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A Study of Safety, Tolerability and Pharmacokinetics of Nivolumab in Chinese Subjects With Previously Treated Advanced or Recurrent Solid Tumors (CheckMate 077)

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ClinicalTrials.gov Identifier: NCT02593786
Recruitment Status : Recruiting
First Posted : November 2, 2015
Last Update Posted : December 13, 2017
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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
Solid Tumors Drug: Nivolumab Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 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 : December 25, 2015
Estimated Primary Completion Date : April 7, 2019
Estimated Study Completion Date : July 30, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

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



Primary Outcome Measures :
  1. 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 [ Time Frame: Up to 100 days after last dose of study drug ]
    Serious Adverse event (SAE), Adverse event (AE)

  2. 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 [ Time Frame: Up to 100 days after last dose of study drug ]

Secondary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: Up to 100 days after last dose of study drug ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02593786


Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

Locations
China, Guangdong
Local Institution Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Site 0001         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02593786     History of Changes
Other Study ID Numbers: CA209-077
First Posted: November 2, 2015    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
Nivolumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs