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DDriver

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)

Open
Grade
High grade
Prior lines
1, 2
Biomarkers
BRCA1, HRD, BRCA2
Histology
Serous, Endometrioid
Platin
Platinum sensitive
Phase
II
IMP
Tuvusertib, Lartesertib, Niraparib
principal investigator
Prof. Dr. Els Van Nieuwenhuysen

Treatment

This trial consists of two different treatment options:

  • Tuvusertib + Niraparib
  • Tuvusertib + Lartesertib

Tuvusertib, lartesertib and niraparib are administered orally.

Patients are randomized to one of either treatment groups.
 

Treatment duration

The treatment can continue until disease progression, unacceptable toxicity or withdrawal of consent

Eligibility

Main inclusion criteria:

  • high grade serous or high grade endometrioid ovarian, primary peritoneal, and/or fallopian tube cancer that is recurrent
  • germline or somatic deleterious or suspected deleterious mutations in the genes BRCA1 and/or BRCA2, 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.
  • Clinically benefited from PARPi maintenance by at least 6 months
  • Progression on first-line maintenance PARPi: 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)
  • Progression on second-line maintenance PARPi: Participants are not allowed any additional systemic anticancer treatments before study entry (i.e. PARPi is the last treatment before study entry)
  • Measurable disease
     

Disclaimer: This is an overview of the main in- and exclusion criteria which can also be found on clinicaltrials.gov (NCT06433219). Criteria might change during the course of the study due to amendments. Inclusion in the trial remains the responsibility of the principal investigator of the trial and will depend on patient eligibility and slot availability.

Contact

In case you feel your patient might be eligible for this trial or in case you want to have more information about this trial, please feel free to contact us via: lgog@uzleuven.be

More information on this trial (NCT06433219)