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Closed (no longer recruiting)Last updated: 26 February 2024

REGN4018: This phase I/II trial is trying to understand how safe a type of targeted drug therapy is in order to determine an appropriate amount to use alone or in combination with other drugs in the treatment of recurrent ovarian, fallopian tube or primary peritoneal cancerA Phase 1/2 Study of REGN4018 (A MUC16xCD3 Bispecific Antibody) Administered Alone or in Combination With Cemiplimab in Patients With Recurrent Ovarian Cancer

Clinical summary


Eligible patients will receive REGN4018 as a monotherapy or in combination with cemiplimab in a series of dose escalation cohorts over 6-week cycles.


This trial is treating patients with recurrent ovarian, fallopian tube or primary peritoneal cancer


Female Reproductive System Cancers Gynaecological





Trial Acronym


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Trial Identifiers

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Trial sponsor

Regeneron Pharmaceuticals

Scientific Title

A Phase 1/2 Study of REGN4018 (A MUC16xCD3 Bispecific Antibody) Administered Alone or in Combination With Cemiplimab in Patients With Recurrent Ovarian Cancer



  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)
    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 1 to 3 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)
    2. 1-2 prior lines of systemic therapy


  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
  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 cardiac findings 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 Inclusion/Exclusion Criteria apply


  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.


  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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