Pembrolizumab in Combination with Bevacizumab and Pegylated Liposomal Doxorubicin in Patients with Ovarian Cancer

Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Study ID
NCT03596281
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Pembrolizumab — DRUG
    200mg Q3W IV
  • Bevacizumab — DRUG
    400 or 300 mg Q3W IV
  • pegylated liposomal doxorubicin (PLD) — DRUG
    15 or 20 or 30 mg/m² Q3W IV

Study Details

French multicenter, open-label, phase 1b, evaluating via the mTPI design the paired treatment of pembrolizumab and PLD (cohort A), pembrolizumab and bevacizumab (cohort B) and finally the combination treatment of the three drugs PLD plus bevacizumab and pembrolizumab (cohort C). Thanks to an expansion cohort C+ the ORR will be evaluated in a total of 19 patients at the RP2 D using an exact binomial one-step Fleming-type design. Cohort A and B will be opened for inclusions at the same time. Once safety of the dual combinations confirmed in cohorts A and B,cohort C will be opened for inclusions.

Key Dates

First listed
Jul 23, 2018
Start date
Dec 5, 2018
Status verified
Oct 2024
Primary completion
Mar 11, 2021
Completion
Apr 11, 2023

Study Design

Enrollment
47 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A
  • Experimental: Cohort B

Primary Outcome Measure

Dose Limiting Toxicity (DLT) [ Time Frame: Up to 3 weeks ]

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