Ubamatamab alone and with other cancer drugs for platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2, multi-center trial gives adults with platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer ubamatamab either alone or paired with bevacizumab, cemiplimab, fianlimab, or pegylated liposomal doxorubicin (PLD). The study will monitor safety, tolerability, anti-tumor activity, blood levels of the drugs, and whether the body develops antibodies against the treatments. Eligible participants must have measurable disease by RECIST 1.1, ECOG performance status 0–1, and adequate organ and bone marrow function. Research visits occur at participating U.S. centers and include regular imaging and laboratory testing to track response and side effects.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

1. Participants with histologically or cytologically confirmed diagnosis of advanced serous or endometrioid ovarian (regardless of the grade), primary peritoneal, or fallopian tube cancer (clear cell, mucinous, and carcinosarcoma are excluded)
2. Must have progression on prior therapy documented radiographically and must have at least 1 measurable lesion (not previously irradiated) that can be accurately measured by RECIST 1.1
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
4. Adequate organ and bone marrow function, as described in the protocol
5. Platinum-Resistant Ovarian Cancer, as described in the protocol

Key Exclusion Criteria:

1. Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose of study intervention(s)
2. Documented allergic or acute hypersensitivity reaction attributed to antibody treatments or doxorubicin hydrochloride or components of study intervention(s)
3. Another malignancy that is progressing or requires active treatment, as described in the protocol
4. Untreated or active Central Nervous System (CNS) metastases, or carcinomatous meningitis, as described in the protocol
5. Uncontrolled infections including but not limited to human immunodeficiency virus, hepatitis B or hepatitis C infection, or diagnosis of immunodeficiency
6. Moderate to large or ascites, as described in the protocol
7. Bowel obstruction within last 3 months or current need for parenteral nutrition

NOTE: Other protocol-defined inclusion/exclusion criteria apply

Where it's running

• The University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• UC San Diego Health
  La Jolla, California, United States Recruiting
• Cedars Sinai Medical Center
  Los Angeles, California, United States Recruiting
• Mayo Clinic Jacksonville
  Jacksonville, Florida, United States Recruiting
• University of Miami Sylvester Comprehensive Cancer Center
  Miami, Florida, United States Recruiting
• Advent Health Cancer Institute
  Orlando, Florida, United States Recruiting

+6 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Clinical Trials Administrator
• Email: clinicaltrials@regeneron.com
• Phone: 844-734-6643

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.