Ubamatamab alone and with other cancer drugs for platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer
Multi-Arm Phase 2 Platform Study of Ubamatamab (REGN4018; MUC16×CD3 Bispecific Antibody) With or Without Additional Agents in Platinum-Resistant Ovarian Cancer
This trial will test whether ubamatamab by itself or combined with bevacizumab, cemiplimab, fianlimab, or pegylated liposomal doxorubicin helps adults with platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Regeneron Pharmaceuticals Industry-sponsored |
| Drugs / interventions | doxorubicin, ubamatamab, bevacizumab, cemiplimab, fianlimab, chemotherapy |
| Locations | 50 sites (Birmingham, Alabama and 49 other locations) |
| Trial ID | NCT06787612 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults with histologically or cytologically confirmed advanced serous or endometrioid ovarian, primary peritoneal, or fallopian tube cancer that is platinum-resistant, with at least one measurable lesion, ECOG 0–1, and adequate organ and marrow function are ideal candidates.
Not a fit: Patients with excluded histologies (clear cell, mucinous, carcinosarcoma), recent major surgery or trauma, known severe allergies to antibody therapies or doxorubicin components, poor performance status, or without measurable disease are unlikely to qualify or benefit.
Why it matters
Potential benefit: If successful, the regimen could provide a new treatment option that improves tumor control for people with platinum-resistant disease.
How similar studies have performed: Other antibody combinations and immune checkpoint approaches have shown activity in some platinum-resistant ovarian cancer trials, but ubamatamab and its specific combinations are relatively new and not yet proven effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Birmingham, Alabama and 49 other locations
- 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)
- Tampa General Hospital Cancer Institute — Tampa, Florida, United States (Recruiting)
- University of Chicago — Chicago, Illinois, United States (Recruiting)
- The University of Kansas Cancer Center — Westwood, Kansas, United States (Recruiting)
- Norton Cancer Institute, St. Matthews Clinic — Louisville, Kentucky, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- Karmanos Cancer Institute — Detroit, Michigan, United States (Recruiting)
- The Ohio State University Comprehensive Cancer Center — Hilliard, Ohio, United States (Recruiting)
- Providence Cancer Institute — Portland, Oregon, United States (Recruiting)
- West Penn Hospital of Allegheny Health Network — Pittsburgh, Pennsylvania, United States (Recruiting)
- Avera Cancer Institute Sioux Falls — Sioux Falls, South Dakota, United States (Recruiting)
- UT Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
- Swedish Cancer Institute — Seattle, Washington, United States (Recruiting)
- University of Wisconsin — Madison, Wisconsin, United States (Recruiting)
- Princess Margaret Cancer Centre — Toronto, Ontario, Canada (Recruiting)
- Research Institute - McGill University Health Centre — Montreal, Quebec, Canada (Recruiting)
- Centre Hospitalier Universitaire (CHU) de Quebec - Universite Laval — Québec, Canada (Recruiting)
- National Cancer Center — Gyeonggi-do, Gyeonggi-do, South Korea (Recruiting)
- Seoul National University Bundang Hospital — Seongnam-si, Gyeonggi-do, South Korea (Recruiting)
- Gachon University Gil Medical Center — Incheon, Seoul, South Korea (Recruiting)
- Keimyung University Dongsan Hospital — Daegu, South Korea (Recruiting)
- Severance Hospital Yonsei University Health System — Seoul, South Korea (Recruiting)
- Asan Medical Center, Univ. of Ulsan — Seoul, South Korea (Recruiting)
- Samsung Medical Center — Seoul, South Korea (Recruiting)
- Gangnam Severance Hospital — Seoul, South Korea (Recruiting)
- Seoul National University Hospital — Seoul, South Korea (Recruiting)
- Korea University Guro Hospital — Seoul, South Korea (Recruiting)
- Changhua Christian Hospital — Changhua, Changhua City, Taiwan (Recruiting)
- Chi Mei Medical Center — Tainan, Taiwan (Recruiting)
- Mackay Memorial Hospital — Taipei, Taiwan (Recruiting)
- National Taiwan University Hospital — Taipei, Taiwan (Recruiting)
- Taipei Veterans General Hospital — Taipei, Taiwan (Recruiting)
- Tri-Service General Hospital — Taipei, Taiwan (Recruiting)
- Taipei Municipal Wan Fang Hospital — Taipei, Taiwan (Recruiting)
- Medicalpark Seyhan Hospital — Seyhan, Adana, Turkey (Türkiye) (Recruiting)
- Hacettepe University — Altındağ, Ankara, Turkey (Türkiye) (Recruiting)
- Medipol University Hospital — Istanbul, Bagcilar, Turkey (Türkiye) (Recruiting)
- Gaziantep Medicalpoint Hospital — Gaziantep, Sehitkamil, Turkey (Türkiye) (Recruiting)
- Baskent University — Adana, Turkey (Türkiye) (Recruiting)
- Sbu Doctor Abdurrahman Yurtaslan Ankara Onkoloji Suam — Ankara, Turkey (Türkiye) (Recruiting)
- Ankara Bilkent City Hospital — Ankara, Turkey (Türkiye) (Recruiting)
- Memorial Ankara Hospital — Ankara, Turkey (Türkiye) (Recruiting)
- Cerrahpasa Medical Faculty At Istanbul University Cerrahpasa — Istanbul, Turkey (Türkiye) (Recruiting)
- Izmir Ekonomi Universitesi (IEU) Medical Point Izmir Hastanesi (Izmir Economy University Medical Point Izmir Hospital) — Izmir, Turkey (Türkiye) (Recruiting)
- Sakarya University - Education and Research Hospital — Sakarya, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Clinical Trials Administrator
- Email: clinicaltrials@regeneron.com
- Phone: 844-734-6643
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.