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

August 25, 2025 updated by: Bristol-Myers Squibb

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
37

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events (AEs) in Part 1.
Time Frame: 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
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.
Time Frame: 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
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.
Time Frame: 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
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.
Time Frame: 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.
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.
Time Frame: 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.
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
Time Frame: 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)

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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cmax - Maximum Observed Serum Concentration in Part 1.
Time Frame: 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)
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.
Time Frame: 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.
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.
Time Frame: 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 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.
Time Frame: 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.
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.
Time Frame: 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.
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.
Time Frame: 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. 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.
Time Frame: At Cycle 3 Day 1 for Arm A, Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)
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.
Time Frame: 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)
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.
Time Frame: At Cycle 3 Day 1 for Arm A, Cycle 2 Day 1 for Arm B and C (1 cycle = 42 days)

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.
Time Frame: 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 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.
Time Frame: 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 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.
Time Frame: 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.
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
Time Frame: 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)

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
Time Frame: 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)
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
Time Frame: Approximately 5.92 Months
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
Time Frame: From first dose to 100 days post last dose (approximately 102 weeks)
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
Time Frame: From first dose to 100 days post last dose (approximately 102 weeks)
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
Time Frame: From first dose to 100 days post last dose (approximately 102 weeks)
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
Time Frame: From first dose to 100 days post last dose (approximately 102 weeks)
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 2, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 5, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 5, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 20, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 22, 2017

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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