Pembrolizumab (MK-3475) in Patients With Recurrent Malignant Glioma With a Hypermutator Phenotype (NCT02658279)

🧪 Interventions in This Study

• Pembrolizumab (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Histologically confirmed diagnosis of malignant glioma by enrolling institution:
2. WHO grade IV tumors (GBM or its variants)
3. WHO grade III anaplastic astrocytoma or oligodendroglial tumors or
4. WHO grade II gliomas, if MRI shows contrast enhancement
5. Tumor recurrence after previous treatment, which must have included at least radiation therapy and one cytotoxic chemotherapy. There is no limit on number of previous recurrences or lines of treatment.
6. Previously obtained tumor sample exhibits a hypermutator phenotype. For the purposes of this trial, a hypermutator phenotype is defined as tumors harboring 30 mutations (non-synonymous somatic point or indel mutations) detected by the MSK-IMPACT or comparable next generation sequencing performed in a CLIA environment. Contingent to approval by the MSK Principal Investigator, patients with less than 30 mutations may be eligible if they display a mutation in a mismatch repair gene or other mutations in genes known to be associated with hypermutator phenotypes or microsatellite instability, including but not limited to MLH1, MSH2, MSH6, PMS2, POLE, POLD as determined by validated methods, or if microsatellite instability is present, as identified by polymerase chain reaction (PCR) or other validated methods. \*Note: The MSK-IMPACT (Integrated Mutation Profiling for Actionable Cancer Targets) assay is a next generation genomic profiling performed on formalin-fixed, paraffin-embedded (FFPE) tumor tissue in a CLIA-certified Molecular Diagnostic Service laboratory. IMPACT provides full exon coverage of 410 cancer related genes and can detect base substitutions, small indels, copy number alterations and selected gene re-rearrangements. In some cases, additional assays such as Sanger Sequencing or fluorescence in situ hybridization (FISH) may be required to confirm specific results detected on IMPACT. Patients at MSK will have this assay to determine eligibility. Use of other validated next-generation sequencing techniques for eligibility may be considered, provided they are performed in a CLIA-certified laboratory and are approved by the MSK Principal Investigator.
7. Be willing and able to provide written informed consent/assent for the trial.
8. Be ≥ 18 years of age on day of signing informed consent.
9. An interval of ≥ 12 weeks from the end of prior radiation therapy is required unless there is either: i) histopathologic confirmation of recurrent tumor, or ii) new enhancement on MRI outside of the radiation treatment field
10. An interval of ≥ 4 weeks after the last administration of any investigational agent or any other treatment prior to first dose of pembrolizumab
11. Must have recovered (i.e., ≤ Grade 1 or at baseline) from adverse events of any previous treatment. Note: Surgical resection for recurrent tumor prior to enrollment is allowed.
12. Karnofsky performance status of ≥ 70

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (16 Sites)

• University of California, Los Angeles — Los Angeles, California
• University of California San Francisco — San Francisco, California
• University of Miami — Miami, Florida
• Massachusetts General Hospital — Boston, Massachusetts
• Brigham and Women's Hospital — Boston, Massachusetts
• Dana Farber Cancer Institute — Boston, Massachusetts
• Memorial Sloan Kettering Cancer Center — Basking Ridge, New Jersey
• Memorial Sloan Kettering Monmouth — Middletown, New Jersey
• Memorial Sloan Kettering Bergen — Montvale, New Jersey
• Memorial Sloan Kettering Commack — Commack, New York
• Memorial Sloan Kettering Westchester — East White Plains, New York
• Memorial Sloan Kettering Cancer Center — New York, New York
• Memorial Sloan Kettering Nassau — Uniondale, New York
• Cleveland Clinic — Cleveland, Ohio
• Md Anderson Cancer Center — Houston, Texas
• University of Utah — Salt Lake City, Utah

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Glioma

• All-Trans Retinoic Acid (ATRA) Plus PD-1 Inhibition in Recurrent IDH-Mutant Glioma — Philadelphia, Pennsylvania
• Abemaciclib Neuropharmacokinetics of Diffuse Midline Glioma Using Intratumoral Microdialysis — Bethesda, Maryland
• Evaluation of Hippocampal-Avoidance Using Proton Therapy in Low-Grade Glioma — Rochester, Minnesota
• Hyperpolarized 13C-pyruvate Metabolic MRI With Infiltrating Gliomas — Baltimore, Maryland
• Medication Combinations of Dasatinib, Quercetin, Fisetin, Temozolomide, LMP744, and Autologous TLPO Vaccine for the Treatment of Previously Treated Glioma With Residual Disease — Rochester, Minnesota

Explore by condition: All Glioma clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Review the official NIH record below to find the coordinating site.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.