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Immunotherapy

Efineptakin Alfa + Pembrolizumab for Glioblastoma

Phase 2

Recruiting

Led By Jian L. Campian, M.D., Ph.D.

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial tests the safety of a new immunotherapy drug, efineptakin alfa, in combination with pembrolizumab, to treat patients with recurrent glioblastoma.

Who is the study for?

Adults with recurrent Grade IV glioblastoma, previously treated with surgery, radiation, and temozolomide. Participants must have good organ function, be willing to provide tissue samples, and agree to use contraception if they can have children. Excluded are those on other trials, pregnant or nursing individuals, people needing high-dose steroids or with severe diseases that could interfere with the trial.Check my eligibility

What is being tested?

The trial is testing efineptakin alfa combined with pembrolizumab in patients whose glioblastoma has returned. Efineptakin alfa boosts the immune system's ability to fight cancer cells while pembrolizumab may prevent tumor growth by helping the immune system attack cancer.See study design

What are the potential side effects?

Potential side effects include reactions related to boosting the immune system which might lead to inflammation in various organs. There could also be infusion-related reactions and general symptoms like fatigue.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall survival rate

Secondary outcome measures

Changes in absolute lymphocyte counts (ALC)

Incidence of adverse events

Objective response rate (ORR)

+1 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183

21%

Fatigue

13%

Nausea

11%

Back pain

Shortness of Breath

Anemia

Abdominal pain

Diarrhea

Pneumonia

Kidney Injury and/or Infection

Dyspnea

Weight Loss

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Pleural effusion

Atrial fibrillation with rapid ventricular response

Thrombocytopenia

Respiratory failure

Skin rash

colitis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (efineptakin alfa, pembrolizumab)Experimental Treatment3 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 2

~1730

Pembrolizumab

2017

Completed Phase 2

~2010

Do I qualify?Apply below to find out

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Who is running the clinical trial?

NeoImmune TechUNKNOWN

3 Previous Clinical Trials

208 Total Patients Enrolled

Merck Sharp & Dohme LLCIndustry Sponsor

3,888 Previous Clinical Trials

5,054,970 Total Patients Enrolled

3 Trials studying Gliosarcoma

118 Patients Enrolled for Gliosarcoma

National Cancer Institute (NCI)NIH

13,660 Previous Clinical Trials

40,924,487 Total Patients Enrolled

142 Trials studying Gliosarcoma

10,791 Patients Enrolled for Gliosarcoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients currently being accepted into this clinical trial?

"The clinicaltrials.gov website suggests that this particular trial is not currently recruiting patients for the study. The initial posting was on November 15th, 2022 and there have been no updates since September 22nd of the same year. Although this study isn't looking for more participants, there are 1,466 other trials currently underway that are searching for volunteers."

Answered by AI

Has Pembrolizumab received regulatory approval from the FDA?

"Pembrolizumab is still in Phase 2 of clinical trials, so there is not yet definitive evidence supporting its efficacy. However, there is data suggesting that it is safe, which gives it a score of 2."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Efineptakin Alfa and Pembrolizumab for the Treatment of Recurrent Glioblastoma

2023. "Efineptakin Alfa and Pembrolizumab for the Treatment of Recurrent Glioblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05465954.