Pembrolizumab for Carcinoma, Squamous Cell

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Carcinoma, Squamous Cell+15 More
Pembrolizumab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

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
  • Carcinoma, Squamous Cell
  • Oropharyngeal Squamous Cell Carcinoma
  • Recurrent Laryngeal Squamous Cell Carcinoma
  • Recurrent Hypopharyngeal Squamous Cell Carcinoma
  • Recurrent Oropharyngeal Squamous Cell Carcinoma
  • Recurrent Oral Cavity Squamous Cell Carcinoma
  • Hypopharyngeal Squamous Cell Carcinoma
  • Squamous cell carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: Up to 5 years from date of registration

Year 2
Overall survival (OS)
Year 5
Disease free survival
Year 5
Incidence of adverse events
PD-L1 expression

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Pembrolizumab+EP
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%Arthralgia
13%Rash
13%Headache
12%Hypothyroidism
11%Insomnia
11%Pruritus
11%Back pain
10%Weight decreased
9%Hyponatraemia
9%Aspartate aminotransferase increased
8%Oedema peripheral
8%Upper respiratory tract infection
8%Alanine aminotransferase increased
8%Pneumonia
7%Abdominal pain
7%Blood creatinine increased
7%Hypokalaemia
7%Febrile neutropenia
6%Abdominal pain upper
6%Stomatitis
6%Dysgeusia
6%Erythema
6%Dry skin
5%Hyperthyroidism
5%Dyspepsia
5%Dysphagia
5%Chest pain
5%Blood alkaline phosphatase increased
5%Musculoskeletal pain
5%Hypertension
5%Nasopharyngitis
5%Musculoskeletal chest pain
5%Pain in extremity
4%Urinary tract infection
4%Hypotension
2%Death
2%Acute kidney injury
2%Pneumonitis
2%Pulmonary embolism
2%Atrial fibrillation
1%Neutropenic sepsis
1%Inappropriate antidiuretic hormone secretion
1%Diabetes mellitus
1%Hemiparesis
1%Transient ischaemic attack
1%Superior vena cava syndrome
1%Pneumothorax
1%Gastritis
1%Aortic aneurysm
1%Sepsis
1%Pleural infection
1%Infusion related reaction
1%Clostridium difficile colitis
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT03066778) in the Pembrolizumab+EP ARM group. Side effects include: Neutropenia with 54%, Anaemia with 45%, Nausea with 38%, Alopecia with 34%, Decreased appetite with 31%.

Trial Design

3 Treatment Groups

Arm B (cisplatin, carboplatin, IMRT, PBRT)
1 of 3
Arm C (pembrolizumab)
1 of 3
Arm A (pembrolizumab, IMRT, PBRT)
1 of 3

Active Control

Experimental Treatment

282 Total Participants · 3 Treatment Groups

Primary Treatment: Pembrolizumab · No Placebo Group · Phase 2

Arm C (pembrolizumab)
Biological
Experimental Group · 1 Intervention: Pembrolizumab · Intervention Types: Biological
Arm A (pembrolizumab, IMRT, PBRT)Experimental Group · 3 Interventions: Proton Beam Radiation Therapy, Pembrolizumab, Intensity-Modulated Radiation Therapy · Intervention Types: Radiation, Biological, Radiation
Arm B (cisplatin, carboplatin, IMRT, PBRT)ActiveComparator Group · 4 Interventions: Proton Beam Radiation Therapy, Carboplatin, Cisplatin, Intensity-Modulated Radiation Therapy · Intervention Types: Radiation, Drug, Drug, Radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Proton Beam Radiation Therapy
2013
Completed Phase 2
~50
Pembrolizumab
FDA approved
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~1660

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years from date of registration

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,000 Previous Clinical Trials
41,300,625 Total Patients Enrolled
229 Trials studying Carcinoma, Squamous Cell
35,227 Patients Enrolled for Carcinoma, Squamous Cell
Dan P ZandbergPrincipal InvestigatorECOG-ACRIN Cancer Research Group
1 Previous Clinical Trials
108 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are between 18 and 79 years of age.
Positive margins are defined as malignancy at or within 1 mm of the margin
Patient must have a PD-L1 Combined Positive Score (CPS) ≥ 1 in a Clinical Laboratory Improvement Act (CLIA) certified laboratory
Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
Patient must have had prior radiation to the area of recurrent or second primary tumor
Patient must have completed prior radiation a minimum of 6 months prior to randomization.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 10th, 2021

Last Reviewed: November 7th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.