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 | | Cohort Expansion |
Nivolumab | Opdivo, BMS-936558 | Cohort Expansion |
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 Cisplatin Ineligible Muscle Invasive Bladder Cancer patients will receive either monotherapy BMS-986310, or BMS-986310 + Nivolumab, or Nivolumab monotherapy.
Sub-Study B: A cohort of PD[L]1 relapsed / refractory tumor cancer patients will be treated with monotherapy BMS-986310 followed by 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, in one of the following tumor types: Renal cell
carcinoma, Melanoma, colorectal cancer (CRC) microsatellite instability (MSI)-High
(determined by Clinical Laboratory Improvement Amendments (CLIA) validated assay, testing
methodology must be provided), Bladder cancer, Squamous Cell Carcinoma of the Head and Neck
(SCCHN), 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) Participants must be newly diagnosed, no prior history of treatment for bladder cancer
ii) Participants must not meet criteria for standard of care neoadjuvant therapy and must
be candidates for SOC surgical resection of primary tumor.
iii) Histologically confirmed muscle-Invasive bladder cancer (MIBC) pure or mixed histology
urothelial carcinoma Part 2 - Patients with relapsed / refractory solid tumors where no
other standard of care treatment option is available.
Exclusion Criteria:
- History of severe adverse drug reactions to nonsteroidal anti-inflammatory drugs
(NSAIDs) or Cyclooxygenase-2 (COX-2) inhibitors.
- Participants with an active, known or suspected autoimmune disease.
- Evidence of organ dysfunction or any clinically significant deviation from normal in
physical examination, vital signs, ECG or clinical laboratory determinations beyond
what is consistent with the target population
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: | |
Measure: | Summary of PK parameters at T-HALF |
Time Frame: | up to 3 years |
Safety Issue: | |
Description: | |
Measure: | Summary of PK parameter AUC(INF) after single dose |
Time Frame: | up to 3 years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Completed |
Lead Sponsor: | Bristol-Myers Squibb |
Last Updated
March 17, 2021