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

Similar Trials

1

Radiation Therapy

1

Efineptakin alfa

1

Pembrolizumab

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

Similar Trials

1

Radiation Therapy

1

Efineptakin alfa

1

Pembrolizumab

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 - 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.

References

2021. "Testing What Happens When an Immunotherapy Drug (Pembrolizumab) is Added to Radiation or Given by Itself Compared to the Usual Treatment of Chemotherapy With Radiation After Surgery for Recurrent Head and Neck Squamous Cell Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04671667.

Pembrolizumab for Carcinoma, Squamous Cell

Study Summary

Treatment Effectiveness

Effectiveness Progress

Similar Trials

Study Objectives

Trial Safety

Safety Progress

Similar Trials

Side Effects for

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

Trial Logistics

Trial Timeline

Who is running the clinical trial?

Eligibility Criteria

About The Reviewer

Other Trials to Consider

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Pembrolizumabfor Oral Squamous Cell Carcinoma

Pembrolizumabfor Relapse

Pembrolizumabfor Squamous cell carcinoma

Cisplatinfor Stage III Lip and Oral Cavity Cancer AJCC v8

Sorafenibfor Carcinoma

Neck Dissection Impairment Indexfor Carcinoma

Pembrolizumabfor Recurrent Respiratory Papillomatosis

Pembrolizumabfor HPV-Related Squamous Cell Carcinoma

Pembrolizumabfor Malignant neoplasm of larynx

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