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

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

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.

Study Overview

• Status: Completed
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: Ipilimumab; Drug: Nivolumab

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100021
      • Local Institution - 0015
    • Beijing, Beijing Municipality, China, 100142
      • Local Institution - 0001
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Local Institution
    • Guangzhou, Guangdong, China, 510655
      • Local Institution - 0012
  • Heilongjiang
    • Harbin, Heilongjiang, China, 155040
      • Local Institution - 0011
  • Henan
    • Zhengzhou, Henan, China, 450052
      • Local Institution
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Local Institution - 0021
  • Shan1xi
    • Xi'an, Shan1xi, China, 710061
      • Local Institution - 0020
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200025
      • Local Institution - 0016
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Local Institution - 0018
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300222
      • Local Institution - 0004
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Local Institution - 0013

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nivo/Ipi Combination Therapy A	Drug: Ipilimumab; Specified dose on specified days; Other Names: BMS-734016; Yervoy; Drug: Nivolumab; Specified dose on specified days; Other Names: BMS-936558; Opdivo
Experimental: Nivo/Ipi Combination Therapy B	Drug: Ipilimumab; Specified dose on specified days; Other Names: BMS-734016; Yervoy; Drug: Nivolumab; Specified dose on specified days; Other Names: BMS-936558; Opdivo
Experimental: Nivo/Ipi Combination Therapy C	Drug: Ipilimumab; Specified dose on specified days; Other Names: BMS-734016; Yervoy; Drug: Nivolumab; Specified dose on specified days; Other Names: BMS-936558; Opdivo
Experimental: Nivo/Ipi Combination Arm D	Drug: Ipilimumab; Specified dose on specified days; Other Names: BMS-734016; Yervoy; Drug: Nivolumab; Specified dose on specified days; Other Names: BMS-936558; Opdivo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events (AEs) in Part 1.	Number of participants with Adverse events	From first dose to 100 days post last dose (Approximately on average Arm A: 8.77 Months, Arm B 20.4 Months, Arm C 24.1 Months)
Number of Participants With Serious Adverse Events (SAEs) in Part 1.	Number of participants with Adverse events	From first dose to 100 days post last dose (Approximately on average Arm A: 8.77 Months, Arm B 20.4 Months, Arm C 24.1 Months)
Number of Participants With Adverse Events Leading to Discontinuation in Part 1.	Number of participants with Adverse events	From first dose to 100 days post last dose (Approximately on average Arm A: 8.77 Months, Arm B 20.4 Months, Arm C 24.1 Months)
Number of Participants With Adverse Events Leading to Death in Part 1.	Number of participants with Adverse Events leading to death.	From first dose to 100 days post last dose (Approximately on average Arm A: 8.77 Months, Arm B 20.4 Months, Arm C 24.1 Months)
Number of Participants With Clinical Laboratory Abnormalities in Part 1.	Number of participants with clinical laboratory abnormalities.	From first dose to 100 days post last dose (Approximately on average Arm A: 8.77 Months, Arm B 20.4 Months, Arm C 24.1 Months)
BICR-Assessed ORR in Part 2	ORR is defined as the number of subjects with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) assessed by BICR, according to RECIST v1.1 criteria, divided by the number of treated subjects. The BOR is defined as the best response designation recorded between the date of first dose and the date of initial objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurs first. For participants without documented progression or subsequent therapy, all available response designations will contribute to the BOR determination. For purposes of analysis, if a subject receives one dose and discontinues the study without assessment or receives subsequent therapy prior to assessment, this participant will be counted in the denominator (as nonrespondent).	between the date of first dose and the date of initial objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurs first as assessed by BICR. (Approximately on average 3.21 Months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax - Maximum Observed Serum Concentration in Part 1.	Cmax - Maximum observed serum concentration in Part 1.	At Cycle 1 Day 1 and Cycle 3 Day 1 for Arm A, Cycle 1 and Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)
Tmax - Time of Maximum Observed Serum Concentration in Part 1.	Tmax - Time of maximum observed serum concentration in Part 1.	At Cycle 1 Day 1 and Cycle 3 Day 1 for Arm A, Cycle 1 and Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)
AUC(0-T) - Area Under the Plasma Concentration-time Curve in Part 1.	AUC(0-T) - Area under the plasma concentration-time curve from time zero to the last time of the last quantifiable concentration. in Part 1.	At Cycle 1 Day 1 and Cycle 3 Day 1 for Arm A, Cycle 1 and Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)
AUC(TAU) - Area Under the Concentration-time Curve in One Dosing Interval in Part 1.	AUC(TAU) - Area under the concentration-time curve in one dosing interval in Part 1.	At Cycle 1 Day 1 and Cycle 3 Day 1 for Arm A, Cycle 1 and Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)
Ceoinf - Serum Concentration Achieved at the End of Study Drug Infusion in Part 1.	Ceoinf - Serum concentration achieved at the end of study drug infusion in Part 1.	At Cycle 1 Day 1 and Cycle 3 Day 1 for Arm A, Cycle 1 and Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)
Ctau - Concentration at the End of Dosing Interval in Part 1.	Ctau - Concentration at the end of dosing interval in Part 1. The Ctau is equivilant to the CTrough at these time points.	At Cycle 1 Day 1 and Cycle 3 Day 1 for Arm A, Cycle 1 and Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)
CLT - Total Body Clearance in Part 1.	CLT - Total body clearance in Part 1.	At Cycle 3 Day 1 for Arm A, Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)
Css-avg - Average Concentration Over a Dosing Interval (AUC(TAU)/Tau) in Part 1.	Css-avg - Average concentration over a dosing interval (AUC(TAU)/tau) in Part 1.	At Cycle 1 Day 1 and Cycle 3 Day 1 for Arm A, Cycle 1 and Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)
AI - Accumulation Index in Part 1.	AI - Accumulation index; ratio of an exposure measure at steady-state to that after the first dose (exposure measure includes AUC (TAU) in Part 1. Here SS = Steady State Here FD = First Dose	At Cycle 3 Day 1 for Arm A, Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)
T-HALFeff - Effective Elimination Half-life in Part 1.	T-HALFeff - Effective elimination half-life that explains the degree of accumulation observed for a specific exposure measure (exposure measure includes AUC(TAU), Cmax, or Ctau) in Part 1.	At Cycle 3 Day 1 for Arm A, Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)
Number of Participants With Nivolumab Anti Drug Antibodies in Part 1.	Number of participants with nivolumab Anti Drug Antibodies in Part 1.	At baseline and from first dose to last dose (Approximately on average of Arm A 24.54 weeks, Arm B 76 weeks, Arm C 92.5 Weeks)
Number of Participants With Ipilimumab Anti Drug Antibodies in Part 1.	Number of participants with Ipilimumab Anti Drug Antibodies in Part 1.	At baseline and from first dose to last dose (Approximately on average of Arm A 24.54 weeks, Arm B 76 weeks, Arm C 92.5 Weeks)
Investigator-Assessed ORR in Part 2	ORR is defined as the number of subjects with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) assessed by Investigator, according to RECIST v1.1 criteria, divided by the number of treated subjects. The BOR is defined as the best response designation recorded between the date of first dose and the date of initial objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurs first. For participants without documented progression or subsequent therapy, all available response designations will contribute to the BOR determination. For purposes of analysis, if a subject receives one dose and discontinues the study without assessment or receives subsequent therapy prior to assessment, this participant will be counted in the denominator (as nonrespondent).	between the date of first dose and the date of initial objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurs first as assessed by the Investigator. (Approximately on average 2 Months)
Investigator-Assessed Disease Control Rate (DCR) in Part 2	The percentage of participants whose BOR is confirmed CR or confirmed PR or stable disease (SD) for at least 12 weeks as per investigator.	between the date of first dose and the date of initial objectively documented progression per RECIST v1.1 as assessed by the Investigator. (Approximately on average 5 Months)
BICR-Assessed Disease Control Rate (DCR) in Part 2	The percentage of participants whose BOR is confirmed CR or confirmed PR or stable disease (SD) for at least 12 weeks as per BICR.	Approximately 5.92 Months
BICR-Assessed Duration of Response (DOR) in Part 2	The time between the date of first confirmed response to the date of the first documented tumor progression (per RECIST 1.1), or death due to any cause, whichever occurs first as per BICR.	From first dose to 100 days post last dose (approximately 102 weeks)
Investigator-Assessed Duration of Response (DOR) in Part 2	The time between the date of first confirmed response to the date of the first documented tumor progression (per RECIST 1.1), or death due to any cause, whichever occurs first as per investigator.	From first dose to 100 days post last dose (approximately 102 weeks)
BICR-Assessed Progression Free Survival (PFS) in Part 2	The time between the date of first confirmed response to the date of the first documented tumor progression (per RECIST 1.1), or death due to any cause, whichever occurs first as per BICR.	From first dose to 100 days post last dose (approximately 102 weeks)
Investigator-Assessed Progression Free Survival (PFS) in Part 2	The time between the date of first confirmed response to the date of the first documented tumor progression (per RECIST 1.1), or death due to any cause, whichever occurs first as per investigator.	From first dose to 100 days post last dose (approximately 102 weeks)

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2017
• Primary Completion (Actual): January 5, 2024
• Study Completion (Actual): January 5, 2024

Study Registration Dates

• First Submitted: June 20, 2017
• First Submitted That Met QC Criteria: June 20, 2017
• First Posted (Actual): June 22, 2017

Study Record Updates

• Last Update Posted (Estimated): September 15, 2025
• Last Update Submitted That Met QC Criteria: August 25, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Nivolumab; Ipilimumab
• Other Study ID Numbers: CA209-672

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes