Clinical trial NCT02593786: A Study of Safety, Tolerability and Pharmacokinetics of Nivolumab in Chinese Subjects With Previously Treated Advanced or Recurrent Solid Tumors
Official title: A Phase 1/2, Open-Label Study of Nivolumab (BMS-936558) in Chinese Subjects With Previously Treated Advanced or Recurrent Solid Tumors (CheckMate 077: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 077)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Solid Tumors
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2015-11-01
Enrollment: 58
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 whether nivolumab is safe and effective in the treatment of advanced or recurrent solid tumors in Chinese subjects.


Eligibility criteria: Inclusion Criteria:

* Chinese subjects with advanced or recurrent solid tumors

Exclusion Criteria:

* Subjects with brain metastases are excluded unless clinically stable for more than 2 weeks at the time of enrollment as determined by the investigator
* Subjects with carcinomatous meningitis are excluded

Primary outcomes:
measure: The Number of Participants Experiencing Drug-Related Grade 3-4 Adverse Events (AEs)
timeFrame: From first dose to 100 days after last dose (up to approximately 28 months)
measure: The Number of Participants Experiencing Drug-Related Grade 3-4 Serious Adverse Events (SAEs)
timeFrame: From first dose to 100 days after last dose (up to approximately 28 months)
measure: The Number of Participants Experiencing Abnormal Hepatic Laboratory Test Results
timeFrame: From first dose to 100 days after last dose (up to approximately 28 months)
measure: The Number of Participants Experiencing Toxicity Grade 3-4 Laboratory Test Results
timeFrame: From first dose to 100 days after last dose (up to approximately 28 months)
Secondary outcomes:
measure: Best Overall Response (BOR)
timeFrame: From first dose up to approximately 28 months
measure: Duration of Response (DOR)
timeFrame: From the date of first response (CR or PR) to the date of the first documented tumor progression or death due to any cause, whichever occurs first. (Up to approximately 28 months)
measure: Objective Response Rate (ORR)
timeFrame: From first dose up to approximately 28 months
measure: Response Rate at 24 Weeks
timeFrame: Week 24
measure: Disease Control Rate (DCR) at 24 Weeks
timeFrame: Week 24
measure: The Number of Participants With Positive Anti Drug Antibody (ADA) Assessments at Baseline and Positive or Negative ADA Samples After Treatment
timeFrame: From pre-dose on day 1 Cycle 1 up to participants end of study (up to approximately 28 months)
measure: Cmax - Maximum Observed Serum Concentration
timeFrame: Day 1 Cycle 1, 3, 5, 6 (pre-dose, 0.5, 4, 8, 24, 48, 96, 168, hours post dose. Cohort C-D includes also 336 hours post dose)
measure: Tmax - Time of Maximum Observed Serum Concentration
timeFrame: Day 1 Cycle 1, 3, 5, 6 (pre-dose, 0.5, 4, 8, 24, 48, 96, 168, hours post dose. Cohort C-D includes also 336 hours post dose)
measure: AUC (0-T)-Area Under the Plasma Concentration-Time Curve
timeFrame: Day 1 Cycle 1, 3, 5, 6 (pre-dose, 0.5, 4, 8, 24, 48, 96, 168, hours post dose. Cohort C-D includes also 336 hours post dose)
measure: AUC(TAU) - Area Under the Concentration-Time Curve in One Dosing Interval
timeFrame: Day 1 Cycle 1, 3, 5, 6 (pre-dose, 0.5, 4, 8, 24, 48, 96, 168, hours post dose. Cohort C-D includes also 336 hours post dose)
measure: Ceoinf - Serum Concentration Achieved at the End of Study Drug Infusion
timeFrame: End of infusion on Day 1 of Cycle 1, 3, 5, 6
measure: Ctrough - Trough Observed Serum Concentration at the End of Dosing Interval
timeFrame: Day 1 Cycle 3, 5, 6 (168 hours post dose [Cohort A-B], 336 hours post dose [Cohort C-D])
measure: Ctau - Concentration at the End of Dosing Interval
timeFrame: Day 1 Cycle 1, 3, 5, 6 (pre-dose, 0.5, 4, 8, 24, 48, 96, 168, hours post dose. Cohort C-D includes also 336 hours post dose)
measure: T-HALFeff - Effective Elimination Half-Life
timeFrame: Day 1 Cycle 3, 5, 6 (pre-dose, 0.5, 4, 8, 24, 48, 96, 168, hours post dose. Cohort C-D includes also 336 hours post dose)
measure: CLT - Total Body Clearance
timeFrame: Day 1 Cycle 3, 5, 6 (pre-dose, 0.5, 4, 8, 24, 48, 96, 168, hours post dose. Cohort C-D includes also 336 hours post dose)
measure: AI - Accumulation Index (Cmax)
timeFrame: Day 1 Cycle 3, 5, 6 (pre-dose, 0.5, 4, 8, 24, 48, 96, 168, hours post dose. Cohort C-D includes also 336 hours post dose)
measure: AI - Accumulation Index (Ctau)
timeFrame: Day 1 Cycle 3, 5, 6 (pre-dose, 0.5, 4, 8, 24, 48, 96, 168, hours post dose. Cohort C-D includes also 336 hours post dose)
measure: AI - Accumulation Index (AUC)
timeFrame: Day 1 Cycle 3, 5, 6 (pre-dose, 0.5, 4, 8, 24, 48, 96, 168, hours post dose. Cohort C-D includes also 336 hours post dose)
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Local Institution - 0001
state: Guangdong
city: Hangzhou
country: China
facility: Local Institution
state: Zhejiang
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Ma Y, Fang W, Zhang Y, Yang Y, Hong S, Zhao Y, Tendolkar A, Chen L, Xu D, Sheng J, Zhao H, Zhang L. A Phase I/II Open-Label Study of Nivolumab in Previously Treated Advanced or Recurrent Nasopharyngeal Carcinoma and Other Solid Tumors. Oncologist. 2019 Jul;24(7):891-e431. doi: 10.1634/theoncologist.2019-0284. Epub 2019 May 2.