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Monoclonal Antibodies

Cetuximab for Squamous Cell Carcinoma

Q: What illnesses does Ipilimumab attempt to palliate?

<p>Ipilimumab is typically used to treat cutaneous <a href="https://www.withpower.com/clinical-trials/melanoma">melanoma</a>, but it can also be beneficial for patients with metastatic melanoma, intermediate risk cases, and those suffering from HNSCC.</p>

Phase 1

Waitlist Available

Led By Robert L Ferris

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is testing the side effects and best dose of ipilimumab given with cetuximab and IMRT for patients with previously untreated head and neck cancer.

Eligible Conditions

Oropharyngeal Carcinoma
Squamous Cell Carcinoma
Laryngeal Squamous Cell Carcinoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of dose limiting toxicities at each dose level assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

Secondary outcome measures

Clinical response by Response Evaluation Criteria in Solid Tumors criteria

HPV status

Myeloid-derived suppressor cell (MDSC) cell counts

+4 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (cetuximab, IMRT, and ipilimumab)Experimental Treatment4 Interventions

Patients receive cetuximab IV over 60-120 minutes on days 1, 8, 15, and 22. Treatment with cetuximab repeats every 4 weeks for 2 courses. Beginning in week 2 of course 1, patients undergo concurrent IMRT 5 days per week for 7 weeks. Beginning in week 4 (day 1 of course 2) patients also receive ipilimumab IV over 90 minutes once every 21 days for 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients achieving disease progression may undergo surgery after completion of therapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cetuximab

2011

Completed Phase 3

~2480

Intensity-Modulated Radiation Therapy

2010

Completed Phase 3

~2160

Ipilimumab

2014

Completed Phase 3

~2620

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,662 Previous Clinical Trials

40,925,862 Total Patients Enrolled

Robert L FerrisPrincipal InvestigatorUniversity of Pittsburgh Cancer Institute (UPCI)

Frequently Asked Questions

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

Are there any other investigations into the use of Ipilimumab in treatment?

"Currently, 437 clinical trials involving ipilimumab are active with 67 of those in Phase 3. Dresden and Arizona have the most research on this drug but there are 25576 total sites conducting studies related to it."

Answered by AI

How many participants are currently being considered for the research study?

"The recruitment period for this clinical trial has concluded, as the last update was made on June 29th 2022. However, there are 2,954 active studies related to stage IVA hypopharyngeal squamous cell carcinoma AJCC v7 and 437 trials that utilize Ipilimumab which remain open to new patients."

Answered by AI

Has Ipilimumab attained the requisite regulatory clearance for commercialization?

"Currently, data on Ipilimumab's safety and efficacy is limited. Therefore, our team at Power assigned a score of 1 to this drug in terms of its security profile."

Answered by AI

Is this research initiative still welcoming participants?

"This experiment has concluded its recruitment of participants. It was initially posted on April 9th 2013 and the description was last amended on June 29th 2022. If you are searching for other clinical trials, there are presently 2,954 studies actively recruiting patients with stage IVA hypopharyngeal squamous cell carcinoma AJCC v7 and 437 research programs looking for volunteers to join a trial involving Ipilimumab."

Answered by AI

What illnesses does Ipilimumab attempt to palliate?

"Ipilimumab is typically used to treat cutaneous melanoma, but it can also be beneficial for patients with metastatic melanoma, intermediate risk cases, and those suffering from HNSCC."

Answered by AI

Recent research and studies

Clinical Cancer ResearchJournal

Phase I Trial of Cetuximab, Radiotherapy, and Ipilimumab in Locally Advanced Head and Neck Cancer

Ferris, Robert L., Jessica Moskovitz, Sheryl Kunning, Ayana T. Ruffin, Carly Reeder, James Ohr, William E. Gooding, et al.. 2022. “Phase I Trial of Cetuximab, Radiotherapy, and Ipilimumab in Locally Advanced Head and Neck Cancer”. Clinical Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1078-0432.ccr-21-0426.

Clinical Cancer ResearchJournal

Phase I Trial of Cetuximab, Radiotherapy, and Ipilimumab in Locally Advanced Head and Neck Cancer

clinicaltrials.govStudy

Ipilimumab, Cetuximab, and Intensity-Modulated Radiation Therapy in Treating Patients With Previously Untreated Stage III-IVB Head and Neck Cancer

2013. "Ipilimumab, Cetuximab, and Intensity-Modulated Radiation Therapy in Treating Patients With Previously Untreated Stage III-IVB Head and Neck Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01935921.