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AHR Antagonist
IK-175 + Nivolumab for Head and Neck Cancer
Phase 1
Waitlist Available
Research Sponsored by Ikena Oncology
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 through study completion including the treatment period (approximately 18 months) and the follow-up period (up to 12 months)
Awards & highlights
Study Summary
This trial will test if a new drug is safe and effective in treating head and neck cancer that has returned or is resistant to other treatments.
Who is the study for?
Adults with head and neck squamous cell carcinoma that's resistant or has come back after PD-1 inhibitor treatment. They must have had platinum-based chemo unless it wasn't suitable for them, be in a decent health state (ECOG 0-2), and have tumors showing some PD-L1. Pregnant women, those with serious heart issues, untreated brain metastases, or conditions affecting drug absorption can't join.Check my eligibility
What is being tested?
The trial is testing the combination of an oral AHR blocker called IK-175 with Nivolumab to see if it's safe and how well it works against cancer that didn't respond to previous treatments. It will also look at how the body processes these drugs and search for markers predicting who might benefit.See study design
What are the potential side effects?
Possible side effects include reactions related to immune system activation by Nivolumab such as inflammation in various organs, skin problems, fatigue, potential digestive disturbances from IK-175, and interactions affecting liver function.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion including the treatment period (approximately 18 months) and the follow-up period (up to 12 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion including the treatment period (approximately 18 months) and the follow-up period (up to 12 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Frequency and severity of adverse events leading to dose modifications and/or treatment discontinuation in subjects receiving IK-175 in combination with nivolumab [Safety and Tolerability]
Frequency and severity of serious adverse events (SAEs) in subjects receiving IK-175 in combination with nivolumab [Safety and Tolerability]
Frequency and severity of treatment emergent adverse events (TEAEs) in subjects receiving IK-175 in combination with nivolumab [Safety and Tolerability]
+4 moreSecondary outcome measures
PK of IK-175 when administered in combination with nivolumab: area under the plasma concentration-time curve (AUC)
PK of IK-175 when administered in combination with nivolumab: maximum serum concentration (Cmax)
Serum
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Cohort 2Experimental Treatment1 Intervention
450 mg q12h PO IK-175 + nivolumab
Group II: Cohort 1Experimental Treatment1 Intervention
600 mg qd PO IK-175 + nivolumab
Find a Location
Who is running the clinical trial?
Ikena OncologyLead Sponsor
5 Previous Clinical Trials
639 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,514 Total Patients Enrolled
Katherine Kim, MDStudy DirectorIkena Oncology
1 Previous Clinical Trials
198 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My tumor tests positive for PD-L1.I can take care of myself and am up and about more than half of my waking hours.I have a serious heart condition as defined in the study.I have been treated with an AHR inhibitor before.I do not have any severe illnesses that are not under control.I have recovered from major side effects of my previous treatments.I am not pregnant or breastfeeding.My cancer's HPV status does not affect my eligibility.I have had platinum-based chemotherapy for my cancer unless it was not suitable for me.I am taking a medication that cannot be replaced and is affected by certain liver enzymes.I have a condition that affects my ability to take pills or absorb them.I have brain tumors or metastases that are either untreated or causing symptoms.My head or neck cancer has worsened within 3 months after starting PD-1 inhibitor treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1
- Group 2: Cohort 2
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.
How many medical settings are conducting this clinical evaluation?
"This clinical trial is taking place at 4 different sites, located in Seattle, Chicago, Saint Louis and beyond. To help reduce travel time for participants who are accepted into the study, be sure to select a location nearest you."
Answered by AI
What are the principal ends this research seeks to accomplish?
"The key metric of this clinical trial that will be monitored over an 18-month period with up to 6 months post-treatment followup is duration of response (DOR). Additionally, the pharmacokinetics parameters such as area under the plasma concentration-time curve (AUC), half life (t1/2) and minimum serum concentration (Cmin) are being evaluated."
Answered by AI
Has the administration granted authorization for IK-175 plus nivolumab?
"Given the limited data backing up its efficacy and safety, our Power team rated IK-175 + nivolumab at a 1 on their scale."
Answered by AI
Are there opportunities to participate in this research available for individuals?
"Data on clinicaltrials.gov reveals that this trial, originally posted in September 1st 2022 and last updated 22nd of the same month, is no longer looking for participants; however, there are thousands of other medical studies currently recruiting patients."
Answered by AI
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