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ivosidenib and nivolumab

Phase 2

Advanced Solid Tumor | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Feb 27, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment15
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04056910Ivosidenib (AG-120) With Nivolumab in IDH1 Mutant TumorsPHASE2 COMPLETED 15Sep 20, 2021Nov 13, 2023Feb 27, 20251 United States
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Study Endpoints
Primary Endpoints
Best Overall Response
At 8 weeks after first treatment; up to 14 months for cohort

Number of patients with Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to \<10 mm, Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters or Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters per RECIST v1.1 Criteria, or, per RANO Criteria: Complete Response (CR): Observed in consecutive assessments ≥4 weeks apart per RANO. Partial Response (PR): Observed in consecutive assessments ≥4 weeks apart per RANO.

Six Month Progression-Free Survival (PFS6)
At 6 months

Percentage of participants surviving without objective tumor progression at six months after the initiation of treatment. Per RECIST v1.1 Criteria: Progressive Disease (PD): ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression. Per RANO Criteria: Progressive Disease: No CR, PR, SD prior to PD. Progression: 25% or more increase in enhancing lesions despite stable or increasing steroid dose, increase (significant) in non-enhancing FLAIR/T2W lesions, not attributable to other non-tumor causes, any new lesions; clinical deterioration (not attributable to other non-tumor causes and not due to steroid decrease)

Secondary Endpoints
Occurrence of Dose Limiting Toxicity (DLT)
Up to 24 months
Adverse Events Related to Treatment
Up to 24 months
Progression Free Survival (PFS)
Up to 25 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Concurrent dosing of ivosidenib and nivolumabEXPERIMENTALIvosidenib will be administered concurrently with nivolumab on a Q28 day schedule.
Interventions
NameTypeDescription
ivosidenib and nivolumabDRUGIvosidenib will be administered orally at a dose of 500 mg (provided as 250 mg strength tablets) daily. The dose may be reduced to 250 mg for patients experiencing more than one event of Grade 2 nausea or vomiting (related or unrelated), or Grade 3 or Grade 4 adverse events. Nivolumab will be administered at 480 mg IV every 28 days.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Be ≥18 years of age. * Have a histopathological diagnosis (fresh or banked tumor biopsy sample, preferably collected within the last 3 years) of an advanced solid tumor for which curative treatment is not available and have undergone appropriate standard of care treatment opti...

Countries:United States
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