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Immunotherapy for Recurrent Head and Neck Cancer

Phase < 1
Recruiting
Led By Haythem Ali, MD
Research Sponsored by Henry Ford Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial will test whether immunotherapy can help people with recurrent head and neck cancer after surgery.

Who is the study for?
This trial is for adults with recurrent squamous cell carcinoma of the head and neck, except in certain areas like nasopharynx. They must have tried surgery, radiation, or chemotherapy before and can't be eligible for salvage radiation therapy now. They should not have other cancers (with some exceptions) or have used immunotherapy within the last year.Check my eligibility
What is being tested?
The study tests Pembrolizumab as a follow-up treatment after surgical removal of cancer to see if it's effective and feasible. It's given intravenously and aims to help patients whose cancer has returned despite previous treatments.See study design
What are the potential side effects?
Pembrolizumab may cause immune-related side effects such as inflammation in various organs, allergic reactions, fatigue, skin issues, hormone gland problems (like thyroid), and could potentially worsen pre-existing autoimmune diseases.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of recurrence at 1 year, will be measured by RECIST 1.1 as the primary measure for assessment of tumor, date of disease progression, and as a basis for all protocol guidelines related to disease status (e.g., discontinuation of study treatment).
Secondary outcome measures
Determine the feasibility of immunotherapy for head and neck cancer following salvage surgery to produce preliminary data for 15 patients regarding efficacy. All side effects and symptoms will be assessed by CTCAE v5.0.
Rate of completion of all planned therapy. All drug related toxicities will be graded by CTCAE v5.0.
Toxicity rates measured by laboratory assessments and all adverse events and serious adverse events will be assessed by CTCAE v5.0.

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

1Treatment groups
Experimental Treatment
Group I: Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA]Experimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Henry Ford Health SystemLead Sponsor
300 Previous Clinical Trials
2,099,984 Total Patients Enrolled
Haythem Ali, MDPrincipal Investigator - Henry Ford Health System
Henry Ford Health System, Henry Ford Wyandotte Hospital
University Of Baghdad (Medical School)
Providence Hosp Medical Ctrs (Residency)

Media Library

Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA] Clinical Trial Eligibility Overview. Trial Name: NCT04188951 — Phase < 1
Head and Neck Cancers Research Study Groups: Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA]
Head and Neck Cancers Clinical Trial 2023: Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA] Highlights & Side Effects. Trial Name: NCT04188951 — Phase < 1
Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA] 2023 Treatment Timeline for Medical Study. Trial Name: NCT04188951 — Phase < 1

Frequently Asked Questions

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

What conditions does this therapy usually remediate?

"This medication intervention has been approved to treat malignant neoplasms, irresectable melanoma, and microsatellite instability high cases."

Answered by AI

Are there other precedents for this therapeutic approach?

"At present, 962 trials are ongoing for this medication with 122 of them in the advanced phase 3. Although Houston, Texas hosts most studies related to this treatment, there are 35 769 locations across the globe enrolling patients."

Answered by AI

Is it possible to sign up for enrollment in this research experiment?

"This research project is in need of 15 volunteers between the ages 18 and 85 who have been diagnosed with head neoplasms. To be eligible, applicants must meet numerous criteria including having a history of squamous cell carcinoma (excluding nasopharynx, paranasal sinuses or salivary gland tumors), displaying high-risk features such as extra nodal invasion, positive margins perineural invasion or vascular embolism, not being suitable for salvage radiation therapy, agreeing to consenting to participation in the study and having gone through an attempted surgery to excise all recurrent disease following definitive treatment consisting of any combination of chemotherapy, surgery and"

Answered by AI

Is the enrollment criteria for this experiment inclusive of individuals older than thirty?

"This trial is searching for participants who are at least 18 and not older than 85."

Answered by AI

Are new participants still accepted for this experiment?

"Clinicaltrials.gov indicates that this study is still searching for participants, with the original posting having been on December 10th 2019 and an update to the information taking place on December 3rd of the same year."

Answered by AI

What is the current number of participants in this research?

"Affirmative. As per the information found on clinicaltrials.gov, this investigation is still searching for enrollees; it was first advertised in December 10th 2019 and had its most recent update on December 3rd 2019. The study necessitates 15 participants from a single location to participate."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
HFHS-1801-A Pilot Study of Immunotherapy as Consolidation Therapy for Patients With Recurrent Head and Neck Cancer
Haythem Ali, M.D. 2019. "HFHS-1801-A Pilot Study of Immunotherapy as Consolidation Therapy for Patients With Recurrent Head and Neck Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04188951.
~3 spots leftby Apr 2025
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