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RECRUITINGPhase 2INTERVENTIONAL

Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer

Multi-Arm Phase 2 Platform Study of Ubamatamab (REGN4018; MUC16×CD3 Bispecific Antibody) With or Without Additional Agents in Platinum-Resistant Ovarian Cancer

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Key Who May Qualify: 1. Participants with diagnosed by tissue sample (biopsy-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 Who Should NOT Join This Trial: 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 weakened immune system virus, hepatitis B or hepatitis C infection, or diagnosis of weakened immune system 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Ubamatamab

Administered per the protocol

DRUG

Bevacizumab

Administered per the protocol

DRUG

Cemiplimab

Administered per the protocol

DRUG

Fianlimab

Administered per the protocol

DRUG

PLD

Administered per the protocol

DRUG

Sarilumab

Administered per the protocol

Locations (20)

The University of Alabama at Birmingham
Birmingham, Alabama, United States
UC San Diego Health
La Jolla, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Tampa General Hospital Cancer Institute
Tampa, Florida, United States
University of Chicago
Chicago, Illinois, United States
The University of Kansas Cancer Center
Westwood, Kansas, United States
Norton Cancer Institute, St. Matthews Clinic
Louisville, Kentucky, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
The Ohio State University Comprehensive Cancer Center
Hilliard, Ohio, United States
Providence Cancer Institute
Portland, Oregon, United States
Avera Cancer Institute Sioux Falls
Sioux Falls, South Dakota, United States
Swedish Cancer Institute
Seattle, Washington, United States
University of Wisconsin
Madison, Wisconsin, United States
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Research Institute - McGill University Health Centre
Montreal, Quebec, Canada
Centre Hospitalier Universitaire (CHU) de Quebec - Universite Laval
Québec, Canada
National Cancer Center
Gyeonggi-do, Gyeonggi-do, South Korea