Multi-Arm Phase 2 Platform Study of Ubamatamab (REGN4018; MUC16×CD3 Bispecific Antibody) With or Without Additional Agents in Platinum-Resistant Ovarian Cancer
Regeneron Pharmaceuticals
Summary
This study is researching an experimental drug called ubamatamab, also referred to as "study drug". The study is focused on patients who have advanced ovarian cancer. The aim of the study is to see how safe, tolerable, and effective the study drug is on its own and in combination with other anti-cancer drugs (bevacizumab, cemiplimab, fianlimab and a standard chemotherapy drug, pegylated liposomal doxorubicin \[PLD\]), referred to as "combination drugs'. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug and its experimental combinations * How much study drug and fianlimab is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects) and its combinations
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
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 protoc…
Interventions
- DrugUbamatamab
Administered per the protocol
- DrugBevacizumab
Administered per the protocol
- DrugCemiplimab
Administered per the protocol
- DrugFianlimab
Administered per the protocol
- DrugPLD
Administered per the protocol
- DrugSarilumab
Administered per the protocol
Locations (50)
- The University of Alabama at BirminghamBirmingham, Alabama
- UC San Diego HealthLa Jolla, California
- Cedars Sinai Medical CenterLos Angeles, California
- Mayo Clinic JacksonvilleJacksonville, Florida
- University of Miami Sylvester Comprehensive Cancer CenterMiami, Florida
- Advent Health Cancer InstituteOrlando, Florida