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PD-1 Inhibitor

Pembrolizumab + Stereotactic Radiation for Glioblastoma

Q: What maladies are typically addressed with the use of Pembrolizumab?

<p>Pembrolizumab is used to treat various types of <a href="https://www.withpower.com/clinical-trials/cancer">cancer</a>, such as unresectable <a href="https://www.withpower.com/clinical-trials/melanoma">melanoma</a> and microsatellite instability high. It can also be prescribed if chemotherapy has been unsuccessful in treating disease progression.</p>

Phase 1 & 2

Recruiting

Led By Chirag G Patil, MD, MS

Research Sponsored by Chirag G. Patil

Eligibility Criteria Checklist

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

Must have

Confirmed histologic diagnosis of WHO Grade IV, Glioblastoma Multiforme

ECOG performance status of 0-1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from start of study treatment until death, loss to follow-up, or withdrawal of consent. assessed up to 2 years.

Awards & highlights

Study Summary

This trial is testing if a new combination of drugs and radiation therapy can improve outcomes for people with recurrent glioblastoma.

Who is the study for?

This trial is for adults over 18 with recurrent glioblastoma, a type of brain cancer. Participants must be in good physical condition (ECOG status 0-1), have acceptable lab results, and their tumor should be smaller than 6 cm. They should also be scheduled for standard surgery to remove the tumor.Check my eligibility

What is being tested?

The study tests if combining pembrolizumab (an immunotherapy drug) with stereotactic radiation before surgical removal of the tumor is safe and feasible without delaying surgery. It also looks at how long patients live after treatment and examines immune responses within the tumor.See study design

What are the potential side effects?

Pembrolizumab may cause immune system-related side effects such as inflammation in various organs, skin reactions, fatigue, or flu-like symptoms. Stereotactic radiation could lead to headaches, nausea, hair loss at the treatment site or swelling.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with Grade IV Glioblastoma Multiforme.

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I am fully active or can carry out light work.

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My GBM has come back and I am scheduled for surgery and more radiation.

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I am 18 years old or older.

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My tumor is smaller than 6 cm.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from start of study treatment until death, loss to follow-up, or withdrawal of consent. assessed up to 2 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from start of study treatment until death, loss to follow-up, or withdrawal of consent. assessed up to 2 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of study treatment until death, loss to follow-up, or withdrawal of consent. assessed up to 2 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

Safety and tolerability measured by the incidence of adverse events, serious adverse events and grade 3 or above treatment related adverse events.

Secondary outcome measures

Immune action

Progression free survival

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: Pembrolizumab with stereotactic radiation therapy and surgical resectionExperimental Treatment3 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

Surgical Resection

2018

Completed Phase 2

~420

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Chirag G. PatilLead Sponsor

Merck Sharp & Dohme LLCIndustry Sponsor

3,892 Previous Clinical Trials

5,060,661 Total Patients Enrolled

30 Trials studying Glioblastoma

3,041 Patients Enrolled for Glioblastoma

National Cancer Institute (NCI)NIH

13,665 Previous Clinical Trials

40,925,844 Total Patients Enrolled

322 Trials studying Glioblastoma

23,105 Patients Enrolled for Glioblastoma

Media Library

Pembrolizumab (PD-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04977375 — Phase 1 & 2

Glioblastoma Research Study Groups: Pembrolizumab with stereotactic radiation therapy and surgical resection

Glioblastoma Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT04977375 — Phase 1 & 2

Pembrolizumab (PD-1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04977375 — Phase 1 & 2

Frequently Asked Questions

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

What maladies are typically addressed with the use of Pembrolizumab?

"Pembrolizumab is used to treat various types of cancer, such as unresectable melanoma and microsatellite instability high. It can also be prescribed if chemotherapy has been unsuccessful in treating disease progression."

Answered by AI

Are there any antecedent investigations related to the use of Pembrolizumab?

"Currently, there are 961 studies ongoing for Pembrolizumab. 122 of those active trials have advanced to Phase 3 testing, and 35731 different locations worldwide are conducting research on this medication. Though the majority of these clinical sites are in Houston, Texas, many other medical centres around the world contribute data to support this drug's efficacy and safety."

Answered by AI

What is the capacity of this clinical experiment in terms of participants?

"At this juncture, recruitment for this medical experiment has concluded. It was initially advertised on December 9th 2021 and the information was last modified October 17th 2022. If you are seeking additional trials, there are 442 studies recruiting persons with glioblastoma and an additional 961 research projects deemed suitable for pembrolizumab therapy currently enrolling patients."

Answered by AI

Is it still possible for individuals to participate in this research?

"As evidenced on clinicaltrials.gov, this medical trial is not currently recruiting patients; the last edit to the study was posted October 17th 2022. Although there are no current openings for participation in this particular investigation, over 1400 other experiments remain open right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Trial of Anti-PD-1 Immunotherapy and Stereotactic Radiation in Patients With Recurrent Glioblastoma

Chirag G. Patil 2021. "Trial of Anti-PD-1 Immunotherapy and Stereotactic Radiation in Patients With Recurrent Glioblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04977375.

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