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About
The study was to evaluate the efficacy and safety of avelumab in combination with M6620 + carboplatin in participants with PARPi-resistant, recurrent, platinum sensitive ovarian, primary peritoneal, or fallopian tube cancer.
Full description
The study was intended to be a phase Ib/II trial, but after completing Phase 1b and confirming the safe combination dose, the sponsor decided not to conduct Phase II.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Female participants with recurrent epithelial ovarian cancer who have disease progression following maintenance treatment with a PARPi as defined below:
Confirmed breast cancer gene (BRCA) 1/2 mutation status or agree to its testing on samples collected in the study.
Available formalin-fixed, paraffin-embedded (FFPE) tumor biopsies.
Part A: Optional 2 paired on-treatment biopsies on Day 2 of Cycle 1 (first biopsy) and Day 2 of Cycle 1 or Cycle 2 (second biopsy) respectively, before and after M6620 administration, if assessed as feasible at low risk by the interventional radiologist.
Part B: Histological tissue specimen (tissue block or 8 to 10 unstained slides) must be available. An archival tumor biopsy is acceptable if obtained after the last progression on PARPi treatment and is less than 4 months old. Otherwise, participants must be willing to undergo mandatory biopsy during the Screening Period to obtain sufficient tissue for histological assessment. Participants need to have an attempted biopsy. However, participants who have measurable disease documented by a radiologist as not feasible or safe to be biopsied are eligible to enter the study
Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Other protocol defined inclusion criteria could apply
Exclusion criteria
Treatment with a nonpermitted drug/intervention as listed below:
Current use of the following medications at the time of enrollment:
Other protocol defined exclusion criteria could apply
Primary purpose
Allocation
Interventional model
Masking
3 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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