Clinical trial NCT03195478: A Study of Nivolumab in Combination With Ipilimumab in Chinese Participants With Previously Treated Advanced or Recurrent Solid Tumors
Official title: A Phase 1/2 Study of Nivolumab (BMS-936558) in Combination With Ipilimumab (BMS-734016) in Chinese Participants With Previously Treated Metastatic or Recurrent Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Solid Tumor
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2017-06-22
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and effectiveness of Nivolumab in combination with Ipilimumab in Chinese participants with previously treated late stage cancer.


Eligibility criteria: Inclusion Criteria:

* Mainland Chinese participants with advanced or recurrent solid tumors
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* One prior anti-cancer therapy that did not work or documented refusal to receive chemotherapy or biological therapy

Exclusion Criteria:

* Cancer that has spread to the brain or central nervous system unless it has been adequately treated . In addition, either no longer receiving corticosteroids, or on a stable or decreasing dose of no more than 10 mg daily prednisone (or equivalent)
* Active, known or suspected autoimmune disease or infection
* Positive blood screen for chronic infection of hepatitis B or hepatitis C (HCV antibody positive unless HCV RNA is negative)
* Prior immuno-oncology therapy

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Composite of Number and percent of all treated participants that experience Adverse Events (AEs)
timeFrame: Up to 3.2 years
measure: Composite of Number and percent of all treated participants that experience serious adverse events (SAEs)
timeFrame: Up to 3.2 years
measure: Composite of Number and percent of all treated participants that experience AEs leading to discontinuation
timeFrame: Up to 3.2 years
measure: Composite of Number and percent of all treated subjects that experience AEs leading to death
timeFrame: Up to 3.2 years
measure: Composite of Number and percent of participants with clinical laboratory abnormalities
timeFrame: Up to 3.2 years
measure: Overall response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Blinded Independent Central Review (BICR)
timeFrame: Up to 3.2 years
Secondary outcomes:
measure: Maximum observed serum concentration (Cmax)
timeFrame: Up to 3.2 years
measure: Time of maximum observed serum concentration (Tmax)
timeFrame: Up to 3.2 years
measure: Area under the plasma concentration-time curve from time zero to the last time of the last quantifiable concentration (AUC[0-T])
timeFrame: Up to 3.2 years
measure: Incidence of anti-drug antibodies (ADA)
timeFrame: Up to 3.2 years
measure: ORR by RECIST 1.1 by Investigator
timeFrame: Up to 3.2 years
measure: Disease Control Rate (DCR) by RECIST 1.1 by BICR
timeFrame: Up to 3.2 years
measure: DCR by RECIST 1.1 by Investigator
timeFrame: Up to 3.2 years
measure: Duration of Response (DoR) by RECIST 1.1 by BICR
timeFrame: Up to 3.2 years
measure: DoR by RECIST 1.1 by Investigator
timeFrame: Up to 3.2 years
measure: Progression-Free Survival (PFS) by RECIST 1.1 by BICR
timeFrame: Up to 3.2 years
measure: PFS by RECIST 1.1 by Investigator
timeFrame: Up to 3.2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Local Institution
state: Beijing
city: Beijing
country: China
facility: Local Institution - 0001
state: Beijing
city: Guangzhou
country: China
facility: Local Institution
state: Guangdong
city: Guangzhou
country: China
facility: Local Institution - 0012
state: Guangdong
city: Harbin
country: China
facility: Local Institution - 0011
state: Heilongjiang
city: Zhengzhou
country: China
facility: Local Institution
state: Henan
city: Wuhan
country: China
facility: Local Institution - 0021
state: Hubei
city: XiAn
country: China
facility: Local Institution - 0020
state: Shan1xi
city: Shanghai
country: China
facility: Local Institution - 0016
state: Shanghai
city: Chengdu
country: China
facility: Local Institution - 0018
state: Sichuan
city: Tianjin
country: China
facility: Local Institution - 0004
state: Tianjin
city: Hangzhou
country: China
facility: Local Institution - 0013
state: Zhejiang
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: