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Treatment for recurrent ovarian and other MUC16+ cancers using REGN4018 and cemiplimab

A Phase 1/2 Study of REGN4018 (Ubamatamab), a MUC16×CD3 Bispecific Antibody, Administered Alone or in Combination With Cemiplimab in Patients With Recurrent Ovarian Cancer or Other Recurrent MUC16+ Cancers

Phase1; Phase2 Interventional Regeneron Pharmaceuticals · NCT03564340

This study is testing if a new treatment combining REGN4018 and cemiplimab can help adults with recurrent ovarian and other MUC16+ cancers feel better when other options have run out.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment890 (estimated)
Ages18 Years and up
SexFemale
SponsorRegeneron Pharmaceuticals Industry-sponsored
Drugs / interventionschemotherapy, ubamatamab, cemiplimab
Locations52 sites (Birmingham, Alabama and 51 other locations)
Trial IDNCT03564340 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the safety and efficacy of REGN4018, both alone and in combination with cemiplimab, in adult patients with recurrent ovarian cancer and other MUC16+ cancers. It will assess the pharmacokinetics of the drugs, determining how they are processed in the body, and monitor any therapeutic effects on the targeted cancers. The study includes patients who have experienced relapse after previous treatments and have limited standard therapy options available. The research will also investigate the tolerability of sarilumab when used in conjunction with the primary treatments.

Who should consider this trial

Good fit: Ideal candidates include adults with recurrent ovarian cancer or other MUC16+ cancers who have limited treatment options and have previously received platinum-based therapies.

Not a fit: Patients with carcinosarcoma or those who have not received prior platinum-based therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with recurrent ovarian and other MUC16+ cancers.

How similar studies have performed: Other studies have shown promise with similar immunotherapy approaches, suggesting potential for success in this novel combination.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

1. Ovarian Cancer Cohorts Only: Patients with histologically or cytologically confirmed diagnosis of advanced, epithelial ovarian cancer (except carcinosarcoma), primary peritoneal, or fallopian tube cancer who have all of the following:

   1. serum CA-125 level ≥2 x upper limit of normal (ULN) (in screening, not required for low-grade serous carcinoma)
   2. has received at least 1 line of platinum-containing therapy or must be platinum-intolerant (applicable for dose escalation and non-randomized dose expansion cohorts)
   3. documented relapse or progression on or after the most recent line of therapy
   4. no standard therapy options likely to convey clinical benefit
2. Adequate organ and bone marrow function as defined in the protocol
3. Life expectancy of at least 3 months
4. Randomized phase 2 expansion cohort (Ovarian Cancer only): Platinum-resistant ovarian cancer patients who have had 2 to 4 lines of platinum-based therapy as defined in the protocol.
5. Endometrial Cancer Cohorts Only: histologically confirmed endometrial cancer that has progressed or recurrent after prior anti-Programmed Cell Death Ligand 1 (PD-1) therapy and platinum-based chemotherapy:

   1. MUC16 positivity of tumor cells ≥25% by immunohistochemistry (IHC), as defined in the protocol
   2. 1-4 prior lines of systemic therapy, as described in the protocol

Key Exclusion Criteria:

1. Prior treatment with anti-Programmed Cell Death (PD-1)/PD-L1 therapy, as described in the protocol
2. Ovarian Cancer Expansion cohorts only: More than 4 prior lines of cytotoxic chemotherapy (does not apply to low-grade serous ovarian cancer cohort)
3. Prior treatment with a MUC16 - targeted therapy
4. Untreated or active primary brain tumor, central nervous system (CNS) metastases, or spinal cord compression, as described in the protocol
5. History and/or current cardiovascular disease, as defined in the protocol
6. Severe and/or uncontrolled hypertension at screening. Patients taking anti-hypertensive medication must be on a stable anti-hypertensive regimen

Note: Other protocol-defined Inclusion/Exclusion Criteria apply

Where this trial is running

Birmingham, Alabama and 51 other locations

+2 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Recurrent Ovarian CancerRecurrent Fallopian Tube CancerRecurrent Primary Peritoneal CancerRecurrent Endometrial CancerEndometrial CancerLow-grade Serous Ovarian Cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.