OncoMatch/Clinical Trials/NCT02287428
Personalized NeoAntigen Cancer Vaccine w RT Plus Pembrolizumab for Patients With Newly Diagnosed GBM
Is NCT02287428 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments for glioblastoma.
Treatment: Personalized NeoAntigen Peptides · Pembrolizumab · Temozolomide · Temozolomide · Poly-ICLC — This research study is studying a new type of vaccine as a possible treatment for patients with glioblastoma. This research study is a Phase I clinical trial, which tests the safety of an investigational intervention and also tries to define the appropriate dose of the intervention to use for further studies. "Investigational" means that the intervention is being studied and that research doctors are trying to find more about it. It also means that the FDA (U.S. Food and Drug Administration) has not approved the Personalized NeoAntigen Cancer Vaccine for any use in patients, including people with glioblastoma. The purpose of the initial study cohort (Cohort 1) is to determine if it is possible to make and administer safely a vaccine against glioblastoma by using information gained from specific characteristics of the participants tumor. It is known that glioblastomas have mutations (changes in genetic material) that are specific to an individual patient's tumor. These mutations can cause the tumor cells to produce proteins that appear very different from the body's own cells. It is possible that these proteins used in a vaccine may induce strong immune responses, which may help the body fight any tumor cells that could cause the glioblastoma to come back in the future. Three additional cohorts (1a, 1b, \& 1c) were added to the study following completion of accrual to the original study cohort (cohort 1). Each new cohort receives NeoVax and radiation therapy as administered to cohort 1 and will also receive pembrolizumab: cohort 1a patients will start pembrolizumab w/in 2 weeks after start of RT, and continue every 3 weeks for up to 2 years; cohort 1b patients will start pembrolizumab 2-4 weeks after completion of NeoVax priming, and continue every 3 weeks for up to 2 years; cohort 1c patients will receive a single dose of pembrolizumab administered within 2 weeks after start of RT, re-start 2-4 weeks after completion of NeoVax priming, and continue every 3 weeks for up to 2 years. The rationale for adding these new cohorts is: 1) to assess the safety and feasibility of NeoVax when administered with pembrolizumab; and 2) to determine if the timing of anti-PD-1 administration impacts the immunogenicity of NeoVax. An additional sub-study cohort (1d) is being added for patients whose tumor is MGMT-methylated. Cohort 1d will enroll patients with tumors for which the MGMT status is methylated or partially methylated; patients on cohort 1d will receive standard daily temozolomide during radiation and as adjuvant therapy for up to six cycles following completion of radiation therapy. The rationale for adding cohort 1d is to determine the safety and feasibility of NeoVax when administered with pembrolizumab and temozolomide.
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Biomarker criteria
Required: MGMT promoter methylation (testing required; no eligibility threshold specified)
MGMT promoter methylation status determined by an institutional CLIA-approved laboratory using a methylation specific PCR assay
Allowed: IDH1 mutation
patients with IDH-mutated tumors will also continue to be eligible for trial
Disease stage
Required: Stage IV (WHO)
Grade: IV (WHO)
WHO grade IV glioblastoma or variants
Prior therapy
Must have received: surgery
patient received no prior therapy other than surgery
Cannot have received: stereotactic biopsy
Stereotactic biopsy (without further resection)
Cannot have received: any additional treatment for glioblastoma aside from surgical resection and conventional radiotherapy (Cohort 1) and pembrolizumab (cohorts 1a, 1b and 1c) and temozolomide (cohort 1d) (temozolomide, stereotactic radiosurgery, Gliadel (carmustine; BCNU) wafers, any other intratumoral or intracavitary treatment, brachytherapy, Novo-Tumor Treating Fields (Optune), investigational therapeutic agents)
Exception: Cohort 1d participants may have already initiated or completed their RT with concomitant TMZ, and may have initiated their adjuvant TMZ at the time of study entry as long as they do not have evidence of progressive disease and have undergone a leukopheresis or blood draw with adequate mononuclear cell collection.
Participants who have received or plan to receive any additional treatment for glioblastoma aside from surgical resection and conventional radiotherapy (Cohort 1) and pembrolizumab (cohorts 1a, 1b and 1c) and temozolomide (cohort 1d), including - but not limited to - temozolomide (cohorts 1, 1a, 1b and 1c), stereotactic radiosurgery, placement of Gliadel (carmustine; BCNU) wafers, any other intratumoral or intracavitary treatment, brachytherapy, Novo-Tumor Treating Fields (Optune), or investigational therapeutic agents.
Cannot have received: anti-cancer monoclonal antibody
Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1
Cannot have received: chemotherapy, targeted small molecule therapy, or radiation therapy
Exception: Subjects with ≤ Grade 2 neuropathy are an exception; Cohort 1d participants may have already received their radiation therapy with concomitant temozolomide, and may have initiated their adjuvant temozolomide, at the time of study entry as long as they do not have evidence of progressive disease and have undergone a leukopheresis or blood draw with adequate mononuclear cell collection.
Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., less than or equal to Grade 1 or at baseline) from adverse events due to a previously administered agent.
Cannot have received: anti-PD-1 therapy
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
Lab requirements
Blood counts
ANC: ≥ 1,000 /mcl; Platelets: ≥ 100,000 /mcl; Hemoglobin: ≥ 9 gm/dl or ≥5.6 mmol/L without transfusion or EPO dependency (within 7 days of assessment)
Kidney function
Serum creatinine: ≤ 1.5 X institutional ULN OR Measured or calculated creatinine clearance ≥60 mL/min for subject with creatinine levels > 1.5 X institutional ULN
Liver function
Total bilirubin: ≤ 1.5 X institutional ULN (or ≤ 3.0 X institutional ULN for Gilbert's Syndrome) OR Direct bilirubin ≤ institutional ULN for subjects with total bilirubin levels > 1.5 institutional ULN; AST (SGOT) and ALT (SGPT): ≤ 2.5 X institutional ULN (or ≤ 5.0 X institutional ULN for Gilbert's Syndrome); INR or prothrombin time: ≤ 1.5 times institutional ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants; Activated partial thromboplastin time (aPTT): ≤ 1.5 X institutional ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
Normal hematologic, renal and hepatic function as defined below: ANC: ≥ 1,000 /mcl; Platelets: ≥ 100,000 /mcl; Hemoglobin: ≥ 9 gm/dl or ≥5.6 mmol/L without transfusion or EPO dependency (within 7 days of assessment); INR or prothrombin time: ≤ 1.5 times institutional ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants; Activated partial thromboplastin time (aPTT): ≤ 1.5 X institutional ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants; Serum creatinine: ≤ 1.5 X institutional ULN OR Measured or calculated creatinine clearance ≥60 mL/min for subject with creatinine levels > 1.5 X institutional ULN; Total bilirubin: ≤ 1.5 X institutional ULN (or ≤ 3.0 X institutional ULN for Gilbert's Syndrome) OR Direct bilirubin ≤ institutional ULN for subjects with total bilirubin levels > 1.5 institutional ULN; AST (SGOT) and ALT (SGPT): ≤ 2.5 X institutional ULN (or ≤ 5.0 X institutional ULN for Gilbert's Syndrome)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Massachusetts General Hospital · Boston, Massachusetts
- Dana Farber Cancer Institute · Boston, Massachusetts
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