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Monoclonal Antibodies
Pembrolizumab + Cetuximab for Head and Neck Cancer
Phase 2
Waitlist Available
Led By Assuntina Sacco, M.D.
Research Sponsored by University of California, San Diego
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 or 1
Histologically or cytologically proven squamous cell carcinoma of the head and neck (lip, oral cavity, oropharynx, larynx, hypopharynx, non-EBV related nasopharynx, sinonasal, cutaneous), not amenable to curative intent therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 9 weeks from first on-treatment scan until disease progression or patient withdrawal from study or date of death from any cause, whichever came first, assessed up to 36 months
Awards & highlights
Study Summary
This trial will evaluate the efficacy of a combination of two drugs, pembrolizumab and cetuximab, for patients with recurrent or metastatic head and neck squamous cell carcinoma. There will be four groups of patients, including those who have not received either of the drugs before, those who have not received pembrolizumab but have received cetuximab, those who have received pembrolizumab but not cetuximab, and those with cutaneous head and neck squamous cell carcinoma. A total of 83 patients will be enrolled at four sites.
Who is the study for?
This trial is for adults with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) that can't be treated with surgery or radiation. Participants must have good organ function, performance status of 0 or 1, and not be pregnant or planning to become pregnant. They should agree to use contraception and have not received certain treatments before the study.Check my eligibility
What is being tested?
The trial tests a combination therapy using Pembrolizumab and Cetuximab in four different patient groups based on their previous treatments. It's an open-label phase II study across multiple centers aiming to enroll a total of 83 patients who will receive this combined treatment.See study design
What are the potential side effects?
Potential side effects include allergic reactions, fatigue, skin rash, diarrhea, low blood counts increasing infection risk, liver inflammation, kidney issues, lung problems like pneumonitis (lung tissue swelling), as well as other immune-related adverse events.
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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My cancer in the head or neck area cannot be cured with surgery or radiation.
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My condition did not improve with platinum-based treatment or I cannot receive it.
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I have at least one tumor that can be measured.
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I agree to follow strict birth control measures or abstain from sex during and 120 days after the study.
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My cancer progressed after initially responding to PD-1/PD-L1 inhibitor therapy.
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My skin cancer cannot be treated with surgery or radiation.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 9 weeks from first on-treatment scan until disease progression or patient withdrawal from study or date of death from any cause, whichever came first, assessed up to 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 9 weeks from first on-treatment scan until disease progression or patient withdrawal from study or date of death from any cause, whichever came first, assessed up to 36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response Rate
Secondary outcome measures
Correlative analyses
Duration of Response
Number of patients with grade 3 through grade 5 adverse events that are related to pembrolizumab and cetuximab, graded according to NCI CTCAE v4.03
+2 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Cohort 4Experimental Treatment1 Intervention
cutaneous HNSCC
Pembrolizumab (Keytruda®):
Pembrolizumab is administered on an outpatient basis. 200 mg pembrolizumab will be administered as a 30 minute (-5 min/+10 min) intravenous (IV) infusion every 3 weeks.
Cetuximab (Erbitux®):
The initial cetuximab dose of 400mg/m2 is administered on Cycle 1, Day 1 as a 120-minute IV infusion (maximum infusion rate 10mg/min).1 Subsequent weekly cetuximab doses of 250mg/m2 are administered as 60-minute IV infusions (maximum infusion rate 10mg/min).
Group II: Cohort 3Experimental Treatment1 Intervention
PD-1/PD-L1 inhibitor-refractory, cetuximab-refractory
Pembrolizumab (Keytruda®):
Pembrolizumab is administered on an outpatient basis. 200 mg pembrolizumab will be administered as a 30 minute (-5 min/+10 min) intravenous (IV) infusion every 3 weeks.
Cetuximab (Erbitux®):
The initial cetuximab dose of 400mg/m2 is administered on Cycle 1, Day 1 as a 120-minute IV infusion (maximum infusion rate 10mg/min).1 Subsequent weekly cetuximab doses of 250mg/m2 are administered as 60-minute IV infusions (maximum infusion rate 10mg/min).
Group III: Cohort 2Experimental Treatment1 Intervention
PD-1/PD-L1 inhibitor-refractory, cetuximab-naïve
Pembrolizumab (Keytruda®):
Pembrolizumab is administered on an outpatient basis. 200 mg pembrolizumab will be administered as a 30 minute (-5 min/+10 min) intravenous (IV) infusion every 3 weeks.
Cetuximab (Erbitux®):
The initial cetuximab dose of 400mg/m2 is administered on Cycle 1, Day 1 as a 120-minute IV infusion (maximum infusion rate 10mg/min).1 Subsequent weekly cetuximab doses of 250mg/m2 are administered as 60-minute IV infusions (maximum infusion rate 10mg/min).
Group IV: Cohort 1Experimental Treatment1 Intervention
PD-1/PD-L1 inhibitor-naïve, cetuximab-naïve
Pembrolizumab (Keytruda®):
Pembrolizumab is administered on an outpatient basis. 200 mg pembrolizumab will be administered as a 30 minute (-5 min/+10 min) intravenous (IV) infusion every 3 weeks.
Cetuximab (Erbitux®):
The initial cetuximab dose of 400mg/m2 is administered on Cycle 1, Day 1 as a 120-minute IV infusion (maximum infusion rate 10mg/min).1 Subsequent weekly cetuximab doses of 250mg/m2 are administered as 60-minute IV infusions (maximum infusion rate 10mg/min).
Find a Location
Who is running the clinical trial?
University of California, San DiegoLead Sponsor
1,120 Previous Clinical Trials
1,521,557 Total Patients Enrolled
Assuntina G. Sacco, MDLead Sponsor
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,493 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had major surgery or fully recovered from surgery within the last 14 days.I am a woman able to have children and have a recent negative pregnancy test.I am fully active or can carry out light work.I have an autoimmune disease treated with medication in the last 2 years.I haven't had chemotherapy or radiotherapy in the last 4 weeks, except for palliative care.I haven't had any cancer treatment with monoclonal antibodies in the last 4 weeks or I've recovered from their side effects.I had a severe reaction to previous immunotherapy.I have another cancer besides the one being studied, but it's either not progressing or doesn't need active treatment, except for certain skin cancers or cervical cancer that's been treated.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I have a long-term lung condition affecting the tissue and space around the air sacs.I am currently being treated for an infection.I have active Hepatitis B or C, or I am an HIV carrier.I have not received a live vaccine in the last 30 days.My cancer in the head or neck area cannot be cured with surgery or radiation.My condition did not improve with platinum-based treatment or I cannot receive it.I have at least one tumor that can be measured.I agree to follow strict birth control measures or abstain from sex during and 120 days after the study.I agree to use contraception during and up to 120 days after the study.My cancer progressed after initially responding to PD-1/PD-L1 inhibitor therapy.My skin cancer cannot be treated with surgery or radiation.My cancer originates in my salivary gland.I have never received cetuximab for recurrent or metastatic cancer.You had a severe reaction to cetuximab in the past.I have never received PD-1 or PD-L1 inhibitor immunotherapy.My blood, liver, and kidney functions are all within normal ranges.I have a history of or currently have non-infectious lung inflammation.I have cancer that has spread to my brain or spinal cord.I am 18 years old or older.I have an active tuberculosis infection.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 2
- Group 2: Cohort 4
- Group 3: Cohort 1
- Group 4: Cohort 3
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 indications are Pembrolizumab and Cetuximab prescribed for?
"Pembrolizumab and Cetuximab are primarily employed to combat unresectable melanoma, though they can also be effectual in managing microsatellite instability high, cases with a heightened risk of relapse, or when patients cannot tolerate irinotecan."
Answered by AI
Are there still opportunities to participate in this scientific experiment?
"According to the official clinicaltrials.gov page, this medical trial is not currently enrolling patients despite having been initially posted on March 28th 2017 and last updated October 11th 2022. Nevertheless, there are 4193 other studies actively recruiting at present."
Answered by AI
Are there a plethora of medical centers undertaking this study in the urban area?
"The University of Michigan Cancer Center in Ann Arbor, UCSD Moores Cancer Center in La Jolla, and Washington School of Medicine Cancer Center are three locations that offer the study. An additional four medical centres also have access to this trial."
Answered by AI
What risks do patients face when using Pembrolizumab or Cetuximab?
"As Pembrolizumab and Cetuximab are in Phase 2 of the clinical trial process, there is some evidence that they may be safe. As such, Power has assigned them a score of 2 on its safety scale."
Answered by AI
How many participants are eligible to join the experiment?
"No longer looking for patients, this trial was initially posted on March 28th 2017 and the last update to it was October 11th 2022. If you are still in search of research studies, there are presently 3123 trials actively recruiting individuals with head neoplasms and 1070 medical investigations focusing on Pembrolizumab and Cetuximab that require participants."
Answered by AI
Are there any existing investigations into the efficacy of Pembrolizumab and Cetuximab?
"Initially researched in 2007 at Saint Bartholomew's Hospital, the pembrolizumab-cetuximab combination has been explored in 616 finalized studies to date. Currently there are 1070 active trials of this medication, with numerous sites based in Ann Arbor, Michigan."
Answered by AI
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