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Phase 2 Study of Durvalumab (MEDI4736) in Patients With Glioblastoma

NCT02336165 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2022-10-12

Study results available
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Summary

This is an ongoing Phase 2, open-label, multicenter, non-randomized study of MEDI4736 (durvalumab) in subjects with glioblastoma (GBM) enrolled into 5 non-comparative cohorts. Primary study objectives, which vary by cohort due to differences in subject populations, include evaluation of the clinical efficacy as measured by the overall survival (OS) rate at 12 months (Cohort A), progression-free survival (PFS) at 6 months (Cohorts B, B2, and B3), and OS at 6 months (Cohort C). For all cohorts, secondary objectives include evaluation of the safety/tolerability and clinical efficacy of study treatment, and exploratory objectives include evaluation of the neurologic function and correlative biomarkers.

Conditions

Interventions

DRUG

Durvalumab

Durvalumab is administered as an IV infusion over 60 ± 5 minutes Q2W.

RADIATION

Standard radiotherapy

Focal radiotherapy is administered at 2 Gy given daily 5 days per week for a total of 60 Gy over 30 fractions per local institutional guidelines or local prescribing information. On days when radiotherapy and durvalumab overlap, radiotherapy is administered first followed by durvalumab.

BIOLOGICAL

Bevacizumab

Bevacizumab is administered as an IV infusion (per local prescribing information) Q2W. When durvalumab and bevacizumab are administered together (i.e., Cohorts B2, B3, and C), durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused.

Sponsors & Collaborators

  • MedImmune LLC

    collaborator INDUSTRY

  • Cancer Research Institute, New York City

    collaborator OTHER

  • Cure Brain Cancer Foundation, Australia

    collaborator UNKNOWN

  • Ludwig Institute for Cancer Research

    lead OTHER

Principal Investigators

  • David A. Reardon, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-26
Primary Completion
2018-11-30
Completion
2021-07-06
FDA Drug
Yes

Countries

  • United States
  • Australia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02336165 on ClinicalTrials.gov