Phase 2 Completed N=36 Treatment

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

Solid Tumors

Source: ClinicalTrials.gov NCT03195478 ↗

Enrolled (actual)

Serious AEs

38.9%

Results posted

Sep 2025

Primary outcomePrimary: Number of Participants With Adverse Events (AEs) in Part 1. — 7; 9; 9 Participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Adverse Events (AEs) in Part 1.	7; 9; 9	—
PRIMARY Number of Participants With Serious Adverse Events (SAEs) in Part 1.	4; 3; 3	—
PRIMARY Number of Participants With Adverse Events Leading to Discontinuation in Part 1.	3; 0; 0	—
PRIMARY Number of Participants With Adverse Events Leading to Death in Part 1.	1; 1; 0	—
PRIMARY Number of Participants With Clinical Laboratory Abnormalities in Part 1.	5; 9; 7; 1; 4; 1	—
PRIMARY BICR-Assessed ORR in Part 2	77.8	—
SECONDARY Cmax - Maximum Observed Serum Concentration in Part 1.	59.7; 69.5; 22.5; 104; 27.2; 122	—
SECONDARY Tmax - Time of Maximum Observed Serum Concentration in Part 1.	1.68; 1.62; 1.59; 1.55; 4.78; 1.65	—
SECONDARY AUC(0-T) - Area Under the Plasma Concentration-time Curve in Part 1.	10329; 14141; 4056; 23348; 4323; 23147	—
SECONDARY AUC(TAU) - Area Under the Concentration-time Curve in One Dosing Interval in Part 1.	10333; 13919; 4002; 24467; 4647; 28098	—
SECONDARY Ceoinf - Serum Concentration Achieved at the End of Study Drug Infusion in Part 1.	59.4; 68.4; 22.5; 99.5; 25.4; 120	—
SECONDARY Ctau - Concentration at the End of Dosing Interval in Part 1.	19.7; 16.0; 3.46; 40.6; 3.32; 63.2	—
SECONDARY CLT - Total Body Clearance in Part 1.	8.56; 13.1; 6.99; 13.0; 15.0; NA	—
SECONDARY Css-avg - Average Concentration Over a Dosing Interval (AUC(TAU)/Tau) in Part 1.	30.8; 27.6; 7.94; 48.5; 9.22; 83.6	—
SECONDARY AI - Accumulation Index in Part 1.	1.65; 1.13; 2.71; 1.50; 1.26; NA	—
SECONDARY T-HALFeff - Effective Elimination Half-life in Part 1.	385; 263; 507; 325; 282; NA	—
SECONDARY Number of Participants With Nivolumab Anti Drug Antibodies in Part 1.	0; 2; 0; 0; 0; 3	—
SECONDARY Number of Participants With Ipilimumab Anti Drug Antibodies in Part 1.	1; 0; 2; 0; 0; 0	—
SECONDARY Investigator-Assessed ORR in Part 2	66.7	—
SECONDARY Investigator-Assessed Disease Control Rate (DCR) in Part 2	88.9	—
SECONDARY BICR-Assessed Disease Control Rate (DCR) in Part 2	88.9	—
SECONDARY BICR-Assessed Duration of Response (DOR) in Part 2	NA	—
SECONDARY Investigator-Assessed Duration of Response (DOR) in Part 2	NA	—
SECONDARY BICR-Assessed Progression Free Survival (PFS) in Part 2	NA	—
SECONDARY Investigator-Assessed Progression Free Survival (PFS) in Part 2	NA	—

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03195478). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.