Recruiting
Phase 2

Ubamatamab, Bevacizumab, Cemiplimab, Fianlimab, PLD

Sponsor:

Regeneron Pharmaceuticals

Code:

NCT06787612

Conditions

Ovarian Cancer

Fallopian Tube Cancer

Primary Peritoneal Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ubamatamab

Bevacizumab

Cemiplimab

Fianlimab

PLD

Study Details

Brief summary:

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

Conditions

Ovarian Cancer

Fallopian Tube Cancer

Primary Peritoneal Cancer

Study ID

NCT06787612

Start date

May 28, 2025

Status verified date

Aug, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

297 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A1

experimental: Arm A2

experimental: Arm B

experimental: Arm C

experimental: Arm D

experimental: Arms E1/E2

Interventions

Ubamatamab

Administered per the protocol

Bevacizumab

Administered per the protocol

Cemiplimab

Administered per the protocol

Fianlimab

Administered per the protocol

PLD

Administered per the protocol

Sarilumab

Administered per the protocol

REGN10597

Administered per the protocol

Primary outcome measure

  • Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by investigator assessment [ Time Frame: Up to 3 years ]

Central Contacts and Locations

Central contacts

Clinical Trials Administrator

844-734-6643clinicaltrials@regeneron.com

Locations

The University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

UC San Diego Health

Recruiting

La Jolla, California, United States, 92037

Cedars Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Mayo Clinic Jacksonville

Recruiting

Jacksonville, Florida, United States, 32224

University of Miami Sylvester Comprehensive Cancer Center

Recruiting

Miami, Florida, United States, 33136

Advent Health Cancer Institute

Recruiting

Orlando, Florida, United States, 32804

Tampa General Hospital Cancer Institute

Recruiting

Tampa, Florida, United States, 33606

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

The University of Kansas Cancer Center

Recruiting

Westwood, Kansas, United States, 66205

Norton Cancer Institute, St. Matthews Clinic

Recruiting

Louisville, Kentucky, United States, 40207

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201

The Ohio State University Comprehensive Cancer Center

Recruiting

Hilliard, Ohio, United States, 43026

Providence Cancer Institute

Recruiting

Portland, Oregon, United States, 97213

University of Pittsburgh Medical Center, Magee-Womens Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

West Penn Hospital of Allegheny Health Network

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Avera Cancer Institute Sioux Falls

Recruiting

Sioux Falls, South Dakota, United States, 57105

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Swedish Cancer Institute

Recruiting

Seattle, Washington, United States, 98104

University of Wisconsin

Recruiting

Madison, Wisconsin, United States, 53792

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

CancerCare Manitoba

Recruiting

Winnipeg, Manitoba, Canada, R3E 0V9

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Centre de Santé et de Services Sociaux de la Montérégie-Centre

Recruiting

Greenfield Park, Quebec, Canada, J4V 2H1

Jewish General Hospital

Recruiting

Montreal, Quebec, Canada, H3T 1E2

Research Institute - McGill University Health Centre

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Centre Hospitalier Universitaire (CHU) de Quebec - Universite Laval

Recruiting

Québec, Canada, G1J 0J9

More Information

Sponsor

Regeneron Pharmaceuticals

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Keywords

  • Platinum Resistance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Regeneron Pharmaceuticals on 2026-08-12.