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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1254-0189 | Registry Identifier | ICTRP | |
| 2020-005332-30 | EudraCT Number |
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Early discontinuation based on strategic sponsor decision not driven by any safety concerns
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Primary Objective:
-To determine the antitumor activity of SAR444245 in combination with cemiplimab.
Secondary Objectives:
The duration of the study for an individual patient will start from the signature of the main informed consent and include a screening period of up to 28 days, a treatment period [max 35 cycles or until PD], an end-of-treatment visit 30 days + 7 days following the last administration of study drug (or until the patient receives another anticancer therapy, whichever is earlier), and a follow-up visit 3 months after treatment discontinuation and every 3 months following, until disease progression, or initiation of another antitumor treatment, or final cohort cut-off, whichever is earlier
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A: Melanoma | Experimental | SAR444245 and cemiplimab administered every 3 weeks on Day 1 of each cycle (21 days per cycle) for up to 35 cycles. |
|
| Cohort B: cutaneous squamous cell carcinoma (CSCC) | Experimental | SAR444245 and cemiplimab administered every 3 weeks on Day 1 of each cycle (21 days per cycle) for up to 35 cycles. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| THOR-707 | Drug | Solution for infusion: intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| All Cohorts: Objective Response Rate (ORR) | The ORR was defined as the percentage of participants who had best overall response (BOR) as confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 or modified world health organization (WHO) response criteria. CR was defined as the disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to <10 millimeter (mm) (<1 centimeter [cm]). PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. | From first dose of study treatment administration (Day 1) up to approximately 25 months (Cohorts A and B) |
| Measure | Description | Time Frame |
|---|---|---|
| All Cohorts: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was any AE 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 or was an important medical event. TEAEs were defined as AEs that developed, worsened (according to the investigator's opinion) or became serious during the TE period. |
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Inclusion Criteria:
Participants with tumors arising on the cutaneous hair (non-glabrous) bearing lip with extension onto dry red lip (vermillion) may be eligible after communication with and approval from the Sponsor
Participants with the primary site is nose are only eligible if the primary site was skin, not nasal mucosa with outward extension to skin (the Investigator confirmed)
Participants with mixed histology in which the predominant histology is invasive CSCC may be eligible after communication with and approval from the Sponsor
For participants in the dose escalation:
16 µg/kg: at screening, biopsy is optional but highly recommended; and on-treatment not required
24 µg/kg: at screening, biopsy is mandatory and on-treatment, optional but highly recommended
Exclusion Criteria:
For both cohorts:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beverly Hills Cancer Center & Optima Diagnostic Imaging Site Number : 8400007 | Beverly Hills | California | 90211 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42173654 | Derived | Rojas C, Mortier L, Park JJ, Matamala L, Baakili A, Rao S, Xu J, Andrieu L, Wang R, Wang H, Paehler T, Abbadessa G, Ascierto PA. Phase 1/2 study of pegenzileukin, a pegylated recombinant non-alpha IL-2, with cemiplimab for the treatment of advanced unresectable or metastatic skin cancers. J Immunother Cancer. 2026 May 22;14(5):e014347. doi: 10.1136/jitc-2025-014347. |
| Label | URL |
|---|---|
| ACT16845 Plain Language Results Summary | View source |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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The study was terminated based on strategic sponsor decision not driven by any safety concerns.
Note: Reason for not completed = Reason for permanent full intervention discontinuation.
This study was conducted at 21 centers (corresponds to number of sites which screened at least one participant) in 7 countries. Out of 61 participants who were screened from 15 July 2021 to 25 October 2022, 46 participants were enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A:1L Melanoma ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab | Participants who were immune checkpoint inhibitor (ICI)- naïve and previously untreated locally advanced, unresectable or metastatic melanoma were included in this cohort. Participants received pegenzileukin 16 microgram per kilogram (mcg/kg) along with cemiplimab 350 milligram (mg) via intravenous (IV) infusion over 30 minutes every 3 weeks (q3w) on Day 1 of each cycle (each cycle is 21 days) (as first-line [1L] therapy), until disease progression (PD), unacceptable adverse event (AE) or other full permanent discontinuation criteria was met or completion of Cycle 35. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 20, 2021 | Jan 16, 2026 |
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| Cemiplimab | Drug | Solution for infusion: intravenous infusion |
|
|
| From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B) |
| All Cohorts: Number of Participants With Dose Limiting Toxicities (DLTs) | Selected events that occurred during the DLT observation period were considered as DLT unless due to PD or to a cause obviously unrelated to pegenzileukin. Selected events included: any grade 4 neutropenia irrespective of duration; any febrile neutropenia; grade 3 thrombocytopenia associated with transfusion in addition to bleeding and any grade 4 thrombocytopenia; grade 3 or above: alanine aminotransferase or aspartate aminotransferase, vascular leak syndrome, hypotension, cytokine release syndrome, and AE that did not resolve to grade <=2 within 7 days of starting accepted standard of care medical management; and grade 4 laboratory abnormalities. | From Day 1 to Day 21 of Cycle 1 (each cycle is 21 days: Cohorts A and B) |
| All Cohorts: Complete Response (CR) Rate | The CR rate was defined as the percentage of participants who had a confirmed CR as per RECIST v 1.1 or modified WHO response criteria. CR was defined as the disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to <10 mm (<1 cm). | From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment, approximately 26 months (Cohorts A and B) |
| All Cohorts: Time to Complete Response | The time to CR was defined as the time from the first administration of study treatment to the first tumor assessment at which the overall response was recorded as CR that was subsequently confirmed as per RECIST v 1.1 or modified WHO response criteria. CR was defined as the disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to <10 mm (<1 cm). | From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment, approximately 26 months (Cohorts A and B) |
| All Cohorts: Time to Response (TTR) | The TTR was defined as the time from the first study treatment administration to the first tumor assessment at which the overall response was recorded as PR or CR that was subsequently confirmed as per RECIST v 1.1 or modified WHO response criteria. CR was defined as the disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to <10 mm (<1 cm). PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. | From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment, approximately 26 months (Cohorts A and B) |
| All Cohorts: Duration of Response (DOR) | The DOR was defined as the time from the first tumor assessment at which the overall response was recorded as CR or PR that was subsequently confirmed until documented PD before the initiation of any subsequent anti-cancer therapy or death due to any cause, whichever occurred first, as per RECIST v 1.1 or modified WHO response criteria. CR was defined as the disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to <10 mm (<1 cm). PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. PD was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study), in addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm (0.5 cm). | From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment, approximately 26 months (Cohorts A and B) |
| All Cohorts: Clinical Benefit Rate (CBR) | The CBR was defined as the percentage of participants with clinical benefit: confirmed CR or PR as BOR, or stable disease (SD) lasting at least 6 months, as per RECIST v 1.1 or modified WHO response criteria. CR was defined as the disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to <10 mm (<1 cm). PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. BOR was defined as the best response observed from the start of the study treatment until PD, death, cut-off date or initiation of post-treatment anti-cancer therapy, whichever occurred first. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. | From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment, approximately 26 months (Cohorts A and B) |
| All Cohorts: Progression Free Survival (PFS) | The PFS was defined as the time from the date of first study treatment administration to the date of the first documentation of objective PD, or death due to any cause, whichever occurred first, as per RECIST v 1.1 or modified WHO response criteria. PD was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study), in addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm (0.5 cm). | From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment, approximately 26 months (Cohorts A and B) |
| All Cohorts: Plasma Concentrations of Pegenzileukin | Blood samples were collected at specified timepoints for the assessment of plasma concentrations of pegenzileukin. | Cycle 1 Days 2 and 3 (each cycle is 21 days) |
| All Cohorts: Number of Participants With Anti-Drug Antibodies (ADAs) Against Pegenzileukin | Blood samples were collected at specified timepoints to assess the presence of ADAs against pegenzileukin. Treatment-emergent ADA was defined as at least one treatment-induced or treatment-boosted ADA. Treatment-induced ADA was defined as ADA that developed during the TE period and without pre-existing ADA (including participants without pre-treatment samples). Treatment-boosted ADA was defined as pre-existing ADA that was boosted during the TE period to a significant higher titer than the baseline. Number of participants with treatment-emergent ADA is presented. | From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B) |
| All Cohorts: Concentration Observed Just Before Study Treatment Administration During Repeated Dosing (Ctrough) of Cemiplimab | Blood samples were collected at specified timepoints for the assessment of Ctrough of cemiplimab. The PK population consisted of all participants from exposed population with at least one PK concentration available after the first dose of study treatment. Only participants with data collected at specified timepoints are reported. | Cycles 1, 2, 4, 7, 10, and 15 (each cycle is 21 days) |
| All Cohorts: Concentration at End of Infusion (Ceoi) of Cemiplimab | Blood samples were collected at specified timepoints for the assessment of Ceoi of cemiplimab. The PK population consisted of all participants from exposed population with at least one PK concentration available after the first dose of study treatment. Only participants with data collected at specified timepoints are reported. | Cycles 1, 2, 4, 7, 10, and 15 (each cycle is 21 days) |
| Investigational Site Number : 0360001 |
| Macquarie University |
| New South Wales |
| 2109 |
| Australia |
| Investigational Site Number : 1520005 | Santaigo | Reg Metropolitana de Santiago | 8241470 | Chile |
| Investigational Site Number : 1520002 | Santiago | Reg Metropolitana de Santiago | 7500921 | Chile |
| Investigational Site Number : 1520001 | Santiago | Reg Metropolitana de Santiago | 8420383 | Chile |
| Investigational Site Number : 1520004 | Santiago | Reg Metropolitana de Santiago | Chile |
| Investigational Site Number : 1520006 | Antofagasta | 1420000 | Chile |
| Investigational Site Number : 1520003 | Temuco | 4800827 | Chile |
| Investigational Site Number : 2500003 | Bobigny | 93009 | France |
| Investigational Site Number : 2500002 | Dijon | 21079 | France |
| Investigational Site Number : 2500005 | Lille | 59037 | France |
| Investigational Site Number : 2500001 | Nantes | 44093 | France |
| Investigational Site Number : 2500006 | Pierre-Bénite | 69495 | France |
| Investigational Site Number : 2760004 | Berlin | 10117 | Germany |
| Investigational Site Number : 2760001 | Hamburg | 20246 | Germany |
| Investigational Site Number : 2760003 | Mannheim | 68167 | Germany |
| Investigational Site Number : 2760006 | Minden | 32429 | Germany |
| Investigational Site Number : 2760005 | München | 80337 | Germany |
| Investigational Site Number : 3800001 | Naples | 80131 | Italy |
| Investigational Site Number : 3800004 | Perugia | 06126 | Italy |
| Investigational Site Number : 7240001 | Barcelona | Barcelona [Barcelona] | 08035 | Spain |
| Investigational Site Number : 7240004 | Barcelona | Barcelona [Barcelona] | 08036 | Spain |
| Investigational Site Number : 7240003 | L'Hospitalet de Llobregat | Barcelona [Barcelona] | 08908 | Spain |
| Investigational Site Number : 7240002 | Santander | Cantabria | 39008 | Spain |
| FG001 | Cohort A:1L Melanoma ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab | Participants who were ICI- naïve and previously untreated locally advanced, unresectable or metastatic melanoma were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. |
| FG002 | Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab | Participants with ICI-naïve, metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 16 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as first to third line [1-3L] therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. |
| FG003 | Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab | Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. |
| COMPLETED |
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| NOT COMPLETED |
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|
The exposed population consisted of all participants who had given their informed consent and received at least one dose of study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort A:1L Melanoma ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab | Participants who were ICI- naïve and previously untreated locally advanced, unresectable or metastatic melanoma were included in this cohort. Participants received pegenzileukin 16 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. |
| BG001 | Cohort A:1L Melanoma ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab | Participants who were ICI- naïve and previously untreated locally advanced, unresectable or metastatic melanoma were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. |
| BG002 | Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab | Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 16 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. |
| BG003 | Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab | Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
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| Primary | All Cohorts: Objective Response Rate (ORR) | The ORR was defined as the percentage of participants who had best overall response (BOR) as confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 or modified world health organization (WHO) response criteria. CR was defined as the disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to <10 millimeter (mm) (<1 centimeter [cm]). PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. | The efficacy population consisted of all participants from the exposed population with at least one evaluable post-baseline tumor assessment or who permanently discontinued study treatment. | Posted | Number | 90% Confidence Interval | Percentage of participants | From first dose of study treatment administration (Day 1) up to approximately 25 months (Cohorts A and B) |
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| Secondary | All Cohorts: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was any AE 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 or was an important medical event. TEAEs were defined as AEs that developed, worsened (according to the investigator's opinion) or became serious during the TE period. | The exposed population consisted of all participants who had given their informed consent and received at least one dose of study treatment. | Posted | Count of Participants | Participants | From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B) |
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| Secondary | All Cohorts: Number of Participants With Dose Limiting Toxicities (DLTs) | Selected events that occurred during the DLT observation period were considered as DLT unless due to PD or to a cause obviously unrelated to pegenzileukin. Selected events included: any grade 4 neutropenia irrespective of duration; any febrile neutropenia; grade 3 thrombocytopenia associated with transfusion in addition to bleeding and any grade 4 thrombocytopenia; grade 3 or above: alanine aminotransferase or aspartate aminotransferase, vascular leak syndrome, hypotension, cytokine release syndrome, and AE that did not resolve to grade <=2 within 7 days of starting accepted standard of care medical management; and grade 4 laboratory abnormalities. | The DLT-evaluable population consisted of all exposed participants in the dose escalation who had been treated and observed for at least 21 days. Any participants who had experienced a DLT during DLT observation period were also DLT-evaluable. | Posted | Count of Participants | Participants | From Day 1 to Day 21 of Cycle 1 (each cycle is 21 days: Cohorts A and B) |
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| Secondary | All Cohorts: Complete Response (CR) Rate | The CR rate was defined as the percentage of participants who had a confirmed CR as per RECIST v 1.1 or modified WHO response criteria. CR was defined as the disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to <10 mm (<1 cm). | The efficacy population consisted of all participants from the exposed population with at least one evaluable post-baseline tumor assessment or who permanently discontinued study treatment. | Posted | Number | 90% Confidence Interval | Percentage of participants | From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment, approximately 26 months (Cohorts A and B) |
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| Secondary | All Cohorts: Time to Complete Response | The time to CR was defined as the time from the first administration of study treatment to the first tumor assessment at which the overall response was recorded as CR that was subsequently confirmed as per RECIST v 1.1 or modified WHO response criteria. CR was defined as the disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to <10 mm (<1 cm). | The efficacy population consisted of all participants from the exposed population with at least one evaluable post-baseline tumor assessment or who permanently discontinued study treatment. Only participants with confirmed CR were analyzed. | Posted | Median | Full Range | Months | From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment, approximately 26 months (Cohorts A and B) |
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| Secondary | All Cohorts: Time to Response (TTR) | The TTR was defined as the time from the first study treatment administration to the first tumor assessment at which the overall response was recorded as PR or CR that was subsequently confirmed as per RECIST v 1.1 or modified WHO response criteria. CR was defined as the disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to <10 mm (<1 cm). PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. | The efficacy population consisted of all participants from the exposed population with at least one evaluable post-baseline tumor assessment or who permanently discontinued study treatment. Only participants with confirmed CR or PR were analyzed. | Posted | Median | Full Range | Months | From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment, approximately 26 months (Cohorts A and B) |
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| Secondary | All Cohorts: Duration of Response (DOR) | The DOR was defined as the time from the first tumor assessment at which the overall response was recorded as CR or PR that was subsequently confirmed until documented PD before the initiation of any subsequent anti-cancer therapy or death due to any cause, whichever occurred first, as per RECIST v 1.1 or modified WHO response criteria. CR was defined as the disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to <10 mm (<1 cm). PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. PD was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study), in addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm (0.5 cm). | The efficacy population consisted of all participants from the exposed population with at least one evaluable post-baseline tumor assessment or who permanently discontinued study treatment. Only participants with confirmed CR or PR were analyzed. | Posted | Median | 90% Confidence Interval | Months | From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment, approximately 26 months (Cohorts A and B) |
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| Secondary | All Cohorts: Clinical Benefit Rate (CBR) | The CBR was defined as the percentage of participants with clinical benefit: confirmed CR or PR as BOR, or stable disease (SD) lasting at least 6 months, as per RECIST v 1.1 or modified WHO response criteria. CR was defined as the disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to <10 mm (<1 cm). PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. BOR was defined as the best response observed from the start of the study treatment until PD, death, cut-off date or initiation of post-treatment anti-cancer therapy, whichever occurred first. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. | The efficacy population consisted of all participants from the exposed population with at least one evaluable post-baseline tumor assessment or who permanently discontinued study treatment. | Posted | Number | 90% Confidence Interval | Percentage of participants | From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment, approximately 26 months (Cohorts A and B) |
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| Secondary | All Cohorts: Progression Free Survival (PFS) | The PFS was defined as the time from the date of first study treatment administration to the date of the first documentation of objective PD, or death due to any cause, whichever occurred first, as per RECIST v 1.1 or modified WHO response criteria. PD was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study), in addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm (0.5 cm). | The efficacy population consisted of all participants from the exposed population with at least one evaluable post-baseline tumor assessment or who permanently discontinued study treatment. | Posted | Median | 90% Confidence Interval | Months | From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment, approximately 26 months (Cohorts A and B) |
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| Secondary | All Cohorts: Plasma Concentrations of Pegenzileukin | Blood samples were collected at specified timepoints for the assessment of plasma concentrations of pegenzileukin. | The pharmacokinetic (PK) population consisted of all participants from exposed population with at least one PK concentration available after the first dose of study treatment. Only participants with data collected at specified timepoints are reported. | Posted | Mean | Standard Deviation | Nanograms per milliliter (ng/mL) | Cycle 1 Days 2 and 3 (each cycle is 21 days) |
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| Secondary | All Cohorts: Number of Participants With Anti-Drug Antibodies (ADAs) Against Pegenzileukin | Blood samples were collected at specified timepoints to assess the presence of ADAs against pegenzileukin. Treatment-emergent ADA was defined as at least one treatment-induced or treatment-boosted ADA. Treatment-induced ADA was defined as ADA that developed during the TE period and without pre-existing ADA (including participants without pre-treatment samples). Treatment-boosted ADA was defined as pre-existing ADA that was boosted during the TE period to a significant higher titer than the baseline. Number of participants with treatment-emergent ADA is presented. | The ADA population consisted of all participants from the exposed population with at least one ADA result (positive, negative or inconclusive) after the first dose of study treatment. | Posted | Count of Participants | Participants | From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | All Cohorts: Concentration Observed Just Before Study Treatment Administration During Repeated Dosing (Ctrough) of Cemiplimab | Blood samples were collected at specified timepoints for the assessment of Ctrough of cemiplimab. The PK population consisted of all participants from exposed population with at least one PK concentration available after the first dose of study treatment. Only participants with data collected at specified timepoints are reported. | Eventually, the participants discontinued as they progressed in the study. Hence, fewer participants at each cycle and no participants returned i.e. no sample was collected for Cycle 10 for Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab and Cycle 15 for Cohort A:1L Melanoma ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab and Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab. | Posted | Mean | Standard Deviation | ng/mL | Cycles 1, 2, 4, 7, 10, and 15 (each cycle is 21 days) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | All Cohorts: Concentration at End of Infusion (Ceoi) of Cemiplimab | Blood samples were collected at specified timepoints for the assessment of Ceoi of cemiplimab. The PK population consisted of all participants from exposed population with at least one PK concentration available after the first dose of study treatment. Only participants with data collected at specified timepoints are reported. | Eventually, the participants discontinued as they progressed in the study. Hence, fewer participants at each cycle and no participants returned i.e. no sample was collected for Cycle 10 for Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab and Cycle 15 for Cohort A:1L Melanoma ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab and Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab. | Posted | Mean | Standard Deviation | ng/mL | Cycles 1, 2, 4, 7, 10, and 15 (each cycle is 21 days) |
|
Adverse events data was collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for each participant, approximately 43 months.
Analysis was performed on the exposed 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:1L Melanoma ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab | Participants who were ICI- naïve and previously untreated locally advanced, unresectable or metastatic melanoma were included in this cohort. Participants received pegenzileukin 16 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. | 5 | 20 | 11 | 20 | 19 | 20 |
| EG001 | Cohort A:1L Melanoma ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab | Participants who were ICI- naïve and previously untreated locally advanced, unresectable or metastatic melanoma were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. | 2 | 7 | 4 | 7 | 7 | 7 |
| EG002 | Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab | Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 16 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. | 2 | 16 | 8 | 16 | 16 | 16 |
| EG003 | Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab | Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. | 0 | 3 | 1 | 3 | 3 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Infection | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Abdominal Sepsis | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Cytokine Release Syndrome | Immune system disorders | MedDra 27.1 | Systematic Assessment |
| |
| Immune-Mediated Adrenal Insufficiency | Endocrine disorders | MedDra 27.1 | Systematic Assessment |
| |
| Diabetes Mellitus | Metabolism and nutrition disorders | MedDra 27.1 | Systematic Assessment |
| |
| Diabetic Ketoacidosis | Metabolism and nutrition disorders | MedDra 27.1 | Systematic Assessment |
| |
| Type 1 Diabetes Mellitus | Metabolism and nutrition disorders | MedDra 27.1 | Systematic Assessment |
| |
| Meningoradiculitis | Nervous system disorders | MedDra 27.1 | Systematic Assessment |
| |
| Myasthenic Syndrome | Nervous system disorders | MedDra 27.1 | Systematic Assessment |
| |
| Visual Acuity Reduced | Eye disorders | MedDra 27.1 | Systematic Assessment |
| |
| Cardiogenic Shock | Cardiac disorders | MedDra 27.1 | Systematic Assessment |
| |
| Immune-Mediated Myocarditis | Cardiac disorders | MedDra 27.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Gastric Antral Vascular Ectasia | Gastrointestinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Immune-Mediated Enterocolitis | Gastrointestinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Upper Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Autoimmune Hepatitis | Hepatobiliary disorders | MedDra 27.1 | Systematic Assessment |
| |
| Immune-Mediated Hepatitis | Hepatobiliary disorders | MedDra 27.1 | Systematic Assessment |
| |
| Erythema Multiforme | Skin and subcutaneous tissue disorders | MedDra 27.1 | Systematic Assessment |
| |
| Skin Induration | Skin and subcutaneous tissue disorders | MedDra 27.1 | Systematic Assessment |
| |
| Immune-Mediated Myositis | Musculoskeletal and connective tissue disorders | MedDra 27.1 | Systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | MedDra 27.1 | Systematic Assessment |
| |
| Prerenal Failure | Renal and urinary disorders | MedDra 27.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDra 27.1 | Systematic Assessment |
| |
| Lymphocyte Count Decreased | Investigations | MedDra 27.1 | Systematic Assessment |
| |
| Infusion Related Reaction | Injury, poisoning and procedural complications | MedDra 27.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Onychomycosis | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Oral Herpes | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Postoperative Wound Infection | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Skin Infection | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Superinfection | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Suspected Covid-19 | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Cancer Pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 27.1 | Systematic Assessment |
| |
| Infected Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 27.1 | Systematic Assessment |
| |
| Tumour Haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 27.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDra 27.1 | Systematic Assessment |
| |
| Eosinophilia | Blood and lymphatic system disorders | MedDra 27.1 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDra 27.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDra 27.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDra 27.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDra 27.1 | Systematic Assessment |
| |
| Cytokine Release Syndrome | Immune system disorders | MedDra 27.1 | Systematic Assessment |
| |
| Glucocorticoid Deficiency | Endocrine disorders | MedDra 27.1 | Systematic Assessment |
| |
| Hyperadrenocorticism | Endocrine disorders | MedDra 27.1 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDra 27.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDra 27.1 | Systematic Assessment |
| |
| Immune-Mediated Adrenal Insufficiency | Endocrine disorders | MedDra 27.1 | Systematic Assessment |
| |
| Immune-Mediated Hyperthyroidism | Endocrine disorders | MedDra 27.1 | Systematic Assessment |
| |
| Immune-Mediated Hypothyroidism | Endocrine disorders | MedDra 27.1 | Systematic Assessment |
| |
| Thyroiditis | Endocrine disorders | MedDra 27.1 | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDra 27.1 | Systematic Assessment |
| |
| Diabetes Mellitus | Metabolism and nutrition disorders | MedDra 27.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDra 27.1 | Systematic Assessment |
| |
| Hyperchloraemia | Metabolism and nutrition disorders | MedDra 27.1 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDra 27.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDra 27.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDra 27.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDra 27.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDra 27.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDra 27.1 | Systematic Assessment |
| |
| Confusional State | Psychiatric disorders | MedDra 27.1 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDra 27.1 | Systematic Assessment |
| |
| Depressed Mood | Psychiatric disorders | MedDra 27.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDra 27.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDra 27.1 | Systematic Assessment |
| |
| Ageusia | Nervous system disorders | MedDra 27.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDra 27.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDra 27.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDra 27.1 | Systematic Assessment |
| |
| Immune-Mediated Neuropathy | Nervous system disorders | MedDra 27.1 | Systematic Assessment |
| |
| Parkinsonism | Nervous system disorders | MedDra 27.1 | Systematic Assessment |
| |
| Tension Headache | Nervous system disorders | MedDra 27.1 | Systematic Assessment |
| |
| Acute Macular Neuroretinopathy | Eye disorders | MedDra 27.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDra 27.1 | Systematic Assessment |
| |
| Eye Pain | Eye disorders | MedDra 27.1 | Systematic Assessment |
| |
| Vision Blurred | Eye disorders | MedDra 27.1 | Systematic Assessment |
| |
| Deafness | Ear and labyrinth disorders | MedDra 27.1 | Systematic Assessment |
| |
| Ear Pain | Ear and labyrinth disorders | MedDra 27.1 | Systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDra 27.1 | Systematic Assessment |
| |
| Sinus Tachycardia | Cardiac disorders | MedDra 27.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDra 27.1 | Systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDra 27.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDra 27.1 | Systematic Assessment |
| |
| Systolic Hypertension | Vascular disorders | MedDra 27.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Immune-Mediated Lung Disease | Respiratory, thoracic and mediastinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Productive Cough | Respiratory, thoracic and mediastinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Rhinitis Allergic | Respiratory, thoracic and mediastinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Sinus Polyp | Respiratory, thoracic and mediastinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDra 27.1 | Systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDra 27.1 | Systematic Assessment |
| |
| Immune-Mediated Hepatitis | Hepatobiliary disorders | MedDra 27.1 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDra 27.1 | Systematic Assessment |
| |
| Dermatitis Allergic | Skin and subcutaneous tissue disorders | MedDra 27.1 | Systematic Assessment |
| |
| Erythema Nodosum | Skin and subcutaneous tissue disorders | MedDra 27.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDra 27.1 | Systematic Assessment |
| |
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDra 27.1 | Systematic Assessment |
| |
| Immune-Mediated Dermatitis | Skin and subcutaneous tissue disorders | MedDra 27.1 | Systematic Assessment |
| |
| Pemphigoid | Skin and subcutaneous tissue disorders | MedDra 27.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDra 27.1 | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDra 27.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDra 27.1 | Systematic Assessment |
| |
| Rash Macular | Skin and subcutaneous tissue disorders | MedDra 27.1 | Systematic Assessment |
| |
| Rash Maculo-Papular | Skin and subcutaneous tissue disorders | MedDra 27.1 | Systematic Assessment |
| |
| Skin Lesion | Skin and subcutaneous tissue disorders | MedDra 27.1 | Systematic Assessment |
| |
| Vitiligo | Skin and subcutaneous tissue disorders | MedDra 27.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDra 27.1 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDra 27.1 | Systematic Assessment |
| |
| Groin Pain | Musculoskeletal and connective tissue disorders | MedDra 27.1 | Systematic Assessment |
| |
| Immune-Mediated Arthritis | Musculoskeletal and connective tissue disorders | MedDra 27.1 | Systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDra 27.1 | Systematic Assessment |
| |
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDra 27.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDra 27.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDra 27.1 | Systematic Assessment |
| |
| Rotator Cuff Syndrome | Musculoskeletal and connective tissue disorders | MedDra 27.1 | Systematic Assessment |
| |
| Soft Tissue Necrosis | Musculoskeletal and connective tissue disorders | MedDra 27.1 | Systematic Assessment |
| |
| Trismus | Musculoskeletal and connective tissue disorders | MedDra 27.1 | Systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDra 27.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDra 27.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDra 27.1 | Systematic Assessment |
| |
| Facial Pain | General disorders | MedDra 27.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDra 27.1 | Systematic Assessment |
| |
| Influenza Like Illness | General disorders | MedDra 27.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDra 27.1 | Systematic Assessment |
| |
| Xerosis | General disorders | MedDra 27.1 | Systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDra 27.1 | Systematic Assessment |
| |
| Amylase Increased | Investigations | MedDra 27.1 | Systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDra 27.1 | Systematic Assessment |
| |
| Blood Albumin Decreased | Investigations | MedDra 27.1 | Systematic Assessment |
| |
| Blood Bilirubin Increased | Investigations | MedDra 27.1 | Systematic Assessment |
| |
| Blood Calcium Decreased | Investigations | MedDra 27.1 | Systematic Assessment |
| |
| Blood Chloride Increased | Investigations | MedDra 27.1 | Systematic Assessment |
| |
| Blood Creatine Phosphokinase Increased | Investigations | MedDra 27.1 | Systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDra 27.1 | Systematic Assessment |
| |
| Blood Lactate Dehydrogenase Increased | Investigations | MedDra 27.1 | Systematic Assessment |
| |
| Blood Magnesium Decreased | Investigations | MedDra 27.1 | Systematic Assessment |
| |
| Blood Phosphorus Decreased | Investigations | MedDra 27.1 | Systematic Assessment |
| |
| Blood Triglycerides Increased | Investigations | MedDra 27.1 | Systematic Assessment |
| |
| Blood Urea Increased | Investigations | MedDra 27.1 | Systematic Assessment |
| |
| C-Reactive Protein Increased | Investigations | MedDra 27.1 | Systematic Assessment |
| |
| Cortisol Decreased | Investigations | MedDra 27.1 | Systematic Assessment |
| |
| Gamma-Glutamyltransferase Increased | Investigations | MedDra 27.1 | Systematic Assessment |
| |
| Haemoglobin Decreased | Investigations | MedDra 27.1 | Systematic Assessment |
| |
| Lipase Increased | Investigations | MedDra 27.1 | Systematic Assessment |
| |
| Procalcitonin Increased | Investigations | MedDra 27.1 | Systematic Assessment |
| |
| Protein Total Decreased | Investigations | MedDra 27.1 | Systematic Assessment |
| |
| Prothrombin Time Prolonged | Investigations | MedDra 27.1 | Systematic Assessment |
| |
| Weight Decreased | Investigations | MedDra 27.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDra 27.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDra 27.1 | Systematic Assessment |
| |
| Infusion Related Reaction | Injury, poisoning and procedural complications | MedDra 27.1 | Systematic Assessment |
| |
| Skin Injury | Injury, poisoning and procedural complications | MedDra 27.1 | Systematic Assessment |
| |
| Thermal Burn | Injury, poisoning and procedural complications | MedDra 27.1 | Systematic Assessment |
|
The study was terminated based on strategic sponsor decision not driven by any safety concerns.
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 | Jan 3, 2023 | Jan 16, 2026 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000627974 | cemiplimab |
| D016568 | Drugs, Generic |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
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 |
|
| OG001 |
| Cohort A:1L Melanoma ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab |
Participants who were ICI- naïve and previously untreated locally advanced, unresectable or metastatic melanoma were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. |
| OG002 | Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab | Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 16 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. |
| OG003 | Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab | Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. |
|
|
| OG001 |
| Cohort A:1L Melanoma ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab |
Participants who were ICI- naïve and previously untreated locally advanced, unresectable or metastatic melanoma were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. |
| OG002 | Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab | Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 16 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. |
| OG003 | Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab | Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. |
|
|
| OG002 | Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab | Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 16 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. |
| OG003 | Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab | Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. |
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|
Participants who were ICI- naïve and previously untreated locally advanced, unresectable or metastatic melanoma were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
| OG002 | Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab | Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 16 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. |
| OG003 | Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab | Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. |
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|
Participants who were ICI- naïve and previously untreated locally advanced, unresectable or metastatic melanoma were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. |
| OG002 | Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab | Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 16 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. |
| OG003 | Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab | Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. |
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| OG001 | Cohort A:1L Melanoma ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab | Participants who were ICI- naïve and previously untreated locally advanced, unresectable or metastatic melanoma were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. |
| OG002 | Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab | Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 16 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. |
| OG003 | Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab | Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. |
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| OG001 | Cohort A:1L Melanoma ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab | Participants who were ICI- naïve and previously untreated locally advanced, unresectable or metastatic melanoma were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. |
| OG002 | Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab | Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 16 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. |
| OG003 | Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab | Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. |
|
|
Participants who were ICI- naïve and previously untreated locally advanced, unresectable or metastatic melanoma were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. |
| OG002 | Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab | Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 16 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. |
| OG003 | Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab | Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. |
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| OG002 | Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab | Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 16 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. |
| OG003 | Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab | Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. |
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| Cohort A:1L Melanoma ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab |
Participants who were ICI- naïve and previously untreated locally advanced, unresectable or metastatic melanoma were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. |
| OG002 | Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab | Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 16 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. |
| OG003 | Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab | Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. |
|
|
Participants who were ICI- naïve and previously untreated locally advanced, unresectable or metastatic melanoma were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. |
| OG002 | Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab | Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 16 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. |
| OG003 | Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab | Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. |
|
|
Participants who were ICI- naïve and previously untreated locally advanced, unresectable or metastatic melanoma were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
| OG002 | Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab | Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 16 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. |
| OG003 | Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab | Participants with ICI-naïve, metastatic or locally advanced CSCC who were not candidates for curative surgery or curative radiation and who received no more than 2 prior lines of systemic therapy were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with cemiplimab 350 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1-3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. |
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