OncoMatch/Clinical Trials/NCT04590326
A Study to Find Out How Safe REGN5668 is and How Well it Works In Adult Women When Given With Either Cemiplimab, or Cemiplimab + Fianlimab, or Ubamatamab
Is NCT04590326 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments for ovarian cancer.
Treatment: REGN5668 · Cemiplimab · Ubamatamab · Sarilumab · Cemiplimab + Fianlimab [Fixed Dose Combination (FDC)] — This study is researching an investigational drug called REGN5668 : * alone or, * combined with cemiplimab (also known as REGN2810) or, * combined with both cemiplimab and fianlimab (also known as REGN3767), or * combined with ubamatamab (also known as REGN4018), with or without sarilumab. The main purposes of this study are to: * Learn about the safety and profile of any side effects from the study drugs and to determine the highest, safe dose that can be given to participants with ovarian cancer or cancer of the uterus * Look for signs that the study drugs can treat ovarian cancer or cancer of the uterus This study has 2 parts. The purpose of Part 1 (Escalation) is to find the highest, safe dose of the study drug(s). The purpose of Part 2 (Expansion) is to use the doses chosen in Part 1. Participants with cancer of the uterus will only participate in Part 2. The study is looking at several other research questions, including: * Side effects that may be experienced by participants taking REGN5668 alone and/or in combination with cemiplimab, cemiplimab and fianlimab, or ubamatamab * How REGN5668 works in the body either alone and/or in combination with cemiplimab, cemiplimab and fianlimab, or ubamatamab * How much of the study drugs (REGN5668, cemiplimab, fianlimab, ubamatamab) are in the blood * To see if REGN5668 in combination with cemiplimab, cemiplimab and fianlimab, or ubamatamab works to treat cancer
Check if I qualifyExtracted eligibility criteria
Cancer type
Ovarian Cancer
Endometrial Cancer
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy
has received at least 1 line of platinum-based systemic therapy
Must have received: anti-PD-1 therapy
endometrial cancer that has progressed or recurrent after prior anti-PD-1 therapy and platinum-based chemotherapy
Must have received: platinum-based chemotherapy
endometrial cancer that has progressed or recurrent after prior anti-PD-1 therapy and platinum-based chemotherapy
Cannot have received: MUC16-targeted therapy
Prior treatment with a Mucin 16 (MUC16)-targeted therapy
Lab requirements
Blood counts
adequate organ and bone marrow function as defined in the protocol
Kidney function
adequate organ and bone marrow function as defined in the protocol
Liver function
adequate organ and bone marrow function as defined in the protocol
adequate organ and bone marrow function as defined in the protocol
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope Comprehensive Cancer Center · Duarte, California
- The City of Hope Orange County Lennar Foundation Cancer Center · Irvine, California
- Chao Family Comprehensive Cancer Center · Orange, California
- H. Lee Moffitt Cancer Center · Tampa, Florida
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University · Chicago, Illinois
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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