Description:
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
Title
- Brief Title: 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
Clinical Trial IDs
- ORG STUDY ID:
IIT2019-13-Patil-NeoPD1SRS
- NCT ID:
NCT04977375
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| Pembrolizumab | | Pembrolizumab with stereotactic radiation therapy and surgical resection |
Purpose
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
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Pembrolizumab with stereotactic radiation therapy and surgical resection | Experimental | | |
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.
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Safety and tolerability measured by the incidence of adverse events, serious adverse events and grade 3 or above treatment related adverse events. |
| Time Frame: | From start of study treatment until confirmation of disease progression, intolerable toxicities, withdrawal of consent. Assessed up to 2 years. |
| Safety Issue: | |
| Description: | Safety and tolerability measured by the incidence of adverse events, serious adverse events and grade 3 or above treatment related adverse events as assessed per CTCAE, Version 5.0. |
Secondary Outcome Measures
| Measure: | Progression free survival |
| Time Frame: | From start of study treatment until until confirmation of disease progression, intolerable toxicities, withdrawal of consent. Assessed up to 2 years. |
| Safety Issue: | |
| Description: | From start of study treatment until confirmation of disease progression (per iRANO Criteria), intolerable toxicities, withdrawal of consent, or up to 2 years or 18 cycles of pembrolizumab, whichever comes first. |
| Measure: | Immune action |
| Time Frame: | At baseline, prior to stereotactic radiation therapy, and prior to surgery. |
| Safety Issue: | |
| Description: | To assess the T cell clonality, CD8 T cell activation and Tumor Infiltrating Lymphocyte (TIL) score after treatment. Blood draws for research purposes performed after obtaining consent but prior to neoadjuvant pembrolizumab administration, and at the time of initiation of SRT and at the time of surgery |
Details
| Phase: | Phase 1/Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Not yet recruiting |
| Lead Sponsor: | Chirag G. Patil |
Trial Keywords
- Central Nervous System Tumor
- neurosurgery
- Brain tumor
- spinal cord tumor
- surgical resection
- glioma
- glioblastoma
- neuropathology
- maximal safe resection
- CNS
Last Updated
July 26, 2021
