Clinical trial NCT04977375: Trial of Anti-PD-1 Immunotherapy and Stereotactic Radiation in Patients With Recurrent Glioblastoma
Official title: Phase Ib/II Trial of Anti-PD-1 Immunotherapy and Stereotactic Radiation in Patients With Recurrent Glioblastoma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Glioblastoma Multiforme
Keywords: Central Nervous System Tumor
neurosurgery
Brain tumor
spinal cord tumor
surgical resection
glioma
glioblastoma
neuropathology
maximal safe resection
CNS
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
name: National Cancer Institute (NCI)
First posted: 2021-07-26
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety/tolerability/feasibility of pembrolizumab and radiation therapy before surgical resection in patients with recurrent glioblastoma as defined by treatment-related AEs and the number of patients who do not necessitate a delay in surgical resection, and to assess overall survival. The secondary objectives are to assess progression free survival, and to assess the T cell clonality, CD8 T cell activation and Tumor Infiltrating Lymphocyte (TIL) score after treatment


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Confirmed histologic diagnosis of WHO Grade IV, Glioblastoma Multiforme
* GBM recurrence or progression with planned standard of care surgical resection and repeat radiation
* Tumor size less than 6 cm
* ECOG performance status of 0-1
* Adequate laboratory values

Exclusion Criteria:

* Contraindication to additional radiation
* Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor
* Immunodeficiency diagnosis or receiving chronic systemic steroid therapy (exceeding 10 mg daily of prednisone) or any other form of immunosuppressive therapy
* Severe hypersensitivity to pembrolizumab

Complete inclusion/exclusion criteria are detailed in the protocol.

Primary outcomes:
measure: Safety and tolerability measured by the incidence of adverse events, serious adverse events and grade 3 or above treatment related adverse events.
timeFrame: From start of study treatment until confirmation of disease progression, intolerable toxicities, withdrawal of consent. Assessed up to 2 years.
measure: Overall survival
timeFrame: From start of study treatment until death, loss to follow-up, or withdrawal of consent. Assessed up to 2 years.
Secondary outcomes:
measure: Progression free survival
timeFrame: From start of study treatment until until confirmation of disease progression, intolerable toxicities, withdrawal of consent. Assessed up to 2 years.
measure: Immune action
timeFrame: At baseline, prior to stereotactic radiation therapy, and prior to surgery.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Chirag G Patil, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: