Phase 2
Completed N=12
A Study of BMS-986205 Alone and in Combination With Nivolumab in Chinese Patients With Advanced Malignant Solid Tumors
Source: ClinicalTrials.gov NCT03792750 ↗Enrolled (actual)
12
Serious AEs
25.0%
Results posted
Feb 2022
Primary outcomePrimary: The Number of Participants Experiencing Adverse Events (AE) — 11 Participants
Summary
The purpose of this study is to determine safety and effectiveness of experimental medication BMS-986205 in combination with Nivolumab in patients with cancers that are advanced or have spread.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Participants Experiencing Adverse Events (AE) |
11 | — |
| PRIMARY The Number of Participants Experiencing Serious Adverse Events (SAE) |
3 | — |
| PRIMARY The Number of Participants Experience Adverse Events (AE) Leading to Discontinuation |
5 | — |
| PRIMARY Number of Participant Deaths |
3 | — |
| PRIMARY The Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests |
3; 2; 0; 0; 2; 1 | — |
| PRIMARY The Number of Participants Experiencing Laboratory Abnormalities in Specific Thyroid Tests |
4; 4; 2; 4; 0; 5 | — |
| PRIMARY (Cmax) Maximum Observed Plasma Concentration |
596.0; 701.9; 781.0 | — |
| PRIMARY (Tmax) Time of Maximum Observed Plasma Concentration |
2.5; 2.5; 2.5 | — |
| PRIMARY (AUC(TAU)) Area Under the Concentration-time Curve in One Dosing Interval |
3380.8; 6048.3; 5922.3 | — |
| PRIMARY (CLT/F) Apparent Total Body Clearance |
16.5; 16.9 | — |
| PRIMARY (T-HALF (Eff, AUC)) Effective Elimination Half-life |
22.9 | — |
| PRIMARY (AI_CMAX) Accumulation Index |
1.2 | — |
| PRIMARY (AI_AUC ) Accumulation Index |
1.8 | — |
| PRIMARY (Ctrough) Trough Observed Plasma Concentration |
51.2; 117.4; 154.9; 141.5; 150.2; 161.3 | — |
| PRIMARY (percentUR24) Percent Urinary Recovery Over 24 Hours |
— | — |
| SECONDARY Objective Response Rate (ORR) |
1 | — |
| SECONDARY Best Overall Response (BOR) |
0; 1; 5; 5; 1 | — |
| SECONDARY Duration of Response (DOR) |
72 | — |
| SECONDARY Measurement of Serum Kynurenine Levels |
189.6; 150.8; 180.6; 273.0; 111.0; 124.0 | — |
| SECONDARY Measurement of Tryptophan Levels |
13445.8; 14528.3; 12508.3; 17900.0; 13200.0; 13200.0 | — |
| SECONDARY Number of Participants With Anti-drug Antibodies (ADA) to Nivolumab |
1; 0; 1; 7 | — |
Eligibility Criteria
Inclusion Criteria
- Participants must have histologic or cytological confirmation of a solid tumor that is advanced with measureable disease per RECIST v1.1
- Participants must have received, and then progressed or been intolerant to at least one standard treatment regimen in the advanced or metastatic setting
- Participants must have an ECOG performance status of less than or equal to 1
- Participants must have at least 1 lesion with measurable disease as defined by RECIST Version 1.1
Exclusion Criteria
- Participants must not have suspected, known, or progressive CNS metastases, have untreated CNS metastases, or have the CNS as the only site of disease
- Participants with prior exposure to anti PD-1 or anti-PDL1 therapy
- Participants must not have a history of allergy to any of the study treatment components
Data sourced from ClinicalTrials.gov (NCT03792750). 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.