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IDH1 Inhibitor
Ivosidenib + Nivolumab for Solid Tumors
Phase 2
Waitlist Available
Led By Jason J Luke, MD, PhD
Research Sponsored by Jason J. Luke, MD
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 at 8 weeks after first treatment; up to 14 months for cohort
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a daily pill and a regular IV treatment in patients with advanced tumors that can't be removed or have spread. These patients have a specific genetic mutation and can't be cured by other treatments. The pill stops tumor growth, and the IV boosts the immune system to fight cancer.
Eligible Conditions
- Isocitrate Dehydrogenase 1 Mutation
- Brain Tumor
- Solid Tumors
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 8 weeks after first treatment; up to 14 months for cohort
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 8 weeks after first treatment; up to 14 months for cohort
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Best Overall Response
Six Month Progression-Free Survival (PFS6)
Secondary study objectives
Adverse Events Related to Treatment
Occurrence of dose limiting toxicity (DLT)
Progression Free Survival (PFS)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Concurrent dosing of ivosidenib and nivolumabExperimental Treatment1 Intervention
Ivosidenib will be administered concurrently with nivolumab on a Q28 day schedule.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ivosidenib and nivolumab
2021
Completed Phase 2
~20
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Who is running the clinical trial?
Bristol-Myers SquibbIndustry Sponsor
2,682 Previous Clinical Trials
4,129,553 Total Patients Enrolled
Jason J. Luke, MDLead Sponsor
4 Previous Clinical Trials
700 Total Patients Enrolled
Agios Pharmaceuticals, Inc.Industry Sponsor
53 Previous Clinical Trials
4,165 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are taking medications that can either make the study drug less effective or increase its side effects.You are allergic to any of the ingredients in ivosidenib or nivolumab.You have had a serious heart condition within the past 6 months before starting the study treatment.You have previously taken a medication called an IDH inhibitor.You have received radiation therapy to areas where the disease has spread less than 2 weeks before the start of the study.You have an autoimmune disease that has required medication to treat in the past 2 years.You have brain metastases (cancer that has spread to the brain) that are causing symptoms and require treatment with steroids.You have another type of cancer that is currently growing or needs treatment, and it may affect the accuracy of the study results.You are currently taking medications that can interact with P-glycoprotein transporter and have a narrow range for safe and effective use.You are taking medications that can affect your heart rhythm.You have any other ongoing medical or mental health condition that could make it risky for you to take part in the study or might make it hard to understand the study results.You have a serious infection that needs strong medicine or have had a high fever within the past week without a clear reason.You have had treatments for your liver such as radiation, chemoembolization, or radiofrequency ablation within the past 4 weeks before the start of the study.You have had a type of lung inflammation called non-infectious pneumonitis that needed to be treated with steroids.You have been diagnosed with an advanced solid tumor that cannot be cured and have already tried the usual treatments.You have fully recovered from any side effects or problems caused by previous cancer treatments.Your bone marrow is working properly.
Research Study Groups:
This trial has the following groups:- Group 1: Concurrent dosing of ivosidenib and nivolumab
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.
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