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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1254-0107 | Registry Identifier | ICTRP | |
| MK-3475-B71 | Other Identifier | Merck Sharp & Dohme LLC. | |
| KEYNOTE-B71 | Other Identifier | Merck Sharp & Dohme LLC. | |
| 2020-005331-78 | EudraCT Number |
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Early discontinuation based on strategic sponsor decision not driven by any safety concerns.
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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The Primary Objective was:
-To determine the antitumor activity of SAR444245 in combination with other anticancer therapies.
The Secondary Objectives were:
The duration of the study for an individual participant started from the signature of the main informed consent and included a screening period of up to 28 days, a treatment period [max 35 cycles {cohorts A1, A2, and B1} = 735 days or until PD {cohort C1}], an end-of-treatment visit at least 30 days following the last administration of study drug (or until the participant 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 death, whichever is earlier
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A1: NSCLC, PD-L1 TPS >=50%:Pegenzileukin 24 μg/kg + Pembrolizumab as 1L Therapy | Experimental | Participants with previously untreated Stage IV non-small cell lung cancer (NSCLC) and programmed cell death-ligand 1 (PD-L1) tumor proportion score (TPS) of >=50% were included in this cohort. Participants received pegenzileukin 24 microgram per kilogram (μg/kg) along with pembrolizumab 200 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. |
|
| Cohort A2: NSCLC, PD-L1 TPS 1%-49%:Pegenzileukin 24 μg/kg+Pembrolizumab as 1L Therapy | Experimental | Participants with previously untreated Stage IV NSCLC and PD-L1 TPS of 1%-49% were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 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. |
|
| Cohort B1: NSCLC:Pegenzileukin 24 μg/kg+Pembrolizumab as 2/3L Therapy | Experimental | Participants with NSCLC for whom standard of care (SOC) was not in their best interest or where no SOC was established were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as second-line or third-line [2/3L] therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| THOR-707 | Drug | Intravenous infusion: solution for infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cohorts A1 and A2: Objective Response Rate (ORR) | ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. CR. 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 21 months |
| Cohorts B1: Objective Response Rate | ORR was defined as the percentage of participants who had a confirmed CR or PR as per RECIST v1.1. 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 14 months |
| Cohorts C1: Objective Response Rate | ORR was defined as the percentage of participants who had a confirmed CR or PR assessed by the investigator as per modified RECIST (mRECIST) v1.1. CR. 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 approximately 21 months |
| 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:
Participant must have been ≥18 years of age (or country's legal age of majority if >18 years), at the time of signing the informed consent.
Histologically or cytologically confirmed diagnosis of Stage IV NSCLC (cohorts A1, A2, and B1), or unresectable malignant pleural mesothelioma (cohort C1).
Cohort A1: PD-L1 expression TPS ≥ 50%
Cohort A2: PD-L1 expression TPS 1 - 49%
Prior anticancer therapy
Cohorts A1 and A2: No prior systemic therapy for advanced/metastatic NSCLC. Participants who received adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 6 months prior to the development of metastatic disease.
Cohort B1: One prior anti-PD1/PD-L1 regimen (may include chemotherapy) plus one additional chemotherapy regimen
Cohort C1: One or two prior systemic treatments that include pemetrexed-based regimen in combination with platinum agent.
All cohorts must have had a measurable disease
Mandatory baseline biopsy for the first 20 participants to enroll in cohorts A1, A2
Cohort B1: Based on the Investigator's judgment, either docetaxel or pemetrexed is not the best treatment option for the participant.
Females were eligible to participate if they were not pregnant or breastfeeding, not a woman of childbearing potential (WOCBP) or are a WOCBP that agrees:
Males were eligible to participate if they agree to refrain from donating or cryopreserving sperm, and either abstain from heterosexual intercourse OR use approved contraception during study treatment and for at least 210 days after discontinuing study treatment.
Capable of giving signed informed consent.
Exclusion Criteria:
Participants were excluded from the study if any of the following criteria applied:
The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University Hospital Site Number : 8400009 | Philadelphia | Pennsylvania | 19107 | United States | ||
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| Label | URL |
|---|---|
| ACT16849 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. The Cohorts B2 and A3 were not initiated and no participants were enrolled.
Note: Reason for not completed = Reason for permanent full intervention discontinuation.
This study was conducted at 31 centers (corresponds to number of sites which screened at least one participant) in 11 countries. Out of 152 participants who were screened from 23 September 2021 to 07 October 2022, 106 participants were enrolled in the study and were assigned to 1 of the 4 cohorts (Cohorts A1, A2, B1, and C1) based on their disease type.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A1:NSCLC, PD-L1 TPS >=50%:Pegenzileukin 24 μg/kg + Pembrolizumab as 1L Therapy | Participants with previously untreated Stage IV non-small cell lung cancer (NSCLC) and programmed cell death-ligand 1 (PD-L1) tumor proportion score (TPS) of >=50% were included in this cohort. Participants received pegenzileukin 24 microgram per kilogram (μg/kg) along with pembrolizumab 200 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 | Jul 31, 2025 |
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| Cohort C1: Mesothelioma: Pegenzileukin 24 μg /kg+Pembrolizumab as 2/3L Therapy | Experimental | Participants with mesothelioma who had no SOC established and had experienced PD during or after at least one but no more than 2 prior regimens were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. |
|
|
| Pembrolizumab | Drug | Intravenous infusion: solution for infusion |
|
|
| From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1) |
| All Cohorts: Number of Participants With Dose Limiting Toxicities (DLTs) | Selected events that occurred during DLT observation period were considered as DLT unless due to PD or to a cause obviously unrelated to pegenzileukin. Selected events included: grade (G) 4 neutropenia for >=7 consecutive days, G3 or 4 neutropenia complicated by fever or microbiologically or radiographically documented infection, G3 or 4 thrombocytopenia associated with clinically significant bleeding that required clinical intervention; G3 or above alanine aminotransferase or aspartate aminotransferase in combination with a bilirubin >2 times upper limit of normal with no evidence of cholestasis or another cause such as viral infection or other drugs;G3 or above vascular leak syndrome, hypotension, and cytokine release syndrome;any other G3; G3 or 4 non-hematologic laboratory value; any death not clearly due to the underlying disease or extraneous causes;any toxicity that required permanent discontinuation of the study treatment(s). | From Day 1 to Day 21 of Cycle 1 (each cycle is 21 days) |
| All Cohorts: Time to Response (TTR) | TTR was defined as the time from the date of 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 (NSCLC) and assessed by the investigator as per mRECIST v1.1 (mesothelioma). 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 27 months (Cohorts A1 and A2), 14 months (Cohort B1), and 24 months (Cohort C1) |
| All Cohorts: Duration of Response (DOR) | DOR was defined as time from date of first tumor assessment at which overall response was recorded as CR or PR that was subsequently confirmed to date of first documentation of objective PD before initiation of any post-treatment anti-cancer therapy or death due to any cause, whichever occurred first, as per RECIST v 1.1 (NSCLS) and assessed by investigator as per mRECIST v1.1 (mesothelioma). CR: 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: at least a 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters. PD:at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (this included baseline sum if that was smallest on study), in addition to relative increase of 20%, 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 27 months (Cohorts A1 and A2), 14 months (Cohort B1), and 24 months (Cohort C1) |
| All Cohorts: Clinical Benefit Rate (CBR) | The CBR was defined as the percentage of participants with clinical benefit: confirmed CR or PR as best overall response (BOR), or stable disease (SD) that lasted at least 6 months as per RECIST v 1.1 (NSCLS) and assessed by investigator as per mRECIST v1.1 (mesothelioma). CR: 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: at least a 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters. BOR was the best response observed from start of the study treatment until PD, death, cut-off date or initiation of post-treatment anticancer 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 27 months (Cohorts A1 and A2), 14 months (Cohort B1), and 24 months (Cohort C1) |
| All Cohorts: Progression Free Survival (PFS) | The PFS was defined as the time from the date of first study treatment 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 (NSCLS) and assessed by investigator as per mRECIST v1.1 (mesothelioma). 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 27 months (Cohorts A1 and A2), 14 months (Cohort B1), and 24 months (Cohort C1) |
| All Cohorts: Plasma Concentrations of Pegenzileukin | Blood samples were collected at specified timepoints for the assessment of plasma concentrations of pegenzileukin. The pharmacokinetic (PK) parameters were calculated using non-compartmental method. | Days 2 and 3 of Cycle 1 (each cycle is 21 days) |
| All Cohorts: Concentration at End of Infusion (Ceoi) of Pegenzileukin | Blood samples were collected at specified timepoints for the assessment of Ceoi of pegenzileukin. | Cycles 1, 2, 4, 7, 10, and 15 (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 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1) |
| Thomas Jefferson University - North East Site Number : 8401009 |
| Philadelphia |
| Pennsylvania |
| 19114 |
| United States |
| Investigational Site Number : 0320002 | CABA | Buenos Aires | 1430 | Argentina |
| Investigational Site Number : 0360002 | Richmond | Victoria | 3121 | Australia |
| Investigational Site Number : 1520005 | Santaigo | Reg Metropolitana de Santiago | 8241470 | Chile |
| Investigational Site Number : 1520004 | Santiago | Reg Metropolitana de Santiago | 7500713 | 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 : 1520003 | Temuco | 4800827 | Chile |
| Investigational Site Number : 2500006 | Bordeaux | France |
| Investigational Site Number : 2500005 | Paris | 75018 | France |
| Investigational Site Number : 2500001 | Saint-Herblain | 44800 | France |
| Investigational Site Number : 2500003 | Toulouse | 31059 | France |
| Investigational Site Number : 3800005 | Aviano (PN) | Friuli Venezia Giulia | 33081 | Italy |
| Investigational Site Number : 3800001 | Rozzano | Milano | 20089 | Italy |
| Investigational Site Number : 3800002 | Orbassano | Torino | 10043 | Italy |
| Investigational Site Number : 3800006 | Bologna | 40138 | Italy |
| Investigational Site Number : 3800004 | Milan | 20133 | Italy |
| Investigational Site Number : 3800008 | Padova | 35128 | Italy |
| Investigational Site Number : 3920001 | Sapporo | Hokkaido | 003-0804 | Japan |
| Investigational Site Number : 6160002 | Poznan | Greater Poland Voivodeship | 60-693 | Poland |
| Investigational Site Number : 6160001 | Warsaw | Masovian Voivodeship | 02-781 | Poland |
| Investigational Site Number : 6160003 | Gdansk | Pomeranian Voivodeship | 80-214 | Poland |
| Investigational Site Number : 6160004 | Olsztyn | Warmian-Masurian Voivodeship | 10-357 | Poland |
| Investigational Site Number : 4100002 | Seoul | Seoul-teukbyeolsi | 03080 | South Korea |
| Investigational Site Number : 4100003 | Seoul | Seoul-teukbyeolsi | 05505 | South Korea |
| Investigational Site Number : 4100001 | Seoul | Seoul-teukbyeolsi | 06351 | South Korea |
| Investigational Site Number : 7240006 | Barcelona | Barcelona [Barcelona] | 08035 | Spain |
| Investigational Site Number : 7240003 | Girona | Girona [Gerona] | 17007 | Spain |
| Investigational Site Number : 7240004 | Madrid | Madrid, Comunidad de | 28046 | Spain |
| Investigational Site Number : 7240002 | Madrid | 28034 | Spain |
| Investigational Site Number : 7240001 | Madrid | 28041 | Spain |
| Investigational Site Number : 1580003 | Taichung | 404 | Taiwan |
| Investigational Site Number : 1580002 | Tainan | 704 | Taiwan |
| Investigational Site Number : 1580005 | Taipei | Taiwan |
| FG001 | Cohort A2:NSCLC, PD-L1 TPS 1%-49%:Pegenzileukin 24 μg/kg+Pembrolizumab as 1L Therapy | Participants with previously untreated Stage IV NSCLC and PD-L1 TPS of 1%-49% were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 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 B1: NSCLC:Pegenzileukin 24 μg/kg+Pembrolizumab as 2/3L Therapy | Participants with NSCLC for whom standard of care (SOC) was not in their best interest or where no SOC was established were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as second-line or third-line [2/3L] therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. |
| FG003 | Cohort C1:Mesothelioma: Pegenzileukin 24 μg /kg+Pembrolizumab as 2/3L Therapy | Participants with mesothelioma who had no SOC established and had experienced PD during or after at least one but no more than 2 prior regimens were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L 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 (pegenzileukin or other anticancer therapies).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort A1:NSCLC, PD-L1 TPS >=50%:Pegenzileukin 24 μg/kg + Pembrolizumab as 1L Therapy | Participants with previously untreated Stage IV NSCLC and PD-L1 TPS of >=50% were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 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 A2:NSCLC, PD-L1 TPS 1%-49%:Pegenzileukin 24 μg/kg+Pembrolizumab as 1L Therapy | Participants with previously untreated Stage IV NSCLC and PD-L1 TPS of 1%-49% were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 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 B1: NSCLC:Pegenzileukin 24 μg/kg+Pembrolizumab as 2/3L Therapy | Participants with NSCLC for whom SOC was not in their best interest or where no SOC was established were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. |
| BG003 | Cohort C1:Mesothelioma:Pegenzileukin 24 μg /kg+Pembrolizumab as 2/3L Therapy | Participants with mesothelioma who had no SOC established and had experienced PD during or after at least one but no more than 2 prior regimens were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L 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 | Cohorts A1 and A2: Objective Response Rate (ORR) | ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. CR. 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 21 months |
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| Primary | Cohorts B1: Objective Response Rate | ORR was defined as the percentage of participants who had a confirmed CR or PR as per RECIST v1.1. 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. | 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 14 months |
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| Primary | Cohorts C1: Objective Response Rate | ORR was defined as the percentage of participants who had a confirmed CR or PR assessed by the investigator as per modified RECIST (mRECIST) v1.1. CR. 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. | Posted | Number | 90% Confidence Interval | percentage of participants | From first dose of study treatment administration (Day 1) up to approximately 21 months |
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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 (pegenzileukin or other anticancer therapies). | 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 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1) |
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| Secondary | All Cohorts: Number of Participants With Dose Limiting Toxicities (DLTs) | Selected events that occurred during DLT observation period were considered as DLT unless due to PD or to a cause obviously unrelated to pegenzileukin. Selected events included: grade (G) 4 neutropenia for >=7 consecutive days, G3 or 4 neutropenia complicated by fever or microbiologically or radiographically documented infection, G3 or 4 thrombocytopenia associated with clinically significant bleeding that required clinical intervention; G3 or above alanine aminotransferase or aspartate aminotransferase in combination with a bilirubin >2 times upper limit of normal with no evidence of cholestasis or another cause such as viral infection or other drugs;G3 or above vascular leak syndrome, hypotension, and cytokine release syndrome;any other G3; G3 or 4 non-hematologic laboratory value; any death not clearly due to the underlying disease or extraneous causes;any toxicity that required permanent discontinuation of the study treatment(s). | The DLT-evaluable population consisted of all exposed participants in the safety run-in who had been 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) |
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| Secondary | All Cohorts: Time to Response (TTR) | TTR was defined as the time from the date of 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 (NSCLC) and assessed by the investigator as per mRECIST v1.1 (mesothelioma). 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 | Mean | Standard Deviation | months | From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 27 months (Cohorts A1 and A2), 14 months (Cohort B1), and 24 months (Cohort C1) |
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| Secondary | All Cohorts: Duration of Response (DOR) | DOR was defined as time from date of first tumor assessment at which overall response was recorded as CR or PR that was subsequently confirmed to date of first documentation of objective PD before initiation of any post-treatment anti-cancer therapy or death due to any cause, whichever occurred first, as per RECIST v 1.1 (NSCLS) and assessed by investigator as per mRECIST v1.1 (mesothelioma). CR: 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: at least a 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters. PD:at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (this included baseline sum if that was smallest on study), in addition to relative increase of 20%, 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 27 months (Cohorts A1 and A2), 14 months (Cohort B1), and 24 months (Cohort C1) |
| ||||||||||||||||||||||||||||||
| Secondary | All Cohorts: Clinical Benefit Rate (CBR) | The CBR was defined as the percentage of participants with clinical benefit: confirmed CR or PR as best overall response (BOR), or stable disease (SD) that lasted at least 6 months as per RECIST v 1.1 (NSCLS) and assessed by investigator as per mRECIST v1.1 (mesothelioma). CR: 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: at least a 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters. BOR was the best response observed from start of the study treatment until PD, death, cut-off date or initiation of post-treatment anticancer 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 27 months (Cohorts A1 and A2), 14 months (Cohort B1), and 24 months (Cohort C1) |
| ||||||||||||||||||||||||||||||
| Secondary | All Cohorts: Progression Free Survival (PFS) | The PFS was defined as the time from the date of first study treatment 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 (NSCLS) and assessed by investigator as per mRECIST v1.1 (mesothelioma). 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 27 months (Cohorts A1 and A2), 14 months (Cohort B1), and 24 months (Cohort C1) |
| ||||||||||||||||||||||||||||||
| 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) parameters were calculated using non-compartmental method. | 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. Limited or no participants returned on the Cycle 1 Day 3 for sample collection. | Posted | Mean | Standard Deviation | nanogram/milliliter (ng/mL) | Days 2 and 3 of Cycle 1 (each cycle is 21 days) |
| ||||||||||||||||||||||||||||||
| Secondary | All Cohorts: Concentration at End of Infusion (Ceoi) of Pegenzileukin | Blood samples were collected at specified timepoints for the assessment of Ceoi of pegenzileukin. | The PK population consisted of all participants from exposed population with at least 1 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 on Cycle 15 in Cohort B1 Arm. | Posted | Mean | Standard Deviation | ng/mL | Cycles 1, 2, 4, 7, 10, and 15 (each cycle is 21 days) |
| ||||||||||||||||||||||||||||||
| 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 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1) |
|
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 28 months (Cohorts A1 and A2), 15 months (Cohort B1), and 25 months (Cohort C1). All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, approximately 32 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 A1:NSCLC, PD-L1 TPS >=50%:Pegenzileukin 24 μg/kg + Pembrolizumab as 1L Therapy | Participants with previously untreated Stage IV NSCLC and PD-L1 TPS of >=50% were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 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. | 3 | 17 | 6 | 17 | 16 | 17 |
| EG001 | Cohort A2:NSCLC, PD-L1 TPS 1%-49%:Pegenzileukin 24 μg/kg+Pembrolizumab as 1L Therapy | Participants with previously untreated Stage IV NSCLC and PD-L1 TPS of 1%-49% were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 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. | 13 | 20 | 11 | 20 | 18 | 20 |
| EG002 | Cohort B1: NSCLC:Pegenzileukin 24 μg/kg+Pembrolizumab as 2/3L Therapy | Participants with NSCLC for whom SOC was not in their best interest or where no SOC was established were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. | 26 | 40 | 21 | 40 | 38 | 40 |
| EG003 | Cohort C1:Mesothelioma:Pegenzileukin 24 μg /kg+Pembrolizumab as 2/3L Therapy | Participants with mesothelioma who had no SOC established were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. | 18 | 29 | 13 | 29 | 27 | 29 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Covid-19 | Infections and infestations | MedDra 27.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDra 27.0 | Systematic Assessment |
| |
| Oesophageal Candidiasis | Infections and infestations | MedDra 27.0 | Systematic Assessment |
| |
| Pleural Infection Bacterial | Infections and infestations | MedDra 27.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDra 27.0 | Systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDra 27.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDra 27.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDra 27.0 | Systematic Assessment |
| |
| Immune Thrombocytopenia | Blood and lymphatic system disorders | MedDra 27.0 | Systematic Assessment |
| |
| Cytokine Release Syndrome | Immune system disorders | MedDra 27.0 | Systematic Assessment |
| |
| Drug Hypersensitivity | Immune system disorders | MedDra 27.0 | Systematic Assessment |
| |
| Adrenal Insufficiency | Endocrine disorders | MedDra 27.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDra 27.0 | Systematic Assessment |
| |
| Brain Oedema | Nervous system disorders | MedDra 27.0 | Systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDra 27.0 | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDra 27.0 | Systematic Assessment |
| |
| Haemorrhage Intracranial | Nervous system disorders | MedDra 27.0 | Systematic Assessment |
| |
| Hemiparaesthesia | Nervous system disorders | MedDra 27.0 | Systematic Assessment |
| |
| Hepatic Encephalopathy | Nervous system disorders | MedDra 27.0 | Systematic Assessment |
| |
| Ischaemic Stroke | Nervous system disorders | MedDra 27.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDra 27.0 | Systematic Assessment |
| |
| Transient Ischaemic Attack | Nervous system disorders | MedDra 27.0 | Systematic Assessment |
| |
| Acute Coronary Syndrome | Cardiac disorders | MedDra 27.0 | Systematic Assessment |
| |
| Cardiac Failure Acute | Cardiac disorders | MedDra 27.0 | Systematic Assessment |
| |
| Immune-Mediated Myocarditis | Cardiac disorders | MedDra 27.0 | Systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDra 27.0 | Systematic Assessment |
| |
| Capillary Leak Syndrome | Vascular disorders | MedDra 27.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDra 27.0 | Systematic Assessment |
| |
| Acute Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDra 27.0 | Systematic Assessment |
| |
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDra 27.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDra 27.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDra 27.0 | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDra 27.0 | Systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDra 27.0 | Systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDra 27.0 | Systematic Assessment |
| |
| Pulmonary Hypertension | Respiratory, thoracic and mediastinal disorders | MedDra 27.0 | Systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDra 27.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDra 27.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDra 27.0 | Systematic Assessment |
| |
| Immune-Mediated Enterocolitis | Gastrointestinal disorders | MedDra 27.0 | Systematic Assessment |
| |
| Immune-Mediated Pancreatitis | Gastrointestinal disorders | MedDra 27.0 | Systematic Assessment |
| |
| Malignant Ascites | Gastrointestinal disorders | MedDra 27.0 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDra 27.0 | Systematic Assessment |
| |
| Nephritis | Renal and urinary disorders | MedDra 27.0 | Systematic Assessment |
| |
| Scrotal Oedema | Reproductive system and breast disorders | MedDra 27.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDra 27.0 | Systematic Assessment |
| |
| Disease Progression | General disorders | MedDra 27.0 | Systematic Assessment |
| |
| General Physical Health Deterioration | General disorders | MedDra 27.0 | Systematic Assessment |
| |
| Multiple Organ Dysfunction Syndrome | General disorders | MedDra 27.0 | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDra 27.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDra 27.0 | Systematic Assessment |
| |
| Infusion Related Reaction | Injury, poisoning and procedural complications | MedDra 27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDra 27.0 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDra 27.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDra 27.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDra 27.0 | Systematic Assessment |
| |
| Oral Fungal Infection | Infections and infestations | MedDra 27.0 | Systematic Assessment |
| |
| Oral Infection | Infections and infestations | MedDra 27.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDra 27.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDra 27.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDra 27.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDra 27.0 | Systematic Assessment |
| |
| Vascular Device Infection | Infections and infestations | MedDra 27.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDra 27.0 | Systematic Assessment |
| |
| Cytokine Release Syndrome | Immune system disorders | MedDra 27.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDra 27.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDra 27.0 | Systematic Assessment |
| |
| Immune-Mediated Hypophysitis | Endocrine disorders | MedDra 27.0 | Systematic Assessment |
| |
| Immune-Mediated Hypothyroidism | Endocrine disorders | MedDra 27.0 | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDra 27.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDra 27.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDra 27.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDra 27.0 | Systematic Assessment |
| |
| Anxiety Disorder | Psychiatric disorders | MedDra 27.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDra 27.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDra 27.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDra 27.0 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDra 27.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDra 27.0 | Systematic Assessment |
| |
| Sleep Deficit | Nervous system disorders | MedDra 27.0 | Systematic Assessment |
| |
| Trigeminal Neuralgia | Nervous system disorders | MedDra 27.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDra 27.0 | Systematic Assessment |
| |
| Periorbital Oedema | Eye disorders | MedDra 27.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDra 27.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDra 27.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDra 27.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDra 27.0 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDra 27.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDra 27.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDra 27.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDra 27.0 | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDra 27.0 | Systematic Assessment |
| |
| Pleuritic Pain | Respiratory, thoracic and mediastinal disorders | MedDra 27.0 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDra 27.0 | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDra 27.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDra 27.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDra 27.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDra 27.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDra 27.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDra 27.0 | Systematic Assessment |
| |
| Hepatic Cytolysis | Hepatobiliary disorders | MedDra 27.0 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDra 27.0 | Systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDra 27.0 | Systematic Assessment |
| |
| Dry Skin | Skin and subcutaneous tissue disorders | MedDra 27.0 | Systematic Assessment |
| |
| Immune-Mediated Dermatitis | Skin and subcutaneous tissue disorders | MedDra 27.0 | Systematic Assessment |
| |
| Night Sweats | Skin and subcutaneous tissue disorders | MedDra 27.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDra 27.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDra 27.0 | Systematic Assessment |
| |
| Rash Maculo-Papular | Skin and subcutaneous tissue disorders | MedDra 27.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDra 27.0 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDra 27.0 | Systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDra 27.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDra 27.0 | Systematic Assessment |
| |
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDra 27.0 | Systematic Assessment |
| |
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDra 27.0 | Systematic Assessment |
| |
| Sacral Pain | Musculoskeletal and connective tissue disorders | MedDra 27.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDra 27.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDra 27.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDra 27.0 | Systematic Assessment |
| |
| Feeling Hot | General disorders | MedDra 27.0 | Systematic Assessment |
| |
| Influenza Like Illness | General disorders | MedDra 27.0 | Systematic Assessment |
| |
| Lithiasis | General disorders | MedDra 27.0 | Systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | MedDra 27.0 | Systematic Assessment |
| |
| Oedema | General disorders | MedDra 27.0 | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDra 27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDra 27.0 | Systematic Assessment |
| |
| Xerosis | General disorders | MedDra 27.0 | Systematic Assessment |
| |
| Amylase Increased | Investigations | MedDra 27.0 | Systematic Assessment |
| |
| Blood Bilirubin Increased | Investigations | MedDra 27.0 | Systematic Assessment |
| |
| Blood Magnesium Increased | Investigations | MedDra 27.0 | Systematic Assessment |
| |
| Blood Thyroid Stimulating Hormone Increased | Investigations | MedDra 27.0 | Systematic Assessment |
| |
| Lipase Increased | Investigations | MedDra 27.0 | Systematic Assessment |
| |
| Weight Decreased | Investigations | MedDra 27.0 | Systematic Assessment |
| |
| Infusion Related Reaction | Injury, poisoning and procedural complications | MedDra 27.0 | 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 | Dec 6, 2022 | Jul 31, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000086002 | Mesothelioma, Malignant |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D008654 | Mesothelioma |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018301 | Neoplasms, Mesothelial |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D010997 | Pleural Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| 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 |
|
|
|
| Participants |
|
|
| OG001 | Cohort A2:NSCLC, PD-L1 TPS 1%-49%:Pegenzileukin 24 μg/kg+Pembrolizumab as 1L Therapy | Participants with previously untreated Stage IV NSCLC and PD-L1 TPS of 1%-49% were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 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 B1: NSCLC:Pegenzileukin 24 μg/kg+Pembrolizumab as 2/3L Therapy | Participants with NSCLC for whom SOC was not in their best interest or where no SOC was established were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. |
| OG003 | Cohort C1:Mesothelioma:Pegenzileukin 24 μg /kg+Pembrolizumab as 2/3L Therapy | Participants with mesothelioma who had no SOC established and had experienced PD during or after at least one but no more than 2 prior regimens were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. |
|
|
| OG001 | Cohort A2:NSCLC, PD-L1 TPS 1%-49%:Pegenzileukin 24 μg/kg+Pembrolizumab as 1L Therapy | Participants with previously untreated Stage IV NSCLC and PD-L1 TPS of 1%-49% were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 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 B1: NSCLC:Pegenzileukin 24 μg/kg+Pembrolizumab as 2/3L Therapy | Participants with NSCLC for whom SOC was not in their best interest or where no SOC was established were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. |
| OG003 | Cohort C1:Mesothelioma:Pegenzileukin 24 μg /kg+Pembrolizumab as 2/3L Therapy | Participants with mesothelioma who had no SOC established and had experienced PD during or after at least one but no more than 2 prior regimens were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. |
|
|
| OG001 |
| Cohort A2:NSCLC, PD-L1 TPS 1%-49%:Pegenzileukin 24 μg/kg+Pembrolizumab as 1L Therapy |
Participants with previously untreated Stage IV NSCLC and PD-L1 TPS of 1%-49% were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 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 B1: NSCLC:Pegenzileukin 24 μg/kg+Pembrolizumab as 2/3L Therapy | Participants with NSCLC for whom SOC was not in their best interest or where no SOC was established were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. |
| OG003 | Cohort C1:Mesothelioma:Pegenzileukin 24 μg /kg+Pembrolizumab as 2/3L Therapy | Participants with mesothelioma who had no SOC established and had experienced PD during or after at least one but no more than 2 prior regimens were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. |
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| OG001 | Cohort A2:NSCLC, PD-L1 TPS 1%-49%:Pegenzileukin 24 μg/kg+Pembrolizumab as 1L Therapy | Participants with previously untreated Stage IV NSCLC and PD-L1 TPS of 1%-49% were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 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 B1: NSCLC:Pegenzileukin 24 μg/kg+Pembrolizumab as 2/3L Therapy | Participants with NSCLC for whom SOC was not in their best interest or where no SOC was established were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. |
| OG003 | Cohort C1:Mesothelioma:Pegenzileukin 24 μg /kg+Pembrolizumab as 2/3L Therapy | Participants with mesothelioma who had no SOC established and had experienced PD during or after at least one but no more than 2 prior regimens were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. |
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|
| OG001 | Cohort A2:NSCLC, PD-L1 TPS 1%-49%:Pegenzileukin 24 μg/kg+Pembrolizumab as 1L Therapy | Participants with previously untreated Stage IV NSCLC and PD-L1 TPS of 1%-49% were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 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 B1: NSCLC:Pegenzileukin 24 μg/kg+Pembrolizumab as 2/3L Therapy | Participants with NSCLC for whom SOC was not in their best interest or where no SOC was established were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. |
| OG003 | Cohort C1:Mesothelioma:Pegenzileukin 24 μg /kg+Pembrolizumab as 2/3L Therapy | Participants with mesothelioma who had no SOC established and had experienced PD during or after at least one but no more than 2 prior regimens were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. |
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|
| Cohort A2:NSCLC, PD-L1 TPS 1%-49%:Pegenzileukin 24 μg/kg+Pembrolizumab as 1L Therapy |
Participants with previously untreated Stage IV NSCLC and PD-L1 TPS of 1%-49% were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 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 B1: NSCLC:Pegenzileukin 24 μg/kg+Pembrolizumab as 2/3L Therapy | Participants with NSCLC for whom SOC was not in their best interest or where no SOC was established were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. |
| OG003 | Cohort C1:Mesothelioma:Pegenzileukin 24 μg /kg+Pembrolizumab as 2/3L Therapy | Participants with mesothelioma who had no SOC established and had experienced PD during or after at least one but no more than 2 prior regimens were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. |
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|
| OG002 | Cohort B1: NSCLC:Pegenzileukin 24 μg/kg+Pembrolizumab as 2/3L Therapy | Participants with NSCLC for whom SOC was not in their best interest or where no SOC was established were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. |
| OG003 | Cohort C1:Mesothelioma:Pegenzileukin 24 μg /kg+Pembrolizumab as 2/3L Therapy | Participants with mesothelioma who had no SOC established and had experienced PD during or after at least one but no more than 2 prior regimens were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. |
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|
| OG002 | Cohort B1: NSCLC:Pegenzileukin 24 μg/kg+Pembrolizumab as 2/3L Therapy | Participants with NSCLC for whom SOC was not in their best interest or where no SOC was established were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. |
| OG003 | Cohort C1:Mesothelioma:Pegenzileukin 24 μg /kg+Pembrolizumab as 2/3L Therapy | Participants with mesothelioma who had no SOC established and had experienced PD during or after at least one but no more than 2 prior regimens were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. |
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|
| Cohort A2:NSCLC, PD-L1 TPS 1%-49%:Pegenzileukin 24 μg/kg+Pembrolizumab as 1L Therapy |
Participants with previously untreated Stage IV NSCLC and PD-L1 TPS of 1%-49% were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 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 B1: NSCLC:Pegenzileukin 24 μg/kg+Pembrolizumab as 2/3L Therapy | Participants with NSCLC for whom SOC was not in their best interest or where no SOC was established were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. |
| OG003 | Cohort C1:Mesothelioma:Pegenzileukin 24 μg /kg+Pembrolizumab as 2/3L Therapy | Participants with mesothelioma who had no SOC established and had experienced PD during or after at least one but no more than 2 prior regimens were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35. |
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