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

Phase 1

Completed

• Conditions: Solid Tumor
• Interventions: Drug: Nivolumab; Drug: Ipilimumab

• Registration Number: NCT03195478
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-20
• Study First Submitted QC: 2017-06-20
• Study First Posted: 2017-06-22
• Study Start: 2017-08-02
• Primary Completion: 2024-01-05
• Study Completion: 2024-01-05
• Status Verified: 2024-02
• Last Update Submitted: 2024-03-01
• Last Update Posted: 2024-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Nivo/Ipi Combination Therapy B	Ipilimumab	-
Nivo/Ipi Combination Therapy A	Nivolumab	-
Nivo/Ipi Combination Therapy A	Ipilimumab	-
Nivo/Ipi Combination Therapy B	Nivolumab	-
Nivo/Ipi Combination Therapy C	Nivolumab	-
Nivo/Ipi Combination Therapy C	Ipilimumab	-
Nivo/Ipi Combination Arm D	Nivolumab	-
Nivo/Ipi Combination Arm D	Ipilimumab	-

Primary Outcome Measures

Name	Time	Method
Composite of Number and percent of all treated participants that experience Adverse Events (AEs)	Up to 3.2 years	Measured by number of patients Applies to Part 1
Composite of Number and percent of all treated participants that experience AEs leading to discontinuation	Up to 3.2 years	Measured by number of patients Applies to Part 1
Composite of Number and percent of all treated participants that experience serious adverse events (SAEs)	Up to 3.2 years	Measured by number of patients Applies to Part 1
Composite of Number and percent of all treated subjects that experience AEs leading to death	Up to 3.2 years	Measured by number of patients Applies to Part 1
Composite of Number and percent of participants with clinical laboratory abnormalities	Up to 3.2 years	Measured by number of patients Applies to Part 1
Overall response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Blinded Independent Central Review (BICR)	Up to 3.2 years	Applies to Part 2

Secondary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS) by RECIST 1.1 by BICR	Up to 3.2 years	Applies to Part 2
PFS by RECIST 1.1 by Investigator	Up to 3.2 years	Applies to Part 2
Maximum observed serum concentration (Cmax)	Up to 3.2 years	Applies to Part 1
Time of maximum observed serum concentration (Tmax)	Up to 3.2 years	Applies to Part 1
Area under the plasma concentration-time curve from time zero to the last time of the last quantifiable concentration (AUC[0-T])	Up to 3.2 years	Applies to Part 1
Incidence of anti-drug antibodies (ADA)	Up to 3.2 years	Applies to Part 1
ORR by RECIST 1.1 by Investigator	Up to 3.2 years	Applies to Part 2
Disease Control Rate (DCR) by RECIST 1.1 by BICR	Up to 3.2 years	Applies to Part 2
DCR by RECIST 1.1 by Investigator	Up to 3.2 years	Applies to Part 2
Duration of Response (DoR) by RECIST 1.1 by BICR	Up to 3.2 years	Applies to Part 2
DoR by RECIST 1.1 by Investigator	Up to 3.2 years	Applies to Part 2

Trial Locations

Locations (10)

Local Institution - 0001; 🇨🇳 Beijing, Beijing, China

Local Institution - 0012; 🇨🇳 Guangzhou, Guangdong, China

Local Institution - 0020; 🇨🇳 XiAn, Shan1xi, China

Local Institution - 0004; 🇨🇳 Tianjin, Tianjin, China

Local Institution; 🇨🇳 Zhengzhou, Henan, China

Local Institution - 0021; 🇨🇳 Wuhan, Hubei, China

Local Institution - 0011; 🇨🇳 Harbin, Heilongjiang, China

Local Institution - 0018; 🇨🇳 Chengdu, Sichuan, China

Local Institution - 0016; 🇨🇳 Shanghai, Shanghai, China

Local Institution - 0013; 🇨🇳 Hangzhou, Zhejiang, China