OncoMatch/Clinical Trials/NCT06413680
A First-In Human (FIH) Study to Find Out How Well REGN10597 Medicine Given Alone or in Combination With Cemiplimab Works in Adult Participants Who Have Cancer With Tumors That Have Spread in Their Body
Is NCT06413680 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including REGN10597 and Cemiplimab for melanoma.
Treatment: REGN10597 · Cemiplimab — This study is researching an experimental drug called REGN10597 alone or in combination with another drug called cemiplimab (called "study drug(s)"). The study is focused on patients with certain solid tumors that are in an advanced stage. The aim of the study is to see how safe, tolerable, and effective the study drug(s) are. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug(s) * How much study drug(s) is in the blood at different times * Whether the body makes antibodies against the study drug(s) (which could make the study drug(s) less effective or could lead to side effects)
Check if I qualifyExtracted eligibility criteria
Cancer type
Melanoma
Tumor Agnostic
Disease stage
Metastatic disease required
Prior therapy
Must have received: standard-of-care therapy
confirmed progression on standard-of-care therapy
Cannot have received: Interleukin 2/IL15/IL-7 (outside adoptive cell therapy)
Prior treatment with Interleukin 2 (IL2)/IL15/IL-7 given outside the context of concurrent administration with adoptive cell therapy
Cannot have received: anti-PD-1/PD-L1 therapy
Prior treatment with anti-PD1/PD-L1, or an approved systemic therapy or any previous systemic non-immunomodulatory biologic therapy within 4 weeks, as defined in the protocol
Cannot have received: systemic non-immunomodulatory biologic therapy
any previous systemic non-immunomodulatory biologic therapy within 4 weeks, as defined in the protocol
Cannot have received: radiation therapy
Has received radiation therapy or major surgery within 14 days prior to first dose of study drug
Cannot have received: anti-cancer immunotherapy
Exception: unless >4 weeks prior to study intervention and not discontinued due to grade 3 or 4 toxicities
Has had prior anti-cancer immunotherapy within 4 weeks prior to study intervention, and discontinuation due to grade 3 or 4 toxicities
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- USC Norris Comprehensive Cancer Center · Los Angeles, California
- University of California San Francisco (UCSF) · San Francisco, California
- Yale School of Medicine · North Haven, Connecticut
- University of Chicago · Chicago, Illinois
- Start Midwest Cancer Research · Grand Rapids, Michigan
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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