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Alkylating agents

Pembrolizumab + CRT for Head and Neck Cancer

Phase 1
Waitlist Available
Led By Steven F Powell, MD
Research Sponsored by Sanford Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically or cytologically-confirmed head and neck squamous cell carcinoma of the oral cavity (excluding lip), oropharynx, hypopharynx, or larynx
Willing to provide tissue from a recently obtained core or excisional biopsy of a tumor lesion
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through day 240 (this time frame allows capturing of aes that occurred up to 90 days after completion of treatment)
Awards & highlights

Study Summary

This trial is testing a new combination of drugs to treat head and neck cancer. The new combination consists of pembrolizumab, a standard chemotherapy drug, and cisplatin, a radiation therapy. Patients will not be randomized, and all will receive the new combination.

Who is the study for?
This trial is for adults with stage III-IVB head and neck squamous cell carcinoma, who can undergo chemoradiation therapy. They must have good performance status, no prior head and neck radiation, not be on immunosuppressives or have active infections, and agree to use contraception.Check my eligibility
What is being tested?
The study tests pembrolizumab combined with standard cisplatin-based chemoradiotherapy (CRT) in patients. It's a single-arm trial where all participants receive the same treatment without randomization to evaluate safety and effectiveness.See study design
What are the potential side effects?
Possible side effects include immune-related reactions due to pembrolizumab, such as inflammation of organs; infusion reactions; fatigue; nausea from cisplatin; skin changes from radiation; plus increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is a type of throat or mouth cancer, not including the lip.
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I am willing to give a tissue sample from a recent biopsy.
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My cancer is at an advanced stage (stage III, IVA, or IVB).
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I am not pregnant and agree to use birth control.
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I agree to use birth control during the study.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My organs are functioning well.
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I am at least 18 years old.
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I am a candidate for treatment aimed at curing my cancer using both chemotherapy and radiation at the same time.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through day 240 (this time frame allows capturing of aes that occurred up to 90 days after completion of treatment)
This trial's timeline: 3 weeks for screening, Varies for treatment, and through day 240 (this time frame allows capturing of aes that occurred up to 90 days after completion 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
Adverse Events Will be Assessed and Graded Using CTCAE 4.0. Occurrences With Max Grade and Percentage/Number of Participants Affected by AEs Will be Provided.
Secondary outcome measures
Evaluation of the Efficacy of Pembrolizumab Given in Combination With Definitive CRT by Determining the Number of Participants With Complete Response at Treatment End (Day 150)

Side effects data

From 2012 Phase 3 trial • 256 Patients • NCT01005680
51%
Neutropenia
47%
Leukopenia
46%
Nausea
43%
Vomiting
35%
Anaemia
31%
Decreased appetite
26%
Haemoglobin decreased
26%
Fatigue
25%
Constipation
25%
White blood cell count decreased
24%
Neutrophil count decreased
19%
Alanine aminotransferase increased
13%
Platelet count decreased
12%
Rash
10%
Aspartate aminotransferase increased
10%
Thrombocytopenia
9%
Blood sodium decreased
8%
Hypokalaemia
7%
Insomnia
7%
Pyrexia
6%
Hyponatraemia
6%
Blood creatinine increased
6%
Lymphopenia
6%
Diarrhoea
6%
Dyspepsia
6%
Red blood cell count decreased
6%
Cough
4%
Dizziness
2%
Bone marrow failure
1%
Ischaemic stroke
1%
Cerebral infarction
1%
Dyspnoea
1%
Pulmonary embolism
1%
Embolism venous
1%
Superior vena cava syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gemcitabine Plus Cisplatin (GC)
Pemetrexed Plus Cisplatin (PC)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment3 Interventions
Pembrolizumab + Cisplatin + Radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
2013
Completed Phase 3
~1940
Radiation
2003
Completed Phase 3
~1020

Find a Location

Who is running the clinical trial?

Sanford HealthLead Sponsor
48 Previous Clinical Trials
61,864 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,860 Previous Clinical Trials
5,047,795 Total Patients Enrolled
Steven F Powell, MDPrincipal InvestigatorSanford Research
1 Previous Clinical Trials
50 Total Patients Enrolled

Media Library

Cisplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT02586207 — Phase 1
Head and Neck Cancers Research Study Groups: Single Arm
Head and Neck Cancers Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT02586207 — Phase 1
Cisplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02586207 — Phase 1

Frequently Asked Questions

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

Are there any published accounts detailing Cisplatin's efficacy in the medical field?

"The City of Hope Comprehensive Cancer Center initially began researching cisplatin in 1997, with 1214 trials having been completed since then. At present, 1555 live clinical studies are being conducted across the country, many of which originate from Fargo, North dakota."

Answered by AI

Are there any available enrollment slots for this clinical experiment?

"This research is no longer recruiting participants. According to the clinicaltrials.gov records, recruitment first began on November 1st 2015 and concluded in April 19th 2022. Alternatives are available; 2911 studies for oropharynx cancer patients and 1555 trials involving Cisplatin treatment are currently accepting enrollees."

Answered by AI

In what context is Cisplatin typically administered?

"Cisplatin has been shown to be an effective treatment for malignant tumours, inoperable melanomas, and microsatellite instability high conditions."

Answered by AI

How many research centers are carrying out this trial?

"The list of medical centres involved in this trial includes Sanford-Roger Maris Cancer Center (Fargo), the Sanford Health Centre (Sioux Falls) and the Sanford-Bismarck Medical Facility, plus other 4 sites."

Answered by AI

How many individuals are partaking in this clinical experiment?

"Recruitment for this research has closed. The trial was posted on November 1st, 2015 and last updated April 19th 2022. For those seeking to join other trials, 2911 are recruiting patients with oropharynx cancers and 1555 studies have open enrollment for cisplatin treatments."

Answered by AI

What are the potential risks associated with Cisplatin treatment?

"The safety of Cisplatin was estimated to be 1 on a scale from 1-3 due to the fact that this is only its initial stage of clinical trials and there is limited data supporting both efficacy and safety."

Answered by AI
Recent research and studies
~6 spots leftby Mar 2025