Malignant MelanomaPhase 1/2NCT04913220
A Study of SAR444245 Combined With Cemiplimab for the Treatment of Participants With Various Advanced Skin Cancers (Pegathor Skin 201)
A Phase 1/2 study testing THOR-707 and Cemiplimab in people with Malignant Melanoma and Squamous Cell Carcinoma of Skin, run by Sanofi at 24 sites in 7 countries.
Trial summary
Primary Objective: -To determine the antitumor activity of SAR444245 in combination with cemiplimab. Secondary Objectives: To determine the recommended phase 2 dose and to assess the safety profile of SAR444245 when combined with cemiplimab To assess other indicators of antitumor activity To assess the concentrations… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Melanoma, Squamous Cell Carcinoma of Skin
- What is being tested?
- THOR-707 and Cemiplimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 24 sitesin 7 countries
- Study dates
- 15 Jul 2021to 18 Feb 2025
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must be ≥18 years of age (or country's legal age of majority if >18 years), at the time of signing the informed consent.
- Participants with:
- Cohort A: Histologically confirmed unresectable locally advanced or metastatic melanoma that are not amenable to local therapy
- Cohort B: Histologically confirmed metastatic CSCC or locally advanced
- CSCC that are not candidates for curative surgery or radiation. Special considerations for the following categories:
- Participants with tumors arising on the cutaneous hair (non-glabrous) bearing lip with extension onto dry red lip (vermillion) may be eligible after communication with and approval from the Sponsor
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- Participants with the primary site is nose are only eligible if the primary site was skin, not nasal mucosa with outward extension to skin (the Investigator confirmed)
- Participants with mixed histology in which the predominant histology is invasive CSCC may be eligible after communication with and approval from the Sponsor
- Participants in both cohorts must have at least one measurable lesion
- Provision of tumor tissue:
- For participants in the dose escalation:
- 16 µg/kg: at screening, biopsy is optional but highly recommended; and on-treatment not required
- 24 µg/kg: at screening, biopsy is mandatory and on-treatment, optional but highly recommended
- For the other participants : Mandatory baseline biopsy for the participants to enroll in cohort A with skin metastasis and in cohort B. Mandatory on-treatment biopsy for participants in Cohort A with skin metastasis and participants in Cohort B.
- Females are eligible to participate if they are not pregnant or breastfeeding, not a woman of childbearing potential (WOCBP) or are a WOCBP that agrees: to use approved contraception method and submit to regular pregnancy testing prior to treatment and for at least 180 days after discontinuing study treatment and to refrain from donating or cryopreserving eggs for 180 days after discontinuing study treatment.
- Males are 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
Who cannot join
- Participants are excluded from the study if any of the following criteria apply:
- Eastern Cooperative Oncology Group (ECOG) performance status of ≥2
- Poor organ function
- Participants with baseline SpO2 ≤92%
- Active brain metastases or leptomeningeal disease.
- History of allogenic tissue/solid organ transplant.
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- Last administration of prior antitumor therapy or any investigational treatment within 28 days or less than 5 times the half-life, whichever is shorter; major surgery or local intervention within 28 days.
- History of lung disease
- Comorbidity requiring corticosteroid therapy
- Antibiotic use (excluding topical antibiotics) ≤14 days prior to first dose of IMP
- Severe or unstable cardiac condition within 6 months prior to starting study treatment
- Active, known, or suspected autoimmune disease that has required systemic treatment in the past 2 years
- Known second malignancy either progressing or requiring active treatment within the last 3 years
- For both cohorts:
- Prior immune checkpoint inhibitors except in the context of adjuvant or neoadjuvant; Participants who were on control arm of a study with an investigational anti-PD-1/PD-L1 are eligible.
- Received adjuvant or neoadjuvant therapy during the 6 months prior to development of metastatic disease.
- For Cohort A: any prior systemic treatment for advanced/metastatic disease
- For Cohort B: >2 prior lines of any systemic treatment for advanced/metastatic disease
- Inability to undergo any contrast-enhanced radiologic response assessment
- Receipt of a live-virus vaccination within 28 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
24 sites in 7 countries.
24 sites in 7 countries
Chile6 sites
Investigational Site Number : 1520006
Antofagasta, 1420000
Investigational Site Number : 1520005
Santaigo, Reg Metropolitana de Santiago, 8241470
Investigational Site Number : 1520002
Santiago, Reg Metropolitana de Santiago, 7500921
Investigational Site Number : 1520001
Santiago, Reg Metropolitana de Santiago, 8420383
Investigational Site Number : 1520004
Santiago, Reg Metropolitana de Santiago
Investigational Site Number : 1520003
Temuco, 4800827
France5 sites
Investigational Site Number : 2500003
Bobigny, 93009
Investigational Site Number : 2500002
Dijon, 21079
Investigational Site Number : 2500005
Lille, 59037
Investigational Site Number : 2500001
Nantes, 44093
Investigational Site Number : 2500006
Pierre-Bénite, 69495
Germany5 sites
Investigational Site Number : 2760004
Berlin, 10117
Investigational Site Number : 2760001
Hamburg, 20246
Investigational Site Number : 2760003
Mannheim, 68167
Investigational Site Number : 2760006
Minden, 32429
Investigational Site Number : 2760005
München, 80337
Spain4 sites
Investigational Site Number : 7240001
Barcelona, Barcelona [Barcelona], 08035
Investigational Site Number : 7240004
Barcelona, Barcelona [Barcelona], 08036
Investigational Site Number : 7240003
L'Hospitalet de Llobregat, Barcelona [Barcelona], 08908
Investigational Site Number : 7240002
Santander, Cantabria, 39008
Italy2 sites
Investigational Site Number : 3800001
Naples, 80131
Investigational Site Number : 3800004
Perugia, 06126
United States1 site
Beverly Hills Cancer Center & Optima Diagnostic Imaging Site Number : 8400007
Beverly Hills, California, 90211
Australia1 site
Investigational Site Number : 0360001
Macquarie University, New South Wales, 2109
About this study
Official title: A Phase 1/2 Non-randomized, Open-label, Multi-cohort, Multi-center Study Assessing the Clinical Benefit of SAR444245 (THOR- 707) Combined With Cemiplimab for the Treatment of Participants With Advanced Unresectable or Metastatic Skin Cancers
Primary Objective:
-To determine the antitumor activity of SAR444245 in combination with cemiplimab.
Secondary Objectives:
- To determine the recommended phase 2 dose and to assess the safety profile of SAR444245 when combined with cemiplimab
- To assess other indicators of antitumor activity
- To assess the concentrations of SAR444245 when given in combination with cemiplimab
- To assess the immunogenicity of SAR444245
- To assess active concentrations of cemiplimab when given in combination with SAR444245
Read the detailed description
The duration of the study for an individual patient will start from the signature of the main informed consent and include a screening period of up to 28 days, a treatment period [max 35 cycles or until PD], an end-of-treatment visit 30 days + 7 days following the last administration of study drug (or until the patient receives another anticancer therapy, whichever is earlier), and a follow-up visit 3 months after treatment discontinuation and every 3 months following, until disease progression, or initiation of another antitumor treatment, or final cohort cut-off, whichever is earlier
- Being tested
- THOR-707, Cemiplimab
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THOR-707Drug
Solution for infusion: intravenous infusion
CemiplimabDrug
Also called Libtayo® or generic
Solution for infusion: intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: Melanoma | Experimental | SAR444245 and cemiplimab administered every 3 weeks on Day 1 of each cycle (21 days per cycle) for up to 35 cycles. Receives: Drug: THOR-707; Drug: Cemiplimab |
| Cohort B: cutaneous squamous cell carcinoma (CSCC) | Experimental | SAR444245 and cemiplimab administered every 3 weeks on Day 1 of each cycle (21 days per cycle) for up to 35 cycles. Receives: Drug: THOR-707; Drug: Cemiplimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
All Cohorts: Objective Response Rate (ORR)
The ORR was defined as the percentage of participants who had best overall response (BOR) as confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 or modified world health organization (WHO) response criteria. CR was defined as the disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to <10 millimeter (mm) (<1 centimeter [cm]). PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Measured: From first dose of study treatment administration (Day 1) up to approximately 25 months (Cohorts A and B)
Secondary outcomes (12)
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.
Measured: From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B)
All Cohorts: Number of Participants With Dose Limiting Toxicities (DLTs)
Selected events that occurred during the DLT observation period were considered as DLT unless due to PD or to a cause obviously unrelated to pegenzileukin. Selected events included: any grade 4 neutropenia irrespective of duration; any febrile neutropenia; grade 3 thrombocytopenia associated with transfusion in addition to bleeding and any grade 4 thrombocytopenia; grade 3 or above: alanine aminotransferase or aspartate aminotransferase, vascular leak syndrome, hypotension, cytokine release syndrome, and AE that did not resolve to grade <=2 within 7 days of starting accepted standard of care medical management; and grade 4 laboratory abnormalities.
Measured: From Day 1 to Day 21 of Cycle 1 (each cycle is 21 days: Cohorts A and B)
All Cohorts: Complete Response (CR) Rate
The CR rate was defined as the percentage of participants who had a confirmed CR as per RECIST v 1.1 or modified WHO response criteria. CR was defined as the disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to <10 mm (<1 cm).
Measured: From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment, approximately 26 months (Cohorts A and B)
All Cohorts: Time to Complete Response
The time to CR was defined as the time from the first administration of study treatment to the first tumor assessment at which the overall response was recorded as CR that was subsequently confirmed as per RECIST v 1.1 or modified WHO response criteria. CR was defined as the disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to <10 mm (<1 cm).
Measured: From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment, approximately 26 months (Cohorts A and B)
All Cohorts: Time to Response (TTR)
The TTR was defined as the time from the first study treatment administration to the first tumor assessment at which the overall response was recorded as PR or CR that was subsequently confirmed as per RECIST v 1.1 or modified WHO response criteria. CR was defined as the disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to <10 mm (<1 cm). PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Measured: From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment, approximately 26 months (Cohorts A and B)
All Cohorts: Duration of Response (DOR)
The DOR was defined as the time from the first tumor assessment at which the overall response was recorded as CR or PR that was subsequently confirmed until documented PD before the initiation of any subsequent anti-cancer therapy or death due to any cause, whichever occurred first, as per RECIST v 1.1 or modified WHO response criteria. CR was defined as the disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to <10 mm (<1 cm). PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. PD was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study), in addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm (0.5 cm).
Measured: From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment, approximately 26 months (Cohorts A and B)
All Cohorts: Clinical Benefit Rate (CBR)
The CBR was defined as the percentage of participants with clinical benefit: confirmed CR or PR as BOR, or stable disease (SD) lasting at least 6 months, as per RECIST v 1.1 or modified WHO response criteria. CR was defined as the disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to <10 mm (<1 cm). PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. BOR was defined as the best response observed from the start of the study treatment until PD, death, cut-off date or initiation of post-treatment anti-cancer therapy, whichever occurred first. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Measured: From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment, approximately 26 months (Cohorts A and B)
All Cohorts: Progression Free Survival (PFS)
The PFS was defined as the time from the date of first study treatment administration to the date of the first documentation of objective PD, or death due to any cause, whichever occurred first, as per RECIST v 1.1 or modified WHO response criteria. PD was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study), in addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm (0.5 cm).
Measured: From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment, approximately 26 months (Cohorts A and B)
All Cohorts: Plasma Concentrations of Pegenzileukin
Blood samples were collected at specified timepoints for the assessment of plasma concentrations of pegenzileukin.
Measured: Cycle 1 Days 2 and 3 (each cycle is 21 days)
All Cohorts: Number of Participants With Anti-Drug Antibodies (ADAs) Against Pegenzileukin
Blood samples were collected at specified timepoints to assess the presence of ADAs against pegenzileukin. Treatment-emergent ADA was defined as at least one treatment-induced or treatment-boosted ADA. Treatment-induced ADA was defined as ADA that developed during the TE period and without pre-existing ADA (including participants without pre-treatment samples). Treatment-boosted ADA was defined as pre-existing ADA that was boosted during the TE period to a significant higher titer than the baseline. Number of participants with treatment-emergent ADA is presented.
Measured: From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B)
All Cohorts: Concentration Observed Just Before Study Treatment Administration During Repeated Dosing (Ctrough) of Cemiplimab
Blood samples were collected at specified timepoints for the assessment of Ctrough of cemiplimab. The PK population consisted of all participants from exposed population with at least one PK concentration available after the first dose of study treatment. Only participants with data collected at specified timepoints are reported.
Measured: Cycles 1, 2, 4, 7, 10, and 15 (each cycle is 21 days)
All Cohorts: Concentration at End of Infusion (Ceoi) of Cemiplimab
Blood samples were collected at specified timepoints for the assessment of Ceoi of cemiplimab. The PK population consisted of all participants from exposed population with at least one PK concentration available after the first dose of study treatment. Only participants with data collected at specified timepoints are reported.
Measured: Cycles 1, 2, 4, 7, 10, and 15 (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start15 Jul 2021
- Primary completion22 Aug 2023
- Study completion18 Feb 2025
Why it stopped: Early discontinuation based on strategic sponsor decision not driven by any safety concerns
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant MelanomaStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04913220
- Sponsor's protocol ID
- ACT16845
- Other IDs
- U1111-1254-0189, 2020-005332-30
- Status last verified
- Dec 2025
- First submitted
- 28 May 2021
- Last updated
- 4 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
Rojas C, Mortier L, Park JJ, Matamala L, Baakili A, Rao S, Xu J, Andrieu L, Wang R, Wang H, Paehler T, Abbadessa G, Ascierto PA. Phase 1/2 study of pegenzileukin, a pegylated recombinant non-alpha IL-2, with cemiplimab for the treatment of advanced unresectable or metastatic skin cancers. J Immunother Cancer. 2026 May 22;14(5):e014347. doi: 10.1136/jitc-2025-014347.
PubMed 42173654
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Non-randomized, Open-label, Multi-cohort, Multi-center Study Assessing the Clinical Benefit of SAR444245 (THOR- 707) Combined With Cemiplimab for the Treatment of Participants With Advanced Unresectable or Metastatic Skin Cancers
- ClinicalTrials.gov ID
- NCT04913220
- Acronym / sponsor ID
- ACT16845
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Early discontinuation based on strategic sponsor decision not driven by any safety concerns
- Enrolment
- 46 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 22 Aug 2023 (actual)
- Study completion
- 18 Feb 2025 (actual)
- First posted
- 4 Jun 2021 (actual)
- Results
- Posted 4 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective:
-To determine the antitumor activity of SAR444245 in combination with cemiplimab.
Secondary Objectives:
- To determine the recommended phase 2 dose and to assess the safety profile of SAR444245 when combined with cemiplimab
- To assess other indicators of antitumor activity
- To assess the concentrations of SAR444245 when given in combination with cemiplimab
- To assess the immunogenicity of SAR444245
- To assess active concentrations of cemiplimab when given in combination with SAR444245
Detailed description
The duration of the study for an individual patient will start from the signature of the main informed consent and include a screening period of up to 28 days, a treatment period [max 35 cycles or until PD], an end-of-treatment visit 30 days + 7 days following the last administration of study drug (or until the patient receives another anticancer therapy, whichever is earlier), and a follow-up visit 3 months after treatment discontinuation and every 3 months following, until disease progression, or initiation of another antitumor treatment, or final cohort cut-off, whichever is earlier
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A: Melanoma | Experimental | Drug: THOR-707, Drug: CemiplimabSAR444245 and cemiplimab administered every 3 weeks on Day 1 of each cycle (21 days per cycle) for up to 35 cycles. |
| Cohort B: cutaneous squamous cell carcinoma (CSCC) | Experimental | Drug: THOR-707, Drug: CemiplimabSAR444245 and cemiplimab administered every 3 weeks on Day 1 of each cycle (21 days per cycle) for up to 35 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Participant must be ≥18 years of age (or country's legal age of majority if >18 years), at the time of signing the informed consent.
- Participants with:
- Cohort A: Histologically confirmed unresectable locally advanced or metastatic melanoma that are not amenable to local therapy
- Cohort B: Histologically confirmed metastatic CSCC or locally advanced
- CSCC that are not candidates for curative surgery or radiation. Special considerations for the following categories:
Key exclusion criteria (21 listed)
- Participants are excluded from the study if any of the following criteria apply:
- Eastern Cooperative Oncology Group (ECOG) performance status of ≥2
- Poor organ function
- Participants with baseline SpO2 ≤92%
- Active brain metastases or leptomeningeal disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| THOR-707Solution for infusion: intravenous infusion | Drug | Cohort A: Melanoma, Cohort B: cutaneous squamous cell carcinoma (CSCC) |
| CemiplimabAlso: Libtayo® or genericSolution for infusion: intravenous infusion | Drug | Cohort A: Melanoma, Cohort B: cutaneous squamous cell carcinoma (CSCC) |
Primary outcome
All Cohorts: Objective Response Rate (ORR)
Time frame: 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.
12 secondary outcomes
All Cohorts: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Time frame: From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B)
All Cohorts: Number of Participants With Dose Limiting Toxicities (DLTs)
Time frame: From Day 1 to Day 21 of Cycle 1 (each cycle is 21 days: Cohorts A and B)
All Cohorts: Complete Response (CR) Rate
Time frame: From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment, approximately 26 months (Cohorts A and B)
All Cohorts: Time to Complete Response
Time frame: From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment, approximately 26 months (Cohorts A and B)
All Cohorts: Time to Response (TTR)
Time frame: From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment, approximately 26 months (Cohorts A and B)
All Cohorts: Duration of Response (DOR)
Time frame: From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment, approximately 26 months (Cohorts A and B)
All Cohorts: Clinical Benefit Rate (CBR)
Time frame: From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment, approximately 26 months (Cohorts A and B)
All Cohorts: Progression Free Survival (PFS)
Time frame: From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment, approximately 26 months (Cohorts A and B)
All Cohorts: Plasma Concentrations of Pegenzileukin
Time frame: Cycle 1 Days 2 and 3 (each cycle is 21 days)
All Cohorts: Number of Participants With Anti-Drug Antibodies (ADAs) Against Pegenzileukin
Time frame: From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment; approximately 27 months (Cohorts A and B)
All Cohorts: Concentration Observed Just Before Study Treatment Administration During Repeated Dosing (Ctrough) of Cemiplimab
Time frame: Cycles 1, 2, 4, 7, 10, and 15 (each cycle is 21 days)
All Cohorts: Concentration at End of Infusion (Ceoi) of Cemiplimab
Time frame: Cycles 1, 2, 4, 7, 10, and 15 (each cycle is 21 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42173654Rojas C, Mortier L, Park JJ, Matamala L, Baakili A, Rao S, Xu J, Andrieu L, Wang R, Wang H, Paehler T, Abbadessa G, Ascierto PA. Phase 1/2 study of pegenzileukin, a pegylated recombinant non-alpha IL-2, with cemiplimab for the treatment of advanced unresectable or metastatic skin cancers. J Immunother Cancer. 2026 May 22;14(5):e014347. doi: 10.1136/jitc-2025-014347.
- ACT16845 Plain Language Results SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
24 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing THOR-707 and Cemiplimab in people with Malignant Melanoma and Squamous Cell Carcinoma of Skin, run by Sanofi at 24 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Chile, France, Germany, Spain, Italy and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All Cohorts: Objective Response Rate (ORR) (time frame: From first dose of study treatment administration (Day 1) up to approximately 25 months (Cohorts A and B)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04913220, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.