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PD-1 Inhibitor

Pembrolizumab + Stereotactic Radiation for Glioblastoma

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
Must not have
Immunodeficiency diagnosis or receiving chronic systemic steroid therapy (exceeding 10 mg daily of prednisone) or any other form of immunosuppressive therapy
Contraindication to additional radiation
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
No Placebo-Only Group

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.
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.
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
Select...
I have been diagnosed with Grade IV Glioblastoma Multiforme.
Select...
I am fully active or can carry out light work.
Select...
My GBM has come back and I am scheduled for surgery and more radiation.
Select...
I am 18 years old or older.
Select...
My tumor is smaller than 6 cm.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am not on high-dose steroids or any drugs that weaken my immune system.
Select...
I cannot receive more radiation treatment.
Select...
I have been treated with drugs targeting immune checkpoints.

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.
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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
Immune action
Progression free survival

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999
64%
Radiation skin injury
63%
Stomatitis
58%
Anaemia
56%
Nausea
48%
Dry mouth
45%
Constipation
45%
Weight decreased
44%
Dysphagia
42%
Neutrophil count decreased
33%
Dysgeusia
33%
Vomiting
32%
Fatigue
31%
White blood cell count decreased
28%
Hypomagnesaemia
26%
Decreased appetite
25%
Hypothyroidism
25%
Hypokalaemia
24%
Lymphocyte count decreased
24%
Platelet count decreased
23%
Oropharyngeal pain
23%
Blood creatinine increased
22%
Diarrhoea
22%
Odynophagia
20%
Hypoacusis
20%
Alanine aminotransferase increased
20%
Hyponatraemia
19%
Tinnitus
19%
Oral candidiasis
19%
Asthenia
16%
Pyrexia
16%
Cough
15%
Aspartate aminotransferase increased
15%
Rash
14%
Insomnia
13%
Acute kidney injury
13%
Pharyngeal inflammation
13%
Pruritus
12%
Dysphonia
12%
Gamma-glutamyltransferase increased
11%
Pneumonia
11%
Dehydration
10%
Hyperthyroidism
10%
Hypoalbuminaemia
10%
Hypocalcaemia
10%
Headache
10%
Productive cough
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Urinary tract infection
7%
Ear pain
7%
Localised oedema
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Sepsis
3%
Pneumonia aspiration
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Clostridium difficile colitis
1%
Systemic infection
1%
Cardiac arrest
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo + CRT Followed by Placebo
Pembrolizumab + CRT Followed by Pembrolizumab

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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 3
~2810
Surgical Resection
2018
Completed Phase 2
~420

Find a Location

Who is running the clinical trial?

Chirag G. PatilLead Sponsor
Merck Sharp & Dohme LLCIndustry Sponsor
4,005 Previous Clinical Trials
5,185,428 Total Patients Enrolled
31 Trials studying Glioblastoma
3,702 Patients Enrolled for Glioblastoma
National Cancer Institute (NCI)NIH
13,917 Previous Clinical Trials
41,014,443 Total Patients Enrolled
330 Trials studying Glioblastoma
23,366 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
~3 spots leftby Dec 2025
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