurrent/progressive disease (PD) or death whichever occurred 1st. In absence of disease progression or death before analysis cut-off date or date of initiation of further anticancer treatment, DOR was censored at date of last valid response. RECIST 1.1 criteria was used for assessment in HCC/SCCHN/EOC Cohorts and RANO criteria for GBM Cohort. Per RECIST 1.1, CR: disappearance of all target lesions; PR: at least 30% decrease in sum of diameters of target lesions, PD: at least 20% increase in sum of diameters of target lesions. Per RANO criteria; CR: no change in size of T1-Gd+ disease, stable/reduced T2/FLAIR signal, no new lesion, no corticosteroid use, and stable/improved status; PR: >=50% change in size of T1-Gd+, stable/reduced T2/FLAIR signal, no new lesion, stable/reduced corticosteroid use, and stable/improved status. PD:>=25% increase size of T1-Gd+/increased T2/FLAIR signal/presence of new lesion/worsening status. | Analysis was performed on all treated population. Here 'overall number of participants analyzed' signifies participants with available data for this outcome measure and '0' in 'overall number of participants analyzed' signifies that no participant in the Cohort D-1 achieved any response, and hence, no DOR was analyzed. | 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 of exposure: up to 108 weeks) |
| |||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) | PFS was defined as time (in months) from 1st study treatment administration to date of 1st documented radiographic progression or date of death from any cause, whichever was 1st. Participants who didn't experience progression or death before analysis cut-off date/date of initiation of new anticancer treatment, PFS was censored at date of last valid disease assessment not showing progression performed prior to initiation of further anticancer treatment or analysis cut-off date, whichever was 1st. RECIST 1.1 criteria was used for assessment in HCC/SCCHN/EOC Cohorts and RANO criteria for GBM Cohort. Per RECIST 1.1 criteria, PD: at least 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study. Appearance of 1 or more new lesions was also considered progression. Per RANO criteria, PD: >=25% increase in product of perpendicular diameters of any target lesion, or worsening neurologic status not explained by causes unrelated to tumor progression. | Analysis was performed on all-treated population. Kaplan-Meier method was used for analysis. | Posted | Median | 95% Confidence Interval | months | From date of first study treatment administration until disease progression or death or study cut-off whichever occurred first (maximum duration of exposure: up to 108 weeks) |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Response as Per Response Assessment for Neuro-Oncology (RANO) Criteria: GBM Cohort | Response rate for participants with GBM was defined as percentage of participants with CR & PR as best overall response (BOR), assessed by Investigators using RANO criteria. BOR was derived per RANO criteria using disease assessments performed from 1st dose of treatment through study excluding any assessments performed after cut-off date or following initiation of further anticancer treatment. Per RANO criteria; CR was defined as no change in size of T1-gadolinium-enhancing (T1-Gd+) disease, stable or reduced T2/FLAIR signal, no new lesion, no corticosteroid use, and stable or improved clinical status; PR was defined as >=50% change in size of T1-Gd+ disease, stable or reduced T2/FLAIR signal, no new lesion, stable or reduced corticosteroid use, and stable or improved clinical status. Progressive disease was defined as >=25% increase size of T1-Gd+ disease, or increased T2/FLAIR signal, or presence of new lesion, or worsening clinical status. | Analysis was performed on all-treated population. Data for this outcome measure was not collected and analyzed for Cohort A, B and C because the RANO criteria for the assessment of response could not be used to assess the response for solid tumors such as HCC, SCCHN and EOC. | Posted | Number | 90% Confidence Interval | percentage of participants | From randomization until progression, or death, or study cut-off whichever occurred first (maximum duration of exposure: 54 weeks for Cohort D-1) |
|
From Baseline up to 30 days after last study treatment administration (maximum duration of exposure: 106 weeks for Cohort A, 108 weeks for Cohort B, 61 weeks for Cohort C and 54 weeks for Cohort D-1)
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 A: HCC: Isatuximab + Atezolizumab | Participants with HCC received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 106 weeks). | 4 | 27 | 12 | 27 | 25 | 27 |
| EG001 | Cohort B: SCCHN: Isatuximab + Atezolizumab | Participants with SCCHN received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 108 weeks). | 8 | 29 | 16 | 29 | 24 | 29 |
| EG002 | Cohort C: EOC: Isatuximab + Atezolizumab | Participants with EOC received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 61 weeks). | 3 | 18 | 8 | 18 | 18 | 18 |
| EG003 | Cohort D-1: GBM: Isatuximab + Atezolizumab | Participants with GBM received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 54 weeks). | 1 | 33 | 9 | 33 | 32 | 33 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Localised Infection | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Periorbital Infection | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Pneumonia Bacterial | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Pyuria | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Sepsis | 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 |
| |
| Malignant Ascites | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 25.0 | Systematic Assessment |
| |
| Skin Neoplasm Bleeding | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 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 |
| |
| Tumour Pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 25.0 | Systematic Assessment |
| |
| Tumour Rupture | 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 |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDra 25.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDra 25.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDra 25.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDra 25.0 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Peripheral Motor Neuropathy | Nervous system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Status Epilepticus | Nervous system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Arterial Haemorrhage | Vascular disorders | MedDra 25.0 | Systematic Assessment |
| |
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Laryngeal Oedema | Respiratory, thoracic and mediastinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Haemoperitoneum | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Intra-Abdominal Haemorrhage | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Malignant Dysphagia | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Immune-Mediated Hepatitis | Hepatobiliary disorders | MedDra 25.0 | Systematic Assessment |
| |
| Neck Mass | Musculoskeletal and connective tissue disorders | MedDra 25.0 | Systematic Assessment |
| |
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDra 25.0 | Systematic Assessment |
| |
| Pathological Fracture | Musculoskeletal and connective tissue disorders | MedDra 25.0 | Systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | MedDra 25.0 | Systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDra 25.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDra 25.0 | Systematic Assessment |
| |
| Disease Progression | General disorders | MedDra 25.0 | Systematic Assessment |
| |
| General Physical Health Deterioration | General disorders | MedDra 25.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDra 25.0 | Systematic Assessment |
| |
| Blood Bilirubin Increased | Investigations | MedDra 25.0 | Systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDra 25.0 | Systematic Assessment |
| |
| Infusion Related Reaction | Injury, poisoning and procedural complications | MedDra 25.0 | Systematic Assessment |
| |
| Euthanasia | Surgical and medical procedures | MedDra 25.0 | Systematic Assessment |
| |
| Device Occlusion | Product Issues | MedDra 25.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Ear Infection | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Oral Herpes | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Respiratory Tract Infection | 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 |
| |
| 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 |
| |
| Anaemia | Blood and lymphatic system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Lymph Node Pain | 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 |
| |
| Adrenal Insufficiency | Endocrine disorders | MedDra 25.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDra 25.0 | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDra 25.0 | Systematic Assessment |
| |
| Confusional State | Psychiatric disorders | MedDra 25.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDra 25.0 | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Disturbance In Attention | Nervous system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Motor Dysfunction | Nervous system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Dry Eye | Eye disorders | MedDra 25.0 | Systematic Assessment |
| |
| Periorbital Oedema | Eye disorders | MedDra 25.0 | Systematic Assessment |
| |
| Visual Acuity Reduced | Eye disorders | MedDra 25.0 | Systematic Assessment |
| |
| Ear Pruritus | Ear and labyrinth disorders | MedDra 25.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDra 25.0 | Systematic Assessment |
| |
| Diastolic Hypertension | Vascular disorders | MedDra 25.0 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDra 25.0 | Systematic Assessment |
| |
| Hot Flush | Vascular disorders | MedDra 25.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDra 25.0 | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDra 25.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Epistaxis | 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 |
| |
| 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 Lower | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Abdominal Pain Upper | 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 |
| |
| Dry Mouth | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Intestinal Obstruction | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Dry Skin | Skin and subcutaneous tissue disorders | MedDra 25.0 | Systematic Assessment |
| |
| Onychoclasis | Skin and subcutaneous tissue disorders | MedDra 25.0 | Systematic Assessment |
| |
| Onycholysis | 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 |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDra 25.0 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDra 25.0 | Systematic Assessment |
| |
| Musculoskeletal Chest Pain | 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 |
| |
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDra 25.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDra 25.0 | Systematic Assessment |
| |
| Catheter Site Haematoma | General disorders | MedDra 25.0 | Systematic Assessment |
| |
| Fatigue | 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 |
| |
| Pyrexia | General disorders | MedDra 25.0 | Systematic Assessment |
| |
| Vessel Puncture Site Haemorrhage | General disorders | MedDra 25.0 | Systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDra 25.0 | Systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDra 25.0 | Systematic Assessment |
| |
| Platelet Count Decreased | Investigations | MedDra 25.0 | Systematic Assessment |
| |
| Weight Decreased | Investigations | MedDra 25.0 | Systematic Assessment |
| |
| Infusion Related Reaction | Injury, poisoning and procedural complications | MedDra 25.0 | Systematic Assessment |
|
Study was stopped after performance of interim analysis for 4 cohorts (Cohort A [HCC], Cohort B [SCCHN], Cohort C [EOC] & Cohort D-1 [GBM]) as the efficacy results observed in each cohort did not fulfill the pre-planned interim analysis criteria allowing the study to move to Phase 2 Stage 2 in these 4 cohorts.
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 | Sep 12, 2019 | May 2, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C000599209 | isatuximab |
| C000594389 | atezolizumab |
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 |
|
| Units | Counts |
|---|
| Participants |
|
|
| Participants |
|
|
| OG001 | Cohort B: SCCHN: Isatuximab + Atezolizumab | Participants with SCCHN received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 108 weeks). |
| OG002 | Cohort C: EOC: Isatuximab + Atezolizumab | Participants with EOC received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 61 weeks). |
|
|
|
|
| OG001 |
| Cohort B: SCCHN: Isatuximab + Atezolizumab |
Participants with SCCHN received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 108 weeks). |
| OG002 | Cohort C: EOC: Isatuximab + Atezolizumab | Participants with EOC received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 61 weeks). |
| OG003 | Cohort D-1: GBM: Isatuximab + Atezolizumab | Participants with GBM received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 54 weeks). |
|
|
Participants with SCCHN received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 108 weeks).
| OG002 | Cohort C: EOC: Isatuximab + Atezolizumab | Participants with EOC received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 61 weeks). |
| OG003 | Cohort D-1: GBM: Isatuximab + Atezolizumab | Participants with GBM received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 54 weeks). |
|
|
Participants with SCCHN received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 108 weeks).
| OG002 | Cohort C: EOC: Isatuximab + Atezolizumab | Participants with EOC received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 61 weeks). |
| OG003 | Cohort D-1: GBM: Isatuximab + Atezolizumab | Participants with GBM received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 54 weeks). |
|
|
| Cohort B: SCCHN: Isatuximab + Atezolizumab |
Participants with SCCHN received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 108 weeks). |
| OG002 | Cohort C: EOC: Isatuximab + Atezolizumab | Participants with EOC received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 61 weeks). |
| OG003 | Cohort D-1: GBM: Isatuximab + Atezolizumab | Participants with GBM received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 54 weeks). |
|
|
| OG002 | Cohort C: EOC: Isatuximab + Atezolizumab | Participants with EOC received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 61 weeks). |
| OG003 | Cohort D-1: GBM: Isatuximab + Atezolizumab | Participants with GBM received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 54 weeks). |
|
|
| Cohort B: SCCHN: Isatuximab + Atezolizumab |
Participants with SCCHN received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 108 weeks). |
| OG002 | Cohort C: EOC: Isatuximab + Atezolizumab | Participants with EOC received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 61 weeks). |
| OG003 | Cohort D-1: GBM: Isatuximab + Atezolizumab | Participants with GBM received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 54 weeks). |
|
|
Participants with SCCHN received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 108 weeks).
| OG002 | Cohort C: EOC: Isatuximab + Atezolizumab | Participants with EOC received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 61 weeks). |
| OG003 | Cohort D-1: GBM: Isatuximab + Atezolizumab | Participants with GBM received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 54 weeks). |
|
|
| OG002 | Cohort C: EOC: Isatuximab + Atezolizumab | Participants with EOC received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 61 weeks). |
| OG003 | Cohort D-1: GBM: Isatuximab + Atezolizumab | Participants with GBM received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 54 weeks). |
|
|
| Cohort C: EOC: Isatuximab + Atezolizumab |
Participants with EOC received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 61 weeks). |
| OG003 | Cohort D-1: GBM: Isatuximab + Atezolizumab | Participants with GBM received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 54 weeks). |
|
|
| OG002 |
| Cohort C: EOC: Isatuximab + Atezolizumab |
Participants with EOC received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 61 weeks). |
| OG003 | Cohort D-1: GBM: Isatuximab + Atezolizumab | Participants with GBM received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 54 weeks). |
|
|
| OG002 | Cohort C: EOC: Isatuximab + Atezolizumab | Participants with EOC received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 61 weeks). |
| OG003 | Cohort D-1: GBM: Isatuximab + Atezolizumab | Participants with GBM received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 54 weeks). |
|
|
| OG002 | Cohort C: EOC: Isatuximab + Atezolizumab | Participants with EOC received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 61 weeks). |
| OG003 | Cohort D-1: GBM: Isatuximab + Atezolizumab | Participants with GBM received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 54 weeks). |
|
|
| OG002 | Cohort C: EOC: Isatuximab + Atezolizumab | Participants with EOC received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 61 weeks). |
| OG003 | Cohort D-1: GBM: Isatuximab + Atezolizumab | Participants with GBM received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 54 weeks). |
|
|
| OG002 | Cohort C: EOC: Isatuximab + Atezolizumab | Participants with EOC received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 61 weeks). |
| OG003 | Cohort D-1: GBM: Isatuximab + Atezolizumab | Participants with GBM received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 54 weeks). |
|
|
| OG002 | Cohort C: EOC: Isatuximab + Atezolizumab | Participants with EOC received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 61 weeks). |
| OG003 | Cohort D-1: GBM: Isatuximab + Atezolizumab | Participants with GBM received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 54 weeks). |
|
|
Participants with EOC received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 61 weeks). |
| OG003 | Cohort D-1: GBM: Isatuximab + Atezolizumab | Participants with GBM received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 54 weeks). |
|
| OG002 | Cohort C: EOC: Isatuximab + Atezolizumab | Participants with EOC received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 61 weeks). |
| OG003 | Cohort D-1: GBM: Isatuximab + Atezolizumab | Participants with GBM received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 54 weeks). |
|
|
| OG001 | Cohort B: SCCHN: Isatuximab + Atezolizumab | Participants with SCCHN received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 108 weeks). |
| OG002 | Cohort C: EOC: Isatuximab + Atezolizumab | Participants with EOC received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 61 weeks). |
| OG003 | Cohort D-1: GBM: Isatuximab + Atezolizumab | Participants with GBM received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 54 weeks). |
|
|
| OG001 | Cohort B: SCCHN: Isatuximab + Atezolizumab | Participants with SCCHN received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure:108 weeks). |
| OG002 | Cohort C: EOC: Isatuximab + Atezolizumab | Participants with EOC received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 61 weeks). |
| OG003 | Cohort D-1: GBM: Isatuximab + Atezolizumab | Participants with GBM received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 54 weeks). |
|
|
| OG001 | Cohort B: SCCHN: Isatuximab + Atezolizumab | Participants with SCCHN received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 108 weeks). |
| OG002 | Cohort C: EOC: Isatuximab + Atezolizumab | Participants with EOC received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 61 weeks). |
| OG003 | Cohort D-1: GBM: Isatuximab + Atezolizumab | Participants with GBM received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 54 weeks). |
|
|
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|