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Alkylating agents

Pembrolizumab for Head and Neck Squamous Cell Carcinoma

Geisinger Medical Center, Danville, PA
Targeting 5 different conditionsPembrolizumab +6 morePhase 2RecruitingLed by Dan P ZandbergResearch Sponsored by National Cancer Institute (NCI)

Study Summary

This trial is testing pembrolizumab, a monoclonal antibody, in combination with radiation therapy or pembrolizumab alone compared to the usual approach of chemotherapy plus radiation therapy after surgery in treating patients with head and neck squamous cell carcinoma that has come back or patients with a second head and neck cancer that is not from metastasis.

Eligible Conditions
  • Squamous Cell Carcinoma
  • Head and Neck Squamous Cell Carcinoma
  • Oral Cancers
  • Oropharyngeal Carcinoma
  • Laryngeal Squamous Cell Carcinoma

Eligibility Criteria

Inclusion Criteria

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

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events
Overall survival (OS)
Secondary outcome measures
Disease free survival
PD-L1 expression

Side effects data

From 2021 Phase 3 trial • 453 Patients • NCT03066778
54%
Neutropenia
45%
Anaemia
38%
Nausea
34%
Alopecia
31%
Decreased appetite
29%
Constipation
27%
Fatigue
26%
Thrombocytopenia
22%
Leukopenia
21%
Diarrhoea
20%
Cough
17%
Asthenia
17%
Dyspnoea
16%
Vomiting
14%
Pyrexia
14%
Dizziness
13%
Headache
13%
Arthralgia
13%
Rash
12%
Hypothyroidism
11%
Pruritus
11%
Insomnia
11%
Back pain
10%
Weight decreased
9%
Hyponatraemia
9%
Aspartate aminotransferase increased
8%
Pneumonia
8%
Oedema peripheral
8%
Upper respiratory tract infection
8%
Alanine aminotransferase increased
7%
Febrile neutropenia
7%
Abdominal pain
7%
Blood creatinine increased
7%
Hypokalaemia
6%
Abdominal pain upper
6%
Stomatitis
6%
Dry skin
6%
Erythema
6%
Dysgeusia
5%
Hyperthyroidism
5%
Dyspepsia
5%
Dysphagia
5%
Nasopharyngitis
5%
Blood alkaline phosphatase increased
5%
Pain in extremity
5%
Musculoskeletal chest pain
5%
Musculoskeletal pain
5%
Chest pain
5%
Hypertension
4%
Hypotension
4%
Urinary tract infection
2%
Atrial fibrillation
2%
Death
2%
Acute kidney injury
2%
Pneumonitis
2%
Pulmonary embolism
1%
Hemiparesis
1%
Clostridium difficile colitis
1%
Neutropenic sepsis
1%
Pleural infection
1%
Sepsis
1%
Infusion related reaction
1%
Diabetes mellitus
1%
Aortic aneurysm
1%
Inappropriate antidiuretic hormone secretion
1%
Pneumothorax
1%
Transient ischaemic attack
1%
Gastritis
1%
Superior vena cava syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab+EP
Placebo+EP
Pembrolizumab Second Course

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm C (pembrolizumab)Experimental Treatment3 Interventions
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 6 weeks for 9 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI throughout the trial.
Group II: Arm B (cisplatin, carboplatin, IMRT, PBRT)Active Control6 Interventions
Patients receive cisplatin or carboplatin IV on day 1. Treatment repeats every 7 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo IMRT or PBRT QD for a total of 30 fractions in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~2890
Magnetic Resonance Imaging
2017
Completed Phase 3
~1250
Pembrolizumab
2017
Completed Phase 3
~2030

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,489 Previous Clinical Trials
41,266,493 Total Patients Enrolled
Dan P ZandbergPrincipal InvestigatorECOG-ACRIN Cancer Research Group
1 Previous Clinical Trials
72 Total Patients Enrolled

Media Library

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT04671667 — Phase 2
Squamous Cell Carcinoma Research Study Groups: Arm B (cisplatin, carboplatin, IMRT, PBRT), Arm C (pembrolizumab)
Squamous Cell Carcinoma Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT04671667 — Phase 2
Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04671667 — Phase 2

Frequently Asked Questions

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

What illnesses does Pembrolizumab commonly target?

"Pembrolizumab is a useful medication for treating malignant neoplasms, unresectable melanoma, microsatellite instability high, and patients with a high risk of recurrence."

Answered by AI

How many patients are enrolled in this clinical trial?

"The data on clinicaltrials.gov does show that this trial is currently looking for patients. The trial was first posted on 1/8/2021 and was last updated on 11/9/2022. They are hoping to enroll 282 participants from 94 different sites."

Answered by AI

Do many hospitals in Canada offer this research opportunity to patients?

"There are 94 locations where this trial is currently accepting patients, which include MedStar Washington Hospital Center in Washington D.C., Cone Health Cancer Center in Greensboro, North Carolina, and Annie Penn Memorial Hospital in Reidsville, Pennsylvaniatar Washington Hospital Center in Washington D.C., Cone Health Cancer Center in Greensboro, North Carolina, and Annie Penn Memorial Hospital in Reidsville, Pennsylvania."

Answered by AI

Does this research require participants to be of a certain age?

"This trial is seeking patients aged 18 to 79. However, there are currently 364 other trials underway for minors and 5417 for senior citizens."

Answered by AI

Are new participants being accepted into this research project?

"That is correct. The clinical trial is actively recruiting patients, as indicated by the most recent update on 11/9/2022. This information can be found on clinicaltrials.gov, where the study was originally posted on 1/8/2021. Currently, 94 medical facilities are enrolling a total of 282 individuals in this research project."

Answered by AI

What is the FDA's stance on Pembrolizumab?

"At Power, we gave Pembrolizumab a score of 2 on our safety scale. This is because while there is some data indicating that it is safe, there is no evidence yet to suggest that it actually works."

Answered by AI

How can I become involved in this experiment?

"Carcinoma patients that are between 18 and 79 years old may be eligible for this study. If accepted, they would become one of the around 282 people in the trial."

Answered by AI

What other investigations have included Pembrolizumab?

"Pembrolizumab was first pioneered at City of Hope Comprehensive Cancer Center in 1997 and, since then, 1918 trials have been completed. Right now, 2064 more are ongoing with a large portion taking place within Washingtone Cancer Center in 1997 and, since then, 1918 trials have been completed. Right now, 2064 more are ongoing with a large portion taking place within Washington D.C."

Answered by AI
~88 spots leftby Feb 2026