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Spots Global Cancer Trial Database for A Study of SAR444245 Combined With Cemiplimab for the Treatment of Participants With Various Advanced Skin Cancers (Pegathor Skin 201)

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Trial Identification

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

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

Study ID: NCT04913220

Interventions

THOR-707
Cemiplimab

Study Description

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

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

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Beverly Hills Cancer Center & Optima Diagnostic Imaging Site Number : 8400007, Beverly Hills, California, United States

Investigational Site Number : 0360001, Macquarie University, New South Wales, Australia

Investigational Site Number : 1520005, Santaigo, Reg Metropolitana De Santiago, Chile

Investigational Site Number : 1520002, Santiago, Reg Metropolitana De Santiago, Chile

Investigational Site Number : 1520001, Santiago, Reg Metropolitana De Santiago, Chile

Investigational Site Number : 1520004, Santiago, Reg Metropolitana De Santiago, Chile

Investigational Site Number : 1520006, Antofagasta, , Chile

Investigational Site Number : 1520003, Temuco, , Chile

Investigational Site Number : 2500003, Bobigny, , France

Investigational Site Number : 2500002, Dijon, , France

Investigational Site Number : 2500005, Lille, , France

Investigational Site Number : 2500001, Nantes, , France

Investigational Site Number : 2500006, Pierre Benite, , France

Investigational Site Number : 2760004, Berlin, , Germany

Investigational Site Number : 2760001, Hamburg, , Germany

Investigational Site Number : 2760003, Mannheim, , Germany

Investigational Site Number : 2760006, Minden, , Germany

Investigational Site Number : 2760005, München, , Germany

Investigational Site Number : 3800001, Napoli, , Italy

Investigational Site Number : 3800004, Perugia, , Italy

Investigational Site Number : 7240001, Barcelona, Barcelona [Barcelona], Spain

Investigational Site Number : 7240004, Barcelona, Barcelona [Barcelona], Spain

Investigational Site Number : 7240003, Hospitalet de Llobregat, Barcelona [Barcelona], Spain

Investigational Site Number : 7240002, Santander, Cantabria, Spain

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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