OSE2101 Alone or in Combination With Pembrolizumab vs BSC in Patient With Platinum-sensitive Recu… (NCT04713514) | Clinical Trial Compass
Active — Not RecruitingPhase 2
OSE2101 Alone or in Combination With Pembrolizumab vs BSC in Patient With Platinum-sensitive Recurrent OC
Belgium, France180 participantsStarted 2021-08-05
Plain-language summary
The proposed study is an international randomized phase II, multicenter, open-label, three arms trial to assess best supportive care (BSC) vs OSE2101 and vs OSE2101 + pembrolizumab as maintenance treatment for patients with platinum sensitive relapsed ovarian cancers, previously treated with chemotherapy (regardless of the number of prior lines of platinum-based chemotherapy), bevacizumab (if eligible) and a PARP inhibitor (if eligible).
Patients in Complete Response, Partial Response, or Stable Disease at the end of chemotherapy with at least 4 cycles of platinum based chemotherapy will be randomized in one of the three arms (randomization 1:1:2). They will receive one or the two study treatments or BSC until progression, or intolerance, or up to 2 years (from 1st study treatment dose).
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Signed and dated informed consent document for the study, willing and able to comply with protocol requirements, including:
✓. HLA-A2 phenotype determination by genetic test (blood)
✓. participation in translational research in HLA-A2 positive
✓. authorization for long term follow up if HLA-A2 negative
✓. Histologically proven non-mucinous epithelial ovarian cancer
✓. Positive HLA-A2 phenotype
✓. Age ≥ 18 years
✓. ECOG Performance Status (PS) 0-1
Exclusion criteria
✕. Patient with contra-indications to immune therapies
✕. Ongoing immunotherapy (checkpoint inhibition, antigen immunotherapy that would be scheduled to continue concomitantly to the study)
What they're measuring
1
Progression free survival (PFS)
Timeframe: from date to randomization to date of event, assessed up to 4 years
. Use of any of the following immunomodulatory agents within 30 days prior to the first dose of study drug: Systemic corticosteroids (at dose higher than 10 mg/day equivalent prednisone); if systemic corticoid use, corticoid must be stopped at least 7 days before study treatment start Interferons Interleukins Live vaccine
✕. Prior cancer vaccine therapy
✕. Patient eligible for cytoreductive surgery at the time of inclusion
✕. Patient with clinical, radiological or biological progression (according GCIG criteria) at the end of last chemotherapy
✕. Prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
✕. Patient with active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.