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Ivosidenib + Nivolumab for Solid Tumors
Study Summary
This trial will test a new combination drug treatment for people with advanced solid tumors or brain tumors. Researchers will track how well the treatment works and how safe it is.
- Isocitrate Dehydrogenase 1 Mutation
- Brain Tumor
- Solid Tumors
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?
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- 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.
- Group 1: Concurrent dosing of ivosidenib and nivolumab
- 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
To what health conditions are ivosidenib and nivolumab typically prescribed?
"Ivosidenib and nivolumab can be beneficial to those with malignant neoplasms, unresectable melanoma, or squamous cell carcinoma."
Have ivosidenib and nivolumab been given the green light by the FDA?
"With a score of 2 out of 3, we here at Power have surmised that the combination of ivosidenib and nivolumab is relatively safe. This judgement was based on existing data which indicates safety but not efficacy."
Is this investigation the inaugural of its kind?
"Since 2012, ivosidenib and nivolumab have been subject to ongoing clinical research. Initially funded by Ono Pharmaceutical Co. Ltd., the first trial in 2012 included 659 participants and as a result of its success it was approved for Phase 1 & 2 drug trials. Currently there are 738 active studies involving patients from 2391 cities across 57 countries."
Is there a precedent of utilizing ivosidenib and nivolumab in prior research?
"Currently, 738 investigations into ivosidenib and nivolumab are in progress. Of those studies that are still live, 84 of them have reached Phase 3. While the majority take place in Basel, BE, there is a total of 41 168 clinical trial sites worldwide enrolled for this investigation."
Is enrollment still available for this clinical exploration?
"Clinicaltrials.gov reveals that this investigation is currently seeking participants, with the initial posting taking place on May 17th 2021 and most recent update occurring on March 14th 2022."
What is the uppermost limit of participants for this medical experiment?
"Affirmative. According to the data provided on clinicaltrials.gov, this medical trial is still recruiting patients. This study was launched on May 17th 2021 and updated lastly in March 14th 2022 with an objective of enrolling 35 people from one distinct healthcare facility."
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