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Ovarian CancerPhase 2NCT06433219

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

A Phase 2 study testing Tuvusertib (M1774), Niraparib and Lartesertib (M4076) in people with Ovarian Cancer, run by EMD Serono Research & Development Institute, Inc. at 84 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. 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?
Tuvusertib (M1774), Niraparib and Lartesertib (M4076)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
84 sitesin 13 countries
Study dates
30 Oct 2024to 11 Aug 2026
Phase
Phase 2
Are there results?
None posted in the registry

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

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

84 sites in 13 countries.

84 sites in 13 countries

France13 sites

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

    Angers

  • Centre Francois Baclesse - Service d'Oncologie Medicale

    Caen

  • Centre Oscar Lambret - service de cancerologie gynecologique

    Lille

  • Centre Leon Berard - Service d'Oncologie Medicale

    Lyon

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

    Paris

  • Hopital Tenon - service d'oncologie medicale

    Paris

  • Hôpital Cochin - Hematologie et Oncologie Médicale

    Paris

  • Hôpital Européen Georges Pompidou - Hématologie Oncologie

    Paris

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

    Paris

  • Centre Hospitalier Lyon Sud - service d'oncologie medicale

    Pierre-Bénite

  • Centre de Radiotherapie Clinique Sainte Anne - 300207251

    Strasbourg

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

    Strasbourg

  • Institut Gustave Roussy - Oncologie Médicale

    Villejuif

Other trials in France

Italy10 sites

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

    Bologna

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

    Bologna

  • Osp Cannizzaro Catania

    Catania

  • Azienda Ospedaliero-Universitaria Renato Dulbecco - Centro Oncologico

    Catanzaro

  • IEO Istituto Europeo di Oncologia - Unità Ginecologia Oncologica Medica

    Milan

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

    Milan

  • Istituto Nazionale Tumori Fondazione G. Pascale - Gynecology

    Naples

  • IOV - Istituto Oncologico Veneto IRCCS - Radiologia Oncologica

    Padova

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

    Roma

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

    Rome

Other trials in Italy

United Kingdom10 sites

  • Addenbrooke's Hospital - Dept of Oncology

    Cambridge

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

    Glasgow

  • Royal Surrey County Hospital - Dept of Oncology

    Guildford

  • St James's University Hospital - Dept of Oncology

    Leeds

  • Guy's Hospital - Dept of Medical Oncology

    London

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

    London

  • University College London Hospitals - NIHR/Wellcome Trust

    London

  • The Christie Hospital - Dept of Oncology

    Manchester

  • Mount Vernon Hospital - Dept of Oncology

    Northwood

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

    Sutton

Other trials in United Kingdom

United States9 sites

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109

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

    Chicago, Illinois, 60637

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

    Columbus, Georgia, 31904

  • Next Oncology - Virginia

    Fairfax, Virginia, 22031

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10021

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

    New York, New York, 10029

  • University of California San Francisco - UCSF Medical Center

    San Francisco, California, 94158

Other trials in United States

Germany9 sites

  • Charité - Campus Virchow-Klinikum - Klinik fuer Gynaekologie

    Berlin

  • Universitaetsklinikum Bonn AoeR - Frauenklinik

    Bonn

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

    Dresden

  • Kliniken Essen-Mitte - Gynaekologie und Gynaekologische Onkologie

    Essen

  • Universitaetsklinikum Leipzig AoeR - Klinik und Poliklinik fuer Frauenheilkunde

    Leipzig

  • Universitaetsklinikum Muenster - Parent

    Münster

  • Universitätsklinikum Münster - Gynecology

    Münster

  • Caritas-Krankenhaus St. Josef - Klinik fuer Chirurgie

    Regensburg

  • Universitaetsklinikum Tuebingen - Parent

    Tübingen

Other trials in Germany

Spain8 sites

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

    Badalona

  • Hospital Clinic de Barcelona - Servicio de Oncologia

    Barcelona

  • Hospital Universitari Vall d'Hebron - Oncology Dept.

    Barcelona

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

    Girona

  • Clinica Universidad de Navarra (MAD) - Oncology Service

    Madrid

  • Hospital Universitario 12 de Octubre - Servicio de Oncologia

    Madrid

  • Hospital Universitario Ramon y Cajal - Servicio de Oncologia

    Madrid

  • Hospital Regional Universitario de Malaga - Oncology Dept

    Málaga

Other trials in Spain

Poland6 sites

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

    Bydgoszcz

  • Szpitale Pomorskie spó

    Gdynia

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

    Krakow

  • Instytut MSF Sp.z.o.o

    Lodz

  • Europejskie Centrum Zdrowia - Oddzial Onkologii

    Otwock

  • MICS Centrum Medyczne Torun - Medicovernn

    Torun

Other trials in Poland

Israel5 sites

  • Rambam Medical Center

    Haifa

  • The Lady Davis Carmel Medical Center

    Haifa

  • Hadassah University Hospital - Ein Kerem

    Jerusalem

  • Shaare Zedek

    Jerusalem

  • Chaim Sheba Medical Center

    Ramat Gan

Other trials in Israel

Switzerland5 sites

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

    Bellinzona

  • Kantonsspital Frauenfeld - 150509250

    Frauenfeld

  • Kantonsspital Baselland - standort Liestal - Klinik fuer Onkologie

    Liestal

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

    Sankt Gallen

  • Universitaetsspital Zuerich - Klinik fuer Gynaekologie

    Zurich

Other trials in Switzerland

Australia3 sites

  • Chris O'Brien Lifehouse

    Camperdown

  • St George Private Hospital

    Kogarah

  • Liverpool Hospital - PARENT

    Liverpool

Other trials in Australia

Denmark3 sites

  • Ålborg Universitets Hospital - PARENT

    Aalborg

  • Rigshospitalet

    Copenhagen

  • Sjaellands Universitetshospital - other

    Odense

Other trials in Denmark

Belgium2 sites

  • Cliniques Universitaires Saint-Luc - STL

    Brussels

  • UZ Leuven

    Leuven

Other trials in Belgium

Netherlands1 site

  • Catharina Ziekenhuis Eindhoven - Parent

    Eindhoven

Other trials in Netherlands

About this study

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)

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.

Conditions
Ovarian Cancer
Being tested
Tuvusertib (M1774), Niraparib, Lartesertib (M4076)
Keywords
Ataxia telangiectasia mutated Rad3-related, Ataxia telangiectasia mutated, Poly-ADP ribose polymerase inhibitor resistance, Homologous recombination deficiency
Medical subject headings
Ovarian Neoplasms, Hereditary Sensory and Autonomic Neuropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tuvusertib (M1774)Drug

    Also called M1774, VXc-400, VRT-1363004, substance code MSC2584415A

    Tuvusertib will be administered orally.

  • NiraparibDrug

    Also called GSK3985771, MK-4827

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

  • Lartesertib (M4076)Drug

    Also called M4076, substance code MSC2585823A

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

Study groups in NCT06433219
Study groupRoleWhat they receive
Part A, Arm 1: Tuvusertib with NiraparibExperimentalIn Part A, participants will be randomized to one of 2 arms to receive tuvusertib in combination with either niraparib or lartesertib.
Receives: Drug: Tuvusertib (M1774); Drug: Niraparib
Part A, Arm 2: Tuvusertib with LartesertibExperimentalIn Part A, participants will be randomized to one of 2 arms to receive tuvusertib in combination with either niraparib or lartesertib.
Receives: Drug: Tuvusertib (M1774); Drug: Lartesertib (M4076)
Part B (dose optimization), dosing regimen 1 :Tuvusertib+Niraparib or Tuvusertib +LartesertibExperimentalIn Part B, the most favorable combination treatment from Part A will be further explored at 2 different dosing regimens and compared to tuvusertib monotherapy.
Receives: Drug: Tuvusertib (M1774); Drug: Niraparib; Drug: Lartesertib (M4076)
Part B (dose optimization), dosing regimen 2: Tuvusertib + Niraparib or Tuvusertib + LartesertibExperimentalIn Part B, the most favorable combination treatment from Part A will be further explored at 2 different dosing regimens and compared to tuvusertib monotherapy.
Receives: Drug: Tuvusertib (M1774); Drug: Niraparib; Drug: Lartesertib (M4076)
Part B: Tuvusertib MonotherapyExperimentalIn Part B, the most favorable combination treatment from Part A will be further explored at 2 different dosing regimens and compared to tuvusertib monotherapy.
Receives: Drug: Tuvusertib (M1774)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A and Part B: Confirmed Objective Response (OR) According to RECIST v1.1 as Assessed by Investigator

    Measured: Time from randomization to final assessment or until progressive disease, death, discontinuation criteria, approximately up to 3.5 years

  2. Part A and Part B: Number of Participants With Treatment-Emergent Adverse Events (TEAE), Serious TEAEs and Related TEAEs

    Measured: Time from randomization to final assessment at end of safety follow-up visit, approximately up to 3.5 years

Secondary outcomes (3)

  1. Part A and Part B: Duration of Response (DoR) According to RECIST 1.1 as Assessed by the Investigator

    Measured: Time from randomization to final assessment or until progressive disease, death, discontinuation criteria, approximately up to 3.5 years

  2. Part A and Part B: Progression Free Survival (PFS) According to RECIST 1.1 as Assessed by the Investigator

    Measured: Time from randomization to final assessment or until progressive disease, death, discontinuation criteria, approximately up to 3.5 years

  3. Part B: Overall Survival

    OS is defined as the time from randomization to death due to any cause.

    Measured: Time from date of randomization to death, approximately 3.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2024
  2. Study start30 Oct 2024
  3. Primary completion11 Aug 2026
  4. Study completion11 Aug 2026

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06433219
Sponsor's protocol ID
MS201924_0002
Other IDs
2024-511202-23-00
Status last verified
Sep 2026
First submitted
22 May 2024
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: IPD supporting publicly available results will be evaluated for sharing.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tuvusertib (M1774), Niraparib and Lartesertib (M4076) in people with Ovarian Cancer, run by EMD Serono Research & Development Institute, Inc. at 84 sites in 13 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 8 inclusion and 8 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: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 84 sites in France, Italy, United Kingdom, United States, Germany and 8 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A and Part B: Confirmed Objective Response (OR) According to RECIST v1.1 as Assessed by Investigator (time frame: Time from randomization to final assessment or until progressive disease, death, discontinuation criteria, approximately up to 3.5 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?

On the ClinicalTrials.gov record for NCT06433219.

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 14 Sep 2026.

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