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

NCT03195478 | Completed Phase 1 Results FDA Drug

• 1 other identifier: CA209-672
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 12

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.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (19)

• 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.

  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.

  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.

  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)

Study Arms (4)

Nivo/Ipi Combination Therapy A

EXPERIMENTAL

Drug: Nivolumab; Drug: Ipilimumab

Nivo/Ipi Combination Therapy B

EXPERIMENTAL

Drug: Nivolumab; Drug: Ipilimumab

Nivo/Ipi Combination Therapy C

EXPERIMENTAL

Drug: Nivolumab; Drug: Ipilimumab

Nivo/Ipi Combination Arm D

EXPERIMENTAL

Drug: Nivolumab; Drug: Ipilimumab

Interventions

Nivolumab DRUG

Specified dose on specified days

Also known as: BMS-936558, Opdivo

Nivo/Ipi Combination Arm D; Nivo/Ipi Combination Therapy A; Nivo/Ipi Combination Therapy B; Nivo/Ipi Combination Therapy C

Ipilimumab DRUG

Specified dose on specified days

Also known as: BMS-734016, Yervoy

Nivo/Ipi Combination Arm D; Nivo/Ipi Combination Therapy A; Nivo/Ipi Combination Therapy B; Nivo/Ipi Combination Therapy C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (12)

Local Institution - 0015

Beijing, Beijing Municipality, 100021, China

Location

Local Institution - 0001

Beijing, Beijing Municipality, 100142, China

Location

Local Institution

Guangzhou, Guangdong, 510080, China

Location

Local Institution - 0012

Guangzhou, Guangdong, 510655, China

Location

Local Institution - 0011

Harbin, Heilongjiang, 155040, China

Location

Local Institution

Zhengzhou, Henan, 450052, China

Location

Local Institution - 0021

Wuhan, Hubei, 430030, China

Location

Local Institution - 0020

Xi'an, Shan1xi, 710061, China

Location

Local Institution - 0016

Shanghai, Shanghai Municipality, 200025, China

Location

Local Institution - 0018

Chengdu, Sichuan, 610041, China

Location

Local Institution - 0004

Tianjin, Tianjin Municipality, 300222, China

Location

Local Institution - 0013

Hangzhou, Zhejiang, 310009, China

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Interventions

Nivolumab; Ipilimumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

"AUC(TAU) for ipi in Arm A, Cycle 1 and Cycle 3 could not be reported because there were not enough PK samples collected. Samples were only taken up to 336 hours after dosing, but the full TAU is 1008 hours, so it was not possible to calculate AUC(TAU) for these cycles. In Cycle 2, only a single PK sample was collected (at Week 3, prior to nivo dose administration) for both nivo and ipi. Therefore, AUC(TAU) could not be calculated or reported for nivo and ipi in Arm A, Cycle 2."

Results Point of Contact

• Title: Bristol-Myers Squibb Study Directo
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

1-855-907-3286

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: June 22, 2017
• Study Start: August 2, 2017
• Primary Completion: January 5, 2024
• Study Completion: January 5, 2024
• Last Updated: September 15, 2025
• Results First Posted: September 15, 2025

Record last verified: 2025-08

Locations

CN (12)