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SBRT + Pembrolizumab for Head and Neck Cancer (KEYSTROKE Trial)

Q: How hazardous is the use of Pembrolizumab to human health?

Our team at Power gave Pembrolizumab a score of 2 out of 3 due to the fact that it is currently in phase two of testing, meaning there is some data indicating safety but none validating efficacy.

Q: How many people are actively involved in this experiment?

This research requires 102 qualified participants. If you meet the criteria, you can enroll at either University of <a href="https://www.withpower.com/clinical-trials/texas">Texas</a> Southwestern in Dallas or the University of <a href="https://www.withpower.com/clinical-trials/arizona">Arizona</a> <a href="https://www.withpower.com/clinical-trials/cancer">Cancer</a> Center - North Campus in Tucson.

Q: What numbers of healthcare facilities are presently participating in this experiment?

This clinical trial has 17 sites, including the University of <a href="https://www.withpower.com/clinical-trials/texas">Texas</a> Southwestern in Dallas, University of <a href="https://www.withpower.com/clinical-trials/arizona">Arizona</a> <a href="https://www.withpower.com/clinical-trials/cancer">Cancer</a> Center - North Campus in Tucson and <a href="https://www.withpower.com/clinical-trials/ohio">Ohio</a> State University in Columbus.

Q: Is there still availability for participants in this experiment?

Affirmative. Information hosted on clinicaltrials.gov confirms that this trial is presently enrolling individuals; it was first posted to the website on November 14th 2018 and last updated July 18th 2022. The study necessitates 102 participants across 17 different medical centres.

Q: What conditions can Pembrolizumab typically be administered to address?

Patients suffering from malignant neoplasms, unresectable <a href="https://www.withpower.com/clinical-trials/melanoma">melanoma</a>, and microsatellite instability high can be offered relief through pembrolizumab.

Q: Has Pembrolizumab been studied in past clinical trials?

Pembrolizumab was first investigated at City of Hope in 2010, and since then there are 260 completed clinical trials. Currently, 961 medical studies that include this medication are actively recruiting patients - with many based out of Dallas, <a href="https://www.withpower.com/clinical-trials/texas">Texas</a>.

Phase 2

Recruiting

Led By Stuart J. Wong, MD

Research Sponsored by RTOG Foundation, Inc.

Eligibility Criteria Checklist

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

Must have

Disease must be limited to a single site or adjacent sites that can be treated in a single contiguous target volume with a maximum total tumor dimension <7.5cm

Hematologic, hepatic, renal, and coagulation criteria within specified ranges

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed up to 5 years

Awards & highlights

KEYSTROKE Trial Summary

This trial will evaluate whether adding pembrolizumab to Stereotactic Body Radiation Therapy (SBRT) re-irradiation will improve progression-free survival for patients with recurrent or new second primary Head and Neck Squamous Cell Carcinoma (HNSCC).

Who is the study for?

This trial is for adults with a confirmed diagnosis of head and neck squamous cell carcinoma that has come back or is a new second primary. It's not for those who can be cured by surgery without high risk, have distant metastases, recent other cancer treatments, immune deficiencies, certain heart conditions within the last 6 months, active infections needing IV antibiotics, pregnant or breastfeeding women, or those unwilling to use contraception.Check my eligibility

What is being tested?

The study tests if adding Pembrolizumab (an immunotherapy drug) to Stereotactic Body Radiation Therapy improves progression-free survival in patients with recurrent or new head and neck cancer. The phase II trial includes an initial safety review before fully proceeding.See study design

What are the potential side effects?

Pembrolizumab may cause immune system-related side effects like inflammation in various organs including lungs (pneumonitis), liver issues, skin reactions; it could also lead to fatigue and infusion-related reactions.

KEYSTROKE Trial Eligibility Criteria

Inclusion Criteria

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

Select...

My cancer is in one area or close areas, all under 7.5cm in size.

Select...

My blood, liver, kidney, and clotting tests are within normal ranges.

Select...

My head or neck cancer cannot be removed with surgery.

Select...

Surgery to remove my cancer is not an option for me due to high risk or medical reasons.

Select...

I am 18 years old or older.

KEYSTROKE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed 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

Progression Free Survival (PFS)

Secondary outcome measures

Overall Survival (OS)

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

KEYSTROKE Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm IIExperimental Treatment1 Intervention

Patients receive Stereotactic Body Radiation Therapy (SBRT) over 2 weeks. Arm II patients who experience progressive disease within 2 years after the start of SBRT will be allowed to cross over to receive pembrolizumab for up to 2 years.

Group II: Arm IExperimental Treatment2 Interventions

Patients receive Stereotactic Body Radiation Therapy (SBRT) over 2 weeks and then receive pembrolizumab every 3 weeks for up to 2 years.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

Stereotactic Body Radiation Therapy (SBRT)

2018

Completed Phase 2

~740

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

RTOG Foundation, Inc.Lead Sponsor

6 Previous Clinical Trials

1,410 Total Patients Enrolled

Merck Sharp & Dohme LLCIndustry Sponsor

3,888 Previous Clinical Trials

5,054,902 Total Patients Enrolled

Stuart J. Wong, MDPrincipal InvestigatorRTOG Foundation

4 Previous Clinical Trials

77 Total Patients Enrolled

Media Library

Stereotactic Body Radiation Therapy (SBRT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03546582 — Phase 2

Frequently Asked Questions

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

How hazardous is the use of Pembrolizumab to human health?

"Our team at Power gave Pembrolizumab a score of 2 out of 3 due to the fact that it is currently in phase two of testing, meaning there is some data indicating safety but none validating efficacy."

Answered by AI

How many people are actively involved in this experiment?

"This research requires 102 qualified participants. If you meet the criteria, you can enroll at either University of Texas Southwestern in Dallas or the University of Arizona Cancer Center - North Campus in Tucson."

Answered by AI

What numbers of healthcare facilities are presently participating in this experiment?

"This clinical trial has 17 sites, including the University of Texas Southwestern in Dallas, University of Arizona Cancer Center - North Campus in Tucson and Ohio State University in Columbus."

Answered by AI

Is there still availability for participants in this experiment?

"Affirmative. Information hosted on clinicaltrials.gov confirms that this trial is presently enrolling individuals; it was first posted to the website on November 14th 2018 and last updated July 18th 2022. The study necessitates 102 participants across 17 different medical centres."

Answered by AI

What conditions can Pembrolizumab typically be administered to address?

"Patients suffering from malignant neoplasms, unresectable melanoma, and microsatellite instability high can be offered relief through pembrolizumab."

Answered by AI

Has Pembrolizumab been studied in past clinical trials?

"Pembrolizumab was first investigated at City of Hope in 2010, and since then there are 260 completed clinical trials. Currently, 961 medical studies that include this medication are actively recruiting patients - with many based out of Dallas, Texas."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

SBRT +/- Pembrolizumab in Patients With Local-Regionally Recurrent or Second Primary Head and Neck Carcinoma

2018. "SBRT +/- Pembrolizumab in Patients With Local-Regionally Recurrent or Second Primary Head and Neck Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03546582.

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