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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
Have a histopathological diagnosis of an advanced solid tumor for which curative treatment is not available and have undergone appropriate standard of care treatment options
Have recovered from toxicities associated with prior anticancer therapy to baseline or ≤ grade 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 8 weeks after first treatment; up to 14 months for cohort
Awards & highlights

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.

Eligible Conditions
  • Isocitrate Dehydrogenase 1 Mutation
  • Brain Tumor
  • Solid Tumors

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have been diagnosed with an advanced solid tumor that cannot be cured and have already tried the usual treatments.
Select...
You have fully recovered from any side effects or problems caused by previous cancer treatments.
Select...
Your bone marrow is working properly.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 8 weeks after first treatment; up to 14 months for cohort
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 8 weeks after first treatment; up to 14 months for cohort for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Best Overall Response
Six Month Progression-Free Survival (PFS6)
Secondary outcome measures
Adverse Events Related to Treatment
Occurrence of dose limiting toxicity (DLT)
Progression Free Survival (PFS)

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

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbIndustry Sponsor
2,629 Previous Clinical Trials
4,126,520 Total Patients Enrolled
Jason J. Luke, MDLead Sponsor
4 Previous Clinical Trials
700 Total Patients Enrolled
Agios Pharmaceuticals, Inc.Industry Sponsor
52 Previous Clinical Trials
4,200 Total Patients Enrolled

Media Library

Ivosidenib (IDH1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04056910 — Phase 2
Isocitrate Dehydrogenase 1 Research Study Groups: Concurrent dosing of ivosidenib and nivolumab
Isocitrate Dehydrogenase 1 Clinical Trial 2023: Ivosidenib Highlights & Side Effects. Trial Name: NCT04056910 — Phase 2
Ivosidenib (IDH1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04056910 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~5 spots leftby Mar 2025