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New drug cocktail aims to outsmart resistant ovarian cancer

NCT ID NCT06433219

Disease control Sponsor: EMD Serono Research & Development Institute, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 15, 2026 · Updated 3 times

Summary

This Phase 2 trial tests two experimental drug combinations in 63 women with a specific type of ovarian cancer (BRCA-mutant or HRD-positive) that has worsened after prior PARP inhibitor treatment. Participants receive either tuvusertib plus niraparib or tuvusertib plus lartesertib, all taken orally. The study measures whether tumors shrink or stop growing, and monitors safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tuvusertib, niraparib, lartesertib
What this could lead to
If successful, this could offer a new treatment option for women with BRCA-mutant ovarian cancer whose disease has worsened despite prior PARP inhibitor therapy.
What could go wrong
This is an early Phase 2 trial with only 63 participants, so results may not apply to all patients. The drug combinations may cause side effects or fail to shrink tumors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

63 people

The number who actually took part.

Started

Oct 2024

Finished

Aug 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

fallopian tube cancer hereditary sensory and autonomic neuropathy ovarian cancer ovarian endometrioid adenocarcinoma ovarian serous adenocarcinoma primary peritoneal carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ovarian cancer

Contacts and locations

Locations

  • Addenbrooke's Hospital - Dept of Oncology

    Cambridge, United Kingdom

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

    Bologna, Italy

  • Azienda Ospedaliero-Universitaria Renato Dulbecco - Centro Oncologico

    Catanzaro, Italy

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

    Glasgow, United Kingdom

  • Caritas-Krankenhaus St. Josef - Klinik fuer Chirurgie

    Regensburg, Germany

  • Catharina Ziekenhuis Eindhoven - Parent

    Eindhoven, Netherlands

  • Centre Francois Baclesse - Service d'Oncologie Medicale

    Caen, France

  • Centre Hospitalier Lyon Sud - service d'oncologie medicale

    Pierre-Bénite, France

  • Centre Leon Berard - Service d'Oncologie Medicale

    Lyon, France

  • Centre Oscar Lambret - service de cancerologie gynecologique

    Lille, France

  • Centre de Radiotherapie Clinique Sainte Anne - 300207251

    Strasbourg, France

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

    Columbus, Georgia, 31904, United States

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

    Bydgoszcz, Poland

  • Chaim Sheba Medical Center

    Ramat Gan, Israel

  • Charité - Campus Virchow-Klinikum - Klinik fuer Gynaekologie

    Berlin, Germany

  • Chris O'Brien Lifehouse

    Camperdown, Australia

  • Clinica Universidad de Navarra (MAD) - Oncology Service

    Madrid, Spain

  • Cliniques Universitaires Saint-Luc - STL

    Brussels, Belgium

  • Europejskie Centrum Zdrowia - Oddzial Onkologii

    Otwock, Poland

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

    Rome, Italy

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

    Paris, France

  • Guy's Hospital - Dept of Medical Oncology

    London, United Kingdom

  • Hadassah University Hospital - Ein Kerem

    Jerusalem, Israel

  • Hopital Tenon - service d'oncologie medicale

    Paris, France

  • Hospital Clinic de Barcelona - Servicio de Oncologia

    Barcelona, Spain

  • Hospital Regional Universitario de Malaga - Oncology Dept

    Málaga, Spain

  • Hospital Universitari Vall d'Hebron - Oncology Dept.

    Barcelona, Spain

  • Hospital Universitario 12 de Octubre - Servicio de Oncologia

    Madrid, Spain

  • Hospital Universitario Ramon y Cajal - Servicio de Oncologia

    Madrid, Spain

  • 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

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

    Angers, France

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

    Badalona, Spain

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

    Girona, Spain

  • IEO Istituto Europeo di Oncologia - Unità Ginecologia Oncologica Medica

    Milan, Italy

  • IOV - Istituto Oncologico Veneto IRCCS - Radiologia Oncologica

    Padova, Italy

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

    Bologna, Italy

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

    New York, New York, 10029, United States

  • Institut Gustave Roussy - Oncologie Médicale

    Villejuif, France

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

    Strasbourg, France

  • Instytut MSF Sp.z.o.o

    Lodz, Poland

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

    Milan, Italy

  • Istituto Nazionale Tumori Fondazione G. Pascale - Gynecology

    Naples, Italy

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

    Roma, Italy

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

    Bellinzona, Switzerland

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

    Krakow, Poland

  • Kantonsspital Baselland - standort Liestal - Klinik fuer Onkologie

    Liestal, Switzerland

  • Kantonsspital Frauenfeld - 150509250

    Frauenfeld, Switzerland

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

    Sankt Gallen, Switzerland

  • Kliniken Essen-Mitte - Gynaekologie und Gynaekologische Onkologie

    Essen, Germany

  • Liverpool Hospital - PARENT

    Liverpool, Australia

  • MICS Centrum Medyczne Torun - Medicovernn

    Torun, Poland

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10021, United States

  • Mount Vernon Hospital - Dept of Oncology

    Northwood, United Kingdom

  • Next Oncology - Virginia

    Fairfax, Virginia, 22031, United States

  • Osp Cannizzaro Catania

    Catania, Italy

  • Rambam Medical Center

    Haifa, Israel

  • Rigshospitalet

    Copenhagen, Denmark

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

    London, United Kingdom

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

    Sutton, United Kingdom

  • Royal Surrey County Hospital - Dept of Oncology

    Guildford, United Kingdom

  • Shaare Zedek

    Jerusalem, Israel

  • Sjaellands Universitetshospital - other

    Odense, Denmark

  • St George Private Hospital

    Kogarah, Australia

  • St James's University Hospital - Dept of Oncology

    Leeds, United Kingdom

  • Szpitale Pomorskie spó

    Gdynia, Poland

  • The Christie Hospital - Dept of Oncology

    Manchester, United Kingdom

  • The Lady Davis Carmel Medical Center

    Haifa, Israel

  • UZ Leuven

    Leuven, Belgium

  • Universitaetsklinikum Bonn AoeR - Frauenklinik

    Bonn, Germany

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

    Dresden, Germany

  • Universitaetsklinikum Leipzig AoeR - Klinik und Poliklinik fuer Frauenheilkunde

    Leipzig, Germany

  • Universitaetsklinikum Muenster - Parent

    Münster, Germany

  • Universitaetsklinikum Tuebingen - Parent

    Tübingen, Germany

  • Universitaetsspital Zuerich - Klinik fuer Gynaekologie

    Zurich, Switzerland

  • University College London Hospitals - NIHR/Wellcome Trust

    London, United Kingdom

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205, United States

  • University of California San Francisco - UCSF Medical Center

    San Francisco, California, 94158, United States

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

    Chicago, Illinois, 60637, United States

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109, United States

  • Universitätsklinikum Münster - Gynecology

    Münster, Germany

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031, United States

  • Ålborg Universitets Hospital - PARENT

    Aalborg, Denmark

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