Clinical trial NCT03792750: A Study of BMS-986205 Alone and in Combination With Nivolumab in Chinese Patients With Advanced Malignant Solid Tumors
Official title: A Phase 1/2 Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of BMS-986205 Alone and in Combination With Nivolumab in Chinese Patients With Advanced Malignant Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Advanced Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2019-01-03
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine safety and effectiveness of experimental medication BMS-986205 in combination with Nivolumab in patients with cancers that are advanced or have spread.


Eligibility criteria: Inclusion Criteria:

* Participants must have histologic or cytological confirmation of a solid tumor that is advanced with measureable disease per RECIST v1.1
* Participants must have received, and then progressed or been intolerant to at least one standard treatment regimen in the advanced or metastatic setting
* Participants must have an ECOG performance status of less than or equal to 1
* Participants must have at least 1 lesion with measurable disease as defined by RECIST Version 1.1

Exclusion Criteria:

* Participants must not have suspected, known, or progressive CNS metastases, have untreated CNS metastases, or have the CNS as the only site of disease
* Participants with prior exposure to anti PD-1 or anti-PDL1 therapy
* Participants must not have a history of allergy to any of the study treatment components

Primary outcomes:
measure: The Number of Participants Experiencing Adverse Events (AE)
timeFrame: From first dose to 100 days after last dose of study therapy (up to approximately 2 years)
measure: The Number of Participants Experiencing Serious Adverse Events (SAE)
timeFrame: From first dose to 100 days after last dose of study therapy (up to approximately 2 years)
measure: The Number of Participants Experience Adverse Events (AE) Leading to Discontinuation
timeFrame: From first dose to 100 days after last dose of study therapy (up to approximately 2 years)
measure: Number of Participant Deaths
timeFrame: From first dose to 100 days after last dose of study therapy (up to approximately 2 years)
measure: The Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests
timeFrame: From first dose to 100 days after last dose of study therapy (up to approximately 2 years)
measure: The Number of Participants Experiencing Laboratory Abnormalities in Specific Thyroid Tests
timeFrame: From first dose to 100 days after last dose of study therapy (up to approximately 2 years)
measure: (Cmax) Maximum Observed Plasma Concentration
timeFrame: pre-dose, 1, 2, 3, 4, 6, 8 hours post dose on Cycle 0 days 1, 14, Cycle 1 day 1
measure: (Tmax) Time of Maximum Observed Plasma Concentration
timeFrame: pre-dose, 1, 2, 3, 4, 6, 8 hours post dose on Cycle 0 days 1, 14, Cycle 1 day 1
measure: (AUC(TAU)) Area Under the Concentration-time Curve in One Dosing Interval
timeFrame: pre-dose, 1, 2, 3, 4, 6, 8 hours post dose on Cycle 0 days 1, 14, Cycle 1 day 1
measure: (CLT/F) Apparent Total Body Clearance
timeFrame: pre-dose, 1, 2, 3, 4, 6, 8 hours post dose on Cycle 0 day 14, Cycle 1 day 1
measure: (T-HALF (Eff, AUC)) Effective Elimination Half-life
timeFrame: pre-dose, 1, 2, 3, 4, 6, 8 hours post dose on Cycle 0 day 14
measure: (AI_CMAX) Accumulation Index
timeFrame: pre-dose, 1, 2, 3, 4, 6, 8 hours post dose on Cycle 0 day 14
measure: (AI_AUC ) Accumulation Index
timeFrame: pre-dose, 1, 2, 3, 4, 6, 8 hours post dose on Cycle 0 day 14
measure: (Ctrough) Trough Observed Plasma Concentration
timeFrame: pre-dose, 1, 2, 3, 4, 6, 8 hours post dose on Cycle 0 day 2, 8, 14, Cycle 1 day 1, 2, Cycle 3, 5, 9, 13, and 17 day 1
measure: (percentUR24) Percent Urinary Recovery Over 24 Hours
timeFrame: pre-dose, 1, 2, 3, 4, 6, 8 hours post dose on Cycle 0 Day 1 and 2
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: From first dose up to approximately 2 years
measure: Best Overall Response (BOR)
timeFrame: From first dose up to approximately 2 years
measure: Duration of Response (DOR)
timeFrame: From first dose up to approximately 2 years
measure: Measurement of Serum Kynurenine Levels
timeFrame: Baseline, pre-dose (C1D1), 6 hours post dose (C1D1), pre-dose (C1D2), and at disease progression (actually collected on C3D1, C6D1, C8D1, and end of treatment-an average of 12 cycles)
measure: Measurement of Tryptophan Levels
timeFrame: Baseline, pre-dose (C1D1), 6 hours post dose (C1D1), pre-dose (C1D2), and at disease progression (actually collected on C3D1, C6D1, C8D1, and end of treatment-an average of 12 cycles)
measure: Number of Participants With Anti-drug Antibodies (ADA) to Nivolumab
timeFrame: Baseline, pre-dose (C1D1, C3D1, every 4 Cycles from C5D1), end of treatment - an average of 12 cycles, and follow up. (up to approximately 2 years)
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Local Institution
state: Zhejiang
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: