Clinical trial NCT03351231: An Investigational Immuno-Therapy Study of Experimental Medication BMS-986242 Given in Combination With Nivolumab in Patients With Advanced Cancer
Official title: A Phase 1/2a Study of BMS-986242 Administered in Combination With Nivolumab (BMS-936558, Anti-PD-1) in Advanced Malignant Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2017-11-22
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate safety of experimental medication BMS-986242 and Nivolumab in patients with advanced cancers.


Eligibility criteria: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Histologic or cytological confirmation of a malignancy that is advanced (metastatic and/or unresectable) with measureable disease per RECIST v1.1
* Participants must have received and then progressed or been intolerant to at least 1 standard treatment regimen in the advanced or metastatic setting if such a therapy exists
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Ability to swallow tablets
* Adequate bone marrow and organ function, as defined by the protocol

Exclusion Criteria:

* Participants with known or suspected CNS metastases, untreated CNS metastases, or with the CNS as the only site of disease (patients with controlled brain metastasis allowed to enroll)
* Ocular melanoma
* Any significant acute or chronic medical illness
* Prior malignancy
* Other active malignancy requiring concurrent intervention
* Prior organ allograft or allogeneic bone marrow transplantation
* Participants with active, known, or suspected autoimmune disease
* Requirement for daily supplemental oxygen
* Uncontrolled or significant cardiovascular disease
* Pre-existing liver disease
* Gastrointestinal disease known to interfere with absorption

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Number of Participants With Adverse Events (AE)
timeFrame: From initiation of study treatment until 100 days after discontinuation of study treatment
measure: Number of Participants With Serious Adverse Events (SAE)
timeFrame: From the date of participant's written consent until 100 days after discontinuation of nivolumab or participation in the study
measure: Number of Participants With Dose Limiting Toxicities (DLT)
timeFrame: Approximately 2 years
measure: Number of Participants With AEs Leading to Discontinuation
timeFrame: Approximately 2 years
measure: Number of Deaths
timeFrame: Approximately 2 years
measure: Number of Participants With Laboratory Abnormalities
timeFrame: Approximately 2 years
Secondary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Approximately 2 years
measure: Time of Maximum Observed Plasma Concentration (Tmax)
timeFrame: Approximately 2 years
measure: Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)]
timeFrame: Approximately 2 years
measure: Area Under the Concentration-time Curve From Time Zero to Infinity [AUC(INF)]
timeFrame: Approximately 2 years
measure: Trough Observed Plasma Concentration at the End of the Dosing Interval (Ctrough)
timeFrame: Approximately 2 years
measure: Apparent Elimination Half-life (T-HALF)
timeFrame: Approximately 2 years
measure: Apparent Total Body Clearance (CLT/F)
timeFrame: Approximately 2 years
measure: Apparent Volume of Distribution at Steady State (Vss/F)
timeFrame: Approximately 2 years
measure: Accumulation Index (AI)
timeFrame: Approximately 2 years
measure: Percent Urinary Recovery Over 24 Hours (%UR24)
timeFrame: Approximately 2 years
measure: Percent Urinary Recovery Over 72 Hours (%UR72)
timeFrame: Approximately 2 years
measure: Incidence of Anti-drug Antibody (ADA) to Nivolumab in Combination With BMS-986242
timeFrame: Approximately 2 years
measure: Overall Response Rate (ORR)
timeFrame: Approximately 2 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University Of Alabama At Birmingham
state: Alabama
city: Los Angeles
country: United States
facility: Hoag Memorial Hospital Presbyterian
state: California
city: Los Angeles
country: United States
facility: USC Norris Comprehensive Cancer Center
state: California
city: Baltimore
country: United States
facility: Local Institution
state: Maryland
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: