A Study of SAR444245 Combined With Cemiplimab for the Treatment of Participants With Various Advanced Skin Cancers (Pegathor Skin 201)

NCT04913220 | Terminated Phase 1 Results DMC FDA Drug

• 3 other identifiers: ACT16845U1111-1254-01892020-005332-30
• Study Type: interventional
• Target: 46
• Locations: 7 countries
• Sites: 24

Brief 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 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

Conditions

Malignant Melanoma; Squamous Cell Carcinoma of Skin

Outcome Measures

Primary Outcomes (1)

• All Cohorts: Objective Response Rate (ORR)

  The ORR was defined as the percentage of participants who had best overall response (BOR) as confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 or modified world health organization (WHO) response criteria. CR was defined as the disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to \<10 millimeter (mm) (\<1 centimeter \[cm\]). PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

  From first dose of study treatment administration (Day 1) up to approximately 25 months (Cohorts A and B)

Secondary Outcomes (12)

• 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)

• 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)

• 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)

• 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)

• 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)

Study Arms (2)

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.

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.

Drug: THOR-707; Drug: Cemiplimab

Interventions

THOR-707 DRUG

Solution for infusion: intravenous infusion

Cohort A: Melanoma; Cohort B: cutaneous squamous cell carcinoma (CSCC)

Cemiplimab DRUG

Solution for infusion: intravenous infusion

Also known as: Libtayo® or generic

Cohort A: Melanoma; Cohort B: cutaneous squamous cell carcinoma (CSCC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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:
• µg/kg: at screening, biopsy is optional but highly recommended; and on-treatment not required
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (24)

Beverly Hills Cancer Center & Optima Diagnostic Imaging Site Number : 8400007

Beverly Hills, California, 90211, United States

Location

Investigational Site Number : 0360001

Macquarie University, New South Wales, 2109, Australia

Location

Investigational Site Number : 1520005

Santaigo, Reg Metropolitana de Santiago, 8241470, Chile

Location

Investigational Site Number : 1520002

Santiago, Reg Metropolitana de Santiago, 7500921, Chile

Location

Investigational Site Number : 1520001

Santiago, Reg Metropolitana de Santiago, 8420383, Chile

Location

Investigational Site Number : 1520004

Santiago, Reg Metropolitana de Santiago, Chile

Location

Investigational Site Number : 1520006

Antofagasta, 1420000, Chile

Location

Investigational Site Number : 1520003

Temuco, 4800827, Chile

Location

Investigational Site Number : 2500003

Bobigny, 93009, France

Location

Investigational Site Number : 2500002

Dijon, 21079, France

Location

Investigational Site Number : 2500005

Lille, 59037, France

Location

Investigational Site Number : 2500001

Nantes, 44093, France

Location

Investigational Site Number : 2500006

Pierre-Bénite, 69495, France

Location

Investigational Site Number : 2760004

Berlin, 10117, Germany

Location

Investigational Site Number : 2760001

Hamburg, 20246, Germany

Location

Investigational Site Number : 2760003

Mannheim, 68167, Germany

Location

Investigational Site Number : 2760006

Minden, 32429, Germany

Location

Investigational Site Number : 2760005

München, 80337, Germany

Location

Investigational Site Number : 3800001

Naples, 80131, Italy

Location

Investigational Site Number : 3800004

Perugia, 06126, Italy

Location

Investigational Site Number : 7240001

Barcelona, Barcelona [Barcelona], 08035, Spain

Location

Investigational Site Number : 7240004

Barcelona, Barcelona [Barcelona], 08036, Spain

Location

Investigational Site Number : 7240003

L'Hospitalet de Llobregat, Barcelona [Barcelona], 08908, Spain

Location

Investigational Site Number : 7240002

Santander, Cantabria, 39008, Spain

Location

Related Links

• ACT16845 Plain Language Results Summary

MeSH Terms

Conditions

Melanoma

Interventions

cemiplimab; Drugs, Generic

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Limitations and Caveats

The study was terminated based on strategic sponsor decision not driven by any safety concerns.

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi aventis recherche & développement

Contact-US@sanofi.com

800-633-1610

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2021
• First Posted: June 4, 2021
• Study Start: July 15, 2021
• Primary Completion: August 22, 2023
• Study Completion: February 18, 2025
• Last Updated: February 4, 2026
• Results First Posted: February 4, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

DE (5); AU (1); FR (5); CL (6); IT (2); ES (4); US (1)