Efineptakin Alfa and Pembrolizumab for the Treatment of Recurrent Glioblastoma

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT05465954
Phase
PHASE2
Status
Recruiting
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Conditions

  • High Grade Astrocytic Tumor
  • Recurrent Glioblastoma, IDH-Wildtype
  • Recurrent Gliosarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Correlative studies
  • Efineptakin alfa — BIOLOGICAL
    Given IM
  • Pembrolizumab — BIOLOGICAL
    Given IV
  • Biopsy — PROCEDURE
    Undergo tumor biopsy

Study Details

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.

Key Dates

Start date
Jan 24, 2023
Status verified
Jan 2026
Primary completion
Oct 15, 2027
Completion
Oct 15, 2028

Study Design

Enrollment
54 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (efineptakin alfa, pembrolizumab)
    BEFORE SURGERY: Patients receive pembrolizumab IV over 30 minutes and efineptakin alfa IM on day 1. Patients then undergo surgery 1 week later. AFTER SURGERY: Patients receive pembrolizumab IV over 30 minutes and efineptakin alfa IM on day 1 of each cycle. Cycles repeat every 42 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo MRI or CT at baseline and on study. Patients also undergo tumor biopsy at baseline and blood sample collection on study.

Primary Outcome Measure

Overall survival rate [ Time Frame: Up to 9 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55905
Clinical Trials Referral Office
[email protected]
855-776-0015
Jian L. Campian, MD, PhD (PRINCIPAL_INVESTIGATOR)

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