Tuvusertib Combined With Niraparib or Lartesertib in Participants With Epithelial Ovarian Cancer (DDRiver EOC 302)
NCT ID: NCT06433219
Last Updated: 2025-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
63 participants
INTERVENTIONAL
2024-10-30
2028-01-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Part A, Arm 1: Tuvusertib with Niraparib
In Part A, participants will be randomized to one of 2 arms to receive tuvusertib in combination with either niraparib or lartesertib.
Tuvusertib (M1774)
Tuvusertib will be administered orally.
Niraparib
Niraparib will be administered orally. If selected from Part A, Niraparib will be administered orally in combination with Tuvusertib.
Part A, Arm 2: Tuvusertib with Lartesertib
In Part A, participants will be randomized to one of 2 arms to receive tuvusertib in combination with either niraparib or lartesertib.
Tuvusertib (M1774)
Tuvusertib will be administered orally.
Lartesertib (M4076)
Lartesertib will be administered orally. If selected from Part A, Lartesertib will be administered orally in combination with Tuvusertib
Part B (dose optimization), dosing regimen 1 :Tuvusertib+Niraparib or Tuvusertib +Lartesertib
In Part B, the most favorable combination treatment from Part A will be further explored at 2 different dosing regimens and compared to tuvusertib monotherapy.
Tuvusertib (M1774)
Tuvusertib will be administered orally.
Niraparib
Niraparib will be administered orally. If selected from Part A, Niraparib will be administered orally in combination with Tuvusertib.
Lartesertib (M4076)
Lartesertib will be administered orally. If selected from Part A, Lartesertib will be administered orally in combination with Tuvusertib
Part B (dose optimization), dosing regimen 2: Tuvusertib + Niraparib or Tuvusertib + Lartesertib
In Part B, the most favorable combination treatment from Part A will be further explored at 2 different dosing regimens and compared to tuvusertib monotherapy.
Tuvusertib (M1774)
Tuvusertib will be administered orally.
Niraparib
Niraparib will be administered orally. If selected from Part A, Niraparib will be administered orally in combination with Tuvusertib.
Lartesertib (M4076)
Lartesertib will be administered orally. If selected from Part A, Lartesertib will be administered orally in combination with Tuvusertib
Part B: Tuvusertib Monotherapy
In Part B, the most favorable combination treatment from Part A will be further explored at 2 different dosing regimens and compared to tuvusertib monotherapy.
Tuvusertib (M1774)
Tuvusertib will be administered orally.
Interventions
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Tuvusertib (M1774)
Tuvusertib will be administered orally.
Niraparib
Niraparib will be administered orally. If selected from Part A, Niraparib will be administered orally in combination with Tuvusertib.
Lartesertib (M4076)
Lartesertib will be administered orally. If selected from Part A, Lartesertib will be administered orally in combination with Tuvusertib
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants whose tumor carries germline or somatic deleterious or suspected deleterious mutations in the genes BRCA1 (Breast Cancer gene 1) and BRCA2 (Breast Cancer gene 2), and/or tumors with positive HRD status. The presence of any of these mutations and/or the homologous recombination deficiency (HRD) status will be determined according to routinely used local standard of care tests. Results must be available before screening.
* Radiologically confirmed/documented disease progression while on Poly (ADP-ribose) polymerase (PARP) inhibitors therapy in either first or second-line maintenance setting (only 1 line of PARPi maintenance is allowed with or without bevacizumab). Note: Documentation of disease progression must be within 28 days of last PARPi dose taken. Surgical salvage intervention and/or focal ablative therapies are allowed, (further disease progression after these interventions must be documented), AND Clinically benefited from PARPi maintenance prior to documented progression, as defined by at least 6 months of treatment duration with no progressive disease observed, AND either, Progression on first-line maintenance PARPi: Participants are allowed maximum 1 additional line of platinum-based chemotherapy before study entry. (note: treatment-free interval on platinum rechallenge must be \>6 months, with documented disease progression prior to study entry).
OR Progression on second-line maintenance PARPi: Participants are not allowed any additional systemic anticancer treatments before study entry (that is PARPi is the last treatment before study entry)
* Intolerant to standard of care treatment options or refused standard of care treatment or the participant's treating physician considers that the lack of standard of care treatment is not detrimental for the participant.
* Measurable disease per RECIST v1.1, as assessed by Investigator.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and a life expectancy of at least 6 months.
Exclusion Criteria
* History of additional malignancy within 3 years before the date of enrollment.
* Known brain metastases, unless clinically stable, that is without evidence of progression by imaging for at least 4 weeks prior to the first dose of study intervention, no evidence of new brain metastases, and on a stable or decreasing dose of ≤ 10 mg of prednisone (or equivalent) or without corticosteroids for at least 14 days prior to study intervention administration.
* Active and/or uncontrolled infection.
* History of known hypersensitivity to the active substances or to any excipients (e.g. polysorbate 80) of the study interventions.
* Organ transplantation, including allogenic stem cell transplant.
* Patients with history of drug-induced severe cutaneous adverse reaction (SCAR; including but not limited to Stevens-Johnson syndrome/toxic epidermal necrolysis \[SJS/TEN\], or drug reaction with eosinophilia and systemic symptoms \[DRESS\]), or dose-limiting immune-mediated reactions related to skin.
18 Years
FEMALE
No
Sponsors
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Merck KGaA, Darmstadt, Germany
INDUSTRY
EMD Serono Research & Development Institute, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Responsible
Role: STUDY_DIRECTOR
EMD Serono Research & Development Institute, Inc.
Locations
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University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
University of California San Francisco - UCSF Medical Center
San Francisco, California, United States
Centricity Research Cancer Center - DBA CRRI John B. Amos Cancer Center Research
Columbus, Georgia, United States
University of Chicago Comprehensive Cancer Center at Silver Cross - Carolyn J. Czerkies Pavilion
Chicago, Illinois, United States
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Icahn School of Medicine at Mount Sinai PRIME - Mount Sinai - PRIME
New York, New York, United States
Next Oncology - Virginia
Fairfax, Virginia, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States
Chris O'Brien Lifehouse
Camperdown, , Australia
St George Private Hospital
Kogarah, , Australia
Liverpool Hospital - PARENT
Liverpool, , Australia
Cliniques Universitaires Saint-Luc - STL
Brussels, , Belgium
UZ Leuven
Leuven, , Belgium
Ålborg Universitets Hospital - PARENT
Aalborg, , Denmark
Rigshospitalet
Copenhagen, , Denmark
Sjaellands Universitetshospital - other
Odense, , Denmark
ICO - Site Paul Papin - service d'oncologie medicale
Angers, , France
Centre Francois Baclesse - Service d'Oncologie Medicale
Caen, , France
Centre Oscar Lambret - service de cancerologie gynecologique
Lille, , France
Centre Leon Berard - Service d'Oncologie Medicale
Lyon, , France
Groupe Hospitalier Diaconesses - Hôpital De La Croix Saint Simon - service d'oncologie medicale
Paris, , France
Hopital Tenon - service d'oncologie medicale
Paris, , France
Hôpital Cochin - Hematologie et Oncologie Médicale
Paris, , France
Hôpital Européen Georges Pompidou - Hématologie Oncologie
Paris, , France
Hôpital Saint Joseph - Paris - Service d'Oncologie-Cancerologie
Paris, , France
Centre Hospitalier Lyon Sud - service d'oncologie medicale
Pierre-Bénite, , France
Centre de Radiotherapie Clinique Sainte Anne - 300207251
Strasbourg, , France
Institut de Cancérologie de Strasbourg Europe - ICANS - Service d'oncologie médicale
Strasbourg, , France
Institut Gustave Roussy - Oncologie Médicale
Villejuif, , France
Charité - Campus Virchow-Klinikum - Klinik fuer Gynaekologie
Berlin, , Germany
Universitaetsklinikum Bonn AoeR - Frauenklinik
Bonn, , Germany
Universitaetsklinikum Carl Gustav Carus TU Dresden - Klinik u. Poliklinik f. Frauenheilkunde
Dresden, , Germany
Kliniken Essen-Mitte - Gynaekologie und Gynaekologische Onkologie
Essen, , Germany
Universitaetsklinikum Leipzig AoeR - Klinik und Poliklinik fuer Frauenheilkunde
Leipzig, , Germany
Universitaetsklinikum Muenster - Parent
Münster, , Germany
Universitätsklinikum Münster - Gynecology
Münster, , Germany
Caritas-Krankenhaus St. Josef - Klinik fuer Chirurgie
Regensburg, , Germany
Universitaetsklinikum Tuebingen - Parent
Tübingen, , Germany
Rambam Medical Center
Haifa, , Israel
The Lady Davis Carmel Medical Center
Haifa, , Israel
Hadassah University Hospital - Ein Kerem
Jerusalem, , Israel
Shaare Zedek
Jerusalem, , Israel
Chaim Sheba Medical Center
Ramat Gan, , Israel
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS - Oncologia Medica
Bologna, , Italy
IRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant Orsola - SSD Oncologia Medica Zamagni
Bologna, , Italy
Osp Cannizzaro Catania
Catania, , Italy
Azienda Ospedaliero-Universitaria Renato Dulbecco - Centro Oncologico
Catanzaro, , Italy
IEO Istituto Europeo di Oncologia - Unità Ginecologia Oncologica Medica
Milan, , Italy
Istituto Clinico Humanitas - U.O. di Oncologia Medica ed Ematologia
Milan, , Italy
Istituto Nazionale Tumori Fondazione G. Pascale - Gynecology
Napoli, , Italy
IOV - Istituto Oncologico Veneto IRCCS - Radiologia Oncologica
Padua, , Italy
Istituto Nazionale Tumori Regina Elena IRCCS - UOC Oncologia Medica A
Roma, , Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Ostetricia e ginecologia
Rome, , Italy
Catharina Ziekenhuis Eindhoven - Parent
Eindhoven, , Netherlands
Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy - Dept of Chemotherapy
Bydgoszcz, , Poland
Szpitale Pomorskie spó
Gdynia, , Poland
Jagiellonskie Centrum Innowacji Sp. z o.o. - Centrum Bada
Krakow, , Poland
Instytut MSF Sp.z.o.o
Lodz, , Poland
Europejskie Centrum Zdrowia - Oddzial Onkologii
Otwock, , Poland
MICS Centrum Medyczne Torun - Medicovernn
Torun, , Poland
ICO Badalona - Hospital Universitari Germans Trias i Pujol - Servicio de Oncologia Medica
Badalona, , Spain
Hospital Clinic de Barcelona - Servicio de Oncologia
Barcelona, , Spain
Hospital Universitari Vall d'Hebron - Oncology Dept.
Barcelona, , Spain
ICO Girona - Hospital Universitari de Girona Dr Josep Trueta - Servicio de Oncologia Medica
Girona, , Spain
Clinica Universidad de Navarra (MAD) - Oncology Service
Madrid, , Spain
Hospital Universitario 12 de Octubre - Servicio de Oncologia
Madrid, , Spain
Hospital Universitario Ramon y Cajal - Servicio de Oncologia
Madrid, , Spain
Hospital Regional Universitario de Malaga - Oncology Dept
Málaga, , Spain
Istituto Oncologico della Svizzera Italiana (IOSI)- Ente Ospedaliero Cantonale (EOC) - Ospedale S.Giovann
Bellinzona, , Switzerland
Kantonsspital Frauenfeld - 150509250
Frauenfeld, , Switzerland
Kantonsspital Baselland - standort Liestal - Klinik fuer Onkologie
Liestal, , Switzerland
Kantonsspital St. Gallen - Klinik fuer Med. Onkologie/Haematologie
Sankt Gallen, , Switzerland
Universitaetsspital Zuerich - Klinik fuer Gynaekologie
Zurich, , Switzerland
Addenbrooke's Hospital - Dept of Oncology
Cambridge, , United Kingdom
Beatson West of Scotland Cancer Centre - Dept of Medical Oncology
Glasgow, , United Kingdom
Royal Surrey County Hospital - Dept of Oncology
Guildford, , United Kingdom
St James's University Hospital - Dept of Oncology
Leeds, , United Kingdom
Guy's Hospital - Dept of Medical Oncology
London, , United Kingdom
Royal Marsden Hospital-London - Dept of Haematology/Oncology Research
London, , United Kingdom
University College London Hospitals - NIHR/Wellcome Trust
London, , United Kingdom
The Christie Hospital - Dept of Oncology
Manchester, , United Kingdom
Mount Vernon Hospital - Dept of Oncology
Northwood, , United Kingdom
Royal Marsden Hospital-Sutton - Dept of Oncology (Surrey)
Sutton, , United Kingdom
Countries
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Related Links
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Trial Awareness and Transparency website
US Medical Information website, Medical Resources
Other Identifiers
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2024-511202-23-00
Identifier Type: OTHER
Identifier Source: secondary_id
MS201924_0002
Identifier Type: -
Identifier Source: org_study_id
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