← Back to Search

Alkylating agents

Immunotherapy + Radiation for Head and Neck Cancer

Phase 2

Recruiting

Research Sponsored by Loren Mell, MD

Eligibility Criteria Checklist

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

Must have

High-Intermediate Risk Disease as defined by specific criteria

p16-positive squamous cell carcinoma of the pharynx, larynx or oral cavity

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Study Summary

This trial is testing whether adding the immunotherapy drug pembrolizumab to standard radiation therapy improves outcomes for patients with head and neck squamous cell carcinoma.

Who is the study for?

This trial is for adults with certain high-risk head and neck cancers, including oropharynx, larynx, nasopharynx, and oral cavity squamous cell carcinoma. Participants must have no distant metastases, be HIV negative, not pregnant or breastfeeding, agree to use contraception during the study period and have adequate organ function.Check my eligibility

What is being tested?

The trial compares pembrolizumab (an experimental immunotherapy drug) plus radiation therapy against the standard treatment of cisplatin chemotherapy plus radiation therapy in treating head and neck squamous cell carcinoma.See study design

What are the potential side effects?

Pembrolizumab may cause immune-related side effects such as inflammation in various organs, skin reactions, fatigue and infusion-related reactions. Cisplatin can lead to nausea/vomiting, kidney damage, hearing loss and nerve damage.

Eligibility Criteria

Inclusion Criteria

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

Select...

My condition is considered high-intermediate risk.

Select...

My cancer is p16-positive in the throat, voice box, or mouth.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

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

Acute toxicity

Late toxicity

Patterns of failure

+1 more

Other outcome measures

PD-L1 expression correlations

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

2Treatment groups

Experimental Treatment

Active Control

Group I: Experimental-Radiotherapy/pembrolizumabExperimental Treatment2 Interventions

Intensity-modulated radiation therapy to 70 Gy in 33-35 fractions over 6.5 weeks plus concurrent and adjuvant pembrolizumab 200 mg IV infusion every 3 weeks x 20 cycles

Group II: Control-radiotherapy/cisplatinActive Control2 Interventions

Intensity-modulated radiation therapy to 70 Gy in 33-35 fractions over 6.5 weeks plus concurrent cisplatin 100 mg/m2 every 3 weeks for 3 cycles (7 weeks)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

FDA approved

Radiation therapy

2013

Completed Phase 3

~2850

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor

3,888 Previous Clinical Trials

5,054,890 Total Patients Enrolled

Loren Mell, MDLead Sponsor

1 Previous Clinical Trials

42 Total Patients Enrolled

Media Library

Cisplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT03383094 — Phase 2

Head and Neck Cancers Research Study Groups: Control-radiotherapy/cisplatin, Experimental-Radiotherapy/pembrolizumab

Head and Neck Cancers Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT03383094 — Phase 2

Cisplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03383094 — Phase 2

Frequently Asked Questions

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

In how many different places is this trial organized and taking place?

"The 7 locations where this study is recruiting patients are: Washington University School of Medicine, Siteman Cancer Center in Saint Louis, Vanderbilt-Ingram Cancer Center in Nashville, H. Lee Moffitt Cancer Center & Research Facility in Tampa, and other sites."

Answered by AI

Could you provide the estimated enrollment for this clinical trial?

"Based on the information available on clinicaltrials.gov, this trial is currently looking for participants. The study was posted on 3/15/2018 and was most recently updated on 10/7/2021. 114 individuals are needed across 7 sites."

Answered by AI

What are Pembrolizumab's main therapeutic benefits?

"Pembrolizumab is a standard intervention for malignant neoplasms, but can also be used to treat unresectable melanoma, microsatellite instability high, and other conditions where there is a high risk of recurrence."

Answered by AI

Are new patients currently being accepted into this clinical trial?

"That is correct. The clinical trial detailed on clinicaltrials.gov has an open call for 114 participants at 7 sites. This particular trial was posted on 3/15/2018 and updated as recently as 10/7/2021."

Answered by AI

Are there any other ongoing investigations with Pembrolizumab?

"Pembrolizumab is currently being studied in 1619 active clinical trials, with 365 of those studies classified as Phase 3. Many of these research centres are located in Shanghai; however, Pembrolizumab is being investigated at 70348 different locations worldwide."

Answered by AI

When was Pembrolizumab officially accepted by the FDA?

"While there is some data supporting the safety of Pembrolizumab, it only exists for Phase 2 trials. Efficacy has not been proven yet so it receives a score of 2."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Chemoradiation vs Immunotherapy and Radiation for Head and Neck Cancer

Loren Mell, MD 2018. "Chemoradiation vs Immunotherapy and Radiation for Head and Neck Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03383094.

All > Appendix Cancer > Head And Neck Cancer