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

NCT ID: NCT06787612

Last Updated: 2026-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-28

Study Completion Date

2028-12-07

Brief Summary

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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

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Detailed Description

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Conditions

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Ovarian Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A1

Randomization as described in the protocol

Group Type EXPERIMENTAL

Ubamatamab

Intervention Type DRUG

Administered per the protocol

Sarilumab

Intervention Type DRUG

Prophylaxis administered per the protocol

Arm A2

Randomization as described in the protocol

Group Type EXPERIMENTAL

Ubamatamab

Intervention Type DRUG

Administered per the protocol

Sarilumab

Intervention Type DRUG

Prophylaxis administered per the protocol

Arm B

Randomization as described in the protocol

Group Type EXPERIMENTAL

Ubamatamab

Intervention Type DRUG

Administered per the protocol

Bevacizumab

Intervention Type DRUG

Administered per the protocol

Sarilumab

Intervention Type DRUG

Prophylaxis administered per the protocol

Arm C

Randomization as described in the protocol

Group Type EXPERIMENTAL

Ubamatamab

Intervention Type DRUG

Administered per the protocol

Cemiplimab

Intervention Type DRUG

Administered per the protocol

Fianlimab

Intervention Type DRUG

Administered per the protocol

Sarilumab

Intervention Type DRUG

Prophylaxis administered per the protocol

Arm D

Randomization as described in the protocol

Group Type EXPERIMENTAL

Ubamatamab

Intervention Type DRUG

Administered per the protocol

PLD

Intervention Type DRUG

Administered per the protocol

Sarilumab

Intervention Type DRUG

Prophylaxis administered per the protocol

Interventions

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Ubamatamab

Administered per the protocol

Intervention Type DRUG

Bevacizumab

Administered per the protocol

Intervention Type DRUG

Cemiplimab

Administered per the protocol

Intervention Type DRUG

Fianlimab

Administered per the protocol

Intervention Type DRUG

PLD

Administered per the protocol

Intervention Type DRUG

Sarilumab

Prophylaxis administered per the protocol

Intervention Type DRUG

Other Intervention Names

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REGN4018 Avastin® Libtayo® REGN2810 REGN3767 Doxil® Pegylated liposomal doxorubicin Kevzara® REGN88 SAR153191

Eligibility Criteria

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Inclusion Criteria

1. Participants with histologically or cytologically confirmed diagnosis of advanced serous or endometrioid ovarian, 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

Exclusion Criteria

1. Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose of study drug(s)
2. Documented allergic or acute hypersensitivity reaction attributed to antibody treatments or doxorubicin hydrochloride or components of study drug(s)
3. Another malignancy that is progressing or requires active treatment, as described in the protocol
4. Untreated or active primary brain tumor, Central Nervous System (CNS) metastases, or spinal cord compression, 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

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The University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status RECRUITING

UC San Diego Health

La Jolla, California, United States

Site Status RECRUITING

Cedars Sinai Medical Center

Los Angeles, California, United States

Site Status RECRUITING

Mayo Clinic Jacksonville

Jacksonville, Florida, United States

Site Status RECRUITING

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Site Status RECRUITING

Tampa General Hospital Cancer Institute

Tampa, Florida, United States

Site Status RECRUITING

University of Chicago

Chicago, Illinois, United States

Site Status RECRUITING

The University of Kansas Cancer Center

Westwood, Kansas, United States

Site Status RECRUITING

Norton Cancer Institute, St. Matthews Clinic

Louisville, Kentucky, United States

Site Status RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status RECRUITING

The Ohio State University Comprehensive Cancer Center

Hilliard, Ohio, United States

Site Status RECRUITING

Providence Cancer Institute

Portland, Oregon, United States

Site Status RECRUITING

Avera Cancer Institute Sioux Falls

Sioux Falls, South Dakota, United States

Site Status RECRUITING

Swedish Cancer Institute

Seattle, Washington, United States

Site Status RECRUITING

University of Wisconsin

Madison, Wisconsin, United States

Site Status RECRUITING

National Cancer Center

Gyeonggi-do, Gyeonggi-do, South Korea

Site Status RECRUITING

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Gachon University Gil Medical Center

Incheon, Seoul, South Korea

Site Status RECRUITING

Keimyung University Dongsan Hospital

Daegu, , South Korea

Site Status RECRUITING

Severance Hospital Yonsei University Health System

Seoul, , South Korea

Site Status RECRUITING

Asan Medical Center, Univ. of Ulsan

Seoul, , South Korea

Site Status RECRUITING

Samsung Medical Center

Seoul, , South Korea

Site Status RECRUITING

Gangnam Severance Hospital

Seoul, , South Korea

Site Status RECRUITING

Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Korea University Guro Hospital

Seoul, , South Korea

Site Status RECRUITING

Changhua Christian Hospital

Changhua, Changhua City, Taiwan

Site Status RECRUITING

Chi Mei Medical Center

Tainan, , Taiwan

Site Status RECRUITING

National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Mackay Memorial Hospital

Taipei, , Taiwan

Site Status RECRUITING

Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status RECRUITING

Tri-Service General Hospital

Taipei, , Taiwan

Site Status RECRUITING

Taipei Municipal Wan Fang Hospital

Taipei, , Taiwan

Site Status RECRUITING

Medicalpark Seyhan Hospital

Seyhan, Adana, Turkey (Türkiye)

Site Status RECRUITING

Hacettepe University

Altındağ, Ankara, Turkey (Türkiye)

Site Status RECRUITING

Medipol University Hospital

Istanbul, Bagcilar, Turkey (Türkiye)

Site Status RECRUITING

Gaziantep Medicalpoint Hospital

Gaziantep, Sehitkamil, Turkey (Türkiye)

Site Status RECRUITING

Baskent University

Adana, , Turkey (Türkiye)

Site Status RECRUITING

Sbu Doctor Abdurrahman Yurtaslan Ankara Onkoloji Suam

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Ankara Bilkent City Hospital

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Memorial Ankara Hospital

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Cerrahpasa Medical Faculty At Istanbul University Cerrahpasa

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Sakarya University - Education and Research Hospital

Sakarya, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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United States South Korea Taiwan Turkey (Türkiye)

Central Contacts

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Clinical Trials Administrator

Role: CONTACT

844-734-6643

Other Identifiers

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R4018-ONC-2445

Identifier Type: -

Identifier Source: org_study_id

2024-517806-27-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

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