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

Last updated: February 16, 2026
Sponsor: EMD Serono Research & Development Institute, Inc.
Overall Status: Active - Not Recruiting

Phase

2

Condition

Vaginal Cancer

Ovarian Cancer

Pelvic Cancer

Treatment

Niraparib

Tuvusertib (M1774)

Lartesertib (M4076)

Clinical Study ID

NCT06433219
MS201924_0002
2024-511202-23-00
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically or cytologically confirmed high grade serous or high gradeendometrioid ovarian, primary peritoneal, and/or fallopian tube cancer that isrecurrent.

  • Participants whose tumor carries germline or somatic deleterious or suspecteddeleterious mutations in the genes BRCA1 (Breast Cancer gene 1) and BRCA2 (BreastCancer gene 2), and/or tumors with positive HRD status. The presence of any of thesemutations and/or the homologous recombination deficiency (HRD) status will bedetermined according to routinely used local standard of care tests. Results must beavailable before screening.

  • Radiologically confirmed/documented disease progression while on Poly (ADP-ribose)polymerase (PARP) inhibitors therapy in either first or second-line maintenancesetting (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 dosetaken. Surgical salvage intervention and/or focal ablative therapies are allowed, (further disease progression after these interventions must be documented), ANDClinically benefited from PARPi maintenance prior to documented progression, asdefined by at least 6 months of treatment duration with no progressive diseaseobserved, AND either, Progression on first-line maintenance PARPi: Participants areallowed maximum 1 additional line of platinum-based chemotherapy before study entry. (note: treatment-free interval on platinum rechallenge must be >6 months, withdocumented 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 caretreatment or the participant's treating physician considers that the lack ofstandard 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 lifeexpectancy of at least 6 months.

  • Other Protocol defined inclusion criteria could apply.

Exclusion

Exclusion Criteria:

  • Primary platinum-refractory disease defined as disease progression during primaryplatinum-based chemotherapy or platinum-resistant disease defined as diseaseprogression within 6 months of the platinum administration in either the first orsecond-line setting.

  • History of additional malignancy within 3 years before the date of enrollment.

  • Known brain metastases, unless clinically stable, that is without evidence ofprogression by imaging for at least 4 weeks prior to the first dose of studyintervention, no evidence of new brain metastases, and on a stable or decreasingdose of ≤ 10 mg of prednisone (or equivalent) or without corticosteroids for atleast 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]), ordose-limiting immune-mediated reactions related to skin.

  • Other Protocol defined exclusion criteria could apply.

Study Design

Total Participants: 63
Treatment Group(s): 3
Primary Treatment: Niraparib
Phase: 2
Study Start date:
October 30, 2024
Estimated Completion Date:
June 26, 2026

Connect with a study center

  • Chris O'Brien Lifehouse

    Camperdown 2172563,
    Australia

    Site Not Available

  • St George Private Hospital

    Kogarah 2161185,
    Australia

    Site Not Available

  • Liverpool Hospital - PARENT

    Liverpool,
    Australia

    Site Not Available

  • Liverpool Hospital - PARENT

    Liverpool 2159851,
    Australia

    Site Not Available

  • Cliniques Universitaires Saint-Luc - STL

    Brussels 2800866,
    Belgium

    Site Not Available

  • Cliniques Universitaires Saint-Luc - STL

    Bruxelles,
    Belgium

    Site Not Available

  • UZ Leuven

    Leuven,
    Belgium

    Site Not Available

  • UZ Leuven

    Leuven 2792482,
    Belgium

    Site Not Available

  • Ålborg Universitets Hospital - PARENT

    Aalborg,
    Denmark

    Site Not Available

  • Ålborg Universitets Hospital - PARENT

    Aalborg 2624886,
    Denmark

    Site Not Available

  • Rigshospitalet

    Copenhagen,
    Denmark

    Site Not Available

  • Rigshospitalet

    Copenhagen 2618425,
    Denmark

    Site Not Available

  • Sjaellands Universitetshospital - other

    Odense,
    Denmark

    Site Not Available

  • Sjaellands Universitetshospital - other

    Odense 2615876,
    Denmark

    Site Not Available

  • ICO - Site Paul Papin - service d'oncologie medicale

    Angers 3037656,
    France

    Site Not Available

  • ICO - Site Paul Papin - service d'oncologie medicale

    Angers Cedex 2,
    France

    Site Not Available

  • Centre Francois Baclesse - Service d'Oncologie Medicale

    Caen 3029241,
    France

    Site Not Available

  • Centre Francois Baclesse - Service d'Oncologie Medicale

    Caen Cedex 05,
    France

    Site Not Available

  • Centre Oscar Lambret - service de cancerologie gynecologique

    Lille 2998324,
    France

    Site Not Available

  • Centre Oscar Lambret - service de cancerologie gynecologique

    Lille cedex,
    France

    Site Not Available

  • Centre Leon Berard - Service d'Oncologie Medicale

    Lyon,
    France

    Site Not Available

  • Centre Leon Berard - Service d'Oncologie Medicale

    Lyon 2996944,
    France

    Site Not Available

  • Hôpital Cochin - Hematologie et Oncologie Médicale

    Paris,
    France

    Site Not Available

  • Groupe Hospitalier Diaconesses - Hôpital De La Croix Saint Simon - service d'oncologie medicale

    Paris 2988507,
    France

    Site Not Available

  • Hopital Tenon - service d'oncologie medicale

    Paris 2988507,
    France

    Site Not Available

  • Hôpital Cochin - Hematologie et Oncologie Médicale

    Paris 2988507,
    France

    Site Not Available

  • Hôpital Européen Georges Pompidou - Hématologie Oncologie

    Paris 2988507,
    France

    Site Not Available

  • Hôpital Saint Joseph - Paris - Service d'Oncologie-Cancerologie

    Paris 2988507,
    France

    Site Not Available

  • Hôpital Saint Joseph - Paris - Service d'Oncologie-Cancerologie

    Paris Cedex 14,
    France

    Site Not Available

  • Hopital Tenon - service d'oncologie medicale

    Paris cedex,
    France

    Site Not Available

  • Groupe Hospitalier Diaconesses - Hôpital De La Croix Saint Simon - service d'oncologie medicale

    Paris cedex 12,
    France

    Site Not Available

  • Centre Hospitalier Lyon Sud - service d'oncologie medicale

    Pierre Benite cedex,
    France

    Site Not Available

  • Centre Hospitalier Lyon Sud - service d'oncologie medicale

    Pierre-Bénite 2987314,
    France

    Site Not Available

  • Centre de Radiotherapie Clinique Sainte Anne - 300207251

    Strasbourg,
    France

    Site Not Available

  • Institut de Cancérologie de Strasbourg Europe - ICANS - Service d'oncologie médicale

    Strasbourg,
    France

    Active - Recruiting

  • Centre de Radiotherapie Clinique Sainte Anne - 300207251

    Strasbourg 2973783,
    France

    Site Not Available

  • Institut de Cancérologie de Strasbourg Europe - ICANS - Service d'oncologie médicale

    Strasbourg 2973783,
    France

    Site Not Available

  • Institut Gustave Roussy - Oncologie Médicale

    Villejuif,
    France

    Site Not Available

  • Institut Gustave Roussy - Oncologie Médicale

    Villejuif 2968705,
    France

    Site Not Available

  • Charité - Campus Virchow-Klinikum - Klinik fuer Gynaekologie

    Berlin,
    Germany

    Site Not Available

  • Charité - Campus Virchow-Klinikum - Klinik fuer Gynaekologie

    Berlin 2950159,
    Germany

    Site Not Available

  • Universitaetsklinikum Bonn AoeR - Frauenklinik

    Bonn 2946447,
    Germany

    Site Not Available

  • Please Contact the Communication Center

    Darmstadt, 64293
    Germany

    Site Not Available

  • Universitaetsklinikum Carl Gustav Carus TU Dresden - Klinik u. Poliklinik f. Frauenheilkunde

    Dresden,
    Germany

    Site Not Available

  • Universitaetsklinikum Carl Gustav Carus TU Dresden - Klinik u. Poliklinik f. Frauenheilkunde

    Dresden 2935022,
    Germany

    Site Not Available

  • Kliniken Essen-Mitte - Gynaekologie und Gynaekologische Onkologie

    Essen 2928810,
    Germany

    Site Not Available

  • Universitaetsklinikum Leipzig AoeR - Klinik und Poliklinik fuer Frauenheilkunde

    Leipzig,
    Germany

    Site Not Available

  • Universitaetsklinikum Leipzig AoeR - Klinik und Poliklinik fuer Frauenheilkunde

    Leipzig 2879139,
    Germany

    Site Not Available

  • Universitaetsklinikum Muenster - Parent

    Muenster,
    Germany

    Site Not Available

  • Universitaetsklinikum Muenster - Parent

    Münster 2867543,
    Germany

    Site Not Available

  • Universitätsklinikum Münster - Gynecology

    Münster 2867543,
    Germany

    Site Not Available

  • Caritas-Krankenhaus St. Josef - Klinik fuer Chirurgie

    Regensburg 2849483,
    Germany

    Site Not Available

  • Universitaetsklinikum Tuebingen - Parent

    Tübingen 2820860,
    Germany

    Site Not Available

  • The Lady Davis Carmel Medical Center

    Haifa,
    Israel

    Site Not Available

  • Rambam Medical Center

    Haifa 294801,
    Israel

    Site Not Available

  • The Lady Davis Carmel Medical Center

    Haifa 294801,
    Israel

    Site Not Available

  • Hadassah University Hospital - Ein Kerem

    Jerusalem,
    Israel

    Active - Recruiting

  • Shaare Zedek

    Jerusalem,
    Israel

    Site Not Available

  • Hadassah University Hospital - Ein Kerem

    Jerusalem 281184,
    Israel

    Site Not Available

  • Shaare Zedek

    Jerusalem 281184,
    Israel

    Site Not Available

  • Chaim Sheba Medical Center

    Ramat Gan,
    Israel

    Site Not Available

  • Chaim Sheba Medical Center

    Ramat Gan 293788,
    Israel

    Site Not Available

  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS - Oncologia Medica

    Bologna,
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS - Oncologia Medica

    Bologna 3181928,
    Italy

    Site Not Available

  • IRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant Orsola - SSD Oncologia Medica Zamagni

    Bologna 3181928,
    Italy

    Site Not Available

  • Osp Cannizzaro Catania

    Catania,
    Italy

    Site Not Available

  • Osp Cannizzaro Catania

    Catania 2525068,
    Italy

    Site Not Available

  • Azienda Ospedaliero-Universitaria Renato Dulbecco - Centro Oncologico

    Catanzaro 2525059,
    Italy

    Site Not Available

  • IEO Istituto Europeo di Oncologia - Unità Ginecologia Oncologica Medica

    Milan 6951411,
    Italy

    Site Not Available

  • Istituto Clinico Humanitas - U.O. di Oncologia Medica ed Ematologia

    Milan 6951411,
    Italy

    Site Not Available

  • IEO Istituto Europeo di Oncologia - Unità Ginecologia Oncologica Medica

    Milano,
    Italy

    Active - Recruiting

  • Istituto Clinico Humanitas - U.O. di Oncologia Medica ed Ematologia

    Milano,
    Italy

    Site Not Available

  • Istituto Nazionale Tumori Fondazione G. Pascale - Gynecology

    Napoli,
    Italy

    Site Not Available

  • Istituto Nazionale Tumori Fondazione G. Pascale - Gynecology

    Napoli 9031661,
    Italy

    Site Not Available

  • IOV - Istituto Oncologico Veneto IRCCS - Radiologia Oncologica

    Padua 3171728,
    Italy

    Site Not Available

  • Istituto Nazionale Tumori Regina Elena IRCCS - UOC Oncologia Medica A

    Roma,
    Italy

    Site Not Available

  • Istituto Nazionale Tumori Regina Elena IRCCS - UOC Oncologia Medica A

    Roma 8957247,
    Italy

    Site Not Available

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Ostetricia e ginecologia

    Rome,
    Italy

    Site Not Available

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Ostetricia e ginecologia

    Rome 3169070,
    Italy

    Site Not Available

  • Catharina Ziekenhuis Eindhoven - Parent

    Eindhoven 2756253,
    Netherlands

    Site Not Available

  • Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy - Dept of Chemotherapy

    Bydgoszcz 3102014,
    Poland

    Site Not Available

  • Szpitale Pomorskie spó

    Gdynia,
    Poland

    Site Not Available

  • Szpitale Pomorskie spó

    Gdynia 3099424,
    Poland

    Site Not Available

  • Jagiellonskie Centrum Innowacji Sp. z o.o. - Centrum Bada

    Krakow,
    Poland

    Site Not Available

  • Jagiellonskie Centrum Innowacji Sp. z o.o. - Centrum Bada

    Krakow 3094802,
    Poland

    Site Not Available

  • Instytut MSF Sp.z.o.o

    Lodz,
    Poland

    Site Not Available

  • Instytut MSF Sp.z.o.o

    Lodz 3093133,
    Poland

    Site Not Available

  • Europejskie Centrum Zdrowia - Oddzial Onkologii

    Otwock,
    Poland

    Site Not Available

  • Europejskie Centrum Zdrowia - Oddzial Onkologii

    Otwock 762788,
    Poland

    Site Not Available

  • MICS Centrum Medyczne Torun - Medicovernn

    Torun,
    Poland

    Site Not Available

  • MICS Centrum Medyczne Torun - Medicovernn

    Torun 3083271,
    Poland

    Site Not Available

  • Instytut MSF Sp.z.o.o

    Łódź, 90-302
    Poland

    Site Not Available

  • ICO Badalona - Hospital Universitari Germans Trias i Pujol - Servicio de Oncologia Medica

    Badalona 3129028,
    Spain

    Site Not Available

  • Hospital Clinic de Barcelona - Servicio de Oncologia

    Barcelona,
    Spain

    Site Not Available

  • Hospital Clinic de Barcelona - Servicio de Oncologia

    Barcelona 3128760,
    Spain

    Site Not Available

  • Hospital Universitari Vall d'Hebron - Oncology Dept.

    Barcelona 3128760,
    Spain

    Site Not Available

  • ICO Girona - Hospital Universitari de Girona Dr Josep Trueta - Servicio de Oncologia Medica

    Girona,
    Spain

    Site Not Available

  • ICO Girona - Hospital Universitari de Girona Dr Josep Trueta - Servicio de Oncologia Medica

    Girona 3121456,
    Spain

    Site Not Available

  • Clinica Universidad de Navarra (MAD) - Oncology Service

    Madrid,
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre - Servicio de Oncologia

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Universitario Ramon y Cajal - Servicio de Oncologia

    Madrid,
    Spain

    Active - Recruiting

  • Clinica Universidad de Navarra (MAD) - Oncology Service

    Madrid 3117735,
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre - Servicio de Oncologia

    Madrid 3117735,
    Spain

    Site Not Available

  • Hospital Universitario Ramon y Cajal - Servicio de Oncologia

    Madrid 3117735,
    Spain

    Site Not Available

  • Hospital Regional Universitario de Malaga - Oncology Dept

    Málaga 2514256,
    Spain

    Site Not Available

  • Istituto Oncologico della Svizzera Italiana (IOSI)- Ente Ospedaliero Cantonale (EOC) - Ospedale S.Giovann

    Bellinzona,
    Switzerland

    Site Not Available

  • Istituto Oncologico della Svizzera Italiana (IOSI)- Ente Ospedaliero Cantonale (EOC) - Ospedale S.Giovann

    Bellinzona 2661567,
    Switzerland

    Site Not Available

  • Kantonsspital Frauenfeld - 150509250

    Frauenfeld,
    Switzerland

    Site Not Available

  • Kantonsspital Frauenfeld - 150509250

    Frauenfeld 2660727,
    Switzerland

    Site Not Available

  • Kantonsspital Baselland - standort Liestal - Klinik fuer Onkologie

    Liestal,
    Switzerland

    Site Not Available

  • Kantonsspital Baselland - standort Liestal - Klinik fuer Onkologie

    Liestal 2659891,
    Switzerland

    Site Not Available

  • Kantonsspital St. Gallen - Klinik fuer Med. Onkologie/Haematologie

    Sankt Gallen 2658822,
    Switzerland

    Site Not Available

  • Kantonsspital St. Gallen - Klinik fuer Med. Onkologie/Haematologie

    St. Gallen,
    Switzerland

    Site Not Available

  • Universitaetsspital Zuerich - Klinik fuer Gynaekologie

    Zuerich,
    Switzerland

    Site Not Available

  • Universitaetsspital Zuerich - Klinik fuer Gynaekologie

    Zurich 2657896,
    Switzerland

    Site Not Available

  • Addenbrooke's Hospital - Dept of Oncology

    Cambridge 2653941,
    United Kingdom

    Site Not Available

  • Beatson West of Scotland Cancer Centre - Dept of Medical Oncology

    Glasgow 2648579,
    United Kingdom

    Site Not Available

  • Royal Surrey County Hospital - Dept of Oncology

    Guildford,
    United Kingdom

    Site Not Available

  • Royal Surrey County Hospital - Dept of Oncology

    Guildford 2647793,
    United Kingdom

    Site Not Available

  • St James's University Hospital - Dept of Oncology

    Leeds,
    United Kingdom

    Site Not Available

  • St James's University Hospital - Dept of Oncology

    Leeds 2644688,
    United Kingdom

    Site Not Available

  • Guy's Hospital - Dept of Medical Oncology

    London,
    United Kingdom

    Active - Recruiting

  • University College London Hospitals - NIHR/Wellcome Trust

    London,
    United Kingdom

    Site Not Available

  • Guy's Hospital - Dept of Medical Oncology

    London 2643743,
    United Kingdom

    Site Not Available

  • Royal Marsden Hospital-London - Dept of Haematology/Oncology Research

    London 2643743,
    United Kingdom

    Site Not Available

  • University College London Hospitals - NIHR/Wellcome Trust

    London 2643743,
    United Kingdom

    Site Not Available

  • The Christie Hospital - Dept of Oncology

    Manchester,
    United Kingdom

    Site Not Available

  • The Christie Hospital - Dept of Oncology

    Manchester 2643123,
    United Kingdom

    Site Not Available

  • Mount Vernon Hospital - Dept of Oncology

    Northwood 2641216,
    United Kingdom

    Site Not Available

  • Royal Marsden Hospital-Sutton - Dept of Oncology (Surrey)

    Sutton 2636503,
    United Kingdom

    Site Not Available

  • Istituto Oncologico della Svizzera Italiana (IOSI)- Ente Ospedaliero Cantonale (EOC) - Ospedale S.Giovann

    Little Rock, Arkansas 72205
    United States

    Active - Recruiting

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • University of Arkansas for Medical Sciences

    Little Rock 4119403, Arkansas 4099753 72205
    United States

    Site Not Available

  • University of California San Francisco - UCSF Medical Center

    San Francisco 5391959, California 5332921 94158
    United States

    Site Not Available

  • Centricity Research Cancer Center - DBA CRRI John B. Amos Cancer Center Research

    Columbus, Georgia 31904
    United States

    Site Not Available

  • Centricity Research Cancer Center - DBA CRRI John B. Amos Cancer Center Research

    Columbus 4188985, Georgia 4197000 31904
    United States

    Site Not Available

  • University of Chicago Comprehensive Cancer Center at Silver Cross - Carolyn J. Czerkies Pavilion

    Chicago 4887398, Illinois 4896861 60637
    United States

    Site Not Available

  • Please Contact U.S. Medical Information

    Rockland, Massachusetts 02370
    United States

    Site Not Available

  • University of Michigan Rogel Cancer Center

    Ann Arbor 4984247, Michigan 5001836 48109
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai PRIME - Mount Sinai - PRIME

    New York, New York 10029
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10021
    United States

    Active - Recruiting

  • Icahn School of Medicine at Mount Sinai PRIME - Mount Sinai - PRIME

    New York 5128581, New York 5128638 10029
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York 5128581, New York 5128638 10021
    United States

    Site Not Available

  • Next Oncology - Virginia

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • Next Oncology - Virginia

    Fairfax 4758023, Virginia 6254928 22031
    United States

    Site Not Available

  • Virginia Cancer Specialists, PC

    Fairfax 4758023, Virginia 6254928 22031
    United States

    Site Not Available

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