Home › Trials › NCT06433219

Combining tuvusertib with niraparib or lartesertib for ovarian cancer treatment

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)

Phase 2 Interventional EMD Serono · NCT06433219

This study is testing if a new drug called tuvusertib, combined with either niraparib or lartesertib, can help women with recurrent ovarian cancer whose tumors have not responded to previous treatments.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment60 (estimated)
Ages18 Years and up
SexFemale
SponsorEMD Serono Industry-sponsored
Drugs / interventionsbevacizumab, chemotherapy, prednisone
Locations58 sites (Little Rock, Arkansas and 57 other locations)
Trial IDNCT06433219 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of tuvusertib in combination with either niraparib or lartesertib for patients with epithelial ovarian cancer who have previously shown progression while on a PARP inhibitor. The primary goal is to assess the overall response of the treatment, determining whether tumors shrink, remain stable, or worsen. Participants must have specific genetic mutations or homologous recombination deficiency, which will be confirmed through standard testing. The study aims to provide new treatment options for patients with recurrent ovarian cancer.

Who should consider this trial

Good fit: Ideal candidates are those with recurrent high-grade serous or endometrioid ovarian cancer who have progressed on PARP inhibitors and have specific genetic mutations.

Not a fit: Patients without the required genetic mutations or those who have not progressed on PARP inhibitors may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with resistant ovarian cancer.

How similar studies have performed: Other studies have shown promise in combining targeted therapies for ovarian cancer, suggesting potential success for this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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)

* 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 last platinum administration in the 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.
* Other Protocol defined exclusion criteria could apply.

Where this trial is running

Little Rock, Arkansas and 57 other locations

+8 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Ovarian CancerAtaxia telangiectasia mutated Rad3-relatedAtaxia telangiectasia mutatedPoly-ADP ribose polymerase inhibitor resistanceHomologous recombination deficiency
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.