ivosidenib and nivolumab for Isocitrate Dehydrogenase 1 Mutation

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Isocitrate Dehydrogenase 1 Mutation+2 Moreivosidenib and nivolumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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
  • Advanced Solid Tumors

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 3 Secondary · Reporting Duration: At 8 weeks after first treatment; up to 14 months for cohort

Month 14
Best Overall Response
Up to 24 months
Occurrence of dose limiting toxicity (DLT)
Up to 36 months
Adverse Events Related to Treatment
Progression Free Survival (PFS)
Up to 6 months
Six Month Progression-Free Survival (PFS6)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

Concurrent dosing of ivosidenib and nivolumab
1 of 1

Experimental Treatment

35 Total Participants · 1 Treatment Group

Primary Treatment: ivosidenib and nivolumab · No Placebo Group · Phase 2

Concurrent dosing of ivosidenib and nivolumab
Drug
Experimental Group · 1 Intervention: ivosidenib and nivolumab · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at 8 weeks after first treatment; up to 14 months for cohort

Who is running the clinical trial?

Bristol-Myers SquibbIndustry Sponsor
2,496 Previous Clinical Trials
3,930,292 Total Patients Enrolled
Jason J. Luke, MDLead Sponsor
3 Previous Clinical Trials
278 Total Patients Enrolled
Agios Pharmaceuticals, Inc.Industry Sponsor
49 Previous Clinical Trials
4,004 Total Patients Enrolled
Jason J Luke, MD, PhDPrincipal InvestigatorUPMC Hillman Cancer Center
1 Previous Clinical Trials
144 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have recovered from toxicities associated with prior anticancer therapy to baseline or ≤ grade 1.
You have a hemoglobin level of at least 8 g/dL.
You are 18 years of age or older.\n
You have a documented IDH1 gene mutation based on CLIA certified sequencing.
You have an ECOG PS score of 0 or 1.
Platelets ≥ 100,000/mm3 or 100 × 109/L.
You have an absolute neutrophil count of at least 1,500/mm3 or 1.
You 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.