Pembrolizumab Plus Olaparib in Patients With Recurrent Cervical Cancer

Sponsor
Saitama Medical University International Medical Center
Study ID
NCT04641728
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Pembrolizumab — DRUG
    pembrolizumab 200 mg every three weeks (Q3W)
  • Olaparib — DRUG
    olaparib 300 mg twice daily (BID)

Study Details

This trial is a multicenter, single-arm, phase 2 study of pembrolizumab in combination with olaparib in recurrent or metastatic cervical cancer patients who had disease progression during or after platinum-based chemotherapy.

Key Dates

Start date
Jan 1, 2021
Status verified
Jul 2022
Primary completion
Dec 31, 2022
Completion
Dec 31, 2023

Study Design

Enrollment
28 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: pembrolizumab plus olaparib
    Until RECIST-based confirmation of progressive disease (PD), death, manifestation of intolerable toxicity, or participant withdrawal from the study, study participants will continue intravenous infusion of pembrolizumab 200 mg every three weeks (Q3W) in combination with oral olaparib 300 mg twice daily (BID) (combination therapy)

Primary Outcome Measure

Objective Response Rate [ Time Frame: 3 years ]

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