Phase 2
Completed N=58
A Study of Safety, Tolerability and Pharmacokinetics of Nivolumab in Chinese Subjects With Previously Treated Advanced or Recurrent Solid Tumors
Source: ClinicalTrials.gov NCT02593786 ↗Enrolled (actual)
58
Serious AEs
39.7%
Results posted
Oct 2022
Primary outcomePrimary: The Number of Participants Experiencing Drug-Related Grade 3-4 Adverse Events (AEs) — 1; 1; 0; 0 Participants
Summary
The purpose of this study is to determine whether nivolumab is safe and effective in the treatment of advanced or recurrent solid tumors in Chinese subjects.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Participants Experiencing Drug-Related Grade 3-4 Adverse Events (AEs) |
1; 1; 0; 0 | — |
| PRIMARY The Number of Participants Experiencing Drug-Related Grade 3-4 Serious Adverse Events (SAEs) |
0; 1; 0; 0 | — |
| PRIMARY The Number of Participants Experiencing Abnormal Hepatic Laboratory Test Results |
0; 3; 0; 1; 0; 2 | — |
| PRIMARY The Number of Participants Experiencing Toxicity Grade 3-4 Laboratory Test Results |
1; 2; 0; 1; 0; 0 | — |
| SECONDARY Best Overall Response (BOR) |
0; 0; 0; 0; 3; 2 | — |
| SECONDARY Duration of Response (DOR) |
NA; NA; 6.1; NA; NA; NA | — |
| SECONDARY Objective Response Rate (ORR) |
0; 100; 11.1; 0; 100; 0 | — |
| SECONDARY Response Rate at 24 Weeks |
0; 100; 11.1; 0; 100; 0 | — |
| SECONDARY Disease Control Rate (DCR) at 24 Weeks |
100; 0; 100; 11.1; 0; 100 | — |
| SECONDARY The Number of Participants With Positive Anti Drug Antibody (ADA) Assessments at Baseline and Positive or Negative ADA Samples After Treatment |
1; 4; 0; 0; 1; 0 | — |
| SECONDARY Cmax - Maximum Observed Serum Concentration |
57.025; 77.674; 108.455; 206.630; 132.222; 171.604 | — |
| SECONDARY Tmax - Time of Maximum Observed Serum Concentration |
4.00; 4.00; 4.0; 4.01; 8.00; 8.00 | — |
| SECONDARY AUC (0-T)-Area Under the Plasma Concentration-Time Curve |
8353.429; 11646.854; 23567.315; 49115.208; 28442.153; 35649.049 | — |
| SECONDARY AUC(TAU) - Area Under the Concentration-Time Curve in One Dosing Interval |
8732.232; 12112.137; 23567.315; 49115.208; 30823.993; 37794.083 | — |
| SECONDARY Ceoinf - Serum Concentration Achieved at the End of Study Drug Infusion |
55.020; 66.746; 93.168; 171.494; 122.051; 152.058 | — |
| SECONDARY Ctrough - Trough Observed Serum Concentration at the End of Dosing Interval |
62.417; 62.115; 92.796; 61.530 | — |
| SECONDARY Ctau - Concentration at the End of Dosing Interval |
16.430; 20.788; 26.143; 40.910; 65.286; 78.278 | — |
| SECONDARY T-HALFeff - Effective Elimination Half-Life |
551.194; 510.262; 732.44; 677.642 | — |
| SECONDARY CLT - Total Body Clearance |
5.732; 6.350; 4.769; 6.772 | — |
| SECONDARY AI - Accumulation Index (Cmax) |
2.150; 2.034; 1.255; 1.613 | — |
| SECONDARY AI - Accumulation Index (Ctau) |
3.333; 3.215; 2.053; 2.675 | — |
| SECONDARY AI - Accumulation Index (AUC) |
2.942; 2.707; 2.033; 2.389 | — |
Eligibility Criteria
Inclusion Criteria
- Chinese subjects with advanced or recurrent solid tumors
Exclusion Criteria
- Subjects with brain metastases are excluded unless clinically stable for more than 2 weeks at the time of enrollment as determined by the investigator
- Subjects with carcinomatous meningitis are excluded
Data sourced from ClinicalTrials.gov (NCT02593786). 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.