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Triple Drug Combo for Head and Neck Cancer
Study Summary
This trialtests if a combination of 3 drugs is more effective than one drug for treating advanced head and neck cancer.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- My cancer is in my throat, mouth, or voice box.My tumor is invading major blood vessels and causing active bleeding.I do not have active brain metastases or have had brain radiation in the last 4 weeks.I am fully active or can carry out light work.My head or neck cancer can't be treated with the intent to cure, and I haven't refused surgery that could potentially cure a recurrence.My tumor is PD-L1 positive with a score of 1% or higher.I can provide tissue samples for testing or am willing to have a biopsy.I have not had any drug treatments for my recurrent or metastatic head and neck cancer.I haven't had cancer treatment or been in a clinical study in the last 21 days.I haven't had major chest radiation or palliative radiation in the last week.My cancer is not in my nasopharynx, sinonasal cavity, or salivary glands.My cancer came back or got worse within 6 months after my last treatment.I still have side effects from previous treatments that are not mild.I still have side effects from previous cancer treatments or surgeries.My throat cancer's HPV status is documented.
- Group 1: Treatment Group 2: Retifanlimab + INCAGN02385
- Group 2: Treatment Group 3: Retifanlimab + INCAGN02385 + INCAGN02390
- Group 3: Treatment Group 1: Retifanlimab Monotherapy
- 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
How many human subjects are involved in this experiment?
"The sponsor, Incyte Biosciences International Sàrl, needs 162 patients that match the clinical trial's inclusion criteria to begin. The trial will be conducted at different locations including Innovative Clinical Research Institute in Long Beach, California and Fox Chase Cancer Center in Philadelphia, Pennsylvania."
Which age group is this research project meant for?
"This research is only enrolling patients aged 18 to 99, which differentiates it from the 94 other trials conducted for minors and the 2971 senior citizen studies."
Are we still enrolling people for this experiment?
"Yes, that is accurate. The listing on clinicaltrials.gov includes information suggesting that the trial is still open for recruitment. This particular study was posted on November 14th, 2020 and updated on the 15th of November, 2020. They are looking to have a total of 162 patients enrolled from 22 different sites."
Are there different groups of patients being studied in various parts of the country?
"There are 22 clinical trial sites for this study, which are situated in Long Beach, Philadelphia, Montreal and other various locations. To limit travel costs and time, please select the location nearest you."
What is the FDA's official stance on the use of Retifanlimab + INCAGN02385 + INCAGN02390?
"This is a Phase 2 trial, so while there is some data supporting safety, none of it supports efficacy. Therefore, our team at Power has given Treatment Group 3: Retifanlimab + INCAGN02385 + INCAGN02390 a score of 2 for safety."
Who would be an ideal candidate for this research project?
"This clinical trial is looking for 162 participants that have been diagnosed with head and neck cancer. The age range for applicants is 18 to 99 years old. There are several notable eligibility requirements that potential participants should be aware of, which are listed below: •Histologically or cytologically confirmed R/M SCCHN that is not amenable to therapy with curative intent •Participants who refuse potentially curative salvage surgery for recurrent disease are ineligible •Eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx •Participants must not"
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