Study: NCT03018288

Intervention type: DRUG
Group type: OTHER
Intervention: Pembrolizumab
Description: Pembrolizumab at 200mg will be administered on day 1 as a 30-minute intravenous (IV) infusion (prior to radiation therapy (RT) every 3 weeks during RT on days 1, 22 and 43. At one year, if participants are doing well, they may continue pembrolizumab for 12 more months alone or in conjunction with heat shock protein peptide complex -96 (HSPPC 96) or placebo vaccine if any is available.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pembrolizumab
Description: Pembrolizumab at 200mg will be administered on day 1 as a 30-minute intravenous (IV) infusion (prior to radiation therapy (RT) every 3 weeks during RT on days 1, 22 and 43. At one year, if participants are doing well, they may continue pembrolizumab for 12 more months alone or in conjunction with heat shock protein peptide complex -96 (HSPPC 96) or placebo vaccine if any is available.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pembrolizumab
Description: Pembrolizumab at 200mg will be administered on day 1 as a 30-minute intravenous (IV) infusion (prior to radiation therapy (RT) every 3 weeks during RT on days 1, 22 and 43. At one year, if participants are doing well, they may continue pembrolizumab for 12 more months alone or in conjunction with heat shock protein peptide complex -96 (HSPPC 96) or placebo vaccine if any is available.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Pembrolizumab
Description: Pembrolizumab at 200mg will be administered on day 1 as a 30-minute intravenous (IV) infusion (prior to radiation therapy (RT) every 3 weeks during RT on days 1, 22 and 43. At one year, if participants are doing well, they may continue pembrolizumab for 12 more months alone or in conjunction with heat shock protein peptide complex -96 (HSPPC 96) or placebo vaccine if any is available.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: HSPPC-96
Description: One week post RT, patients will receive weekly x 4 a dose of heat shock protein peptide complex -96 (HSPPC 96) 0.4mL intradermal vaccine or placebo. HSPPC-96 vaccine or placebo will then be given 21 days after the day 5 dose of temozolomide (TMZ). HSPPC-96 vaccine or placebo vaccine will be given for 6 cycles or until supply runs out. Participants who receive placebo will be matched for number of vaccine injections that were generated by their tumor tissue. At one year, if participants are doing well, they may continue pembrolizumab for 12 more months alone or in conjunction with HSPPC-96 or placebo vaccine if any is available.

Intervention type: DRUG
Group type: OTHER
Intervention: Temozolomide
Description: Temozolomide (TMZ) will be administered on day 1 of radiation therapy (before radiation therapy (RT) treatment) and continue throughout RT at the dose of 75 mg/m\^2. Post RT: The starting TMZ dose will be 150 mg/m\^2/day for cycle 1, days 1-5, with a single dose escalation to 200 mg/m\^2/day (days 29-33) and for all subsequent treatment if no treatment-related adverse events greater than Grade 2 are noted. TMZ will be given for 6 cycles.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Temozolomide
Description: Temozolomide (TMZ) will be administered on day 1 of radiation therapy (before radiation therapy (RT) treatment) and continue throughout RT at the dose of 75 mg/m\^2. Post RT: The starting TMZ dose will be 150 mg/m\^2/day for cycle 1, days 1-5, with a single dose escalation to 200 mg/m\^2/day (days 29-33) and for all subsequent treatment if no treatment-related adverse events greater than Grade 2 are noted. TMZ will be given for 6 cycles.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Temozolomide
Description: Temozolomide (TMZ) will be administered on day 1 of radiation therapy (before radiation therapy (RT) treatment) and continue throughout RT at the dose of 75 mg/m\^2. Post RT: The starting TMZ dose will be 150 mg/m\^2/day for cycle 1, days 1-5, with a single dose escalation to 200 mg/m\^2/day (days 29-33) and for all subsequent treatment if no treatment-related adverse events greater than Grade 2 are noted. TMZ will be given for 6 cycles.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Temozolomide
Description: Temozolomide (TMZ) will be administered on day 1 of radiation therapy (before radiation therapy (RT) treatment) and continue throughout RT at the dose of 75 mg/m\^2. Post RT: The starting TMZ dose will be 150 mg/m\^2/day for cycle 1, days 1-5, with a single dose escalation to 200 mg/m\^2/day (days 29-33) and for all subsequent treatment if no treatment-related adverse events greater than Grade 2 are noted. TMZ will be given for 6 cycles.

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: One week post radiation therapy (RT), participants will receive weekly x 4 a dose of heat shock protein peptide complex -96 (HSPPC 96) 0.4mL intradermal vaccine or placebo. HSPPC-96 vaccine or placebo will then be given 21 days after the day 5 dose of Temozolomide (TMZ). HSPPC-96 vaccine or placebo vaccine will be given for 6 cycles or until supply runs out. Participants who receive placebo will be matched for number of vaccine injections that were generated by their tumor tissue. At one year, if participants are doing well, they may continue pembrolizumab for 12 more months alone or in conjunction with HSPPC-96 or placebo vaccine if any is available.

Intervention type: PROCEDURE
Group type: OTHER
Intervention: Surgery
Description: Tissue for vaccine production and neo-epitope monitoring.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Surgery
Description: Tissue for vaccine production and neo-epitope monitoring.