Pembrolizumab for Squamous cell carcinoma

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

Study Summary

This trial is to find out the possible side effects of pembrolizumab and radiation therapy before and during surgery in treating patients with head and neck squamous cell cancer.

Eligible Conditions
  • Squamous cell carcinoma
  • Carcinoma
  • Recurrent Laryngeal Squamous Cell Carcinoma
  • Recurrent Oral Cavity Squamous Cell Carcinoma
  • Recurrent Pharyngeal Squamous Cell Carcinoma

Treatment Effectiveness

Study Objectives

2 Primary · 5 Secondary · Reporting Duration: Up to 5 years

Month 24
Progression-free survival (PFS)
Month 24
Local control rate
Day 100
Incidence of adverse events
Up to 5 years
Health related quality of life
Objective-response rate (ORR)
Overall survival
PD-L1 expression

Trial Safety

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 A (pembrolizumab, salvage surgery, IORT)
1 of 3
Arm B (pembrolizumab, EBRT, salvage surgery, IORT)
1 of 3
Arm C (pembrolizumab, EBRT, salvage surgery, IORT)
1 of 3

Experimental Treatment

45 Total Participants · 3 Treatment Groups

Primary Treatment: Pembrolizumab · No Placebo Group · Phase 1

Arm A (pembrolizumab, salvage surgery, IORT)Experimental Group · 4 Interventions: Pembrolizumab, Salvage Surgery, Quality-of-Life Assessment, Intraoperative Radiation Therapy · Intervention Types: Biological, Procedure, Other, Radiation
Arm B (pembrolizumab, EBRT, salvage surgery, IORT)Experimental Group · 5 Interventions: External Beam Radiation Therapy, Pembrolizumab, Salvage Surgery, Quality-of-Life Assessment, Intraoperative Radiation Therapy · Intervention Types: Radiation, Biological, Procedure, Other, Radiation
Arm C (pembrolizumab, EBRT, salvage surgery, IORT)Experimental Group · 5 Interventions: External Beam Radiation Therapy, Pembrolizumab, Salvage Surgery, Quality-of-Life Assessment, Intraoperative Radiation Therapy · Intervention Types: Radiation, Biological, Procedure, Other, Radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
External Beam Radiation Therapy
2006
Completed Phase 3
~2470
Pembrolizumab
FDA approved
Intraoperative Radiation Therapy
2012
N/A
~500

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years

Who is running the clinical trial?

Ohio State University Comprehensive Cancer CenterLead Sponsor
284 Previous Clinical Trials
285,914 Total Patients Enrolled
Dukagjin M Blakaj, MD, PhDPrincipal InvestigatorOhio State University Comprehensive Cancer Center

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have hematologic, renal, and hepatic function.
You have a disease that can be removed by surgery.
You have a disease that can be measured by CT or MRI.
You are at least 18 years old.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 3rd, 2021

Last Reviewed: November 28th, 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.