Olaparib, Durvalumab and UV1 in Relapsed Ovarian Cancer

Sponsor
Nordic Society of Gynaecological Oncology - Clinical Trials Unit
Study ID
NCT04742075
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Olaparib + durvalumab + UV1 — DRUG
    The subjects are randomized 1:1:2 to receive treatment until progression of disease or untorable toxicity.

Study Details

This prospective, multicenter, open-label, randomized phase II maintenance study is evaluating the efficacy of UV1-olaparib-durvalumab combination as maintenance therapy after platinum combination therapy for BRCAwt patients with relapsed ovarian cancer.

Key Dates

Start date
Dec 15, 2021
Status verified
Feb 2026
Primary completion
May 1, 2026
Completion
Dec 31, 2030

Study Design

Enrollment
188 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: (A) Olaparib
    Olaparib 300 mg tablets twice daily until progressive disease or unacceptable toxicity.
  • Experimental: (B) Olaparib + durvalumab
    Olaparib 300 mg tablets twice daily until progressive disease or unacceptable toxicity. Durvalumab 1500 mg IV every 4 weeks for 24 months or until disease progression or unacceptable toxicity.
  • Experimental: (C) Olaparib + durvalumab + UV1
    Olaparib 300 mg tablets twice daily until disease progression or unacceptable toxicity. Durvalumab 1500 mg IV every 4 weeks for 24 months or until disease progression or unacceptable toxicity. Eight UV1 vaccinations during the first 5 month: Four UV1 vaccinations 300 μg (+ 75 μg of sargramostim) during the first 10 days with a minimum of 2 days apart. From cycle 2-5 subjects will receive one UV1 (+ sargramostim) vaccination every 4th week.

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: 72 months ]

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