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Recruiting NCT06787612

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

Phase II Interventional Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ubamatamab, Bevacizumab, Cemiplimab, Fianlimab.
Who it may be relevant to
Registry conditions: Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Canada, South Korea, Taiwan, Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • 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

Primary outcome measures

  • Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by investigator assessment [Time frame: Up to 3 years]
Secondary outcome measures (12)
  • 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]
  • 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]

Eligibility criteria

Inclusion criteria

  • 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)
  • 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
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate organ and bone marrow function, as described in the protocol
  • Platinum-Resistant Ovarian Cancer, as described in the protocol

Exclusion criteria

  • Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose of study intervention(s)
  • Documented allergic or acute hypersensitivity reaction attributed to antibody treatments or doxorubicin hydrochloride or components of study intervention(s)
  • Another malignancy that is progressing or requires active treatment, as described in the protocol
  • Untreated or active Central Nervous System (CNS) metastases, or carcinomatous meningitis, as described in the protocol
  • Uncontrolled infections including but not limited to human immunodeficiency virus, hepatitis B or hepatitis C infection, or diagnosis of immunodeficiency
  • Moderate to large or ascites, as described in the protocol
  • Bowel obstruction within last 3 months or current need for parenteral nutrition

NOTE: Other protocol-defined inclusion/exclusion criteria apply

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 21 centers
  • The University of Alabama at Birmingham — Birmingham
  • UC San Diego Health — La Jolla
  • Cedars Sinai Medical Center — Los Angeles
  • Mayo Clinic Jacksonville — Jacksonville
  • University of Miami Sylvester Comprehensive Cancer Center — Miami
  • Advent Health Cancer Institute — Orlando
  • Tampa General Hospital Cancer Institute — Tampa
  • University of Chicago — Chicago
  • … and 13 more centers
Turkey (Türkiye) · 11 centers
  • Medicalpark Seyhan Hospital — Seyhan
  • Hacettepe University — Altındağ
  • Medipol University Hospital — Istanbul
  • Gaziantep Medicalpoint Hospital — Gaziantep
  • Baskent University — Adana
  • Sbu Doctor Abdurrahman Yurtaslan Ankara Onkoloji Suam — Ankara
  • Ankara Bilkent City Hospital — Ankara
  • Memorial Ankara Hospital — Ankara
  • … and 3 more centers
South Korea · 10 centers
  • National Cancer Center — Gyeonggi-do
  • Seoul National University Bundang Hospital — Seongnam-si
  • Gachon University Gil Medical Center — Incheon
  • Keimyung University Dongsan Hospital — Daegu
  • Severance Hospital Yonsei University Health System — Seoul
  • Asan Medical Center, Univ. of Ulsan — Seoul
  • Samsung Medical Center — Seoul
  • Gangnam Severance Hospital — Seoul
  • … and 2 more centers
Taiwan · 7 centers
  • Changhua Christian Hospital — Changhua
  • Chi Mei Medical Center — Tainan
  • Mackay Memorial Hospital — Taipei
  • National Taiwan University Hospital — Taipei
  • Taipei Veterans General Hospital — Taipei
  • Tri-Service General Hospital — Taipei
  • Taipei Municipal Wan Fang Hospital — Taipei
Canada · 5 centers
  • CancerCare Manitoba — Winnipeg
  • Princess Margaret Cancer Centre — Toronto
  • Centre de Santé et de Services Sociaux de la Montérégie-Centre — Greenfield Park
  • Research Institute - McGill University Health Centre — Montreal
  • Centre Hospitalier Universitaire (CHU) de Quebec - Universite Laval — Québec

Identifiers

NCT: NCT06787612 · R4018-ONC-2445 · 2024-517806-27-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗