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Alkylating agents
Cemiplimab + Chemotherapy for Head and Neck Cancer
Phase 2
Recruiting
Led By Marcelo R Bonomi, MD
Research Sponsored by Marcelo Bonomi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
At least one measurable lesion as defined by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 on screening computed tomography (CT) or magnetic resonance imaging (MRI)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing cemiplimab in combination with paclitaxel and carboplatin to treat squamous cell carcinoma of the head and neck.
Who is the study for?
Adults with recurrent or metastatic squamous cell carcinoma of the head and neck, who haven't had systemic therapy for this condition before. Participants must have proper kidney function, no recent vaccines, not be on immunosuppressants, and agree to use contraception. Excluded are those with certain heart conditions, active infections like HIV or hepatitis B/C, known brain metastases unless stable, or a history of pneumonitis.Check my eligibility
What is being tested?
The trial is testing cemiplimab (an immune system-boosting monoclonal antibody) combined with low-dose paclitaxel and carboplatin (chemotherapy drugs). The goal is to see if this combination is more effective in stopping cancer growth compared to other treatments for head and neck cancers that have spread or returned after treatment.See study design
What are the potential side effects?
Possible side effects include immune-related reactions due to cemiplimab such as inflammation in organs; chemotherapy-related issues like nausea, hair loss from paclitaxel; fatigue; blood cell count changes leading to increased infection risk; and potential allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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I have at least one tumor that can be measured on a CT or MRI scan.
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I am 18 years old or older.
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My cancer has returned or spread and is located in my mouth, throat, voice box, or the area below my pharynx.
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It has been at least 4 weeks since my last cancer treatment or surgery.
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I haven't received any systemic therapy for my recurrent/metastatic disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Heart rate
Secondary outcome measures
Incidence of adverse events
Overall survival (OS)
Progression-free survival (PFS)
Other outcome measures
Squamous cell carcinoma
OS of patients with CPS < 1%, > 1%, and > 20%
PFS of patients with combined positive score (CPS) < 1%, > 1%, and > 20%
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (cemiplimab, paclitaxel, carboplatin)Experimental Treatment3 Interventions
Patients will be treated with a combination of cemiplimab 350 mg every three weeks, with weekly combination of paclitaxel 25 mg/m2 and carboplatin AUC 1. Treatment will continue for a total of 24 months or until disease progression or unacceptable toxicity. Weekly chemotherapy will stop after six months of treatment (24 weeks). A ten patient safety run-in phase will be initially performed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
2011
Completed Phase 4
~5380
Cemiplimab
2015
Completed Phase 3
~1340
Carboplatin
2014
Completed Phase 3
~6670
Find a Location
Who is running the clinical trial?
Marcelo BonomiLead Sponsor
Marcelo R Bonomi, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have HIV, hepatitis B, or hepatitis C.I am fully active or can carry out light work.Your creatinine level in the blood is less than or equal to 1.6 milligrams per deciliter.I have at least one tumor that can be measured on a CT or MRI scan.I have not received any live vaccines in the last 30 days.I am 18 years old or older.Your total bilirubin level in your blood should be no higher than 1.6 mg/dL.I haven't had serious heart problems like heart failure or a heart attack in the last 6 months.I am not pregnant or breastfeeding.My cancer has returned or spread and is located in my mouth, throat, voice box, or the area below my pharynx.Your liver enzymes (AST and ALT) are not more than 2.5 times the normal level.My cancer is p-16 positive squamous cell carcinoma from an unknown primary, treated for head and neck cancer before.I have been treated with antibody-based immunotherapy before.I have been treated with PI3K inhibitors before.I have had pneumonitis in the last 5 years.It has been at least 4 weeks since my last cancer treatment or surgery.You have a high level of a type of white blood cell called neutrophils.You have enough platelets in your blood (at least 100,000 cells per microliter).Your hemoglobin level is at least 9 grams per deciliter.Your potassium levels are not too low.If you are a woman who could become pregnant, you need to have a negative pregnancy test before starting the study.Your white blood cell count is higher than 2,500 cells per microliter.My condition can be treated with the aim of curing it.My condition needs steroids or other drugs to suppress my immune system.My brain metastases have been stable for at least 21 days.My cancer is in the nasopharynx, salivary glands, lip, or sinonasal area.I haven't received any systemic therapy for my recurrent/metastatic disease.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (cemiplimab, paclitaxel, carboplatin)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the most popular use for Paclitaxel?
"Paclitaxel is an effective therapy for treating palliative care patients, those with malignant peritoneal neoplasms, and metastatic cutaneous squamous cell carcinomas."
Answered by AI
Could you please list other instances where Paclitaxel has been used in medical trials?
"At the moment, there are 1281 ongoing studies that involve paclitaxel. Of these trials, 346 are in phase 3. Not only is Shanghai conducting several of these trials, but there are 68535 locations around the world where paclitaxel studies are taking place."
Answered by AI
How many patients are being included in this trial?
"That is correct, the online clinicaltrials.gov registry currently lists this study as actively recruiting patients. This particular trial was first made public on November 30th, 2021 and has since been updated on May 18th, 2022. They are looking for 42 individuals to participate at 1 locations."
Answered by AI
Could you explain the risks associated with Paclitaxel?
"Paclitaxel is a Phase 2 medication, which means that while there is evidence suggesting it is safe, there is no data showing that it is effective."
Answered by AI
Are people currently being signed up for this research project?
"This particular clinical trial, which was brought to the public's attention on November 30th 2021, is still searching for volunteers. The listing was updated as recently as May 18th 2022."
Answered by AI
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