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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1251-5073 | Registry Identifier | ICTRP | |
| KEYNOTE-B75 | Other Identifier | Merck Sharp & Dohme LLC. | |
| 2021-002105-99 | 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 study was a phase 2 multi-cohort, non-randomized, open-label, multi-center study assessing the clinical benefit of SAR444245 combined with other anticancer therapies for the treatment of participants aged 18 years and older with HNSCC. This study was structured as a master protocol for the investigation of SAR444245 with other anticancer therapies.
Substudy 1-Cohort A1 aimed to establish proof-of-concept that SAR444245 combined with the anti-PD1 antibody pembrolizumab, will result in a significant increase in the observed number of objective responses in trial participants with HNSCC who were treatment-naïve for recurrent and/or metastatic (R/M) disease.
Substudy 4-Cohort B1 aimed to establish proof-of-concept that SAR444245 combined with the anti-PD1 antibody pembrolizumab, will result in a significant increase in the observed number of objective responses in trial participants with HNSCC who have received treatment with PD1/PD-L1 and platinum-based regimen.
Substudy 5-Cohort B2 aimed to establish proof-of-concept that SAR444245 combined with cetuximab will result in a significant increase in the observed number of objective responses in trial participants with HNSCC previously treated with platinum-based regimen & cetuximab-naive after failure of no more than 2 regimens for recurrent and/or metastatic (R/M) disease.
The duration of the study for an individual participant started from the signature of the main informed consent and included:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A1 (sub study 01) treatment- naïve | Experimental | Participants with HNSCC, who were treatment-naïve for R/M disease and have a PD-L1 Combined Positive Score (CPS) ≥1, received pembrolizumab followed by SAR444245. Both drugs administered by intravenous (IV) infusion on Day 1 of each 21-day treatment cycle for up to 35 cycles. |
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| Cohort B1: (sub study 04) PD1/PD-L1 and platinum-based treatments | Experimental | Participants with HNSCC who received treatment with a PD1/PD-L1-based regimen & platinum-based regimen and have failed no more than 2 regimens for R/M disease, received pembrolizumab followed by SAR444244. Both drugs administered IV infusion on Day 1 of each 21-day treatment cycle for up to 35 cycles |
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| Cohort B2: (sub study 05) cetuximab- naïve | Experimental | Participants with R/M HNSCC, who were cetuximab-naïve, have received treatment with a platinum-based regimen, and have failed no more than 2 regimens for R/M disease, received treatment with cetuximab followed by SAR444245. Cetuximab IV was given on days 1, 8, and 15 of each 21 day. SAR444245 was administered by IV infusion on Day 1 of each 21-day treatment cycle. Dosing of both drugs continued until disease progression, unacceptable toxicity, or withdrawal of consent. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pembrolizumab | Drug | Pharmaceutical Form: Concentration for solution for infusion Route of Administration: Intravenous Infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cohort A1: 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 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 |
| Cohort B1: Objective Response Rate | ORR was defined as the percentage of participants who had a confirmed CR or PR as per RECIST v 1.1. 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 approximately 21 months |
| Cohort B2: Objective Response Rate | ORR was defined as the percentage of participants who had a confirmed CR or PR as per RECIST v 1.1. 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 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:
-Participants were ≥ 18 years of age inclusive, at the time of signing the informed consent
Exclusion Criteria:
-Eastern Cooperative Oncology Group (ECOG) performance status of ≥2
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope- Site Number : 8400007 | Duarte | California | 91010 | United States | ||
| University of Colorado- Site Number : 8400004 |
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| Label | URL |
|---|---|
| Related Info | View source |
| ACT16903 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. Cohort A2 was not initiated and no participants were enrolled. Note: Reason for not completed = Reason for permanent full intervention discontinuation.
This study was conducted at 27 centers (corresponds to number of site which screened at least one participant) in 12 countries. Out of 91 participants who were screened from 08 October 2021 to 21 October 2022, a total of 59 participants were enrolled in the study and were assigned to 1 of the 3 cohorts (Cohorts A1, B1 and B2) based on their disease type.
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| ID | Title | Description |
|---|---|---|
| FG000 | CohortA1:R/M HNSCC Treatment-naïve for R/M Disease:Pegenzileukin 24mcg/kg+Pembrolizumab as 1LTherapy | Participants with head and neck squamous cell carcinoma (HNSCC) who were treatment-naïve for recurrent and/or metastatic (R/M) disease with programmed cell death-ligand 1 (PD-L1) combined positive score (CPS) >=1 were included in this cohort. Participants received pegenzileukin 24 microgram per kilogram (mcg/kg) along with pembrolizumab 200 milligram (mg) via intravenous (IV) infusion 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), 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 | Dec 22, 2021 | Jul 23, 2025 |
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| SAR444245 (Thor-707) | Drug | Pharmaceutical Form: Concentrate for solution for infusion Route of Administration: Intravenous Infusion |
|
| Cetuximab | Drug | Pharmaceutical Form: Solution for infusion Route of Administration: Intravenous Infusion |
|
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| From first dose of study treatment administration (Day 1) up to 30 days post last dose of study treatment administration, up to approximately 28 months (Cohort A1), 27 months (Cohort B1) and 26 months (Cohort B2) |
| 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. 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 (Cohort A1), 26 months (Cohort B1) and 25 months (Cohort B2) |
| All Cohorts: Duration of Response (DOR) | DOR was defined as the time from the date of first tumor assessment at which the overall response was recorded as CR or PR that was subsequently confirmed to the date of first documentation of objective PD before the initiation of any post-treatment anti-cancer therapy or death due to any cause, whichever occurred first, as per RECIST v 1.1. 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. 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 (Cohort A1), 26 months (Cohort B1) and 25 months (Cohort B2) |
| All Cohorts: Clinical Benefit Rate (CBR) | CBR was defined as the percentage of participants with clinical benefit (confirmed CR or PR as best overall response [BOR], or SD lasting at least 6 months), as per RECIST v 1.1. 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 <10mm (<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 recorded from the start of the study treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started). 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 (Cohort A1), 26 months (Cohort B1) and 25 months (Cohort B2) |
| All Cohorts: Progression-Free Survival (PFS) | 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. 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 (Cohort A1), 26 months (Cohort B1) and 25 months (Cohort B2) |
| Plasma Concentration of Pegenzileukin | Blood samples were collected at specified timepoints for the assessment of plasma concentration of pegenzileukin. | Cycle 1 Day 2 (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 are presented. | From first dose of study treatment administration (Day 1) up to 30 days post last dose of study treatment administration, up to approximately 28 months (Cohort A1), 27 months (Cohort B1) and 26 months (Cohort B2) |
| Aurora |
| Colorado |
| 80045 |
| United States |
| University of Michigan- Site Number : 8400008 | Ann Arbor | Michigan | 48109 | United States |
| Thomas Jefferson University Hospital Site Number : 8400003 | Philadelphia | Pennsylvania | 19107 | United States |
| Seattle Cancer Care Alliance Site Number : 8400006 | Seattle | Washington | 98115 | United States |
| Investigational Site Number : 0320001 | Buenos Aires | 1012 | Argentina |
| Investigational Site Number : 1240001 | Montreal | Quebec | H4A 3J1 | Canada |
| Investigational Site Number : 1520003 | Santiago | Reg Metropolitana de Santiago | 7500921 | Chile |
| Investigational Site Number : 1520001 | Santiago | Reg Metropolitana de Santiago | 8420383 | Chile |
| Investigational Site Number : 1520004 | Viña del Mar | Valparaiso | 2540488 | Chile |
| Investigational Site Number : 1520002 | Temuco | 4800827 | Chile |
| Investigational Site Number : 2500003 | Bordeaux | 33075 | France |
| Investigational Site Number : 2500008 | Lyon | 69008 | France |
| Investigational Site Number : 2500006 | Paris | 75015 | France |
| Investigational Site Number : 2500002 | Strasbourg | 67033 | France |
| Investigational Site Number : 2500001 | Villejuif | 94800 | France |
| Investigational Site Number : 2760004 | Berlin | 12200 | Germany |
| Investigational Site Number : 3800003 | Brescia | 25123 | Italy |
| Investigational Site Number : 5280002 | Amsterdam | 1066 | Netherlands |
| Investigational Site Number : 5280001 | Nijmegen | 6500 HB | Netherlands |
| Investigational Site Number : 4100002 | Seoul | Seoul-teukbyeolsi | 05505 | South Korea |
| Investigational Site Number : 4100001 | Seoul | Seoul-teukbyeolsi | 06351 | South Korea |
| Investigational Site Number : 7240001 | Barcelona | Barcelona [Barcelona] | 08035 | Spain |
| Investigational Site Number : 7240004 | Barcelona | Barcelona [Barcelona] | 08036 | Spain |
| Investigational Site Number : 7240005 | Madrid | Madrid, Comunidad de | 28040 | Spain |
| Investigational Site Number : 7240003 | Madrid | Madrid, Comunidad de | 28046 | Spain |
| Investigational Site Number : 1580003 | Tainan | 704 | Taiwan |
| FG001 | Cohort B1: R/M HNSCC: Pegenzileukin 24 mcg/kg + Pembrolizumab as 2/3L Therapy | Participants with R/M HNSCC previously treated with programmed cell death protein (PD1)/PD-L1-based regimen and platinum-based regimen after failure of no more than 2 regimens for R/M disease were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as second or third line [2/3L] therapy), until PD, unacceptable AE, other full permanent discontinuation criteria was met or completion of Cycle 35. |
| FG002 | Cohort B2: R/M HNSCC: Pegenzileukin 24 mcg/kg + Cetuximab as 2/3L Therapy | Participants with R/M HNSCC previously treated with platinum-based regimen and cetuximab-naïve after failure of no more than 2 regimens for R/M disease were included in this cohort. Participants received pegenzileukin 24 mcg/kg q3w on Day 1 of each cycle along with cetuximab as an initial loading dose of 400 mg/square meter (m^2) on Cycle 1 Day 1 followed by 250 mg/m^2 starting via IV infusion once weekly from Cycle 1 Day 8 (each cycle is 21 days) (as 2/3L therapy) until PD. |
| COMPLETED |
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| NOT COMPLETED |
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The exposed population included all participants who had given their informed consent and received at least one dose of study treatment (pegenzileukin or other anticancer therapies).
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| ID | Title | Description |
|---|---|---|
| BG000 | CohortA1:R/M HNSCC Treatment-naïve for R/M Disease:Pegenzileukin 24mcg/kg+Pembrolizumab as 1LTherapy | Participants with HNSCC who were treatment-naïve for R/M disease with PD-L1 CPS >=1 were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 1L therapy), until PD, unacceptable AE, other full permanent discontinuation criteria was met or completion of Cycle 35. |
| BG001 | Cohort B1: R/M HNSCC: Pegenzileukin 24 mcg/kg + Pembrolizumab as 2/3L Therapy | Participants with R/M HNSCC previously treated with PD1/PD-L1-based regimen and platinum-based regimen after failure of no more than 2 regimens for R/M disease were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE, other full permanent discontinuation criteria was met or completion of Cycle 35. |
| BG002 | Cohort B2: R/M HNSCC: Pegenzileukin 24 mcg/kg + Cetuximab as 2/3L Therapy | Participants with R/M HNSCC previously treated with platinum-based regimen and cetuximab-naïve after failure of no more than 2 regimens for R/M disease were included in this cohort. Participants received pegenzileukin 24 mcg/kg q3w on Day 1 of each cycle along with cetuximab as an initial loading dose of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 starting via IV infusion once weekly from Cycle 1 Day 8 (each cycle is 21 days) (as 2/3L therapy) until PD. |
| BG003 | 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 | Cohort A1: 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 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 included 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 | Cohort B1: Objective Response Rate | ORR was defined as the percentage of participants who had a confirmed CR or PR as per RECIST v 1.1. 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 included 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 | Cohort B2: Objective Response Rate | ORR was defined as the percentage of participants who had a confirmed CR or PR as per RECIST v 1.1. 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 included 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 included 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 administration (Day 1) up to 30 days post last dose of study treatment administration, up to approximately 28 months (Cohort A1), 27 months (Cohort B1) and 26 months (Cohort B2) |
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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. 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 included 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 27 months (Cohort A1), 26 months (Cohort B1) and 25 months (Cohort B2) |
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| Secondary | All Cohorts: Duration of Response (DOR) | DOR was defined as the time from the date of first tumor assessment at which the overall response was recorded as CR or PR that was subsequently confirmed to the date of first documentation of objective PD before the initiation of any post-treatment anti-cancer therapy or death due to any cause, whichever occurred first, as per RECIST v 1.1. 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. 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 included 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 (Cohort A1), 26 months (Cohort B1) and 25 months (Cohort B2) |
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| Secondary | All Cohorts: Clinical Benefit Rate (CBR) | CBR was defined as the percentage of participants with clinical benefit (confirmed CR or PR as best overall response [BOR], or SD lasting at least 6 months), as per RECIST v 1.1. 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 <10mm (<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 recorded from the start of the study treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started). 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 included 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 (Cohort A1), 26 months (Cohort B1) and 25 months (Cohort B2) |
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| Secondary | All Cohorts: Progression-Free Survival (PFS) | 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. 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 included 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 (Cohort A1), 26 months (Cohort B1) and 25 months (Cohort B2) |
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| Secondary | Plasma Concentration of Pegenzileukin | Blood samples were collected at specified timepoints for the assessment of plasma concentration of pegenzileukin. | The pharmacokinetic (PK) population included all participants from exposed population with at least one PK concentration available after the first dose of study treatment. | Posted | Mean | Standard Deviation | nanograms per milliliter | Cycle 1 Day 2 (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 are presented. | The ADA population included all participants from 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 administration (Day 1) up to 30 days post last dose of study treatment administration, up to approximately 28 months (Cohort A1), 27 months (Cohort B1) and 26 months (Cohort B2) |
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AEs and SAEs were collected from first dose of study treatment administration (Day 1) up to 30 days post last dose of study treatment administration, up to approximately 28 months (Cohort A1), 27 months (Cohort B1) and 26 months (Cohort B2). All-cause mortality (deaths) were collected from first dose of study treatment administration (Day 1) to the end of follow-up for death for each participant, up to approximately 30 months.
Analysis was performed on the exposed population.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CohortA1:R/M HNSCC Treatment-naïve for R/M Disease:Pegenzileukin 24mcg/kg+Pembrolizumab as 1LTherapy | Participants with HNSCC who were treatment-naïve for R/M disease with PD-L1 CPS >=1 were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 1L therapy), until PD, unacceptable AE, other full permanent discontinuation criteria was met or completion of Cycle 35. | 8 | 20 | 11 | 20 | 20 | 20 |
| EG001 | Cohort B1: R/M HNSCC: Pegenzileukin 24 mcg/kg + Pembrolizumab as 2/3L Therapy | Participants with R/M HNSCC previously treated with PD1/PD-L1-based regimen and platinum-based regimen after failure of no more than 2 regimens for R/M disease were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE, other full permanent discontinuation criteria was met or completion of Cycle 35. | 13 | 20 | 11 | 20 | 18 | 20 |
| EG002 | Cohort B2: R/M HNSCC: Pegenzileukin 24 mcg/kg + Cetuximab as 2/3L Therapy | Participants with R/M HNSCC previously treated with platinum-based regimen and cetuximab-naïve after failure of no more than 2 regimens for R/M disease were included in this cohort. Participants received pegenzileukin 24 mcg/kg q3w on Day 1 of each cycle along with cetuximab as an initial loading dose of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 starting via IV infusion once weekly from Cycle 1 Day 8 (each cycle is 21 days) (as 2/3L therapy) until PD. | 10 | 19 | 8 | 19 | 19 | 19 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abscess Neck | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Atypical Pneumonia | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Catheter Site Infection | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Pneumonia Aspiration | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Staphylococcal Infection | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Wound Infection | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Cytokine Release Syndrome | Immune system disorders | MedDra 27.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDra 27.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDra 27.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDra 27.1 | Systematic Assessment |
| |
| Acute Cardiac Event | Cardiac disorders | MedDra 27.1 | Systematic Assessment |
| |
| Acute Myocardial Infarction | Cardiac disorders | MedDra 27.1 | Systematic Assessment |
| |
| Cardiac Arrest | Cardiac disorders | MedDra 27.1 | Systematic Assessment |
| |
| Cardio-Respiratory Arrest | Cardiac disorders | MedDra 27.1 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDra 27.1 | Systematic Assessment |
| |
| Capillary Leak Syndrome | Vascular disorders | MedDra 27.1 | Systematic Assessment |
| |
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Obstructive Airways Disorder | Respiratory, thoracic and mediastinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | MedDra 27.1 | Systematic Assessment |
| |
| Death | General disorders | MedDra 27.1 | Systematic Assessment |
| |
| Disease Progression | General disorders | MedDra 27.1 | Systematic Assessment |
| |
| General Physical Health Deterioration | General disorders | MedDra 27.1 | Systematic Assessment |
| |
| Hyperthermia | General disorders | MedDra 27.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDra 27.1 | Systematic Assessment |
| |
| Systemic Inflammatory Response Syndrome | General disorders | MedDra 27.1 | Systematic Assessment |
| |
| Infusion Related Reaction | Injury, poisoning and procedural complications | MedDra 27.1 | Systematic Assessment |
| |
| Wound Haemorrhage | Injury, poisoning and procedural complications | MedDra 27.1 | Systematic Assessment |
| |
| Gastrostomy | Surgical and medical procedures | MedDra 27.1 | Systematic Assessment |
| |
| Device Occlusion | Product Issues | MedDra 27.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bacteraemia | 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 |
| |
| Conjunctivitis | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Localised Infection | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Oral Candidiasis | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Oral Herpes | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Pneumonia Aspiration | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Post Procedural Infection | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDra 27.1 | Systematic Assessment |
| |
| Hyperleukocytosis | 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 |
| |
| Hypothyroidism | Endocrine disorders | MedDra 27.1 | Systematic Assessment |
| |
| Cell Death | Metabolism and nutrition disorders | MedDra 27.1 | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDra 27.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDra 27.1 | Systematic Assessment |
| |
| Hypokalaemia | 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 |
| |
| Depression | Psychiatric disorders | MedDra 27.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDra 27.1 | Systematic Assessment |
| |
| Panic Attack | Psychiatric disorders | MedDra 27.1 | Systematic Assessment |
| |
| Brain Fog | 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 |
| |
| Presyncope | Nervous system disorders | MedDra 27.1 | Systematic Assessment |
| |
| Eye Pain | Eye disorders | MedDra 27.1 | Systematic Assessment |
| |
| Ear Pain | Ear and labyrinth disorders | MedDra 27.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDra 27.1 | Systematic Assessment |
| |
| Sinus Tachycardia | Cardiac disorders | MedDra 27.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDra 27.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDra 27.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDra 27.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Lung Disorder | Respiratory, thoracic and mediastinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Nasal Inflammation | Respiratory, thoracic and mediastinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Pharyngeal Haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Productive Cough | Respiratory, thoracic and mediastinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Abdominal Distension | Gastrointestinal 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 |
| |
| 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 |
| |
| Dysphagia | Gastrointestinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Oral Dysaesthesia | Gastrointestinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Salivary Hypersecretion | Gastrointestinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Tongue Ulceration | Gastrointestinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDra 27.1 | Systematic Assessment |
| |
| Cellulite | Skin and subcutaneous tissue disorders | MedDra 27.1 | Systematic Assessment |
| |
| Decubitus Ulcer | Skin and subcutaneous tissue disorders | MedDra 27.1 | Systematic Assessment |
| |
| Dermatitis Acneiform | Skin and subcutaneous tissue disorders | MedDra 27.1 | Systematic Assessment |
| |
| Dry Skin | Skin and subcutaneous tissue disorders | MedDra 27.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDra 27.1 | Systematic Assessment |
| |
| Night Sweats | Skin and subcutaneous tissue disorders | MedDra 27.1 | Systematic Assessment |
| |
| Onycholysis | Skin and subcutaneous tissue disorders | MedDra 27.1 | Systematic Assessment |
| |
| Palmar-Plantar Erythrodysaesthesia Syndrome | Skin and subcutaneous tissue disorders | MedDra 27.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDra 27.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDra 27.1 | Systematic Assessment |
| |
| Rash Maculo-Papular | Skin and subcutaneous tissue disorders | MedDra 27.1 | Systematic Assessment |
| |
| Rash Vesicular | Skin and subcutaneous tissue disorders | MedDra 27.1 | Systematic Assessment |
| |
| Skin Discharge | Skin and subcutaneous tissue disorders | MedDra 27.1 | Systematic Assessment |
| |
| Skin Swelling | Skin and subcutaneous tissue disorders | MedDra 27.1 | Systematic Assessment |
| |
| Skin Ulcer | 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 |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDra 27.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDra 27.1 | Systematic Assessment |
| |
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDra 27.1 | Systematic Assessment |
| |
| Pathological Fracture | Musculoskeletal and connective tissue disorders | MedDra 27.1 | Systematic Assessment |
| |
| Chromaturia | Renal and urinary disorders | MedDra 27.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDra 27.1 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDra 27.1 | Systematic Assessment |
| |
| Adverse Drug Reaction | General disorders | MedDra 27.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDra 27.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDra 27.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDra 27.1 | Systematic Assessment |
| |
| Feeling Hot | General disorders | MedDra 27.1 | Systematic Assessment |
| |
| Hyperpyrexia | General disorders | MedDra 27.1 | Systematic Assessment |
| |
| Influenza Like Illness | General disorders | MedDra 27.1 | Systematic Assessment |
| |
| Mucosal Inflammation | General disorders | MedDra 27.1 | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDra 27.1 | Systematic Assessment |
| |
| Pain | 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 |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDra 27.1 | Systematic Assessment |
| |
| Blood Alkaline Phosphatase Increased | 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 Glucose 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 Pressure Increased | Investigations | MedDra 27.1 | Systematic Assessment |
| |
| Blood Thyroid Stimulating Hormone Increased | Investigations | MedDra 27.1 | Systematic Assessment |
| |
| Weight Decreased | Investigations | MedDra 27.1 | Systematic Assessment |
| |
| Weight Increased | Investigations | 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 |
|
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 ext 6# | Contact-US@sanofi.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 30, 2022 | Jul 23, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| D000068818 | Cetuximab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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 B1: R/M HNSCC: Pegenzileukin 24 mcg/kg + Pembrolizumab as 2/3L Therapy | Participants with R/M HNSCC previously treated with PD1/PD-L1-based regimen and platinum-based regimen after failure of no more than 2 regimens for R/M disease were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE, other full permanent discontinuation criteria was met or completion of Cycle 35. |
| OG002 | Cohort B2: R/M HNSCC: Pegenzileukin 24 mcg/kg + Cetuximab as 2/3L Therapy | Participants with R/M HNSCC previously treated with platinum-based regimen and cetuximab-naïve after failure of no more than 2 regimens for R/M disease were included in this cohort. Participants received pegenzileukin 24 mcg/kg q3w on Day 1 of each cycle along with cetuximab as an initial loading dose of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 starting via IV infusion once weekly from Cycle 1 Day 8 (each cycle is 21 days) (as 2/3L therapy) until PD. |
|
|
Participants with R/M HNSCC previously treated with PD1/PD-L1-based regimen and platinum-based regimen after failure of no more than 2 regimens for R/M disease were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE, other full permanent discontinuation criteria was met or completion of Cycle 35. |
| OG002 | Cohort B2: R/M HNSCC: Pegenzileukin 24 mcg/kg + Cetuximab as 2/3L Therapy | Participants with R/M HNSCC previously treated with platinum-based regimen and cetuximab-naïve after failure of no more than 2 regimens for R/M disease were included in this cohort. Participants received pegenzileukin 24 mcg/kg q3w on Day 1 of each cycle along with cetuximab as an initial loading dose of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 starting via IV infusion once weekly from Cycle 1 Day 8 (each cycle is 21 days) (as 2/3L therapy) until PD. |
|
|
| OG001 | Cohort B1: R/M HNSCC: Pegenzileukin 24 mcg/kg + Pembrolizumab as 2/3L Therapy | Participants with R/M HNSCC previously treated with PD1/PD-L1-based regimen and platinum-based regimen after failure of no more than 2 regimens for R/M disease were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE, other full permanent discontinuation criteria was met or completion of Cycle 35. |
| OG002 | Cohort B2: R/M HNSCC: Pegenzileukin 24 mcg/kg + Cetuximab as 2/3L Therapy | Participants with R/M HNSCC previously treated with platinum-based regimen and cetuximab-naïve after failure of no more than 2 regimens for R/M disease were included in this cohort. Participants received pegenzileukin 24 mcg/kg q3w on Day 1 of each cycle along with cetuximab as an initial loading dose of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 starting via IV infusion once weekly from Cycle 1 Day 8 (each cycle is 21 days) (as 2/3L therapy) until PD. |
|
|
| OG001 | Cohort B1: R/M HNSCC: Pegenzileukin 24 mcg/kg + Pembrolizumab as 2/3L Therapy | Participants with R/M HNSCC previously treated with PD1/PD-L1-based regimen and platinum-based regimen after failure of no more than 2 regimens for R/M disease were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE, other full permanent discontinuation criteria was met or completion of Cycle 35. |
| OG002 | Cohort B2: R/M HNSCC: Pegenzileukin 24 mcg/kg + Cetuximab as 2/3L Therapy | Participants with R/M HNSCC previously treated with platinum-based regimen and cetuximab-naïve after failure of no more than 2 regimens for R/M disease were included in this cohort. Participants received pegenzileukin 24 mcg/kg q3w on Day 1 of each cycle along with cetuximab as an initial loading dose of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 starting via IV infusion once weekly from Cycle 1 Day 8 (each cycle is 21 days) (as 2/3L therapy) until PD. |
|
|
Participants with R/M HNSCC previously treated with PD1/PD-L1-based regimen and platinum-based regimen after failure of no more than 2 regimens for R/M disease were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE, other full permanent discontinuation criteria was met or completion of Cycle 35. |
| OG002 | Cohort B2: R/M HNSCC: Pegenzileukin 24 mcg/kg + Cetuximab as 2/3L Therapy | Participants with R/M HNSCC previously treated with platinum-based regimen and cetuximab-naïve after failure of no more than 2 regimens for R/M disease were included in this cohort. Participants received pegenzileukin 24 mcg/kg q3w on Day 1 of each cycle along with cetuximab as an initial loading dose of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 starting via IV infusion once weekly from Cycle 1 Day 8 (each cycle is 21 days) (as 2/3L therapy) until PD. |
|
|
| OG002 | Cohort B2: R/M HNSCC: Pegenzileukin 24 mcg/kg + Cetuximab as 2/3L Therapy | Participants with R/M HNSCC previously treated with platinum-based regimen and cetuximab-naïve after failure of no more than 2 regimens for R/M disease were included in this cohort. Participants received pegenzileukin 24 mcg/kg q3w on Day 1 of each cycle along with cetuximab as an initial loading dose of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 starting via IV infusion once weekly from Cycle 1 Day 8 (each cycle is 21 days) (as 2/3L therapy) until PD. |
|
|
| OG001 |
| Cohort B1: R/M HNSCC: Pegenzileukin 24 mcg/kg + Pembrolizumab as 2/3L Therapy |
Participants with R/M HNSCC previously treated with PD1/PD-L1-based regimen and platinum-based regimen after failure of no more than 2 regimens for R/M disease were included in this cohort. Participants received pegenzileukin 24 mcg/kg along with pembrolizumab 200 mg via IV infusion q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE, other full permanent discontinuation criteria was met or completion of Cycle 35. |
| OG002 | Cohort B2: R/M HNSCC: Pegenzileukin 24 mcg/kg + Cetuximab as 2/3L Therapy | Participants with R/M HNSCC previously treated with platinum-based regimen and cetuximab-naïve after failure of no more than 2 regimens for R/M disease were included in this cohort. Participants received pegenzileukin 24 mcg/kg q3w on Day 1 of each cycle along with cetuximab as an initial loading dose of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 starting via IV infusion once weekly from Cycle 1 Day 8 (each cycle is 21 days) (as 2/3L therapy) until PD. |
|
|