Phase 2
Completed N=627
An Investigational Immuno-therapy Study of BMS-986205 Given in Combination With Nivolumab and in Combination With Both Nivolumab and Ipilimumab in Cancers That Are Advanced or Have Spread
Source: ClinicalTrials.gov NCT02658890 ↗Enrolled (actual)
627
Serious AEs
64.7%
Results posted
Aug 2023
Primary outcomePrimary: Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths — 1; 1; 0; 7 Participants
Summary
The purpose of the study is to determine safety and effectiveness of experimental medication BMS-986205 when combined with Nivolumab and in combination with both Nivolumab and Ipilimumab in patients with cancers that are advanced or have spread. Pharmacokinetics and pharmacodynamics of BMS-986205 when combined with Nivolumab and in combination with Nivolumab and Ipilimumab in this patient population will also be assessed.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths |
1; 1; 0; 7; 10; 11 | — |
| PRIMARY Number of Treated Participant With Laboratory Abnormalities - Thyroid |
0; 0; 0; 1; 1; 2 | — |
| PRIMARY Number of Treated Participant With Laboratory Abnormalities - Liver |
0; 1; 0; 2; 1; 1 | — |
| PRIMARY Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 |
0; 0; 0; 0; 0; 1 | — |
| PRIMARY Percentage of Participants With an Objective Response Rate (ORR)- Parts 2 and 3 |
0; 23.5; 4.5; 14.3; 13.3; 28.6 | — |
| PRIMARY Median Duration of Response (DoR) - Parts 2 and 3 |
134.14; NA; 42.57; NA; 76.14; NA | — |
| PRIMARY Progression Free Survival Rate (PFSR) at 24 Weeks - Parts 2 and 3 |
6.6; 38.0; 4.5; 24.2; 20.0; 42.9 | — |
| PRIMARY Progression Free Survival Rate (PFSR) at 1 Year - Parts 2 and 3 |
NA; 19.0; 4.5; 8.1; 13.3; 34.3 | — |
| PRIMARY Progression Free Survival Rate (PFSR) at 2 Years - Parts 2 and 3 |
NA; 12.7; 4.5; 4.0; 6.7; 8.6 | — |
| SECONDARY Cmax |
94.884; 148.975; 349.767; 613.202; 1248.062; 152.082 | — |
| SECONDARY Tmax |
3.050; 3; 4.025; 4.009; 4.300; 3 | — |
| SECONDARY AUC(TAU) |
700.886; 1125.546; 2271.901; 5091.460; 10479.864; 2079.137 | — |
| SECONDARY Ctrough |
12.020; 22.216; 33.918; 90.605; 225.065; 53.307 | — |
| SECONDARY CLT/F |
12.024; 19.754; 20.202; 15.298; 20.541 | — |
| SECONDARY Accumulation Index (AI) - AUC(TAU) |
2.966; 2.380; 2.290; 2.360; 1.9 | — |
| SECONDARY Accumulation Index (AI) - Cmax |
1.603; 1.523; 1.360; 1.646; 1.505 | — |
| SECONDARY Change From Baseline in Serum Kynurenine |
-208.7; -262; -369.7; -314; -326.4; -378.1 | — |
| SECONDARY Percent Change From Baseline in Serum Kynurenine |
-37.7; -46.6; -56.4; -44.7; -44.1; -54 | — |
| SECONDARY Number of Participants With a Best Overall Response (BOR) - Part 1 and Clinical Pharmacology Substudies |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With an Objective Response Rate (ORR) - Part 1 and Clinical Pharmacology Substudies |
0; 0; 0; 10; 0; 5.6 | — |
| SECONDARY Median Duration of Response (DoR) - Part 1 and Clinical Pharmacology Substudies |
52.14; NA; NA; NA | — |
| SECONDARY Progression Free Survival Rate (PFSR) at 24 Weeks - Part 1 and Clinical Pharmacology Substudies |
NA; NA; 14.3; 30.0; 30.7; 28.2 | — |
| SECONDARY Progression Free Survival Rate (PFSR) at 1 Year - Part 1 and Clinical Pharmacology Substudies |
NA; NA; NA; 15; NA; 21.2 | — |
| SECONDARY Progression Free Survival Rate (PFSR) at 2 Years - Part 1 and Clinical Pharmacology Substudies |
NA; NA; NA; NA; NA; 7.1 | — |
| SECONDARY Number of Participants With a Positive Anti-Drug Antibody (ADA) Test |
1; 0; 0; 0; 0; 1 | — |
Eligibility Criteria
For more information regarding Bristol-Myers Squibb (BMS) Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria
- During dose escalation, subjects with advanced solid tumors that have progressed following at least one standard regimen
- During cohort expansion, subjects with advanced cancer that either have received at least one prior therapy or are treatment naive, depending on the specified tumor type
- Subjects must have measurable disease
- Subject must consent to provide previously collected tumor tissue and a tumor biopsy during screening.
- At least 4 weeks since any previous treatment for cancer
- Must be able to swallow pills or capsules
- Eastern Cooperative Oncology Group(ECOG) Performance Status 0-1
Exclusion Criteria
- Active or chronic autoimmune diseases
- Uncontrolled or significant cardiovascular disease
- History of any chronic Hepatitis, active Hepatitis B or C, human immunodeficiency virus (HIV), or acquired immune deficiency syndrome (AIDS)
- Chronic hepatitis: Positive test for Hepatitis B virus surface antigen or Hepatitis C antibody (except for subjects with hepatocellular carcinoma)
- Active central nervous system (CNS) metastases and CNS metastases as the only sites of disease
- Active infection
Other protocol defined inclusion/exclusion criteria could apply
Data sourced from ClinicalTrials.gov (NCT02658890). 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.