Clinical trial NCT03661632: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2018-09-07
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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

Primary outcomes:
measure: Incidence of Adverse Events (AE)
timeFrame: up to 3 years
measure: Incidence of Serious Adverse Events (SAE)
timeFrame: up to 3 years
measure: Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria
timeFrame: up to 3 years
measure: Incidence of AEs leading to dose delays and discontinuation or delay in radical cystectomy (RC)
timeFrame: up to 3 years
measure: Incidence of Laboratory abnormalities
timeFrame: up to 3 years
measure: Incidence of death
timeFrame: up to 3 years
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: up to 3 years
measure: Median duration of response (mDOR)
timeFrame: up to 3 years
measure: Progression free survival rate (PFSR)
timeFrame: up to 24 months
measure: Maximum observed serum concentration (Cmax)
timeFrame: up to 3 years
measure: Observed serum concentration at the end of a dosing interval (Ctau)
timeFrame: up to 3 years
measure: Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
timeFrame: up to 3 years
measure: Apparent total body clearance (CLT/F)
timeFrame: up to 3 years
measure: Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)]
timeFrame: up to 3 years
measure: AUC accumulation index (AI_AUC)
timeFrame: up to 3 years
measure: Cmax accumulation index (AI_Cmax)
timeFrame: up to 3 years
measure: Summary changes of prostaglandin E metabolite (PGEM) in urine
timeFrame: up to 3 years
measure: Summary changes of tumor necrosis factor (TNFa) in blood
timeFrame: up to 3 years
measure: Summary of PK parameters at T-HALF
timeFrame: up to 3 years
measure: Summary of PK parameter AUC(INF) after single dose
timeFrame: up to 3 years
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center
state: Pennsylvania
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Bruxelles
country: Belgium
facility: Local Institution
city: Gent
country: Belgium
facility: Local Institution
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: