OSE2101 Alone or in Combination With Pembrolizumab vs BSC in Patient With Platinum-sensitive Recurrent OC

Sponsor
ARCAGY/ GINECO GROUP
Study ID
NCT04713514
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Platinum-sensitive Ovarian Cancer
  • Relapsed Ovarian Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • OSE2101 — DRUG
    subcutaneous injection on day 1, every 3 weeks for 7 doses then every 6 weeks up to week 48 and then every 12 weeks until intolerance, disease progression, or up to 2 years.
  • Pembrolizumab 25 MG/ML [Keytruda] — DRUG
    400 mg IV infusion on day 1 every 6 weeks until intolerance, disease progression, or up to 2 years.

Study Details

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).

Key Dates

Start date
Aug 5, 2021
Status verified
Nov 2024
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Arm A : Best Supportive Care
    Observational arm (Standard of care)
  • Experimental: Arm B : OSE2101
    OSE2101 monotherapy - subcutaneous injection on day 1, every 3 weeks for 7 doses then every 6 weeks up to week 48 and then every 12 weeks until intolerance, disease progression, or up to 2 years. OSE2101 vaccine is an emulsion of peptides suspension in in Montanide® ISA 51 adjuvant and containing 0.5 mg/mL of each 10 synthetically manufactured peptides (5.0 mg/mL total peptide) in 1.5 mL of emulsion.
  • Experimental: Arm C : OSE2101 + Pembrolizumab
    OSE2101 (subcutaneous injection on day 1, every 3 weeks for 7 doses then every 6 weeks up to week 48 and then every 12 weeks until intolerance, disease progression, or up to 2 years) + pembrolizumab (400 mg IV infusion on day 1 every 6 weeks until intolerance, disease progression, or up to 2 years.

Primary Outcome Measure

Progression free survival (PFS) [ Time Frame: from date to randomization to date of event, assessed up to 4 years ]

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