← Back to Search

PD-1 Inhibitor

Reirradiation + Pembrolizumab for Head and Neck Cancer

Phase 2

Waitlist Available

Led By Dan Zandberg, MD

Research Sponsored by Dan Zandberg

Eligibility Criteria Checklist

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

Must have

Most of the tumor volume (>50%) previously radiated at doses > 45 Gy without exceeding spinal cord tolerance.

Have received only prior radiation treatment course with curative intent.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 36 months (after starting reirradiation and mk-3475)

Awards & highlights

Study Summary

This trial will test reirradiation combined with the anti-PD-1 mAb MK-3475 for people with inoperable recurrence or second primary squamous cell carcinoma of the head and neck.

Who is the study for?

This trial is for adults with a specific type of head and neck cancer that has come back or developed anew and can't be removed by surgery. Participants must have had only one prior radiation treatment, it should be at least 6 months since they finished that treatment, and their cancer needs to be measurable. They should not have used certain immune-targeting drugs before, nor should they have serious infections or other cancers in the last 5 years.Check my eligibility

What is being tested?

The study tests reirradiation combined with pembrolizumab (Keytruda®), an immunotherapy drug, on patients whose head and neck cancer has returned or cannot be surgically removed. The goal is to see if this combination helps control the disease better than previous treatments.See study design

What are the potential side effects?

Pembrolizumab may cause flu-like symptoms, fatigue, skin reactions, diarrhea, hormonal changes affecting thyroid or adrenal function. It might also lead to more serious issues like inflammation in lungs (pneumonitis) or problems with liver function.

Eligibility Criteria

Inclusion Criteria

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

Select...

More than half of my tumor was treated with high-dose radiation without harming my spinal cord.

Select...

I have had only one radiation treatment aimed at curing my disease.

Select...

I am willing to have a feeding tube placed if needed.

Select...

I have a tumor that can be measured by scans.

Select...

I have provided a tissue sample for PD-L1 analysis.

Select...

I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 36 months (after starting reirradiation and mk-3475)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 36 months (after starting reirradiation and mk-3475)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months (after starting reirradiation and mk-3475) 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

Secondary outcome measures

Clinical Benefit Rate (CBR)

Overall Response Rate (ORR)

Overall survival (OS)

+2 more

Side effects data

From 2020 Phase 2 trial • 65 Patients • NCT02085070

83%

Fatigue

62%

Cough

50%

Constipation

50%

Dyspnea

43%

Back pain

40%

Anorexia

36%

Headache

33%

Diarrhea

31%

Pain in extremity

29%

Nausea

24%

Rash maculo-papular

24%

Dizziness

24%

Edema limbs

21%

Anxiety

17%

Insomnia

17%

Hypertension

14%

Abdominal pain

14%

Thromboembolic event

14%

Hypothyroidism

12%

Non-cardiac chest pain

12%

Pruritus

12%

Allergic rhinitis

10%

Vomiting

10%

Pain

10%

Muscle weakness lower limb

10%

Floaters

Gastroesophageal reflux disease

Dyspepsia

Aspartate aminotransferase increased

Fever

Arthralgia

Neck pain

Chest wall pain

Depression

Creatinine increased

Bone pain

Seizure

Alanine aminotransferase increased

Cognitive disturbance

Pneumonitis

Nasal congestion

Chills

Adrenal Insufficienvy

Acute Kidney Injury

Hypokalemia

Colitis

100%

80%

60%

40%

20%

Study treatment Arm

Non-small Cell Lung Cancer Patients

Melanoma Patients

Trial Design

1Treatment groups

Experimental Treatment

Group I: Reirradiation + MK-3475Experimental Treatment2 Interventions

Reirradiation 1.2 Gy BID for 5 days a week for 5 weeks with MK-3475 (Keytruda, pembrolizumab) 200mg intravenous every 3 weeks until 3 months post completion of reirradiation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MK-3475

2014

Completed Phase 2

~1290

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor

3,886 Previous Clinical Trials

5,054,520 Total Patients Enrolled

Dan ZandbergLead Sponsor

5 Previous Clinical Trials

237 Total Patients Enrolled

Dan Zandberg, MDPrincipal Investigator - UPMC Hillman Cancer Center

University of Pittsburgh

2 Previous Clinical Trials

82 Total Patients Enrolled

Media Library

Pembrolizumab (PD-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02289209 — Phase 2

Squamous Cell Carcinoma Research Study Groups: Reirradiation + MK-3475

Squamous Cell Carcinoma Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT02289209 — Phase 2

Pembrolizumab (PD-1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02289209 — Phase 2

Frequently Asked Questions

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

What are the deleterious effects of MK-3475 on humans?

"Even though there is no data yet supporting efficacy, the fact that MK-3475 made it to a Phase 2 trial suggests that there is some evidence of its safety. Therefore, our team rates it as a 2."

Answered by AI

What are the most common indications for MK-3475?

"Oncologists may prescribe MK-3475 to patients with malignant neoplasms, as well as those experiencing disease progression after chemotherapy or suffering from unresectable melanoma."

Answered by AI

What other studies have been conducted with MK-3475?

"Currently, there are 1000 clinical trials underway that are investigating the efficacy of MK-3475. Out of those active trials, 122 are in Phase 3. Many of the trials for MK-3475 are based in Houston, Texas; however, there are 36030 locations across the globe running trials for this treatment."

Answered by AI

Are we still receiving participants for this experiment?

"That is correct, the online information indicates that the trial is currently ongoing and looking for 48 participants at 4 sites. The original posting was on 1/10/2019, with the most recent update being 3/25/2022."

Answered by AI

How many people are given the opportunity to participate in this experiment?

"Yes, this is an active recruitment trial that was originally posted on January 10th, 2019. The last update was March 25th, 20212 and the study is looking for a total of 48 participants across 4 sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Reirradiation With Pembrolizumab in Locoregional Inoperable Recurrence or Second Primary Squamous Cell CA of the Head and Neck

Dan Zandberg 2019. "Reirradiation With Pembrolizumab in Locoregional Inoperable Recurrence or Second Primary Squamous Cell CA of the Head and Neck". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02289209.

All > Pennsylvania > Head And Neck Cancer