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Trial of Anti-PD-1 Immunotherapy and Stereotactic Radiation in Patients With Recurrent Glioblastoma

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ClinicalTrials.gov Identifier: NCT04977375
Recruitment Status : Not yet recruiting
First Posted : July 26, 2021
Last Update Posted : July 26, 2021
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Chirag G. Patil, Cedars-Sinai Medical Center

Tracking Information
First Submitted Date  ICMJE April 22, 2021
First Posted Date  ICMJE July 26, 2021
Last Update Posted Date July 26, 2021
Estimated Study Start Date  ICMJE July 2021
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2021)
  • 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 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.
  • Overall survival [ Time Frame: From start of study treatment until death, loss to follow-up, or withdrawal of consent. Assessed up to 2 years. ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2021)
  • 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. ]
    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.
  • Immune action [ Time Frame: At baseline, prior to stereotactic radiation therapy, and prior to surgery. ]
    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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of Anti-PD-1 Immunotherapy and Stereotactic Radiation in Patients With Recurrent Glioblastoma
Official Title  ICMJE Phase Ib/II Trial of Anti-PD-1 Immunotherapy and Stereotactic Radiation in Patients With Recurrent Glioblastoma
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glioblastoma Multiforme
Intervention  ICMJE
  • Drug: Pembrolizumab
    Pembrolizumab 400mg administered intravenously on Day 1, and then beginning 6 weeks post-surgery, subjects will receive 400 mg pembrolizumab every 6 weeks
  • Radiation: Stereotactic Radiation Therapy
    Standard of care stereotactic radiation of 24 grays over 3 days, administered beginning on Day 7
  • Procedure: Surgical Resection
    Standard of care surgical resection of tumor on Day 10-28
Study Arms  ICMJE Experimental: Pembrolizumab with stereotactic radiation therapy and surgical resection
Interventions:
  • Drug: Pembrolizumab
  • Radiation: Stereotactic Radiation Therapy
  • Procedure: Surgical Resection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 22, 2021)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2024
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Karen Kearns 3109670692 Karen.Kearns@cshs.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04977375
Other Study ID Numbers  ICMJE IIT2019-13-Patil-NeoPD1SRS
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Chirag G. Patil, Cedars-Sinai Medical Center
Study Sponsor  ICMJE Chirag G. Patil
Collaborators  ICMJE Merck Sharp & Dohme Corp.
Investigators  ICMJE
Principal Investigator: Chirag G Patil, MD, MS Cedars-Sinai Medical Center
PRS Account Cedars-Sinai Medical Center
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP