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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)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have high risk disease defined as:

Positive margins and/or extra nodal extension (ENE)

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upup to 5 years from date of registration

Awards & highlights

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years from date of registration

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

Hyponatraemia

Aspartate aminotransferase increased

Pneumonia

Oedema peripheral

Upper respiratory tract infection

Alanine aminotransferase increased

Febrile neutropenia

Abdominal pain

Blood creatinine increased

Hypokalaemia

Abdominal pain upper

Stomatitis

Dry skin

Erythema

Dysgeusia

Hyperthyroidism

Dyspepsia

Dysphagia

Nasopharyngitis

Blood alkaline phosphatase increased

Pain in extremity

Musculoskeletal chest pain

Musculoskeletal pain

Chest pain

Hypertension

Hypotension

Urinary tract infection

Atrial fibrillation

Death

Acute kidney injury

Pneumonitis

Pulmonary embolism

Hemiparesis

Clostridium difficile colitis

Neutropenic sepsis

Pleural infection

Sepsis

Infusion related reaction

Diabetes mellitus

Aortic aneurysm

Inappropriate antidiuretic hormone secretion

Pneumothorax

Transient ischaemic attack

Gastritis

Superior vena cava syndrome

100%

80%

60%

40%

20%

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

0 / 17Eligibility criteria met

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, Pennsylvania tar 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 Washington e 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

Recent research and studies

clinicaltrials.govStudy

Testing What Happens When an Immunotherapy Drug (Pembrolizumab) is Given by Itself Compared to the Usual Treatment of Chemotherapy With Radiation After Surgery for Recurrent Head and Neck Squamous Cell Carcinoma

2021. "Testing What Happens When an Immunotherapy Drug (Pembrolizumab) is 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.

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