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Alkylating agents

Pembrolizumab + Radiation vs Chemotherapy + Radiation for Head and Neck Cancer

Phase 2

Recruiting

Led By Dan P Zandberg

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Patient must not have received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist) are live attenuated vaccines and are not allowed

Patient must have had prior radiation to the area of recurrent or second primary tumor. This is defined as > 50% of the presurgical tumor volume having previously received a dose of > 45 Gy as determined by the treating radiation oncologist

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years from date of registration

Awards & highlights

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.

Who is the study for?

Adults aged 18-79 with recurrent or second primary head and neck squamous cell carcinoma, who've had surgery and prior radiation, can join this trial. They must have no distant disease spread, a specific protein (PD-L1) score >=1, and proper organ function. Those with severe allergies to pembrolizumab, active infections requiring systemic treatment, recent live vaccines, certain heart conditions or transplants are excluded.Check my eligibility

What is being tested?

The trial is testing the effectiveness of pembrolizumab alone versus the usual treatment of chemotherapy combined with radiation after surgery for patients with head and neck cancer that has returned. Pembrolizumab is an immunotherapy drug designed to boost the body's immune response against cancer cells.See study design

What are the potential side effects?

Pembrolizumab may cause immune-related side effects such as inflammation in various organs including lungs (pneumonitis), liver issues (hepatitis), skin reactions (rash), hormone gland problems (thyroid disorders), infusion reactions; whereas chemotherapy can cause nausea, hair loss, fatigue and increased risk of infection.

Eligibility Criteria

Inclusion Criteria

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

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I haven't had any live vaccines in the last 30 days.

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My tumor area previously received high-dose radiation.

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I haven't needed steroids for lung inflammation in the last 3 years.

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I am between 18 and 79 years old.

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My cancer has spread beyond the original tumor site.

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My cancer cells are found right at or very close to the edge of the removed tissue.

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My cancer has returned in the head or neck area where I was previously treated with radiation.

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My recent scans show no signs of cancer spread.

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My heart is healthy enough for treatment, not classified as NYHA class III or IV.

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My tumor's PD-L1 score is 1 or higher, tested in a certified lab.

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I am fully active or can carry out light work.

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I do not have an infection that needs treatment through my body.

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 2024 Phase 2 trial • 57 Patients • NCT03004183

21%

Fatigue

13%

Nausea

11%

Back pain

Shortness of Breath

Anemia

Abdominal pain

Diarrhea

Pneumonia

Kidney Injury and/or Infection

Dyspnea

Weight Loss

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Pleural effusion

Atrial fibrillation with rapid ventricular response

Thrombocytopenia

Respiratory failure

Skin rash

colitis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

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

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Computed Tomography

2017

Completed Phase 2

~2720

Pembrolizumab

2017

Completed Phase 2

~2010

0 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,665 Previous Clinical Trials

40,925,666 Total Patients Enrolled

8 Trials studying Oral Cancers

1,753 Patients Enrolled for Oral Cancers

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

Oral Cancers Research Study Groups: Arm B (cisplatin, carboplatin, IMRT, PBRT), Arm C (pembrolizumab)

Oral Cancers 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."

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 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.

All > Squamous Cell Carcinoma