Trial · NCT04913220
A Study of SAR444245 Combined With Cemiplimab for the Treatment of Participants With Various Advanced Skin Cancers (Pegathor Skin 201)
NCT04913220, Phase 1, Phase 2, Terminated, Sanofi; results first posted 2026-02-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of SAR444245 Combined With Cemiplimab for the Treatment of Participants With Various Advanced Skin Cancers (Pegathor Skin 201). Trials, record NCT04913220. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04913220
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of SAR444245 Combined With Cemiplimab for the Treatment of Participants With Various Advanced Skin Cancers (Pegathor Skin 201)
- NCT number
- NCT04913220
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 46 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Malignant Melanoma, Squamous Cell Carcinoma of Skin
- Interventions
- THOR-707, Cemiplimab
- First posted
- 2021-06-04
- Last updated
- 2026-02-04
- Other registries' IDs
- eudract:2020-005332-30
- Results first posted
- 2026-02-04
- Limitations and caveats
- The study was terminated based on strategic sponsor decision not driven by any safety concerns.
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | All Cohorts: Objective Response Rate (ORR) | From first dose of study treatment administration (Day 1) up to approximately 25 months (Cohorts A and B) | The ORR was defined as the percentage of participants who had best overall response (BOR) as confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 or modified world health organization (WHO) response criteria. CR was defined as the disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to \<10 millimeter (mm) (\<1 centimeter \[cm\]). PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | All Cohorts: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B) | 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. |
| Secondary | All Cohorts: Number of Participants With Dose Limiting Toxicities (DLTs) | From Day 1 to Day 21 of Cycle 1 (each cycle is 21 days: Cohorts A and B) | Selected events that occurred during the DLT observation period were considered as DLT unless due to PD or to a cause obviously unrelated to pegenzileukin. Selected events included: any grade 4 neutropenia irrespective of duration; any febrile neutropenia; grade 3 thrombocytopenia associated with transfusion in addition to bleeding and any grade 4 thrombocytopenia; grade 3 or above: alanine aminotransferase or aspartate aminotransferase, vascular leak syndrome, hypotension, cytokine release syndrome, and AE that did not resolve to grade \<=2 within 7 days of starting accepted standard of care medical management; and grade 4 laboratory abnormalities. |
| Secondary | All Cohorts: Complete Response (CR) Rate | From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment, approximately 26 months (Cohorts A and B) | The CR rate was defined as the percentage of participants who had a confirmed CR as per RECIST v 1.1 or modified WHO response criteria. CR was defined as the disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to \<10 mm (\<1 cm). |
| Secondary | All Cohorts: Time to Complete Response | From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment, approximately 26 months (Cohorts A and B) | The time to CR was defined as the time from the first administration of study treatment to the first tumor assessment at which the overall response was recorded as CR that was subsequently confirmed as per RECIST v 1.1 or modified WHO response criteria. CR was defined as the disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to \<10 mm (\<1 cm). |
| Secondary | All Cohorts: Time to Response (TTR) | From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment, approximately 26 months (Cohorts A and B) | The TTR was defined as the time from the first study treatment administration to the first tumor assessment at which the overall response was recorded as PR or CR that was subsequently confirmed as per RECIST v 1.1 or modified WHO response criteria. CR was defined as the disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to \<10 mm (\<1 cm). PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | All Cohorts: Duration of Response (DOR) | From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment, approximately 26 months (Cohorts A and B) | The DOR was defined as the time from the first tumor assessment at which the overall response was recorded as CR or PR that was subsequently confirmed until documented PD before the initiation of any subsequent anti-cancer therapy or death due to any cause, whichever occurred first, as per RECIST v 1.1 or modified WHO response criteria. CR was defined as the disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to \<10 mm (\<1 cm). PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. PD was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study), in addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm (0.5 cm). |
| Secondary | All Cohorts: Clinical Benefit Rate (CBR) | From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment, approximately 26 months (Cohorts A and B) | The CBR was defined as the percentage of participants with clinical benefit: confirmed CR or PR as BOR, or stable disease (SD) lasting at least 6 months, as per RECIST v 1.1 or modified WHO response criteria. CR was defined as the disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to \<10 mm (\<1 cm). PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. BOR was defined as the best response observed from the start of the study treatment until PD, death, cut-off date or initiation of post-treatment anti-cancer therapy, whichever occurred first. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. |
| Secondary | All Cohorts: Progression Free Survival (PFS) | From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment, approximately 26 months (Cohorts A and B) | The PFS was defined as the time from the date of first study treatment administration to the date of the first documentation of objective PD, or death due to any cause, whichever occurred first, as per RECIST v 1.1 or modified WHO response criteria. PD was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study), in addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm (0.5 cm). |
| Secondary | All Cohorts: Plasma Concentrations of Pegenzileukin | Cycle 1 Days 2 and 3 (each cycle is 21 days) | Blood samples were collected at specified timepoints for the assessment of plasma concentrations of pegenzileukin. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | All Cohorts: Objective Response Rate (ORR) | From first dose of study treatment administration (Day 1) up to approximately 25 months (Cohorts A and B) | 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. | Percentage of participants | NUMBER |
| SECONDARY | All Cohorts: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B) | The exposed population consisted of all participants who had given their informed consent and received at least one dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | All Cohorts: Number of Participants With Dose Limiting Toxicities (DLTs) | From Day 1 to Day 21 of Cycle 1 (each cycle is 21 days: Cohorts A and B) | The DLT-evaluable population consisted of all exposed participants in the dose escalation who had been treated and observed for at least 21 days. Any participants who had experienced a DLT during DLT observation period were also DLT-evaluable. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | All Cohorts: Complete Response (CR) Rate | From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment, approximately 26 months (Cohorts A and B) | 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. | Percentage of participants | NUMBER |
| SECONDARY | All Cohorts: Time to Complete Response | From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment, approximately 26 months (Cohorts A and B) | The efficacy population consisted of all participants from the exposed population with at least one evaluable post-baseline tumor assessment or who permanently discontinued study treatment. Only participants with confirmed CR were analyzed. | Months | MEDIAN |
| SECONDARY | All Cohorts: Time to Response (TTR) | From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment, approximately 26 months (Cohorts A and B) | 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. | Months | MEDIAN |
| SECONDARY | All Cohorts: Duration of Response (DOR) | From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment, approximately 26 months (Cohorts A and B) | 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. | Months | MEDIAN |
| SECONDARY | All Cohorts: Clinical Benefit Rate (CBR) | From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment, approximately 26 months (Cohorts A and B) | 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. | Percentage of participants | NUMBER |
| SECONDARY | All Cohorts: Progression Free Survival (PFS) | From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment, approximately 26 months (Cohorts A and B) | 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. | Months | MEDIAN |
| SECONDARY | All Cohorts: Plasma Concentrations of Pegenzileukin | Cycle 1 Days 2 and 3 (each cycle is 21 days) | The pharmacokinetic (PK) population consisted of all participants from exposed population with at least one PK concentration available after the first dose of study treatment. Only participants with data collected at specified timepoints are reported. | Nanograms per milliliter (ng/mL) | MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group90
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| All Cohorts: Objective Response Rate (ORR) | Cohort A:1L Melanoma ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab | 40.0 | 90% Confidence Interval 21.7 to 60.6 | Percentage of participants | |
| All Cohorts: Objective Response Rate (ORR) | Cohort A:1L Melanoma ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab | 57.1 | 90% Confidence Interval 22.5 to 87.1 | Percentage of participants | |
| All Cohorts: Objective Response Rate (ORR) | Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab | 56.3 | 90% Confidence Interval 33.3 to 77.3 | Percentage of participants | |
| All Cohorts: Objective Response Rate (ORR) | Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab | 0 | 90% Confidence Interval 0.0 to 63.2 | Percentage of participants | |
| All Cohorts: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Cohort A:1L Melanoma ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab | TEAEs | 20 | Participants | |
| All Cohorts: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Cohort A:1L Melanoma ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab | TEAEs | 7 | Participants | |
| All Cohorts: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab | TEAEs | 16 | Participants | |
| All Cohorts: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab | TEAEs | 3 | Participants | |
| All Cohorts: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Cohort A:1L Melanoma ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab | TESAEs | 11 | Participants | |
| All Cohorts: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Cohort A:1L Melanoma ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab | TESAEs | 4 | Participants |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort A:1L Melanoma ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab | 20 | |
| Overall Study | STARTED | Cohort A:1L Melanoma ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab | 7 | |
| Overall Study | STARTED | Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab | 16 | |
| Overall Study | STARTED | Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab | 3 | |
| Overall Study | COMPLETED | Cohort A:1L Melanoma ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab | 4 | |
| Overall Study | COMPLETED | Cohort A:1L Melanoma ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab | 2 | |
| Overall Study | COMPLETED | Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab | 4 | |
| Overall Study | COMPLETED | Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab | 0 | |
| Overall Study | NOT COMPLETED | Cohort A:1L Melanoma ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab | 16 | |
| Overall Study | NOT COMPLETED | Cohort A:1L Melanoma ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab | 5 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events712
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Bronchitis | Infections and infestations | Cohort A:1L Melanoma ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab | 0 | 20 | 0 |
| other | Bronchitis | Infections and infestations | Cohort A:1L Melanoma ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab | 0 | 7 | 0 |
| other | Bronchitis | Infections and infestations | Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab | 2 | 16 | 2 |
| other | Bronchitis | Infections and infestations | Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab | 0 | 3 | 0 |
| other | Covid-19 | Infections and infestations | Cohort A:1L Melanoma ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab | 3 | 20 | 3 |
| other | Covid-19 | Infections and infestations | Cohort A:1L Melanoma ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab | 0 | 7 | 0 |
| other | Covid-19 | Infections and infestations | Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab | 1 | 16 | 1 |
| other | Covid-19 | Infections and infestations | Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab | 1 | 3 | 1 |
| other | Cellulitis | Infections and infestations | Cohort A:1L Melanoma ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab | 0 | 20 | 0 |
| other | Cellulitis | Infections and infestations | Cohort A:1L Melanoma ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab | 0 | 7 | 0 |
1 to 10 of 712Source ClinicalTrials.gov
See all 712 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort A:1L Melanoma ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab | 5 | 20 |
| Total, all-cause mortality | Cohort A:1L Melanoma ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab | 2 | 7 |
| Total, all-cause mortality | Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab | 2 | 16 |
| Total, all-cause mortality | Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab | 0 | 3 |
| Total, other adverse events | Cohort A:1L Melanoma ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab | 19 | 20 |
| Total, other adverse events | Cohort A:1L Melanoma ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab | 7 | 7 |
| Total, other adverse events | Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab | 16 | 16 |
| Total, other adverse events | Cohort B: 1-3L CSCC ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab | 3 | 3 |
| Total, serious adverse events | Cohort A:1L Melanoma ICI-naïve: Pegenzileukin 16 mcg/kg + Cemiplimab | 11 | 20 |
| Total, serious adverse events | Cohort A:1L Melanoma ICI-naïve: Pegenzileukin 24 mcg/kg + Cemiplimab | 4 | 7 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42173654 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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