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

Last updated: January 30, 2025
Sponsor: EMD Serono Research & Development Institute, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Ovarian Cancer

Vaginal 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. The participants will previously have progressed while treated with a poly ADP ribose polymerase (PARP) inhibitor. The primary objective of the study is to assess the effect of the treatment in terms of overall response, i.e. whether the tumor disappears, shrinks, remains unchanged, or gets worse.

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)

  • 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 last platinum administration in the second-linesetting.

  • 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.

  • Other Protocol defined exclusion criteria could apply.

Study Design

Total Participants: 60
Treatment Group(s): 3
Primary Treatment: Niraparib
Phase: 2
Study Start date:
October 30, 2024
Estimated Completion Date:
January 25, 2028

Connect with a study center

  • Liverpool Hospital - PARENT

    Liverpool,
    Australia

    Active - Recruiting

  • Cliniques Universitaires Saint-Luc - STL

    Bruxelles,
    Belgium

    Active - Recruiting

  • UZ Leuven

    Leuven,
    Belgium

    Active - Recruiting

  • Ålborg Universitets Hospital - PARENT

    Aalborg,
    Denmark

    Active - Recruiting

  • Rigshospitalet

    Copenhagen,
    Denmark

    Active - Recruiting

  • Sjaellands Universitetshospital - other

    Odense,
    Denmark

    Active - Recruiting

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

    Angers Cedex 2,
    France

    Active - Recruiting

  • Centre Francois Baclesse - Service d'Oncologie Medicale

    Caen Cedex 05,
    France

    Active - Recruiting

  • Centre Oscar Lambret - service de cancerologie gynecologique

    Lille cedex,
    France

    Active - Recruiting

  • Centre Leon Berard - Service d'Oncologie Medicale

    Lyon,
    France

    Active - Recruiting

  • Hôpital Cochin - Hematologie et Oncologie Médicale

    Paris,
    France

    Active - Recruiting

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

    Paris Cedex 14,
    France

    Active - Recruiting

  • Hopital Tenon - service d'oncologie medicale

    Paris cedex,
    France

    Active - Recruiting

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

    Paris cedex 12,
    France

    Active - Recruiting

  • Centre Hospitalier Lyon Sud - service d'oncologie medicale

    Pierre Benite cedex,
    France

    Active - Recruiting

  • Centre de Radiotherapie Clinique Sainte Anne - 300207251

    Strasbourg,
    France

    Active - Recruiting

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

    Strasbourg,
    France

    Active - Recruiting

  • Institut Gustave Roussy - Oncologie Médicale

    Villejuif,
    France

    Active - Recruiting

  • Charité - Campus Virchow-Klinikum - Klinik fuer Gynaekologie

    Berlin,
    Germany

    Active - Recruiting

  • Please Contact the Communication Center

    Darmstadt, 64293
    Germany

    Site Not Available

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

    Dresden,
    Germany

    Active - Recruiting

  • Universitaetsklinikum Leipzig AoeR - Klinik und Poliklinik fuer Frauenheilkunde

    Leipzig,
    Germany

    Active - Recruiting

  • Universitaetsklinikum Muenster - Parent

    Muenster,
    Germany

    Active - Recruiting

  • The Lady Davis Carmel Medical Center

    Haifa,
    Israel

    Active - Recruiting

  • Hadassah University Hospital - Ein Kerem

    Jerusalem,
    Israel

    Active - Recruiting

  • Shaare Zedek

    Jerusalem,
    Israel

    Active - Recruiting

  • Chaim Sheba Medical Center

    Ramat Gan,
    Israel

    Active - Recruiting

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

    Bologna,
    Italy

    Active - Recruiting

  • Osp Cannizzaro Catania

    Catania,
    Italy

    Active - Recruiting

  • 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

    Active - Recruiting

  • Istituto Nazionale Tumori Fondazione G. Pascale - Gynecology

    Napoli,
    Italy

    Active - Recruiting

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

    Roma,
    Italy

    Active - Recruiting

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

    Rome,
    Italy

    Active - Recruiting

  • Szpitale Pomorskie spó

    Gdynia,
    Poland

    Active - Recruiting

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

    Krakow,
    Poland

    Active - Recruiting

  • Instytut MSF Sp.z.o.o

    Lodz,
    Poland

    Active - Recruiting

  • Europejskie Centrum Zdrowia - Oddzial Onkologii

    Otwock,
    Poland

    Active - Recruiting

  • MICS Centrum Medyczne Torun - Medicovernn

    Torun,
    Poland

    Active - Recruiting

  • Instytut MSF Sp.z.o.o

    Łódź, 90-302
    Poland

    Site Not Available

  • Hospital Clinic de Barcelona - Servicio de Oncologia

    Barcelona,
    Spain

    Active - Recruiting

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

    Girona,
    Spain

    Active - Recruiting

  • Clinica Universidad de Navarra (MAD) - Oncology Service

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre - Servicio de Oncologia

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Universitario Ramon y Cajal - Servicio de Oncologia

    Madrid,
    Spain

    Active - Recruiting

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

    Bellinzona,
    Switzerland

    Active - Recruiting

  • Kantonsspital Frauenfeld - 150509250

    Frauenfeld,
    Switzerland

    Active - Recruiting

  • Kantonsspital Baselland - standort Liestal - Klinik fuer Onkologie

    Liestal,
    Switzerland

    Active - Recruiting

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

    St. Gallen,
    Switzerland

    Active - Recruiting

  • Universitaetsspital Zuerich - Klinik fuer Gynaekologie

    Zuerich,
    Switzerland

    Active - Recruiting

  • Royal Surrey County Hospital - Dept of Oncology

    Guildford,
    United Kingdom

    Active - Recruiting

  • St James's University Hospital - Dept of Oncology

    Leeds,
    United Kingdom

    Active - Recruiting

  • Guy's Hospital - Dept of Medical Oncology

    London,
    United Kingdom

    Active - Recruiting

  • University College London Hospitals - NIHR/Wellcome Trust

    London,
    United Kingdom

    Active - Recruiting

  • The Christie Hospital - Dept of Oncology

    Manchester,
    United Kingdom

    Active - Recruiting

  • 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

    Active - Recruiting

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

    Columbus, Georgia 31904
    United States

    Active - Recruiting

  • Please Contact U.S. Medical Information

    Rockland, Massachusetts 02370
    United States

    Site Not Available

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

    New York, New York 10029
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10021
    United States

    Active - Recruiting

  • Next Oncology - Virginia

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

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