This study is researching an experimental drug called ubamatamab, also referred to as "study drug". The study is focused on participants 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, REGN10597 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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
297
Administered per the protocol
Administered per the protocol
Administered per the protocol
Administered per the protocol
Administered per the protocol
Administered per the protocol
Administered per the protocol
The University of Alabama at Birmingham
Birmingham, Alabama, United States
RECRUITINGUC San Diego Health
La Jolla, California, United States
RECRUITINGCedars Sinai Medical Center
Los Angeles, California, United States
RECRUITINGMayo Clinic Jacksonville
Jacksonville, Florida, United States
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by investigator assessment
Time frame: Up to 3 years
Cancer Antigen (CA) -125 response by Gynecologic Cancer Intergroup (GCIG) Criteria
Time frame: Up to 3 years
Complete Response (CR) rate by RECIST 1.1
Time frame: Up to 3 years
Disease Control Rate (DCR) by RECIST 1.1
Time frame: Up to 3 years
Duration of Response (DOR) by RECIST 1.1
Time frame: Up to 3 years
Progression-Free Survival (PFS) by RECIST 1.1
Time frame: Up to 3 years
Occurrence of Grade ≥ 2 Cytokine Release Syndrome (CRS) by Lee criteria
Time frame: Up to 3 years
Treatment-Emergent Adverse Events (TEAEs) by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: Up to 3 years
TEAEs by Lee criteria
Time frame: Up to 3 years
Concentration of ubamatamab in serum
Time frame: Up to 3 years
Concentration of fianlimab in serum
Time frame: Up to 3 years
Concentration of REGN10597 in serum
Time frame: Up to 3 years
Occurrence of Anti-Drug Antibodies (ADA) to ubamatamab
Time frame: Up to 3 years
Magnitude of ADA to ubamatamab
Time frame: Up to 3 years
Occurrence of ADA to fianlimab
Time frame: Up to 3 years
Magnitude of ADA to fianlimab
Time frame: Up to 3 years
Occurrence of ADA to cemiplimab
Time frame: Up to 3 years
Magnitude of ADA to cemiplimab
Time frame: Up to 3 years
Occurrence of ADA to REGN10597
Time frame: Up to 3 years
Magnitude of ADA to REGN10597
Time frame: Up to 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States
RECRUITINGAdvent Health Cancer Institute
Orlando, Florida, United States
RECRUITINGTampa General Hospital Cancer Institute
Tampa, Florida, United States
RECRUITINGUniversity of Chicago
Chicago, Illinois, United States
RECRUITINGThe University of Kansas Cancer Center
Westwood, Kansas, United States
RECRUITINGNorton Cancer Institute, St. Matthews Clinic
Louisville, Kentucky, United States
RECRUITING...and 46 more locations