Phase 2
Completed N=213
An Investigational Immunotherapy Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Solid Cancers
Advanced Cancer
Source: ClinicalTrials.gov NCT03994601 ↗
Enrolled (actual)
213
Serious AEs
72.4%
Results posted
Jan 2026
Primary outcomePrimary: Safety Related Events for Cohorts 1A, 1B and 2B. — 4; 4; 5; 6 Participants
Summary
The purpose of this study is to determine whether BMS-986288 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of select advanced solid tumors.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety Related Events for Cohorts 1A, 1B and 2B. |
4; 4; 5; 6; 5; 5 | — |
| PRIMARY Dose Limiting Toxicities Cohorts 1A, 1B and 2B. |
0; 0; 0; 0; 0; 1 | — |
| PRIMARY Objective Response Rate by BICR in Cohort 2C |
0; 0; 0 | — |
| SECONDARY Objective Response Rate in Cohorts 1A, 1B and 2B |
0; 25.0; 20.0; 0; 0; 0 | — |
| SECONDARY Duration of Response in Cohorts 1A, 1B and 2B |
5.68; 5.59; NA; NA; NA; 7.16 | — |
| SECONDARY Time to Response in Cohorts 1A, 1B and 2B |
1.64; 1.87; 4.78; 2.56; 6.14; 3.76 | — |
| SECONDARY Progression Free Survival in Cohorts 1A, 1B and 2B |
1.05; 1.49; 1.68; 4.65; 1.81; 1.15 | — |
| SECONDARY Duration of Response by BICR in Cohort 2C |
— | — |
| SECONDARY PFS by BICR in Cohort 2C |
2.10; 4.37; 2.89 | — |
| SECONDARY Overall Survival in Cohort 2C |
NA; 6.67; NA | — |
| SECONDARY Objective Response Rate by Investigator in Cohort 2C |
0; 0; 0 | — |
| SECONDARY Duration of Response by Investigator in Cohort 2C |
— | — |
| SECONDARY PFS by Investigator in Cohort 2C |
2.04; 4.37; 2.89 | — |
| SECONDARY Safety Related Events in Cohort 2C |
34; 12; 4; 24; 7; 3 | — |
| SECONDARY Dose Limiting Toxicities in Cohort 2C |
0; 0; 0 | — |
| SECONDARY Cmax for Cohorts 1A, 1B and 2B |
7346.016; 10146.620; 23583.104; 35151.545; 80443.781; 118980.802 | — |
| SECONDARY Tmax for Cohorts 1A, 1B and 2B |
2.500; 3.725; 0.833; 4.00; 4.00; 3.983 | — |
| SECONDARY AUC(0-T) for Cohorts 1A, 1B and 2B |
1082346.14014; 1861226.97707; 4508154.21783; 6723961.51187; 15142162.8434; 22403650.45029 | — |
| SECONDARY AUC(Tau) for Cohorts 1A, 1B and 2B |
1331755.67815; 2264731.07676; 4605903.87150; 6723961.51187; 16182654.45947; 23790801.57085 | — |
| SECONDARY C(Tau) for Cohorts 1A, 1B and 2B |
323.28443; 1255.33355; 2756.28704; 3459.203; 7295.79216; 12665.79193 | — |
Eligibility Criteria
Inclusion Criteria
- Histologic or cytologic confirmation of select solid tumor that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease and have at least 1 lesion accessible for biopsy
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Received, and then progressed, relapsed, or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting according to select solid tumor histologies
Exclusion Criteria
- Active, known or suspected autoimmune disease
- Active malignancy requiring concurrent intervention
- Primary Central Nervous System (CNS) malignancies or tumors with CNS metastasis as the only site of disease, will be excluded
Other protocol-defined inclusion/exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT03994601). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.