Pembrolizumab for Astrocytoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Mayo Clinic, Rochester, MN
Astrocytoma+6 More
Pembrolizumab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This phase II trial tests the safety and side effects of efineptakin alfa and pembrolizumab in treating patients with glioblastoma that has come back (recurrent). Efineptakin alfa is an immunotherapy drug that works by helping the immune system fight tumor cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving efineptakin alfa and pembrolizumab may kill more tumor cells in patients with recurrent glioblastoma.

Eligible Conditions

  • Astrocytoma
  • Glioblastoma
  • gliosarcoma
  • High Grade Astrocytic Tumor

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Up to 5 years

Week 12
Changes in absolute lymphocyte counts (ALC)
Year 5
Progression free survival time
Up to 5 years
Incidence of adverse events
Objective response rate (ORR)
Up to 9 months
Overall survival rate

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

Treatment (efineptakin alfa, pembrolizumab)
1 of 1
Experimental Treatment

34 Total Participants · 1 Treatment Group

Primary Treatment: Pembrolizumab · No Placebo Group · Phase 2

Treatment (efineptakin alfa, pembrolizumab)Experimental Group · 3 Interventions: Efineptakin alfa, Pembrolizumab, Biospecimen Collection · Intervention Types: Biological, Biological, Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~2670
Biospecimen Collection
2004
Completed Phase 1
~430

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
Closest Location: Mayo Clinic · Rochester, MN
Photo of jacksonville mayo clinic 1Photo of jacksonville mayo clinic 2Photo of jacksonville mayo clinic 3
1989First Recorded Clinical Trial
8 TrialsResearching Astrocytoma
2172 CompletedClinical Trials

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
12,930 Previous Clinical Trials
41,294,426 Total Patients Enrolled
129 Trials studying Astrocytoma
12,626 Patients Enrolled for Astrocytoma
Mayo ClinicLead Sponsor
2,860 Previous Clinical Trials
3,686,127 Total Patients Enrolled
4 Trials studying Astrocytoma
125 Patients Enrolled for Astrocytoma
Jian L CampianPrincipal InvestigatorMayo Clinic in Rochester

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a WHO Grade IV glioblastoma or WHO Grade IV astrocytoma.
You have previously undergone surgery, radiation, and temozolomide.
You have a platelet count of at least 100,000/mm^3.
Creatinine > 1.5 x ULN OR measured or calculated creatinine clearance (per institutional standard) must be > 45 ml/min (obtained < 15 days prior to registration) AND age > 18 years.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.