Phase 2 Ovarian Cancer Trial, Recruiting NCT04590326 Sponsor: Regeneron Pharmaceuticals Condition: Ovarian Cancer
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Phase 2 Ovarian Cancer Trial, Recruiting

NCT04590326
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been diagnosed with advanced ovarian cancer (not a type called carcinosarcoma), primary peritoneal cancer, or fallopian tube cancer, confirmed by a tissue or cell sample, and have already received at least one round of platinum-based chemotherapy (for ovarian cancer participants)
  • You have been diagnosed with endometrial (uterine) cancer that has come back or gotten worse after receiving both immunotherapy (anti-PD-1) and platinum-based chemotherapy (for endometrial cancer participants)
  • You have at least one tumor that can be measured on a scan (for certain groups within the trial)
  • Your blood test shows a specific cancer marker called CA-125 is raised above a certain level (for ovarian cancer participants; confirm with trial site)
  • Your heart, liver, kidneys, and bone marrow are functioning well enough as set out by the trial (confirm with trial site)
  • You are able to carry out daily activities with no or minimal limitations, based on a standard health scale (score of 0 or 1)
  • Your doctors expect you to live for at least 3 more months

Who may not be able to join:

  • You are currently receiving, or have recently received, another experimental treatment, a biological therapy, or cancer immunotherapy
  • You have had another type of cancer in the last 5 years that is still active, needs treatment, or is likely to come back
  • You have previously been treated with a therapy that targets a protein called MUC16
  • You have received more than 5 different rounds of systemic (whole-body) treatment (for certain ovarian cancer groups only)
  • You need to take steroid (corticosteroid) medicines on a regular, ongoing basis
  • You have a significant autoimmune disease that needed treatment with medicines that suppress the immune system, either currently or within the last 5 years
  • You have untreated or currently active cancer that has spread to the brain or spinal cord
  • You have a history of serious heart or blood vessel disease (confirm with trial site for specific conditions)
  • You have a known allergy or bad reaction to the study drug cemiplimab or any of its ingredients

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 5 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Clinical Trial Management, Regeneron Pharmaceuticals

Phone: 844-734-6643

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Regeneron Pharmaceuticals
Registry
ClinicalTrials.gov
Start date
8 December 2020
Est. completion
25 March 2027

Where this trial is recruiting

🇧🇪 Belgium 🇫🇷 France 🇪🇸 Spain 🇺🇸 United States

Primary endpoints

Incidence of Dose Limiting Toxicities (DLT); Incidence of DLTs; Incidence of Treatment-Emergent Adverse Events (TEAEs); Incidence of Serious Adverse Events (SAEs); Incidence of deaths; Incidence of laboratory abnormalities (Grade 3 or higher per National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE] version 5.0 [v5.0]); Concentrations of REGN5668 in serum when dosed alone and in combination with cemiplimab or ubamatamab; Objective Response Rate (ORR) defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (Eisenhauer, 2009) of REGN5668 in combination...

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 5 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov