A Study of Nivolumab in Combination With Ipilimumab in Chinese Participants With Previously Treated Advanced or Recurrent Solid Tumors

Solid Tumor Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03195478
• Other study ID #: CA209-672
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: August 2, 2017
• Est. completion date: January 5, 2024

Study information

• Verified date: February 2024
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 5, 2024
• Est. primary completion date: January 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

Drug:
• Nivolumab
Specified dose on specified days
• Ipilimumab
Specified dose on specified days

Locations

Country	Name	City	State
China	Local Institution	Beijing	Beijing
China	Local Institution - 0001	Beijing	Beijing
China	Local Institution - 0018	Chengdu	Sichuan
China	Local Institution	Guangzhou	Guangdong
China	Local Institution - 0012	Guangzhou	Guangdong
China	Local Institution - 0013	Hangzhou	Zhejiang
China	Local Institution - 0011	Harbin	Heilongjiang
China	Local Institution - 0016	Shanghai	Shanghai
China	Local Institution - 0004	Tianjin	Tianjin
China	Local Institution - 0021	Wuhan	Hubei
China	Local Institution - 0020	XiAn	Shan1xi
China	Local Institution	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of Number and percent of all treated participants that experience Adverse Events (AEs)	Measured by number of patients Applies to Part 1	Up to 3.2 years
Primary	Composite of Number and percent of all treated participants that experience serious adverse events (SAEs)	Measured by number of patients Applies to Part 1	Up to 3.2 years
Primary	Composite of Number and percent of all treated participants that experience AEs leading to discontinuation	Measured by number of patients Applies to Part 1	Up to 3.2 years
Primary	Composite of Number and percent of all treated subjects that experience AEs leading to death	Measured by number of patients Applies to Part 1	Up to 3.2 years
Primary	Composite of Number and percent of participants with clinical laboratory abnormalities	Measured by number of patients Applies to Part 1	Up to 3.2 years
Primary	Overall response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Blinded Independent Central Review (BICR)	Applies to Part 2	Up to 3.2 years
Secondary	Maximum observed serum concentration (Cmax)	Applies to Part 1	Up to 3.2 years
Secondary	Time of maximum observed serum concentration (Tmax)	Applies to Part 1	Up to 3.2 years
Secondary	Area under the plasma concentration-time curve from time zero to the last time of the last quantifiable concentration (AUC[0-T])	Applies to Part 1	Up to 3.2 years
Secondary	Incidence of anti-drug antibodies (ADA)	Applies to Part 1	Up to 3.2 years
Secondary	ORR by RECIST 1.1 by Investigator	Applies to Part 2	Up to 3.2 years
Secondary	Disease Control Rate (DCR) by RECIST 1.1 by BICR	Applies to Part 2	Up to 3.2 years
Secondary	DCR by RECIST 1.1 by Investigator	Applies to Part 2	Up to 3.2 years
Secondary	Duration of Response (DoR) by RECIST 1.1 by BICR	Applies to Part 2	Up to 3.2 years
Secondary	DoR by RECIST 1.1 by Investigator	Applies to Part 2	Up to 3.2 years
Secondary	Progression-Free Survival (PFS) by RECIST 1.1 by BICR	Applies to Part 2	Up to 3.2 years
Secondary	PFS by RECIST 1.1 by Investigator	Applies to Part 2	Up to 3.2 years

External Links

•   BMS Clinical Trial Information