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

Part of paid clinical trials in Beverly Hills, California.

Sponsor
Sanofi
Study ID
NCT04913220
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • THOR-707 — DRUG
    Solution for infusion: intravenous infusion
  • Cemiplimab — DRUG
    Solution for infusion: intravenous infusion

Study Details

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

Key Dates

Start date
Jul 15, 2021
Status verified
Dec 2025
Primary completion
Aug 22, 2023
Completion
Feb 18, 2025

Study Design

Enrollment
46 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A: Melanoma
    SAR444245 and cemiplimab administered every 3 weeks on Day 1 of each cycle (21 days per cycle) for up to 35 cycles.
  • Experimental: Cohort B: cutaneous squamous cell carcinoma (CSCC)
    SAR444245 and cemiplimab administered every 3 weeks on Day 1 of each cycle (21 days per cycle) for up to 35 cycles.

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) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Beverly Hills Cancer Center & Optima Diagnostic Imaging Site Number : 8400007Beverly HillsCalifornia90211-

Find similar trials in Beverly Hills, CA

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Beverly Hills Cancer Center & Optima Diagnostic Imaging· Beverly Hills, CA

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