Description:
The purpose of this study is to determine if BMS-986310 administered in combination with
nivolumab, will demonstrate adequate safety and tolerability, as well as a favorable
risk/benefit profile, to support further clinical testing.
Title
- Brief Title: An Investigational Immunotherapy Study of BMS-986310 Administered Alone and in Combination With Nivolumab in Patients With Advanced Solid Tumors
- Official Title: Phase 1/2 Study of BMS-986310 Administered Alone and in Combination With Nivolumab in Participants With Advanced Solid Tumors
Clinical Trial IDs
- ORG STUDY ID:
CA044-001
- SECONDARY ID:
2018-002108-15
- NCT ID:
NCT03661632
Conditions
Interventions
Drug | Synonyms | Arms |
---|
BMS-986310 | | Dose Escalation |
Nivolumab | Opdivo, BMS-936558 | Dose Escalation |
Purpose
The purpose of this study is to determine if BMS-986310 administered in combination with
nivolumab, will demonstrate adequate safety and tolerability, as well as a favorable
risk/benefit profile, to support further clinical testing.
Trial Arms
Name | Type | Description | Interventions |
---|
Dose Escalation | Experimental | Part 1: BMS-986310 + Nivolumab Combination Dose Escalation
Sub-Study A: A cohort of Triple-Negative Breast Cancer patients will be administered BMS-986310 as Monotherapy
Sub-Study B: A cohort of PD[L]1 Refractory Tumor cancer patients will be randomized 1:1 to receive either monotherapy BMS-986310 or BMS-986310 + Nivolumab | |
Cohort Expansion | Experimental | Part 2: Cohort Expansion will initiate upon consideration of the totality of data from Part 1.
BMS-986310 + Nivolumab combination will be administered in specific patient populations. | |
Eligibility Criteria
Inclusion Criteria:
- Patients with measurable disease per RECIST v1.1 and have at least one lesion
accessible for biopsy.
- ECOG performance status less than or equal to 1
Part 1 and Sub-study B:
i) Part 1 participants must have advanced or metastatic disease where no other standard of
care treatment option is possible.
ii) Sub-study B participants must have advanced or metastatic disease where no other
standard of care treatment is possible, and they must have had disease progression on an
anti-PD-(L)1 based regimen as their most recent prior therapy
Sub-study A:
i) Males and females with histologically confirmed TNBC as defined by ASCO/CAP guidelines.
ii) Participants must be newly diagnosed, no prior history of treatment for TNBC.
iii) Tumor size greater than or equal to 1cm3 iv) Participants must not meet criteria for
standard of care neoadjuvant therapy and must be candidates for SOC surgical resection of
primary tumor.
Part 2 i) Patients with NSCLC ii) Patients with Pancreatic Cancer iii) Patients with TNBC
iiii) Patients with CRC
Exclusion Criteria:
- History of severe adverse drug reactions to nonsteroidal anti-inflammatory drugs
(NSAIDs), or those with adverse reactions to an NSAID that is currently prescribed
- Participants with an active, known or suspected autoimmune disease.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Incidence of Adverse Events (AE) |
Time Frame: | up to 3 years |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Objective response rate (ORR) |
Time Frame: | up to 3 years |
Safety Issue: | |
Description: | |
Measure: | Median duration of response (mDOR) |
Time Frame: | up to 3 years |
Safety Issue: | |
Description: | |
Measure: | Progression free survival rate (PFSR) |
Time Frame: | up to 24 months |
Safety Issue: | |
Description: | |
Measure: | Maximum observed serum concentration (Cmax) |
Time Frame: | up to 3 years |
Safety Issue: | |
Description: | |
Measure: | Observed serum concentration at the end of a dosing interval (Ctau) |
Time Frame: | up to 3 years |
Safety Issue: | |
Description: | |
Measure: | Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] |
Time Frame: | up to 3 years |
Safety Issue: | |
Description: | |
Measure: | Apparent total body clearance (CLT/F) |
Time Frame: | up to 3 years |
Safety Issue: | |
Description: | |
Measure: | Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] |
Time Frame: | up to 3 years |
Safety Issue: | |
Description: | |
Measure: | AUC accumulation index (AI_AUC) |
Time Frame: | up to 3 years |
Safety Issue: | |
Description: | |
Measure: | Cmax accumulation index (AI_Cmax) |
Time Frame: | up to 3 years |
Safety Issue: | |
Description: | |
Measure: | Summary changes of prostaglandin E metabolite (PGEM) in urine |
Time Frame: | up to 3 years |
Safety Issue: | |
Description: | |
Measure: | Summary changes of tumor necrosis factor (TNFa) in blood |
Time Frame: | up to 3 years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Not yet recruiting |
Lead Sponsor: | Bristol-Myers Squibb |
Last Updated