Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ivosidenib and nivolumab · 1 trial · 3 indications
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.
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)
| Arm | Type | Description |
|---|---|---|
| Concurrent dosing of ivosidenib and nivolumab | EXPERIMENTAL | Ivosidenib will be administered concurrently with nivolumab on a Q28 day schedule. |
| Name | Type | Description |
|---|---|---|
| ivosidenib and nivolumab | DRUG | Ivosidenib 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. |
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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
Ivosidenib and nivolumab is an investigational combination being studied for the treatment of advanced solid tumors with an IDH1 mutation, including glioma. It is a Phase 2 combination therapy in oncology.
The combination targets IDH1 mutations in tumors. Ivosidenib is a small molecule inhibitor of mutant IDH1, and nivolumab is a PD-1 immune checkpoint inhibitor, though the specific mechanism of the combination is not detailed here.
Ivosidenib and nivolumab is being developed by Bristol-Myers Squibb Company, traded on the NYSE under the ticker BMY.
Ivosidenib and nivolumab is in Phase 2 clinical development. It is investigational and not approved by the FDA. One Phase 2 trial has been completed.
Ivosidenib and nivolumab was studied in a completed Phase 2 trial, NCT04056910, titled 'Ivosidenib (AG-120) With Nivolumab in IDH1 Mutant Tumors.' The trial enrolled 15 participants with advanced solid tumors, IDH1 mutations, or glioma in the United States.
Yes, ivosidenib and nivolumab is the same as AG-120 with nivolumab. The clinical trial NCT04056910 refers to ivosidenib as AG-120, and the combination is being studied in IDH1 mutant tumors.