Study to Evaluate INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression

Official title

A Phase 3, Randomized, Open-Label Study of INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression

Overview

The purpose of this study is to evaluate INCB123667 versus investigator's choice of chemotherapy in participants with platinum-resistant ovarian cancer with cyclin E1 overexpression.

Interventions

• Drug INCB123667
  Oral; tablet
• Drug Investigator's choice of chemotherapy
  The investigator will select the chemotherapy in accordance with the protocol-defined requirements. The possible choices as defined by the protocol:

Primary outcome measures

• Progression-Free Survival (PFS) by BICR [Time frame: Up to 2 years]
• Overall Survival (OS) [Time frame: Up to 2 years]

Secondary outcome measures (10)

• Objective response by BICR [Time frame: Up to 2 years]
• Duration of Response (DOR) by BICR [Time frame: Up to 2 years]
• Progression-Free Survival (PFS) by investigator [Time frame: Up to 2 years]
• Objective response by investigator [Time frame: Up to 2 years]
• DOR by investigator [Time frame: Up to 2 years]
• Treatment Emergent Adverse Events (TEAEs) [Time frame: Up to 2 years and 30 days]
• TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatment [Time frame: Up to 2 years and 30 days]
• Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-Core 30 (C30) at each postbaseline visit [Time frame: Up to 2 years]
• Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-Core 28 (C28) score at each postbaseline visit [Time frame: Up to 2 years]
• Change from baseline in EQ-5D-5L score at each postbaseline visit [Time frame: Up to 2 years]

Eligibility criteria

Inclusion criteria

• Histological diagnosis of high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer.
• Have platinum-resistant disease.

• Participants who have only had 1 line of platinum-based therapy must have received at least 4 cycles of platinum containing regimen.
• Participants who have received 2 to 4 lines of platinum-based therapy must have progressed on or within 6 months after the last dose of platinum.
• Archival FFPE tumor tissue block or slides from a specimen no older than 5 years must be available. If not available, participant must be willing to undergo a pretreatment tumor biopsy.
• Received at least 1 and no more than 4 prior lines of systemic therapy following the initial diagnosis, after which single-agent chemotherapy is considered an appropriate next therapeutic option.
• Should have received prior treatment with bevacizumab unless there was a contraindication for its use.
• Should have received prior treatment with mirvetuximab soravtansine if the tumor is positive for FRα, unless there is an exception for its use on medical grounds.
• Measurable disease per RECIST v1.1.

Exclusion criteria

• Have endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of these histologies, or low-grade/borderline ovarian cancer.
• Have primary platinum-refractory disease, defined as progression on or within 3 months after the last dose of first line platinum-containing therapy.
• Clinically significant or uncontrolled cardiac disease within 6 months before the first dose of study treatment.
• Known active CNS metastases and/or carcinomatous meningitis.
• Known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 3 years before the first dose of study treatment.
• Clinically significant gastrointestinal abnormalities.

Other protocol-defined Inclusion/Exclusion Criteria may 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 · 48 centers

• Alaska Womens Cancer Care Akwcc — Anchorage
• University of Arizona Cancer Center — Tucson
• City of Hope Medical Center — Duarte
• Providence Medical Foundation — Fullerton
• University of California, San Diego-Moores Cancer Center — La Jolla
• Valkyrie Clinical Trials — Los Angeles
• Uci Health Chao Family Comprehensive Cancer Center — Orange
• Ventura County Hematology Oncology Specialists-Oxnard — Oxnard
• … and 40 more centers

Italy · 19 centers

Center list to be confirmed — check the primary protocol.

Japan · 15 centers

Center list to be confirmed — check the primary protocol.

South Korea · 15 centers

Center list to be confirmed — check the primary protocol.

United Kingdom · 13 centers

Center list to be confirmed — check the primary protocol.

France · 12 centers

• Ch Davignon - Hopital Henri Duffaut — Avignon
• Clinique Tivoli — Bordeaux
• Clinique Pole Sante Leonard de Vinci — Chambray-lès-Tours
• Centre Hospitalier Departemental de Vendee, Hopital de La-Roche-Sur-Yon Les Oudairies — La Roche-sur-Yon
• Centre Hospitalier Universitaire de Grenoble- Hopital Albert Michallon — La Tronche
• Hopital Prive Jean Mermoz — Lyon
• Institut Paoli Calmettes — Marseille
• Centre Antoine Laccassagne — Nice
• … and 4 more centers

Spain · 11 centers

Center list to be confirmed — check the primary protocol.

Germany · 9 centers

• Charite Campus Virchow — Berlin
• Universitaetsklinikum Bonn — Bonn
• Universitaetsklinikum Dresden — Dresden
• … and 6 more centers

Belgium · 6 centers

• Hopital Universitaire de Bruxelles (Hub) - Institut Jules Bordet — Brussels
• Cliniques Universitaires St Luc Ucl — Brussels
• Az Maria Middelares Gent — Ghent
• UZ GENT — Ghent
• Az Groeninge — Kortrijk
• Universitair Ziekenhuis Leuven — Leuven

Canada · 6 centers

• Tom Baker Cancer Center-Alberta Health Services (Ahs) - University of Calgary — Calgary
• Cross Cancer Insititute — Edmonton
• London Health Sciences Centre — London
• University Health Network (Uhn) - Princess Margaret Cancer Centre — Toronto
• Sir Mortimer B. Davis - Jewish General Hospital — Montreal
• Cedars Cancer Centre - McGill University Health Centre (Muhc) - Glen Site — Montreal

Switzerland · 6 centers

Center list to be confirmed — check the primary protocol.

Australia · 5 centers

• Chris O'Brien Lifehouse Hospital — Camperdown
• The Wollongong Hospital — Wollongong
• Mater Hospital Brisbane — South Brisbane
• Icon Cancer Care - Townsville — Townsville
• Eastern Health-Box Hill Hospital — Box Hill

Ireland · 5 centers

Center list to be confirmed — check the primary protocol.

Poland · 5 centers

Center list to be confirmed — check the primary protocol.

Netherlands · 4 centers

Center list to be confirmed — check the primary protocol.

Puerto Rico · 2 centers

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07214779 · INCB123667-305 · 2025-522748-42-00 · GOG-3137 · ENGOT-OV95

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗