Efineptakin Alfa and Pembrolizumab for the Treatment of Recurrent Glioblastoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
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.
Eligibility criteria
Qualifiers
Age >= 18 years
Tissue-confirmed progressive or recurrent World Health Organization (WHO) Grade IV IDH wildtype glioblastoma (including molecular glioblastoma and gliosarcoma)
Previously treated with maximum feasible resection or biopsy, radiation, and temozolomide
Have an enhancing mass on magnetic resonance imaging (MRI) amenable to resection or biopsy of the tumor (as determined by the neurosurgeon pre-operatively) and histological diagnosis of glioblastoma from a prior biopsy or surgery
Disqualifiers
Pregnant persons
Nursing persons
Persons of childbearing potential or able to father a child who are unwilling to employ adequate contraception
Signs or symptoms of life-threatening raised intracranial pressure: as determined by the treating neurosurgeon, including severe headache, nausea, decreasing level of consciousness, precluding 4-7-day delay in scheduling neurosurgery (i.e., immediate surgery is indicated, and patient cannot wait).
Trial design
Treatments tested in this trial
- Biospecimen Collection
- Efineptakin alfa
- Pembrolizumab
- Biopsy
Treatment groups
54 Participants
are divided into 1 treatment groupSponsors and collaborators
Mayo Clinic
Lead sponsor
NeoImmuneTech
Collaborator
Merck Sharp & Dohme LLC
Collaborator
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov