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Chemotherapy

Cemiplimab + Chemotherapy/Immunotherapy for Head and Neck Cancer

Q: What medical conditions is Cemiplimab typically administered to treat?

<p>Cemiplimab can be used to combat <a href="https://www.withpower.com/clinical-trials/lymphoma">lymphoma</a>, non-Hodgkin's disease, and early stage non-<a href="https://www.withpower.com/clinical-trials/small-cell-lung-cancer">small cell lung cancer</a>.</p>

Phase 1

Recruiting

Led By Lara Dunn, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Adequate hepatic function: Total bilirubin <1.5 x upper limit of normal ULN), Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both < 3 x ULN, Alkaline phosphatase (ALP) <2.5 x ULN Note: For patients with Gilbert syndrome, total bilirubin <3x ULN. Upper central must be documented appropriately as past medical history

Serum creatinine <1.5 upper limit of normal (ULN) or estimated creatinine clearance (CrCl) >30 mL/min

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial is testing whether a new immunotherapy drug combo can replace radiation for head and neck cancer patients.

Who is the study for?

This trial is for adults over 18 with certain types of head and neck cancer that can be surgically removed. They must have good blood counts, organ function, no distant metastasis, and not have had prior radiation or systemic therapy for the cancer. Excluded are those with recent serious infections, autoimmune disorders treated in the last 5 years (with some exceptions), live vaccines taken within a month, HIV/HBV/HCV unless controlled, history of immune-related pneumonitis or solid organ transplant.Check my eligibility

What is being tested?

The study tests if combining standard chemotherapy with immunotherapy drugs cetuximab and cemiplimab before surgery is safe and effective enough to potentially skip post-surgery radiation. Participants will receive this combination treatment to see how well it works against head and neck cancers.See study design

What are the potential side effects?

Possible side effects include reactions related to the immune system such as inflammation in various organs, infusion reactions from receiving drugs through a vein, fatigue, skin rashes like acne or dry skin due to cetuximab; cemiplimab may cause similar issues along with potential impacts on liver enzymes.

Eligibility Criteria

Inclusion Criteria

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

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My liver tests are within normal limits, or slightly above if I have Gilbert syndrome.

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My kidney function is within the normal range.

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My cancer is at a stage where surgery followed by radiation or chemotherapy is recommended, without spread to distant parts of the body.

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I am fully active and can carry on all my pre-disease activities without restriction.

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My cancer is a type of squamous cell carcinoma located in the head or neck area.

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I am eligible for surgery.

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I have head and neck cancer that can be removed by surgery and I haven't had radiation or systemic therapy before.

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My condition can be treated with surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year 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 toxicities graded according to NCI CTCAE

Trial Design

1Treatment groups

Experimental Treatment

Group I: Head and Neck Squamous Cell Cancer/HNSCCExperimental Treatment7 Interventions

Participants with locally advanced, resectable head and neck squamous cell carcinoma for which standard-of-care management would entail definitive surgery followed by adjuvant radiation +/- concurrent chemotherapy are eligible.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Post-operative radiation therapy

2003

Completed Phase 2

~50

Cisplatin

2013

Completed Phase 3

~1940

Carboplatin

2014

Completed Phase 3

~6670

Docetaxel

1995

Completed Phase 4

~5620

Cetuximab

2011

Completed Phase 3

~2480

Cemiplimab

2015

Completed Phase 3

~1340

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,935 Previous Clinical Trials

588,825 Total Patients Enrolled

Regeneron PharmaceuticalsIndustry Sponsor

617 Previous Clinical Trials

380,175 Total Patients Enrolled

Lara Dunn, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

2 Previous Clinical Trials

80 Total Patients Enrolled

Media Library

Carboplatin (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04722523 — Phase 1

Head and Neck Cancers Research Study Groups: Head and Neck Squamous Cell Cancer/HNSCC

Head and Neck Cancers Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT04722523 — Phase 1

Carboplatin (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04722523 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the scope of participants currently undergoing this research trial?

"Affirmative. The information posted on clinicaltrials.gov suggests that this medical experiment is presently recruiting subjects, with an original posting of January 20th 2021 and a last edit on October 5th 2022. A total of 10 patients must be enrolled from 6 distinct sites."

Answered by AI

Is the recruitment for this experiment still ongoing?

"As indicated on clinicaltrials.gov, this medical study is currently recruiting patients who meet the criteria. The trial was initially posted on January 20th 2021 and its most recent update took place in October 5th 2022."

Answered by AI

Has Cemiplimab been investigated in other research projects?

"In 1997, cemiplimab was first studied at City of Hope Comprehensive Cancer Center. There have been a total of 2523 completed studies to date and currently 1496 active clinical trials are in operation, mainly based out of Basking Ridge, New jersey."

Answered by AI

How many different sites are involved in this scientific inquiry?

"At present, 6 clinics are administering this clinical trial. These locations include Basking Ridge, Middletown and Harrison as well as 3 other sites. To minimize travel burdens associated with participation, it is suggested that you choose the medical centre closest to your home."

Answered by AI

What medical conditions is Cemiplimab typically administered to treat?

"Cemiplimab can be used to combat lymphoma, non-Hodgkin's disease, and early stage non-small cell lung cancer."

Answered by AI

Has Cemiplimab been granted sanctioning by the FDA?

"Cemiplimab's safety is estimated to be a 1 on the scale of risk due to its status as a Phase 1 trial, where there are few studies available that prove efficacy or confirm safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Cemiplimab With Chemotherapy and Immunotherapy in People With Head and Neck Cancer

2021. "A Study of Cemiplimab With Chemotherapy and Immunotherapy in People With Head and Neck Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04722523.

All > Hnscc