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ACTIVE NOT RECRUITING

NCT06433219

PHASE2

Tuvusertib Combined With Niraparib or Lartesertib in Participants With Epithelial Ovarian Cancer (DDRiver EOC 302)

Sponsor: EMD Serono Research & Development Institute, Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study is to measure the effect and safety of treatment with tuvusertib combined with either niraparib or lartesertib in participants with epithelial ovarian cancer and to assess any differences between tuvusertib monotherapy and combination therapy. The participants will previously have progressed while treated with a poly ADP ribose polymerase (PARP) inhibitor. The primary objectives of this study are to assess the effect of the treatment in terms of overall response, i.e. whether the tumor disappears, shrinks, remains unchanged, or gets worse and safety in terms of adverse events.

Official title: An Open-label, Multicenter, Randomized Phase 2 Study of the ATR Inhibitor Tuvusertib in Combination With the PARP Inhibitor Niraparib or the ATM Inhibitor Lartesertib in Participants With BRCA Mutant and/or Homologous Recombination deﬁciency (HRD)-Positive Epithelial Ovarian Cancer That Progressed on Prior PARP Inhibitor Therapy (DDRiver EOC 302)

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-10-30

Completion Date

2026-06-26

Last Updated

2026-02-18

Healthy Volunteers

Conditions

Ovarian Cancer

Interventions

DRUG

Tuvusertib (M1774)

Tuvusertib will be administered orally.

DRUG

Niraparib

Niraparib will be administered orally. If selected from Part A, Niraparib will be administered orally in combination with Tuvusertib.

DRUG

Lartesertib (M4076)

Lartesertib will be administered orally. If selected from Part A, Lartesertib will be administered orally in combination with Tuvusertib

Inclusion Criteria: * Histologically or cytologically confirmed high grade serous or high grade endometrioid ovarian, primary peritoneal, and/or fallopian tube cancer that is recurrent. * 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. * Other Protocol defined inclusion criteria could apply. Exclusion Criteria: * Primary platinum-refractory disease defined as disease progression during primary platinum-based chemotherapy or platinum-resistant disease defined as disease progression within 6 months of the platinum administration in either the first or second-line setting. * 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. * Other Protocol defined exclusion criteria could apply.

Locations (84)

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

Naples, Italy

IOV - Istituto Oncologico Veneto IRCCS - Radiologia Oncologica

Padova, 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

Clinical Research Directory

Tuvusertib Combined With Niraparib or Lartesertib in Participants With Epithelial Ovarian Cancer (DDRiver EOC 302)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (84)