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Pembrolizumab + IO102-103 for Head and Neck Cancer (KIEO Trial)
Phase 2
Recruiting
Led By Tanguy Seiwert, M.D.
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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 5 years
Awards & highlights
KIEO Trial Summary
This trial is testing if a combo of drugs is safe to take before surgery for metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN). Careful monitoring for side effects and surgery delays will be done.
Who is the study for?
This trial is for adults with resectable head and neck squamous cell carcinoma who can consent to treatment and surgery. They must have good organ function, not be pregnant or breastfeeding, agree to use contraception, and have no severe heart conditions, active infections, recent cancer treatments or live vaccines. Those with certain other cancers or autoimmune diseases are excluded.Check my eligibility
What is being tested?
The safety of combining Pembrolizumab and IO102-103 before surgery in patients with head and neck squamous cell carcinoma is being tested. The goal is to monitor side effects closely and ensure there's no delay in the scheduled surgery due to these investigational drugs.See study design
What are the potential side effects?
Possible side effects from Pembrolizumab and IO102-103 may include reactions at the infusion site, immune-related issues affecting organs like inflammation or pneumonitis (lung problems), fatigue, allergic reactions, as well as potential delays in planned surgeries.
KIEO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pathologic Treatment Response rate
Secondary outcome measures
Disease progression
Major Pathologic Response
Overall Safety
+2 moreKIEO Trial Design
1Treatment groups
Experimental Treatment
Group I: Single CohortExperimental Treatment2 Interventions
Neoadjuvant Pembrolizumab ( 400mg IV infusion x1) + IO102-103 ( Subcutaneous injection weekly x6)
Adjuvant Pembrolizumab ( 400 mg IV infusion Every 6 weeks x8) + IO102-103 ( Subcutaneous injection every 3 week x6 then every 6 weeks x5)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
IO BiotechIndustry Sponsor
8 Previous Clinical Trials
764 Total Patients Enrolled
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
558 Previous Clinical Trials
32,904 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,892 Previous Clinical Trials
5,061,131 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated with specific immune therapy for cancer.I have a history of Hepatitis B or C.I have another cancer besides skin cancer that hasn't needed treatment in the last 2 years.I have not had a recent heart attack or serious heart conditions.I have received an organ or tissue transplant from another person.My cancer is at a stage that can be removed with surgery.I am fully active or restricted in physically strenuous activity but can do light work.I am a male and agree to use contraception or practice abstinence during and for 120 days after the study.I have had treatment for head and neck cancer within the last 4 weeks.I have not received a live vaccine within the last 30 days.I have a non-bulky squamous cell carcinoma in my head or neck and need surgery.I am at least 18 years old.My tumor is small and recommended for surgery by a tumor board.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.My organs are functioning well.I am considered a good candidate for surgery aimed at curing my condition.My brain metastases are stable and haven't progressed in the last 4 weeks.I agree to have a biopsy before and during treatment. A biopsy if the disease worsens is optional.I am using two birth control methods or am not having sex to join this study.I had radiotherapy over 2 weeks ago, recovered from side effects, and didn't have lung inflammation.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.
Research Study Groups:
This trial has the following groups:- Group 1: Single Cohort
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.
Are there still opportunities for participants to join this research?
"According to clinicaltrials.gov, the trial in question is not currently seeking participants; it was initially posted on September 1st 2023 and last updated August 2nd 2023. Even so, there are presently 2738 other trials actively recruiting patients."
Answered by AI
Has the Single Cohort approach been accepted by the FDA?
"Our team at Power scores Single Cohort's safety as a 2, since its status as a Phase 2 trial indicates that there is some data validating the therapy's protective properties but no such evidence for effectiveness."
Answered by AI
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