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

Официальное название

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

Обзор

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

Вмешательства

• Препарат Ubamatamab
  Administered per the protocol
• Препарат Bevacizumab
  Administered per the protocol
• Препарат Cemiplimab
  Administered per the protocol
• Препарат Fianlimab
  Administered per the protocol
• Препарат PLD
  Administered per the protocol
• Препарат Sarilumab
  Administered per the protocol

Первичные конечные точки

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

Вторичные конечные точки (12)

• Cancer Antigen (CA) -125 response by Gynecologic Cancer Intergroup (GCIG) Criteria [Срок оценки: Up to 3 years]
• Complete Response (CR) rate by RECIST 1.1 [Срок оценки: Up to 3 years]
• Disease Control Rate (DCR) by RECIST 1.1 [Срок оценки: Up to 3 years]
• Duration Of Response (DOR) by RECIST 1.1 [Срок оценки: Up to 3 years]
• Progression-Free Survival (PFS) by RECIST 1.1 [Срок оценки: Up to 3 years]
• Occurrence of Grade ≥ 2 Cytokine Release Syndrome (CRS) by Lee criteria [Срок оценки: Up to 3 years]
• Treatment-Emergent Adverse Events (TEAEs) by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 [Срок оценки: Up to 3 years]
• TEAEs by Lee criteria [Срок оценки: Up to 3 years]
• Concentration of ubamatamab in serum [Срок оценки: Up to 3 years]
• Concentration of fianlimab in serum [Срок оценки: Up to 3 years]
• Occurrence of Anti-Drug Antibodies (ADA) to ubamatamab [Срок оценки: Up to 3 years]
• Magnitude of ADA to ubamatamab [Срок оценки: Up to 3 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 21 центр

• 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
• … и ещё 13 центров

Turkey (Türkiye) · 11 центров

• 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
• … и ещё 3 центра

South Korea · 10 центров

• 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
• … и ещё 2 центра

Тайвань · 7 центров

• 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

Канада · 5 центров

• 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

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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