NCT05188508

Pembrolizumab, Olaparib, and Temozolomide for People With Glioma

A Phase II Study of Pembrolizumab, Olaparib, and Temozolomide in Patients With Glioma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 57 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will test the safety and effectiveness of a combination of pembrolizumab, olaparib, and temozolomide to see how well these drugs work when given together in people with a glioma that either did not respond to previous treatment or came back after treatment.

Conditions

• Glioma

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Patients will receive pembrolizumab 200mg IV on day 1 (± 3days) of each cycle. Pembrolizumab will continue every 21 days (± 3 days) throughout the trial.
COMBINATION_PRODUCT	Olaparib and Temozolomide	Olaparib and temozolomide will begin on cycle 3 day 1 and continue through cycle 11. Olaparib will be dosed 200mg orally twice a day (bid) days 1-7 each cycle. Temozolomide 50 mg/m2 will be administered orally days 1-7 each cycle.

Timeline

• Start date: 2022-01-14
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2022-01-12
• Last updated: 2026-03-06

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study