Pembrolizumab, Olaparib, and Temozolomide for People With Glioma
ConditionGlioma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
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.
Eligibility criteria
Qualifiers
Histologically confirmed grade II or III IDH-mutated glioma (absence of known CDKN2A/B deletion) that has recurred after first line therapy (consisting of at least maximum feasible surgical resection). There is no limit on the number of prior therapies or types of therapies patients can have received.
Measurable disease by RANO criteria
Stable dose of corticosteroids for ≥ 4 weeks prior to baseline MRI. Steroid dose not to exceed 2mg/day dexamethasone (or equivalent).
Histologically confirmed IDH-wildtype glioma that has recurred following therapy (consisting of at least maximum feasible surgical resection and radiation therapy).
Disqualifiers
No limit on number of prior therapies
Evidence of significant intracranial hemorrhage
No other investigational or standard anti-tumor therapy allowed
Patients must not have a known history of allergic reaction attributed to study drugs or compounds of similar chemical or biologic composition unless allergic reaction was managed by pre-medication.
Trial design
Treatments tested in this trial
- Pembrolizumab
- Olaparib and Temozolomide
Treatment groups
57 Participants
are divided into 2 treatment groupsSponsors and collaborators
Memorial Sloan Kettering Cancer Center
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
Source ClinicalTrials.gov