Ovarian CancerPhase 3MAESTRA 2NCT07214779
Study to Evaluate INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression
A Phase 3 study testing INCB123667 and Investigator's choice of chemotherapy in people with Ovarian Cancer, run by Incyte Corporation at 198 sites in 16 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- INCB123667 and Investigator's choice of chemotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 466 participants
- Where
- 198 sitesin 16 countries
- Study dates
- 9 Dec 2025to 14 May 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
198 sites in 16 countries. Contact the study team or a site near you to ask about taking part.
198 sites in 16 countries
United States63 sites, 24 recruiting
- Recruiting
Texas Oncology-Abilene
Abilene, Texas, 79606
- Completed
Unm Comprehensive Cancer Center
Albuquerque, New Mexico, 87131
- Completed
Alaska Womens Cancer Care Akwcc
Anchorage, Alaska, 99508
- Completed
Winship Cancer Institute At Emory University
Atlanta, Georgia, 30322
- Completed
Georgia Cancer Center
Augusta, Georgia, 30912
- Completed
University of Colorado Cancer Center
Aurora, Colorado, 80045
- Not yet recruiting
Texas Oncology Cancer Center
Austin, Texas, 78731
- Recruiting
Billings Clinic
Billings, Montana, 59101
- Not yet recruiting
Levine Cancer Center
Charlotte, North Carolina, 28204
- Recruiting
Novant Presbyterian Hospital
Charlotte, North Carolina, 28204
- Completed
University of Virginia Health System
Charlottesville, Virginia, 22908
- Recruiting
Erlanger Health, Inc.
Chattanooga, Tennessee, 37403
- Completed
The University of Chicago Medicine
Chicago, Illinois, 60637
- Completed
Cleveland Clinic Foundation
Cleveland, Ohio, 44195-0001
- Completed
Ohio Health Research Institute
Columbus, Ohio, 43214
- Not yet recruiting
Women'S Cancer Care
Covington, Louisiana, 70433
- Completed
Miami Valley Hospital South
Dayton, Ohio, 45459
- Completed
Henry Ford Cancer - Detroit
Detroit, Michigan, 48202
- Recruiting
City of Hope Medical Center
Duarte, California, 91010
- Completed
St Elizabeth Healthcare
Edgewood, Kentucky, 41017
- Completed
Carle Cancer Center
Effingham, Illinois, 62401-2006
- Recruiting
Oncology Associates of Oregon, P.C.
Eugene, Oregon, 97401
- Completed
Northshore University Health System-Evanston Hospital
Evanston, Illinois, 60201
- Completed
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
- Completed
Jps Health Network
Fort Worth, Texas, 76104
- Completed
Providence Medical Foundation
Fullerton, California, 92835
- Completed
East Carolina University
Greenville, North Carolina, 27834
- Not yet recruiting
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
- Completed
The University of Texas Health Science Center Houston
Houston, Texas, 77030
- Completed
The University of Texas-Md Anderson Cancer Center
Houston, Texas, 77030
- Completed
University of California, San Diego-Moores Cancer Center
La Jolla, California, 92037
- Completed
Women'S Cancer Center of Nevada
Las Vegas, Nevada, 89106
- Recruiting
Valkyrie Clinical Trials
Los Angeles, California, 90067
- Not yet recruiting
Mount Sinai Medical Center Comprehensive Cancer Center
Miami Beach, Florida, 33140
- Completed
Brcr Global
Miramar, Florida, 33027
- Completed
West Virginia University
Morgantown, West Virginia, 26505
- Completed
Uci Health Chao Family Comprehensive Cancer Center
Orange, California, 92868-3298
- Completed
Ventura County Hematology Oncology Specialists-Oxnard
Oxnard, California, 93030
- Recruiting
University of Pittsburgh Cancer Institute Cancer Services
Pittsburgh, Pennsylvania, 15213
- Completed
Allegheny Health Network- West Penn Hospital
Pittsburgh, Pennsylvania, 15224
- Recruiting
Providence Cancer Institute Franz Clinic
Portland, Oregon, 97213
- Completed
Center of Hope
Reno, Nevada, 89511
- Not yet recruiting
Texas Oncology, P.A., San Antonio Medical Center - Uso
San Antonio, Texas, 78240
- Completed
Sarasota Memorial Health Care System
Sarasota, Florida, 34239
- Completed
Maine Center For Cancer Medicine
Scarborough, Maine, 04074
- Completed
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
- Not yet recruiting
Maimonides Medical Center
Short Hills, New Jersey, 07078
- Not yet recruiting
Trials365, Llc
Shreveport, Louisiana, 71103
- Completed
Holy Cross Hospital
Silver Spring, Maryland, 20910
- Recruiting
Sanford Cancer Center-Sioux Falls
Sioux Falls, South Dakota, 57104-8805
- Not yet recruiting
Providence Sacred Heart Medical Center and Children'S Hospital
Spokane, Washington, 99204
- Completed
Mercy Hospital St. Louis - David C. Pratt Cancer Center
St Louis, Missouri, 63141
- Recruiting
Texas Oncology Cancer Center
Sugar Land, Texas, 77479
- Completed
Promedica Flower Hospital
Sylvania, Ohio, 43560
- Not yet recruiting
Greater Baltimore Medical Center
Towson, Maryland, 21204
- Completed
University of Arizona Cancer Center
Tucson, Arizona, 85724-5002
- Not yet recruiting
Texas Oncology (Txo) Northeast Texas (Tyler)
Tyler, Texas, 75702
- Completed
Prohealth Care
Waukesha, Wisconsin, 53188
- Recruiting
Novant Health Oncology Specialists
Winston-Salem, North Carolina, 27103
- Not yet recruiting
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
- Completed
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096
- Completed
Wellspan Gynecologic Oncology
York, Pennsylvania, 17403
- Completed
City of Hope - Chicago Cancer Center
Zion, Illinois, 60099
Italy19 sites
- Completed
Azienda Sanitaria Locale (Asl) Cn2 Alba-Bra
Alba, 12051
- Completed
Ss Antonio & Biagio and C. Arrigo Hospital
Alessandria, 15121
- Completed
Centro Di Riferimento Oncologico Di Aviano
Aviano, 33081
- Completed
Aou Policlinico S. Orsola-Malpighi
Bologna, 40138
- Completed
Ospedale Careggi
Florence, 50134
- Completed
Azienda Socio Santaria Territoriale de Lecco - Ospedale A. Manzoni
Lecco, 23900
- Completed
Ospedale San Raffaele Irccs
Milan, 20132
- Completed
Humanitas San Pio X
Milan, 20159
- Completed
Azienda Ulss 3 Serenissima - Ospedale Di Mirano
Mirano, 30035
- Completed
Istituto Nazionale Tumori Irccs Fondazione Pascale
Naples, 80131
- Completed
Iov - Istituto Oncologico Veneto Irccs
Padova, 35128
- Completed
Irccs Fondazione Policlinico San Matteo
Pavia, 27100
- Completed
Ausl Di Placenza Ospedale Guglielmo Da Saliceto
Piacenza, 29121
- Completed
Ospedale Santa Maria Delle Croci
Ravenna, 48121
- Completed
Irccs Istituto Nazionale Tumori Regina Elena (Irccs Regina Elena National Cancer Institute)
Roma, 00144
- Completed
Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore
Rome, 00168
- Completed
Azienda Ospedaliera Ordine Mauriziano Di Torino
Torino, 10128
- Completed
Ospedale Ca' Foncello
Treviso, 31100
- Completed
Azienda Ospedaliero-Universitaria Friuli Centrale
Udine, 33100
Japan15 sites, 15 recruiting
- Recruiting
Hyogo Cancer Center
Akashi-shi, 673-8558
- Recruiting
Saitama Medical University International Medical Center
Hidaka-shi, 350-1298
- Recruiting
The Cancer Institute Hospital of Jfcr
Kōtoku, 135-8550
- Recruiting
Kurume University Hospital
Kurume, 830-0011
- Recruiting
Shikoku Cancer Center
Matsuyama, 791-0280
- Recruiting
The Jikei University Hospital
Minatoku, 105-8471
- Recruiting
Aichi Cancer Center
Nagoya, 464-8681
- Recruiting
Okayama University Hospital
Okayama, 700-8558
- Recruiting
Osaka International Cancer Institute
Osaka, 541-8567
- Recruiting
Sapporo Medical University Hospital
Sapporo, 060-8543
- Recruiting
Hokkaido University Hospital
Sapporo, 060-8648
- Recruiting
Tohoku University Hospital
Sendai, 980-8574
- Recruiting
Iwate Medical University Hospital
Shiwa-gun, 028-3695
- Recruiting
Shizuoka Cancer Center
Shizuoka, 411-8777
- Not yet recruiting
National Cancer Center Hospital
Tokyo, 104-0045
South Korea15 sites, 3 recruiting
- Completed
Korea University Ansan Hospital
Ansan-si, 15355
- Completed
Samsung Changwon Hospital
Changwon-si, 51353
- Completed
Keimyung University Dongsan Hospital
Daegu, 42601
- Completed
National Cancer Center
Goyang-si, 10408
- Not yet recruiting
Cha Ilsan Medical Center
Goyang-si, 10414
- Completed
Cha University Bundang Cha Medical Center
Seongnam-si, 13520
- Completed
Seoul National University Bundang Hospital (Snubh)
Seongnam-si, 13620
- Completed
Korea University Anam Hospital
Seoul, 02841
- Completed
Seoul National University Hospital
Seoul, 03080
- Completed
Severance Hospital Yonsei University Health System
Seoul, 03722
- Completed
Konkuk University Medical Center
Seoul, 05030
- Completed
Asan Medical Center
Seoul, 05505
- Recruiting
Samsung Medical Center
Seoul, 06351
- Not yet recruiting
Seoul St. Mary'S Hospital
Seoul, 06591
- Completed
Ewha Womans University Mokdong Hospital
Seoul, 07985
United Kingdom13 sites, 12 recruiting
- Recruiting
Addenbrooke'S Hospital - Cambridge University Hospitals Nhs Foundation Trust
Cambridge, CB2 0QQ
- Completed
Velindre Nhs Trust, Velindre Cancer Centre
Cardiff, CF14 2TL
- Recruiting
Royal Surrey County Hospital - Royal Surrey County Hospital Nhs Foundation Trust
Guildford, GU2 7XX
- Recruiting
St James'S University Hospital - Leeds Teaching Hospitals Nhs Trust
Leeds, LS9 7TF
- Recruiting
Clatterbridge Cancer Center
Liverpool, L7 8YA
- Recruiting
University College London Hospitals - University College London Hospitals Nhs Foundation Trust
London, NW1 2BU
- Recruiting
Guy'S Hospital - Guy'S & St Thomas' Nhs Foundation Trust
London, SE1 9RT
- Recruiting
Royal Marsden Hospital - London
London, SW3 6JJ
- Recruiting
The Christie Nhs Foundation Trust
Manchester Greater, M204BX
- Recruiting
Northampton General Hospital - Northampton General Hospital Nhs Trust
Northampton, NN1 5BD
- Not yet recruiting
Mount Vernon Cancer Centre
Northwood, HA6 2RN
- Recruiting
Royal Marsden Hospital - Sutton
Sutton, SM2 5PT
- Recruiting
Musgrove Park Hospital - Somerset Nhs Foundation Trust
Taunton, TA1 5DA
France12 sites, 3 recruiting
- Completed
Ch Davignon - Hopital Henri Duffaut
Avignon, 84902
- Completed
Clinique Tivoli
Bordeaux, 33000
- Not yet recruiting
Clinique Pole Sante Leonard de Vinci
Chambray-lès-Tours, 37170
- Completed
Centre Hospitalier Departemental de Vendee, Hopital de La-Roche-Sur-Yon Les Oudairies
La Roche-sur-Yon, 85925
- Completed
Centre Hospitalier Universitaire de Grenoble- Hopital Albert Michallon
La Tronche, 38700
- Recruiting
Hopital Prive Jean Mermoz
Lyon, 69008
- Completed
Institut Paoli Calmettes
Marseille, 13009
- Completed
Centre Antoine Laccassagne
Nice, 06189
- Not yet recruiting
Hospital Tenon
Paris, 75970
- Completed
Centre Eugene Marquis
Rennes, 35042
- Completed
Hopital de Hautepierre
Strasbourg, 67098
- Completed
Institut Gustave Roussy-Gustave Roussy Cancer Center -Ditep
Villejuif, 94805
Spain12 sites, 3 recruiting
- Completed
Hospital Universitario de Alava
Alava, 01009
- Completed
Ico-Badalona
Badalona, 89016
- Not yet recruiting
Hospital Clinic de Barcelona
Barcelona, 08036
- Completed
Clinica Universidad de Navarra
Madrid, 28022
- Recruiting
Hospital Universitario La Paz
Madrid, 28046
- Recruiting
Hospital Universitario Virgen de La Victoria
Málaga, 29010
- Completed
Hospital Universitario Central de Asturias
Oviedo, 33011
- Completed
Hospital Universitari Son Espases
Palma, 07120
- Completed
Corporacio Sanitaria Universitaria Parc Tauli
Sabadell, 08208
- Completed
Hospital Universitario Virgen Del Rocio
Seville, 41013
- Completed
Hospital Universitario Virgen de Valme
Seville, 41014
- Completed
Fundacion Instituto Valenciano de Oncologia
Valencia, 46009
Germany9 sites, 9 recruiting
- Not yet recruiting
Charite Campus Virchow
Berlin, 13353
- Not yet recruiting
Universitaetsklinikum Bonn
Bonn, 53127
- Not yet recruiting
Universitaetsklinikum Dresden
Dresden, 01307
- Not yet recruiting
Kliniken Essen-Mitte
Essen, 45136
- Not yet recruiting
Klinikum Kassel Gmbh
Kassel, 34125
- Not yet recruiting
Universitatsklinikum Schleswig Holstein
Kiel, 24105
- Not yet recruiting
Universitätsmedizin Mannheim
Mannheim, 68167
- Not yet recruiting
Johannes Wesling Klinikum Minden
Minden, 32429
- Not yet recruiting
Universitaetsklinikum Tuebingen (Ukt)
Tübingen, 72076
Australia6 sites, 2 recruiting
- Recruiting
Eastern Health-Box Hill Hospital
Box Hill, Victoria, 03128
- Completed
Chris O'Brien Lifehouse Hospital
Camperdown, New South Wales, 02050
- Completed
Concord Repatriation General Hospital
Concors, New South Wales, 02139
- Completed
Mater Hospital Brisbane
South Brisbane, Queensland, 04101
- Recruiting
Icon Cancer Care - Townsville
Townsville, Queensland, 04812
- Completed
The Wollongong Hospital
Wollongong, New South Wales, 02500
Belgium6 sites, 3 recruiting
- Completed
Hopital Universitaire de Bruxelles (Hub) - Institut Jules Bordet
Brussels, 01070
- Completed
Cliniques Universitaires St Luc Ucl
Brussels, B-1200
- Recruiting
Az Maria Middelares Gent
Ghent, 09000
- Completed
UZ GENT
Ghent, 09000
- Not yet recruiting
Az Groeninge
Kortrijk, 08500
- Not yet recruiting
Universitair Ziekenhuis Leuven
Leuven, 03000
Canada6 sites, 2 recruiting
- Not yet recruiting
Tom Baker Cancer Center-Alberta Health Services (Ahs) - University of Calgary
Calgary, Alberta, T2N 4N2
- Completed
Cross Cancer Insititute
Edmonton, Alberta, T6G-1Z2
- Completed
London Health Sciences Centre
London, Ontario, N6A 5W9
- Completed
Sir Mortimer B. Davis - Jewish General Hospital
Montreal, Quebec, H3T 1E2
- Recruiting
Cedars Cancer Centre - McGill University Health Centre (Muhc) - Glen Site
Montreal, Quebec, H4A 3J1
- Completed
University Health Network (Uhn) - Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Switzerland6 sites, 4 recruiting
- Recruiting
Ospedale Regionale Di Bellinzona
Bellinzona, 06500
- Completed
Kantonsspital Graubunden
Chur, 07000
- Recruiting
Kantonsspital Frauenfeld
Frauenfeld, 08501
- Recruiting
Hopitaux Universitaires de Geneve (Hug) (Hopital Cantonal)
Geneva, 01205
- Recruiting
Centre Hospitalier Universitaire Vaudois Lausanne (Chuv) - Centre Du Cancer Lausanne-Batiment Hospit
Lausanne, 01011
- Completed
University Hospital of Zurich
Zurich, 08032
Ireland5 sites
- Completed
St. Vincent'S University Hospital
Dublin, D04 Y8V0
- Completed
Mater Misericordiae University Hospital
Dublin, D07 R2WY
- Completed
St. James Hospital
Dublin, D08 NHY1
- Completed
University College Hospital Galway
Galway, H91 YR71
- Completed
University Hospital Waterford
Waterford, X91 ER8E
Poland5 sites, 5 recruiting
- Not yet recruiting
Uniwersytecki Szpital Kliniczny W Bialymstoku
Bialystok, 15-276
- Not yet recruiting
Gdanski Uniwersytet Medyczny
Gdansk, 80-214
- Not yet recruiting
Swietokrzyskie Centrum Onkologii Spzoz
Kielce, 25-734
- Not yet recruiting
Mazowiecki Szpital Wojewodzki, Siedleckie Centrum Onkologii
Siedlce, 08-110
- Not yet recruiting
Uniwersytecki Szpital Kliniczny Nr 2 Pomorskiego Uniwersytetu Medycznego W Szczecinie
Szczecin, 70-111
Netherlands4 sites, 2 recruiting
- Completed
Nki-Avl (Nederlands Kanker Instituut-Anthonie Van Leeuwenhoek)
Amsterdam, 1066 CX
- Recruiting
University Medical Center Groningen
Groningen, 9713 GZ
- Recruiting
Radboud University Medical Center
Nijmegen, 6525 GA
- Completed
Universitair Medisch Centrum Utrecht (Umc Utrecht)
Utrecht, 3584 CX
Puerto Rico2 sites
- Completed
Brcr Global - Hato Rey
San Juan, 00917
- Completed
Brcr Global - Yauco
Yauco, PR, 00698
About this study
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
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.
- Conditions
- Ovarian Cancer
- Being tested
- INCB123667, Investigator's choice of chemotherapy
- Keywords
- INCB123667
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCB123667Drug
Oral; tablet
Investigator's choice of chemotherapyDrug
Also called paclitaxel, pegylated liposomal doxorubicin (PLD), gemcitabine, topotecan
The investigator will select the chemotherapy in accordance with the protocol-defined requirements. The possible choices as defined by the protocol:
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group A (TGA) | Experimental | INCB123667 at the protocol-defined dose. Receives: Drug: INCB123667 |
| Treatment Group B (TGB) | Experimental | Investigator's choice of chemotherapy at the protocol-defined dose as defined by the protocol. Receives: Drug: Investigator's choice of chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 years
Overall Survival (OS)
Defined as the time from the date of randomization until death due to any cause.
Measured: Up to 2 years
Secondary outcomes (10)
Objective response by BICR
Defined as having a best overall response of complete response (CR) or partial response (PR), as determined by BICR per RECIST v1.1.
Measured: Up to 2 years
Duration of Response (DOR) by BICR
Defined as the time from the earliest date of CR or PR until the earliest date of disease progression, as determined by BICR per RECIST v1.1, or death due to any cause, whichever occurs first.
Measured: Up to 2 years
Progression-Free Survival (PFS) by investigator
Defined as the time from the date of randomization until the earliest date of disease progression, as determined by investigator assessment per RECIST v1.1, or death due to any cause, whichever occurs first.
Measured: Up to 2 years
Objective response by investigator
Defined as having a best overall response of CR or PR, as determined by investigator assessment per RECIST v1.1.
Measured: Up to 2 years
DOR by investigator
Defined as the time from the earliest date of CR or PR until the earliest date of disease progression, as determined by investigator assessment per RECIST v1.1, or death due to any cause, whichever occurs first.
Measured: Up to 2 years
Treatment Emergent Adverse Events (TEAEs)
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug until 30 days after the last dose of study drug or the start of new anticancer therapy, whichever occurs first.
Measured: Up to 2 years and 30 days
TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatment
TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatment.
Measured: 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
The EORTC QLQ-C30 is a validated, self-administered questionnaire developed to assess the quality of life in cancer patients. It consists of 30 questions divided into several subscales, including 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, nausea and vomiting, and pain), a global health status/QoL scale, and a number of single-item measures that assess additional symptoms such as dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties.
Measured: 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
The EORTC QLQ-OV28 is a validated, self-administered questionnaire developed as a supplementary module to the core QLQ-C30, specifically designed to assess HRQoL in participants with ovarian cancer. It contains 28 questions across several subscales, including 5 symptom scales (abdominal/gastrointestinal, peripheral neuropathy, hormonal/menopausal, chemotherapy side effects, and attitudes towards disease/treatment), 2 functional scales (body image and sexual functioning), and a number of single-item measures addressing issues such as other abdominal symptoms and hair loss.
Measured: Up to 2 years
Change from baseline in EQ-5D-5L score at each postbaseline visit
The EQ-5D-5L is a validated, self-reported instrument for assessing HRQoL across 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 response levels of severity, ranging from no problems to extreme problems. The questionnaire also includes a visual analog scale for self-rated overall health on a scale from 0 (worst imaginable health) to 100 (best imaginable health).
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start9 Dec 2025
- Primary completion15 Nov 2028 (estimated)
- Study completion14 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 466 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ENGOT Foundation, GOG Foundation
- Responsible party
- Sponsor
- Investigators
- Incyte Medical Monitor, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07214779
- Sponsor's protocol ID
- INCB123667-305
- Other IDs
- 2025-522748-42-00, GOG-3137, ENGOT-OV95, 2025
- Acronym
- MAESTRA 2
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07214779
- Acronym / sponsor ID
- MAESTRA 2 / INCB123667-305
- Conditions
- Ovarian Cancer
- Keywords
- INCB123667
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 466 participants (estimated)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Collaborators
- ENGOT Foundation, GOG Foundation
- Study start
- 9 Dec 2025 (actual)
- Primary completion
- 15 Nov 2028 (estimated)
- Study completion
- 14 May 2029 (estimated)
- First posted
- 9 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group A (TGA) | Experimental | Drug: INCB123667INCB123667 at the protocol-defined dose. |
| Treatment Group B (TGB) | Experimental | Drug: Investigator's choice of chemotherapyInvestigator's choice of chemotherapy at the protocol-defined dose as defined by the protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histological diagnosis of high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer.
- Have platinum-resistant disease.
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INCB123667Oral; tablet | Drug | Treatment Group A (TGA) |
| Investigator's choice of chemotherapyAlso: paclitaxel, pegylated liposomal doxorubicin (PLD), gemcitabine, topotecanThe investigator will select the chemotherapy in accordance with the protocol-defined requirements. The possible choices as defined by the protocol: | Drug | Treatment Group B (TGB) |
Primary outcome
Progression-Free Survival (PFS) by BICR
Time frame: Up to 2 years
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.
Overall Survival (OS)
Time frame: Up to 2 years
Defined as the time from the date of randomization until death due to any cause.
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Study to Evaluate INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 OverexpressionLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Incyte Medical Monitor study director
Incyte Corporation
198 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing INCB123667 and Investigator's choice of chemotherapy in people with Ovarian Cancer, run by Incyte Corporation at 198 sites in 16 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 198 sites in United States, Italy, Japan, South Korea, United Kingdom and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Incyte Corporation Call Center (US) (1.855.463.3463, medinfo@incyte.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) by BICR (time frame: Up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.