NCT04013672

Study of Pembrolizumab Plus SurVaxM for Glioblastoma at First Recurrence

Phase II Study of Pembrolizumab Plus SurVaxM for Glioblastoma at First Recurrence

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: David Peereboom · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to assess the clinical activity of Pembrolizumab and SurVaxM in participants with recurrent glioblastoma.

Detailed description

Primary objective: Assess clinical activity of Pembrolizumab and SurVaxM in participants with recurrent glioblastoma using progression free survival at 6 months (PFS-6). Secondary objective: : Assess safety and tolerability of Pembrolizumab and SurVaxM in participants with recurrent glioblastoma. This is a Phase II study of two arms in participants with recurrent glioblastoma. Arm A will include participants with first recurrence of glioblastoma who have failed prior chemotherapy and radiation but have not received any immunotherapy. Arm B is an exploratory arm of 10 participants who have failed prior anti-PD1 therapy. All patients will receive the study drug combination consisting of SurVaxM and pembrolizumab (PEM) with no randomization, stratification or dose escalation.

Conditions

• Recurrent Glioblastoma

Interventions

Type	Name	Description
DRUG	Pembrolizumab	200 mg IV every 3 weeks
DRUG	SurVaxM	500 mcg per dose, dosed every two weeks for 4 doses and then every 3 months
DRUG	Sargramostim	100 mcg per dose, dosed every two weeks for 4 doses and then every 3 months
DRUG	Montanide ISA 51	1 ml per dose dosed every two weeks for 4 doses and then every 3 months

Timeline

• Start date: 2020-03-19
• Primary completion: 2021-08-16
• Completion: 2022-02-16
• First posted: 2019-07-10
• Last updated: 2024-08-28
• Results posted: 2024-08-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study