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Pembrolizumab + Radiation for Head and Neck Cancer

Phase 2
Waitlist Available
Led By Jared Weiss, MD
Research Sponsored by UNC Lineberger Comprehensive Cancer Center
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 20 weeks after d1 of treatment
Awards & highlights

Study Summary

This trial is testing a new cancer treatment combination for people with head and neck cancer who can't have standard treatment.

Eligible Conditions
  • Head and Neck Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years from start of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years from start of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
20 Week Progression Free Survival Rate
Median Progression Free Survival
One Year Progression Free Survival Rate
+1 more
Secondary outcome measures
Complete Response Rate
Number of Participants With Clinically Relevant Adverse Events
One Year Overall Survival Rate
+6 more

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

2Treatment groups
Experimental Treatment
Group I: RadiationExperimental Treatment1 Intervention
Intensity Modulated Radiation Therapy (IMRT)
Group II: Open labelExperimental Treatment1 Intervention
Pembrolizumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Intensity Modulated Radiation Therapy
2017
Completed Phase 2
~490

Find a Location

Who is running the clinical trial?

UNC Lineberger Comprehensive Cancer CenterLead Sponsor
351 Previous Clinical Trials
88,303 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,542 Total Patients Enrolled
Jared Weiss, MDPrincipal InvestigatorUNC Lineberger Comprehensive Cancer Center
16 Previous Clinical Trials
506 Total Patients Enrolled

Media Library

Intensity Modulated Radiation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT02609503 — Phase 2
Head and Neck Cancers Research Study Groups: Radiation, Open label
Head and Neck Cancers Clinical Trial 2023: Intensity Modulated Radiation Therapy Highlights & Side Effects. Trial Name: NCT02609503 — Phase 2
Intensity Modulated Radiation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT02609503 — Phase 2

Frequently Asked Questions

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

Is the enrollment of geriatric patients part of this research experiment?

"The parameters for qualification to this clinical trial state that participants must be 18-99 years old. Furthermore, 46 studies are available for minors and 1434 trials exist for those over the age of 65."

Answered by AI

Has Pembrolizumab obtained the necessary regulatory approval from the FDA?

"Our team at Power assigned Pembrolizumab a safety rating of 2. This is because while phase two trials offer assurance on the drug's security, there are no extant data supporting its effectiveness."

Answered by AI

What therapeutic indications is Pembrolizumab typically utilized for?

"Pembrolizumab is mostly used to treat malignant tumours, but can also be useful in managing unresectable melanoma, microsatellite instability high (MSI-H), and cases of disease progression after chemotherapy."

Answered by AI

What is the scope of recruitment for this trial?

"This trial is no longer accepting patients, as its initial posting was on May 16th 2016 and it received a final edit December 6th 2021. If one is seeking to join other trials related to head and neck cancer, there are 481 studies available at present; for Pembrolizumab specifically, 961 additional experiments currently have open enrollment."

Answered by AI

Is this trial actively recruiting participants?

"This trial is not currently enrolling patients. According to clinicaltrials.gov, the original posting date was May 16th 2016 and it has been updated most recently on December 6th 2021; although this study does not require any volunteers right now, there are 1442 other clinical trials that do need participants at present."

Answered by AI

Is it possible for me to participate in this trial?

"This clinical trial seeks 29 patients aged 18 to 99 who have been diagnosed with head and neck cancer. Participants must meet the following criteria: histologically or cytologically confirmed stage III-IV (non-metastatic) squamous cell carcinoma of the head and neck according to American Joint Committee on Cancer standards, Eastern Cooperative Oncology Group Performance Status no higher than 1, sufficient bodily organ functionality as evidenced by lab tests conducted within 2 weeks of beginning treatment for males an adequate form of contraception is necessary from first dose through 4 months after last does; females should abstain from heterosexual activity during study period, negative pregnancy test for women"

Answered by AI

Could you enumerate the clinical trials previously conducted with Pembrolizumab?

"Currently, there are 961 active investigations for the efficacy of Pembrolizumab with 122 studies in Phase 3. In Houston Texas alone, several trials have been conducted; however, globally over 35 thousand sites offer research opportunities regarding this drug."

Answered by AI

What beneficial results are expected from this clinical experiment?

"According to the clinical trial sponsor, Merck Sharp & Dohme LLC., the primary objective of this study is 20 Week Progression Free Survival Rate and it will be tracked over a 12 month period from Day 1. Additionally, secondary objectives such as Quality of Life Measured by Functional Assessment of Cancer Therapy - Head and Neck (FACT-HN) score range between 0-4 rating function in 4 domains: physical well-being (PWB), social-family well-being (SFWB), emotional well-being (EWB) and functional wellbeing(FWB). The HNC subscale has additionally an additional 12 items"

Answered by AI
~3 spots leftby Apr 2025