Glioblastoma MultiformePhase 1/2NCT04977375
Trial of Anti-PD-1 Immunotherapy and Stereotactic Radiation in Patients With Recurrent Glioblastoma
A Phase 1/2 study testing Pembrolizumab, Stereotactic Radiation Therapy and Surgical Resection in people with Glioblastoma Multiforme, run by Chirag G. Patil at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma Multiforme
- What is being tested?
- Pembrolizumab, Stereotactic Radiation Therapy and Surgical Resection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2021to Dec 2028
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Clinical Trial Recruitment Navigator, 310-423-5842, GroupCancerTrialInformation@cshs.org
Stephen Shiao, MD, PhD
About this study
Official title: Phase Ib/II Trial of Anti-PD-1 Immunotherapy and Stereotactic Radiation in Patients With Recurrent Glioblastoma
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
- Conditions
- Glioblastoma Multiforme
- Being tested
- Pembrolizumab, Stereotactic Radiation Therapy, Surgical Resection
- Keywords
- Central Nervous System Tumor, neurosurgery, Brain tumor, spinal cord tumor, surgical resection, glioma, glioblastoma, neuropathology, maximal safe resection, CNS
- Medical subject headings
- Glioblastoma, Central Nervous System Neoplasms, Brain Neoplasms, Spinal Cord Neoplasms, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Pembrolizumab 400mg administered intravenously on Day 1, and then beginning 6 weeks post-surgery, subjects will receive 400 mg pembrolizumab every 6 weeks
Stereotactic Radiation TherapyRadiation
Standard of care stereotactic radiation of 24 grays over 3 days, administered beginning on Day 7
Surgical ResectionProcedure or surgery
Standard of care surgical resection of tumor on Day 10-28
| Study group | Role | What they receive |
|---|---|---|
| Pembrolizumab with stereotactic radiation therapy and surgical resection | Experimental | Not described Receives: Drug: Pembrolizumab; Radiation: Stereotactic Radiation Therapy; Procedure: Surgical Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability measured by the incidence of adverse events, serious adverse events and grade 3 or above treatment related adverse events.
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.
Measured: From start of study treatment until confirmation of disease progression, intolerable toxicities, withdrawal of consent. Assessed up to 2 years.
Overall survival
From start of study treatment until death, loss to follow-up, or withdrawal of consent. Subjects who are lost to survival follow-up will not be replaced, and public records may be accessed to assess Overall Survival.
Measured: From start of study treatment until death, loss to follow-up, or withdrawal of consent. Assessed up to 2 years.
Secondary outcomes (2)
Progression free survival
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.
Measured: From start of study treatment until until confirmation of disease progression, intolerable toxicities, withdrawal of consent. Assessed up to 2 years.
Immune action
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
Measured: At baseline, prior to stereotactic radiation therapy, and prior to surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study start9 Dec 2021
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma MultiformeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chirag G. Patil
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Chirag G. Patil, Cedars-Sinai Medical Center
- Investigators
- Chirag G Patil, MD, MS, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04977375
- Sponsor's protocol ID
- IIT2019-13-Patil-NeoPD1SRS
- Other IDs
- R21CA256421
- Status last verified
- Sep 2026
- First submitted
- 22 Apr 2021
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No