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Monoclonal Antibodies
Combination Immunotherapy for Head and Neck Cancer
Phase 1
Recruiting
Led By Glenn Hanna, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Left ventricular ejection fraction (cardiac function) > 40%
Age 18 years or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
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.
Who is the study for?
Adults with advanced head and neck cancer, including oral cavity or salivary gland carcinoma, who've had platinum-based treatment and PD-1/L1 inhibitor therapy. They must have good organ function, no severe allergies to study drugs, not be pregnant or breastfeeding, agree to contraception use during the trial and for some time after. Excludes those with nasopharyngeal carcinoma, recent other treatments or uncontrolled illnesses.Check my eligibility
What is being tested?
The trial is testing a combination of CIML NK donor cells (a type of immune cell), IL-15 superagonist (boosts immune response), Ipilimumab and Cetuximab (cancer-targeting drugs) in patients with recurrent or metastatic squamous cell carcinoma of the head and neck. It aims to assess safety and effectiveness.See study design
What are the potential side effects?
Potential side effects include allergic reactions similar to components in the study drugs, increased risk of infections due to suppressed marrow from chemotherapy regimen used alongside N-803/CIML NK cells infusion. There's also a concern for liver toxicity in hepatitis B/C patients.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart pumps well, with an ejection fraction over 40%.
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I am 18 years old or older.
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My blood, liver, kidney functions, and heart are all within normal ranges.
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My cancer is a confirmed recurrent or metastatic squamous cell carcinoma of the head, neck, or salivary gland.
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I can take care of myself and do some daily activities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of Dose Limiting Toxicity
Secondary outcome measures
complete response (CR) rate
disease-free survival (DFS)
objective response rate (ORR)
+1 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Cohort I without Ipilimumab Lead inExperimental Treatment2 Interventions
Haploidentical donor derived CIML NK cell infusion with subcutaneous N-803 for eligible patients with platinum-refractory and immune checkpoint blockade-refractory, advanced head and neck squamous cell carcinoma (Cohort 1)
CIML NK cell infusion (Dose 0 or -1) infused on Day 0.
Interleukin-15 Superagonist dosed at 15 mcg/kg subcutaneously every 21 days for 4 total doses (a cycle being every 21-days, so 4 cycles).
Group II: Cohort 3 with Cetuximab InfusionsExperimental Treatment3 Interventions
Cohort 3 treated with CIML NK cell infusion after safety is established with the NK cell and N-803 treatments alone, followed by cetuximab infusions.
- Participants in cetuximab subgroup (Cohort 3) will receive lymphodepleting chemotherapy on Day -6 for a total of 5-days, prior to receiving CIML NK cell infusion.
CIML NK cell infusion-Highest Dosed per cohort 1, infused on day 0
Interleukin-15 Superagonist (N-803) Administration
-- dosed at 15 mcg/kg subcutaneously every 21 days for 4 total doses (a cycle being every 21-days, so 4 cycles).
Cetuximab Administration
--dosed at 500mg/m2 IV over 120 minutes for the first dose, then over 60 minutes for subsequent doses. This will be infused every 14 days for 8 doses started on day +15.
Cohort 3 will receive the highest number of CIML NK cells that is still considered safe and ipilimumab.
Group III: Cohort 2 with Ipilimumab Lead InExperimental Treatment3 Interventions
Cohort 2 treated with an ipilimumab lead-in prior to CIML NK cell infusion after safety is established with the NK cell and N-803 treatments alone.
Participants in the ipilimumab subgroup (Cohort 2) will receive a single dose of lead-in ipilimumab via iv per protocol determined dose followed by lymphodepleting chemotherapy on Day -6 for a total of 5-days, prior to receiving CIML NK cell infusion.
CIML NK cell infusion-Highest Dosed per cohort 1, infused on day 0
Interleukin-15 Superagonist (N-803) Administration
-- dosed at 15 mcg/kg subcutaneously every 21 days for 4 total doses (a cycle being every 21-days, so 4 cycles).
Cohort 2 will receive the highest number of CIML NK cells that is still considered safe and ipilimumab.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
2014
Completed Phase 3
~2620
Cetuximab
2011
Completed Phase 3
~2480
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,923 Total Patients Enrolled
Altor BioScienceIndustry Sponsor
17 Previous Clinical Trials
571 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,639 Previous Clinical Trials
4,129,007 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 2 with Ipilimumab Lead In
- Group 2: Cohort 3 with Cetuximab Infusions
- Group 3: Cohort I without Ipilimumab Lead in
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 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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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