Study to Evaluate INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression
MAESTRA 2
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
4 other identifiers
interventional
466
16 countries
178
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 ovarian-cancer
Started Dec 2025
Shorter than P25 for phase_3 ovarian-cancer
178 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 6, 2025
CompletedFirst Posted
Study publicly available on registry
October 9, 2025
CompletedStudy Start
First participant enrolled
December 9, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 14, 2029
July 23, 2026
July 1, 2026
2.9 years
October 6, 2025
July 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Progression-Free Survival (PFS) by BICR
Defined as the time from the date of randomization until the earliest date of disease progression as determined by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause, whichever occurs first.
Up to 2 years
Overall Survival (OS)
Defined as the time from the date of randomization until death due to any cause.
Up to 2 years
Secondary Outcomes (10)
Objective response by BICR
Up to 2 years
Duration of Response (DOR) by BICR
Up to 2 years
Progression-Free Survival (PFS) by investigator
Up to 2 years
Objective response by investigator
Up to 2 years
DOR by investigator
Up to 2 years
- +5 more secondary outcomes
Study Arms (2)
Treatment Group A (TGA)
EXPERIMENTALINCB123667 at the protocol-defined dose.
Treatment Group B (TGB)
EXPERIMENTALInvestigator's choice of chemotherapy at the protocol-defined dose as defined by the protocol.
Interventions
The investigator will select the chemotherapy in accordance with the protocol-defined requirements. The possible choices as defined by the protocol:
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Incyte Corporationlead
- ENGOT Foundationcollaborator
- GOG Foundationcollaborator
Study Sites (178)
Alaska Womens Cancer Care Akwcc
Anchorage, Alaska, 99508, United States
University of Arizona Cancer Center
Tucson, Arizona, 85724-5002, United States
City of Hope Medical Center
Duarte, California, 91010, United States
Providence Medical Foundation
Fullerton, California, 92835, United States
University of California, San Diego-Moores Cancer Center
La Jolla, California, 92037, United States
Valkyrie Clinical Trials
Los Angeles, California, 90067, United States
Chao Family Comprehensive Cancer Center University of California, Irvine
Orange, California, 92868, United States
Ventura County Hematology Oncology Specialists-Oxnard
Oxnard, California, 93030, United States
University of Colorado Cancer Center
Aurora, Colorado, 80045, United States
Brcr Global
Miramar, Florida, 33027, United States
Winship Cancer Institute At Emory University
Atlanta, Georgia, 30322, United States
Georgia Cancer Center
Augusta, Georgia, 30912, United States
Carle Cancer Center
Effingham, Illinois, 62401-2006, United States
Northshore University Health System-Evanston Hospital
Evanston, Illinois, 60201, United States
St Elizabeth Healthcare
Edgewood, Kentucky, 41017, United States
Women'S Cancer Care
Covington, Louisiana, 70433, United States
Maine Center For Cancer Medicine
Scarborough, Maine, 04074, United States
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
Baltimore, Maryland, 21287, United States
Holy Cross Hospital
Silver Spring, Maryland, 20910, United States
Mercy Hospital St. Louis - David C. Pratt Cancer Center
St Louis, Missouri, 63141, United States
Billings Clinic
Billings, Montana, 59101, United States
Women'S Cancer Center of Nevada
Las Vegas, Nevada, 89106, United States
Center of Hope
Reno, Nevada, 89511, United States
Unm Comprehensive Cancer Center
Albuquerque, New Mexico, 87131, United States
Levine Cancer Center
Charlotte, North Carolina, 28204, United States
Novant Presbyterian Hospital
Charlotte, North Carolina, 28204, United States
East Carolina University
Greenville, North Carolina, 27834, United States
Novant Health Oncology Specialists
Winston-Salem, North Carolina, 27103, United States
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Ohio Health Research Institute
Columbus, Ohio, 43214, United States
Promedica Flower Hospital
Sylvania, Ohio, 43560, United States
Oncology Associates of Oregon, P.C.
Eugene, Oregon, 97401, United States
Providence Cancer Institute Franz Clinic
Portland, Oregon, 97213, United States
University of Pittsburgh Cancer Institute Cancer Services
Pittsburgh, Pennsylvania, 15213, United States
Allegheny Health Network- West Penn Hospital
Pittsburgh, Pennsylvania, 15224, United States
Wellspan Gynecologic Oncology
York, Pennsylvania, 17403, United States
Sanford Cancer Center-Sioux Falls
Sioux Falls, South Dakota, 57104-8805, United States
Erlanger Health, Inc.
Chattanooga, Tennessee, 37403, United States
Texas Oncology-Abilene
Abilene, Texas, 79606, United States
Jps Health Network
Fort Worth, Texas, 76104, United States
University of Texas Health Science Cente
San Antonio, Texas, 78229, United States
Texas Oncology Cancer Center
Sugar Land, Texas, 77479, United States
University of Virginia Medical Center
Charlottesville, Virginia, 22908, United States
Inova Schar Cancer Institute
Fairfax, Virginia, 22031, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
Chris O'Brien Lifehouse Hospital
Camperdown, New South Wales, 02050, Australia
The Wollongong Hospital
Wollongong, New South Wales, 02500, Australia
Icon Cancer Care - Townsville
Townsville, Queensland, 04812, Australia
Eastern Health-Box Hill Hospital
Box Hill, Victoria, 03128, Australia
Hopital Universitaire de Bruxelles (Hub) - Institut Jules Bordet
Brussels, 01070, Belgium
Cliniques Universitaires St Luc Ucl
Brussels, B-1200, Belgium
Az Maria Middelares Gent
Ghent, 09000, Belgium
UZ GENT
Ghent, 09000, Belgium
Az Groeninge
Kortrijk, 08500, Belgium
Universitair Ziekenhuis Leuven
Leuven, 03000, Belgium
Tom Baker Cancer Center-Alberta Health Services (Ahs) - University of Calgary
Calgary, Alberta, T2N 4N2, Canada
Cross Cancer Insititute
Edmonton, Alberta, T6G-1Z2, Canada
London Health Sciences Centre
London, Ontario, N6A 5W9, Canada
University Health Network (Uhn) - Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
Sir Mortimer B. Davis - Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
Cedars Cancer Centre - McGill University Health Centre (Muhc) - Glen Site
Montreal, Quebec, H4A 3J1, Canada
Ch Davignon - Hopital Henri Duffaut
Avignon, 84902, France
Clinique Tivoli
Bordeaux, 33000, France
Clinique Pole Sante Leonard de Vinci
Chambray-lès-Tours, 37170, France
Centre Hospitalier Departemental de Vendee, Hopital de La-Roche-Sur-Yon Les Oudairies
La Roche-sur-Yon, 85925, France
Centre Hospitalier Universitaire de Grenoble- Hopital Albert Michallon
La Tronche, 38700, France
Hopital Prive Jean Mermoz
Lyon, 69008, France
Institut Paoli Calmettes
Marseille, 13009, France
Centre Antoine Laccassagne
Nice, 06189, France
Hospital Tenon
Paris, 75970, France
Centre Eugene Marquis
Rennes, 35042, France
Hopital de Hautepierre
Strasbourg, 67098, France
Institut Gustave Roussy-Gustave Roussy Cancer Center -Ditep
Villejuif, 94805, France
Charite-Universitaetsmedizin Berlin-Campus Virchow-Klinikum - Chirurgische Klinik
Berlin, 13353, Germany
Universitaetsklinikum Bonn
Bonn, 53127, Germany
Universitaetsklinikum Dresden
Dresden, 01307, Germany
Kliniken Essen-Mitte
Essen, 45136, Germany
Klinikum Kassel Gmbh
Kassel, 34125, Germany
Universitatsklinikum Schleswig Holstein
Kiel, 24105, Germany
Universitätsmedizin Mannheim
Mannheim, 68167, Germany
Johannes Wesling Klinikum Minden
Minden, 32429, Germany
Universitaetsklinikum Tuebingen (Ukt)
Tübingen, 72076, Germany
St. Vincent'S University Hospital
Dublin, D04 Y8V0, Ireland
Mater Misericordiae University Hospital
Dublin, D07 R2WY, Ireland
St. James Hospital
Dublin, D08 NHY1, Ireland
University College Hospital Galway
Galway, H91 YR71, Ireland
University Hospital Waterford
Waterford, X91 ER8E, Ireland
Azienda Sanitaria Locale (Asl) Cn2 Alba-Bra
Alba, 12051, Italy
Ss Antonio & Biagio and C. Arrigo Hospital
Alessandria, 15121, Italy
Centro Di Riferimento Oncologico Di Aviano
Aviano, 33081, Italy
Aou Policlinico S. Orsola-Malpighi
Bologna, 40138, Italy
Ospedale Careggi
Florence, 50134, Italy
Azienda Socio Santaria Territoriale de Lecco - Ospedale A. Manzoni
Lecco, 23900, Italy
Ospedale San Raffaele Irccs
Milan, 20132, Italy
Humanitas San Pio X
Milan, 20159, Italy
Azienda Ulss 3 Serenissima - Ospedale Di Mirano
Mirano, 30035, Italy
Istituto Nazionale Tumori Irccs Fondazione Pascale
Naples, 80131, Italy
Iov - Istituto Oncologico Veneto Irccs
Padova, 35128, Italy
Irccs Fondazione Policlinico San Matteo
Pavia, 27100, Italy
Ausl Di Placenza Ospedale Guglielmo Da Saliceto
Piacenza, 29121, Italy
Ospedale Santa Maria Delle Croci
Ravenna, 48121, Italy
Irccs Istituto Nazionale Tumori Regina Elena (Irccs Regina Elena National Cancer Institute)
Roma, 00144, Italy
Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore
Rome, 00168, Italy
Azienda Ospedaliera Ordine Mauriziano Di Torino
Torino, 10128, Italy
Ospedale Ca' Foncello
Treviso, 31100, Italy
Azienda Ospedaliero-Universitaria Friuli Centrale
Udine, 33100, Italy
Hyogo Cancer Center
Akashi-shi, 673-8558, Japan
Saitama Medical University International Medical Center
Hidaka-shi, 350-1298, Japan
The Cancer Institute Hospital of Jfcr
Kōtoku, 135-8550, Japan
Kurume University Hospital
Kurume, 830-0011, Japan
Shikoku Cancer Center
Matsuyama, 791-0280, Japan
The Jikei University Hospital
Minatoku, 105-8471, Japan
Aichi Cancer Center
Nagoya, 464-8681, Japan
Okayama University Hospital
Okayama, 700-8558, Japan
Osaka International Cancer Institute
Osaka, 541-8567, Japan
Sapporo Medical University Hospital
Sapporo, 060-8543, Japan
Hokkaido University Hospital
Sapporo, 060-8648, Japan
Tohoku University Hospital
Sendai, 980-8574, Japan
Iwate Medical University Hospital
Shiwa-gun, 028-3695, Japan
Shizuoka Cancer Center
Shizuoka, 411-8777, Japan
Nki-Avl (Nederlands Kanker Instituut-Anthonie Van Leeuwenhoek)
Amsterdam, 1066 CX, Netherlands
University Medical Center Groningen
Groningen, 9713 GZ, Netherlands
Radboud University Medical Center
Nijmegen, 6525 GA, Netherlands
Universitair Medisch Centrum Utrecht (Umc Utrecht)
Utrecht, 3584 CX, Netherlands
Uniwersytecki Szpital Kliniczny W Bialymstoku
Bialystok, 15-276, Poland
Gdanski Uniwersytet Medyczny
Gdansk, 80-214, Poland
Swietokrzyskie Centrum Onkologii Spzoz
Kielce, 25-734, Poland
Mazowiecki Szpital Wojewodzki, Siedleckie Centrum Onkologii
Siedlce, 08-110, Poland
Uniwersytecki Szpital Kliniczny Nr 2 Pomorskiego Uniwersytetu Medycznego W Szczecinie
Szczecin, 70-111, Poland
Brcr Global - Yauco
Yauco, PR, 00698, Puerto Rico
Brcr Global - Hato Rey
San Juan, 00917, Puerto Rico
Korea University Ansan Hospital
Ansan-si, 15355, South Korea
Samsung Changwon Hospital
Changwon-si, 51353, South Korea
Keimyung University Dongsan Hospital
Daegu, 42601, South Korea
National Cancer Center
Goyang-si, 10408, South Korea
Cha Ilsan Medical Center
Goyang-si, 10414, South Korea
Cha University Bundang Cha Medical Center
Seongnam-si, 13520, South Korea
Seoul National University Bundang Hospital (Snubh)
Seongnam-si, 13620, South Korea
Korea University Anam Hospital
Seoul, 02841, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital Yonsei University Health System
Seoul, 03722, South Korea
Konkuk University Medical Center
Seoul, 05030, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Seoul St. Mary'S Hospital
Seoul, 06591, South Korea
Ewha Womans University Mokdong Hospital
Seoul, 07985, South Korea
Hospital Universitario de Alava
Alava, 01009, Spain
Ico-Badalona
Badalona, 89016, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Clinica Universidad de Navarra
Madrid, 28022, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Universitario Virgen de La Victoria
Málaga, 29010, Spain
Hospital Universitario Central de Asturias
Oviedo, 33011, Spain
Hospital Universitari Son Espases
Palma, 07120, Spain
Corporacio Sanitaria Universitaria Parc Tauli
Sabadell, 08208, Spain
Hospital Universitario Virgen Del Rocio
Seville, 41013, Spain
Hospital Universitario Virgen de Valme
Seville, 41014, Spain
Ospedale Regionale Di Bellinzona
Bellinzona, 06500, Switzerland
Kantonsspital Graubunden
Chur, 07000, Switzerland
Kantonsspital Frauenfeld
Frauenfeld, 08501, Switzerland
Hopitaux Universitaires de Geneve (Hug) (Hopital Cantonal)
Geneva, 01205, Switzerland
Centre Hospitalier Universitaire Vaudois Lausanne (Chuv) - Centre Du Cancer Lausanne-Batiment Hospit
Lausanne, 01011, Switzerland
University Hospital of Zurich
Zurich, 08032, Switzerland
Addenbrooke'S Hospital - Cambridge University Hospitals Nhs Foundation Trust
Cambridge, CB2 0QQ, United Kingdom
Velindre Nhs Trust, Velindre Cancer Centre
Cardiff, CF14 2TL, United Kingdom
Royal Surrey County Hospital - Royal Surrey County Hospital Nhs Foundation Trust
Guildford, GU2 7XX, United Kingdom
St James'S University Hospital - Leeds Teaching Hospitals Nhs Trust
Leeds, LS9 7TF, United Kingdom
Clatterbridge Cancer Center
Liverpool, L7 8YA, United Kingdom
University College London Hospitals - University College London Hospitals Nhs Foundation Trust
London, NW1 2BU, United Kingdom
Guy'S Hospital - Guy'S & St Thomas' Nhs Foundation Trust
London, SE1 9RT, United Kingdom
Royal Marsden Hospital - London
London, SW3 6JJ, United Kingdom
The Christie Nhs Foundation Trust
Manchester Greater, M204BX, United Kingdom
Northampton General Hospital - Northampton General Hospital Nhs Trust
Northampton, NN1 5BD, United Kingdom
Mount Vernon Cancer Centre
Northwood, HA6 2RN, United Kingdom
Royal Marsden Hospital - Sutton
Sutton, SM2 5PT, United Kingdom
Musgrove Park Hospital - Somerset Nhs Foundation Trust
Taunton, TA1 5DA, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Incyte Medical Monitor
Incyte Corporation
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2025
First Posted
October 9, 2025
Study Start
December 9, 2025
Primary Completion (Estimated)
November 15, 2028
Study Completion (Estimated)
May 14, 2029
Last Updated
July 23, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
- Access Criteria
- Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency