Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
Conditions
Keywords
Platinum Resistance
Brief 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
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
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by investigator assessment | Up to 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Cancer Antigen (CA) -125 response by Gynecologic Cancer Intergroup (GCIG) Criteria | Up to 3 years |
| Complete Response (CR) rate by RECIST 1.1 | Up to 3 years |
| Disease Control Rate (DCR) by RECIST 1.1 | Up to 3 years |
| Duration Of Response (DOR) by RECIST 1.1 | Up to 3 years |
| Progression-Free Survival (PFS) by RECIST 1.1 | Up to 3 years |
| Occurrence of Grade ≥ 2 Cytokine Release Syndrome (CRS) by Lee criteria | Up to 3 years |
| Treatment-Emergent Adverse Events (TEAEs) by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | Up to 3 years |
| TEAEs by Lee criteria | Up to 3 years |
| Concentration of ubamatamab in serum | Up to 3 years |
| Concentration of fianlimab in serum | Up to 3 years |
| Occurrence of Anti-Drug Antibodies (ADA) to ubamatamab | Up to 3 years |
| Magnitude of ADA to ubamatamab | Up to 3 years |
| Occurrence of ADA to fianlimab | Up to 3 years |
| Magnitude of ADA to fianlimab | Up to 3 years |
| Occurrence of ADA to cemiplimab | Up to 3 years |
| Magnitude of ADA to cemiplimab | Up to 3 years |
Countries
Canada, South Korea, Taiwan, Turkey (Türkiye), United States
Contacts
CONTACTClinical Trials Administrator
STUDY_DIRECTORClinical Trial Management
Regeneron Pharmaceuticals
Outcome results
None listed