CheckMate 077: A Study of Safety, Tolerability and Pharmacokinetics of Nivolumab in Chinese Subjects With Previously Treated Advanced or Recurrent Solid Tumors
Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT02593786
Collaborator
(none)
58
2
2
68.7
29
0.4
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1/Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
58 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Actual Study Start Date
:
Jan 7, 2016
Actual Primary Completion Date
:
Sep 27, 2021
Actual Study Completion Date
:
Sep 27, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Nivolumab monotherapy Nivolumab specified dose on specified days |
Drug: Nivolumab
|
| Experimental: Cohort Expansion Nivolumab specified dose on specified days |
Drug: Nivolumab
|
Outcome Measures
Primary Outcome Measures
- Safety measured by number of subjects who experience AEs, SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations [Up to 100 days after last dose of study drug]
Serious Adverse event (SAE), Adverse event (AE)
- Tolerability measured by number of subjects who experience AEs, SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations [Up to 100 days after last dose of study drug]
Secondary Outcome Measures
- Objective response rate (ORR) [Up to 100 days after last dose of study drug]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Local Institution | Guangzhou | Guangdong | China | 510060 |
| 2 | Local Institution | Hangzhou | Zhejiang | China | 310016 |
Sponsors and Collaborators
- Bristol-Myers Squibb
Investigators
- Study Director: Bristol Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02593786
Other Study ID Numbers:
- CA209-077
First Posted:
Nov 1, 2015
Last Update Posted:
Mar 16, 2022
Last Verified:
Mar 1, 2022