Clinical trial NCT02966548: Safety Study of BMS-986016 With or Without Nivolumab in Patients With Advanced Solid Tumors
Official title: A Phase 1 Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 Monoclonal Antibody (BMS-986016) Administered Alone and in Combination With Anti-PD-1 Monoclonal Antibody (Nivolumab, BMS-936558) in Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Ono Pharmaceutical Co. Ltd
First posted: 2016-11-17
Enrollment: 35
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will be used to determine the safety and tolerability of BMS-986016 administered alone and in combination with Nivolumab in subjects with advanced solid tumors.


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

Inclusion Criteria:

* Must have histologic or cytologic confirmation of an incurable solid malignancy that is advanced (metastatic and/or unresectable)
* Must have received, and then progressed or been intolerant to, standard treatment regimen in the advanced or metastatic setting, if such a therapy exists
* Presence of at least one lesion with measurable disease as defined by RECIST v1.1 criteria for response assessment
* Males and Females, ages 20 years or older, inclusive

Exclusion Criteria:

* Known or suspected CNS (central nervous system) metastases or with the CNS as the only site of active disease
* Other concomitant malignancies (with some exceptions per protocol)
* Any active autoimmune disease or history of known or suspected autoimmune disease
* History of uncontrolled or significant cardiovascular disease

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Number of adverse events (AE)
timeFrame: Approximately 2.2 years
measure: Number of serious adverse events (SAE)
timeFrame: Approximately 2.2 years
measure: Number of deaths
timeFrame: Approximately 2.2 years
measure: Number of laboratory abnormalities
timeFrame: Approximately 2.2 years
Secondary outcomes:
measure: Maximum observed serum concentration (Cmax) of BMS-986016
timeFrame: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up
measure: Time of maximum observed serum concentration (Tmax) of BMS-986016
timeFrame: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up
measure: Trough observed serum concentration (Ctrough) of BMS-986016
timeFrame: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up
measure: Concentration at the end of a dosing interval (Ctau) of BMS-986016
timeFrame: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up
measure: Average concentration over a dosing interval [AUC(TAU)/tau] (Css,avg) of BMS-986016
timeFrame: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up
measure: Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] of BMS-986016
timeFrame: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up
measure: Total body clearance (CLT) of BMS-986016
timeFrame: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up
measure: Volume of distribution at steady state (Vss) of BMS-986016
timeFrame: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up
measure: Effective elimination half-life (T-HALFeff) that explains the degree of AUC accumulation observed (T-HALFeff AUC) of BMS-986016
timeFrame: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up
measure: Effective elimination half-life that explains the degree of Cmax accumulation observed (T-HALFeff Cmax) of BMS-986016
timeFrame: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up
measure: Accumulation index; ration of AUC(TAU) at steady state to AUC(TAU) after the first dose (AI_AUC) of BMS-986016
timeFrame: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up
measure: Cmax accumulation index; ratio of Cmax at steady state to Cmax after the first dose (AI_Cmax) of BMS-986016
timeFrame: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up
measure: Ctau accumulation index; ratio of Ctau at steady state to Ctau after the first dose (AI_Ctau) of BMS-986016
timeFrame: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up
measure: Degree of fluctuation or fluctuation index ([Cmax - Ctau]/Css,avg) (DF) of BMS-986016
timeFrame: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up
measure: Best overall response (BOR)
timeFrame: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up
measure: Duration of response (DOR)
timeFrame: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up
measure: Frequency of positive anti-drug antibody (ADA) to BMS-986016
timeFrame: Cycle 1, 2, 3, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up
measure: Frequency of positive anti-drug antibody (ADA) to Nivolumab
timeFrame: Cycle 1, 2, 3, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up
Other outcomes:
Locations:
city: Kashiwa-shi
country: Japan
facility: Local Institution - 0001
state: Chiba
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: