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Combination Immunotherapy for Head and Neck Cancer
Study Summary
This trial is testing a new combination therapy for advanced head and neck cancer. The therapy consists of CIML NK donor cells, IL-15 superagonist, and ipilimumab. The purpose of this study is to evaluate the safety and efficacy of this new therapy.
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
- I have received an organ transplant from another person.My heart pumps well, with an ejection fraction over 40%.I am 18 years old or older.I do not have autoimmune diseases like Crohn's, lupus, or rheumatoid arthritis, but I can have Hashimoto's thyroiditis.I have a lung condition not caused by infection.I do not have brain metastases.My organ and bone marrow functions are normal.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.I do not have nasopharyngeal carcinoma.I haven't had chemotherapy, immunotherapy, or experimental treatments recently.My blood, liver, kidney functions, and heart are all within normal ranges.I do not have active, uncontrolled hepatitis B or C.My cancer is a confirmed recurrent or metastatic squamous cell carcinoma of the head, neck, or salivary gland.My oropharyngeal cancer's HPV status is known.I do not have HIV due to potential treatment complications.I can take care of myself and do some daily activities.I agree to use effective birth control during and up to 26 weeks after the study.My kidney function is normal or nearly normal.I have had treatments with platinum and PD-1/L1 inhibitors for my head and neck cancer.I have not received a live vaccine in the last 30 days.I am not pregnant or breastfeeding.I haven't taken more than 10 mg of steroids daily for non-autoimmune reasons in the last 4 weeks.I am willing to give blood and tissue samples when diagnosed and during surgery.
- Group 1: Cohort 2 with Ipilimumab Lead In
- Group 2: Cohort 3 with Cetuximab Infusions
- Group 3: Cohort I without Ipilimumab Lead in
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What are the primary conditions that CIML NK cell Infusion is used to manage?
"CIML NK cell Infusion has been traditionally used to treat cutaneous melanoma. However, it has also been used as an effective treatment for complete resection, liver carcinoma, and metastatic melanoma."
What is the current government opinion on CIML NK cell Infusion?
"CIML NK cell Infusion is still in Phase 1 of clinical trials, meaning that safety and efficacy have not been widely studied yet. As such, our team has scored it a 1 in terms of safety."
Are there any more potential candidates that could join this trial?
"That is correct, the listing on clinicaltrials.gov currently says that the study is recruiting patients. This particular trial was posted on July 20th, 2020 and was last updated on April 14th, 2022. The trial is only looking for 12 patients at a single location."
What is the precedent for CIML NK cell Infusion?
"At the current moment, there are 349 ongoing clinical trials researching CIML NK cell Infusion. 41 of those are in Phase 3. The city with the most trials for this treatment is Pittsburgh, Pennsylvania, but there are 21321 locations running studies for this treatment."
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