Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: An International, Randomized, Double-Blind, Controlled Study of Rindopepimut/GM-CSF With Adjuvant Temozolomide in Patients With Newly Diagnosed, Surgically Resected, EGFRvIII-positive Glioblastoma
Brief Summary: This 2-arm, randomized, phase III study will investigate the efficacy and safety of the addition of rindopepimut (an experimental cancer vaccine that may act to promote anti-cancer effects in patients who have tumors that express the EGFRvIII protein) to the current standard of care (temozolomide) in patients with recently diagnosed glioblastoma, a type of brain cancer.

All patients will be administered temozolomide, the standard treatment for glioblastoma. Half the patients will be randomly assigned to receive rindopepimut and half the patients will be randomly assigned to receive a control called keyhole limpet hemocyanin.

Patients will be treated in a blinded fashion (neither the patient or the doctor will know which arm of the study the patient is on). Patients will be treated until disease progression or intolerance to therapy and all patients will be followed for survival.


Options:
A: Arm Label: Conventional adjuvant TMZ; Type: ACTIVE_COMPARATOR; Interventions: Drug: Concurrent temozolomide, Radiation: Concurrent radiation therapy, Drug: 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle | Arm Label: Dose-dense adjuvant TMZ; Type: EXPERIMENTAL; Interventions: Drug: Concurrent temozolomide, Radiation: Concurrent radiation therapy, Drug: 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle | Arm Label: No adjuvant TMZ (not randomized ); Type: OTHER; Interventions: Drug: Concurrent temozolomide, Radiation: Concurrent radiation therapy | Intervention Type: DRUG; Name: Concurrent temozolomide; Assigned to Arm(s): Conventional adjuvant TMZ, Dose-dense adjuvant TMZ, No adjuvant TMZ (not randomized ) | Intervention Type: RADIATION; Name: Concurrent radiation therapy; Assigned to Arm(s): Conventional adjuvant TMZ, Dose-dense adjuvant TMZ, No adjuvant TMZ (not randomized ) | Intervention Type: DRUG; Name: 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle; Assigned to Arm(s): Conventional adjuvant TMZ | Intervention Type: DRUG; Name: 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle; Assigned to Arm(s): Dose-dense adjuvant TMZ
B: Arm Label: Arm I (radiation therapy, temozolomide, placebo); Type: ACTIVE_COMPARATOR; Interventions: Radiation: 3-Dimensional Conformal Radiation Therapy, Radiation: Intensity-Modulated Radiation Therapy, Other: Laboratory Biomarker Analysis, Other: Placebo, Other: Quality-of-Life Assessment, Drug: Temozolomide | Arm Label: Arm II (radiation therapy, temozolomide, bevacizumab); Type: EXPERIMENTAL; Interventions: Radiation: 3-Dimensional Conformal Radiation Therapy, Biological: Bevacizumab, Radiation: Intensity-Modulated Radiation Therapy, Other: Laboratory Biomarker Analysis, Other: Quality-of-Life Assessment, Drug: Temozolomide | Intervention Type: RADIATION; Name: 3-Dimensional Conformal Radiation Therapy; Assigned to Arm(s): Arm I (radiation therapy, temozolomide, placebo), Arm II (radiation therapy, temozolomide, bevacizumab) | Intervention Type: BIOLOGICAL; Name: Bevacizumab; Assigned to Arm(s): Arm II (radiation therapy, temozolomide, bevacizumab) | Intervention Type: RADIATION; Name: Intensity-Modulated Radiation Therapy; Assigned to Arm(s): Arm I (radiation therapy, temozolomide, placebo), Arm II (radiation therapy, temozolomide, bevacizumab) | Intervention Type: OTHER; Name: Laboratory Biomarker Analysis; Assigned to Arm(s): Arm I (radiation therapy, temozolomide, placebo), Arm II (radiation therapy, temozolomide, bevacizumab) | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Arm I (radiation therapy, temozolomide, placebo) | Intervention Type: OTHER; Name: Quality-of-Life Assessment; Assigned to Arm(s): Arm I (radiation therapy, temozolomide, placebo), Arm II (radiation therapy, temozolomide, bevacizumab) | Intervention Type: DRUG; Name: Temozolomide; Assigned to Arm(s): Arm I (radiation therapy, temozolomide, placebo), Arm II (radiation therapy, temozolomide, bevacizumab)
C: Arm Label: Rindopepimut/GM-CSF plus Temozolomide; Type: EXPERIMENTAL; Interventions: Drug: Rindopepimut (CDX-110) with GM-CSF, Drug: Temozolomide | Arm Label: KLH plus Temozolomide; Type: ACTIVE_COMPARATOR; Interventions: Drug: Temozolomide, Drug: KLH | Intervention Type: DRUG; Name: Rindopepimut (CDX-110) with GM-CSF; Assigned to Arm(s): Rindopepimut/GM-CSF plus Temozolomide | Intervention Type: DRUG; Name: Temozolomide; Assigned to Arm(s): KLH plus Temozolomide, Rindopepimut/GM-CSF plus Temozolomide | Intervention Type: DRUG; Name: KLH; Assigned to Arm(s): KLH plus Temozolomide
D: Arm Label: Vaccination; Type: EXPERIMENTAL; Interventions: Biological: autologous dendritic cells | Intervention Type: BIOLOGICAL; Name: autologous dendritic cells; Assigned to Arm(s): Vaccination

Answer: C