Description:
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.
Title
- Brief Title: 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
- Official Title: A Phase 1/2a Study of BMS-986205 Administered in Combination With Nivolumab (Anti-PD-1 Monoclonal Antibody) and in Combination With Both Nivolumab and Ipilimumab (Anti-CTLA-4 Monoclonal Antibody) in Advanced Malignant Tumors
Clinical Trial IDs
- ORG STUDY ID:
CA017-003
- SECONDARY ID:
2015-004914-79
- NCT ID:
NCT02658890
Conditions
- Advanced Cancer
- Melanoma
- Non-Small Cell Lung Cancer
Interventions
| Drug | Synonyms | Arms |
|---|
| BMS-986205 | | Combination Therapy (Dose Escalation) |
| Nivolumab | BMS-936558, ANTI-PD1 | Combination Therapy (Dose Escalation) |
| Ipilimumab | BMS-734016, ANTI-CTLA-4 | Combination Therapy 2 (Dose Expansion) |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Combination Therapy (Dose Escalation) | Experimental | BMS 986205 + Nivolumab specified dose at specified intervals. | |
| Combination Therapy (Dose Expansion) | Experimental | BMS 986205 + Nivolumab specified dose at specified intervals. | |
| Combination Therapy 2 (Dose Expansion) | Experimental | BMS 986205 + both Nivolumab and ipilimumab specified dose at specified intervals | - BMS-986205
- Nivolumab
- Ipilimumab
|
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
| Maximum Eligible Age: | 100 Years |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Safety and tolerability of BMS-986205 as measured by a composite of the incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, deaths, and clinical laboratory test abnormalities. |
| Time Frame: | 100 days after the last dose of study therapy |
| Safety Issue: | |
| Description: | measured by incidence |
Secondary Outcome Measures
| Measure: | Maximum observed plasma concentration (Cmax) of BMS-986205 |
| Time Frame: | Approximately 3 years |
| Safety Issue: | |
| Description: | measured by plasma concentration |
| Measure: | Time of maximum observed plasma concentration (Tmax) of BMS-986205 |
| Time Frame: | Approximately 3 years |
| Safety Issue: | |
| Description: | measured by plasma concentration |
| Measure: | Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986205 |
| Time Frame: | Approximately 3 years |
| Safety Issue: | |
| Description: | measured by plasma concentration |
| Measure: | Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] of BMS-986205 |
| Time Frame: | Approximately 3 years |
| Safety Issue: | |
| Description: | measured by plasma concentration |
| Measure: | Area under the concentration-time curve in 1 dosing interval [AUC(TAU)] of BMS-986205 |
| Time Frame: | Approximately 3 years |
| Safety Issue: | |
| Description: | measured by plasma concentration |
| Measure: | Trough observed plasma concentration at the end of the dosing interval (Ctrough) of BMS-986205 |
| Time Frame: | Approximately 3 years |
| Safety Issue: | |
| Description: | measured by plasma concentration |
| Measure: | Observed plasma concentration at 24 hours (C24) of BMS-986205 |
| Time Frame: | Approximately 3 years |
| Safety Issue: | |
| Description: | measured by plasma concentration |
| Measure: | Apparent terminal phase half-life (T-HALF) of BMS-986205 |
| Time Frame: | Approximately 3 years |
| Safety Issue: | |
| Description: | measured by plasma concentration |
| Measure: | Apparent total body clearance (CLT/F) of BMS-986205 |
| Time Frame: | Approximately 3 years |
| Safety Issue: | |
| Description: | measured by plasma concentration |
| Measure: | Apparent renal clearance (CLR/F) of BMS-986205 |
| Time Frame: | Approximately 3 years |
| Safety Issue: | |
| Description: | measured by plasma concentration |
| Measure: | Volume of distribution of terminal phase (Vz/F) of BMS-986205 |
| Time Frame: | Approximately 3 years |
| Safety Issue: | |
| Description: | measured by plasma concentration |
| Measure: | Apparent volume of distribution at steady state (Vss/F) of BMS-986205 |
| Time Frame: | Approximately 3 years |
| Safety Issue: | |
| Description: | measured by plasma concentration |
| Measure: | Accumulation index (AI) of BMS-986205 |
| Time Frame: | Approximately 3 years |
| Safety Issue: | |
| Description: | measured by plasma concentration |
| Measure: | Percent urinary recovery (%UR) of BMS-986205 |
| Time Frame: | Approximately 3 years |
| Safety Issue: | |
| Description: | measured by urine concentration |
| Measure: | Percent urinary recovery over 24 hours(%UR24) of BMS-986205 |
| Time Frame: | Approximately 3 years |
| Safety Issue: | |
| Description: | measured by urine concentration |
| Measure: | Ratio of metabolite Cmax to parent Cmax, corrected for molecular weight (MR_Cmax) of BMS-986205 |
| Time Frame: | Approximately 3 years |
| Safety Issue: | |
| Description: | measured by plasma concentration |
| Measure: | Ratio of metabolite AUC(0-T) to parent AUC(0-T), corrected for molecular weight (single dose in clinical pharmacology substudy only) [MR_AUC(0-T)] of BMS-986205 |
| Time Frame: | Approximately 3 years |
| Safety Issue: | |
| Description: | measured by plasma concentration |
| Measure: | Ratio of metabolite AUC(TAU) to parent AUC(TAU), corrected for molecular weight [MR_AUC(TAU)] of BMS-986205 |
| Time Frame: | Approximately 3 years |
| Safety Issue: | |
| Description: | measured by plasma concentration |
| Measure: | Ratio of metabolite AUC(INF) to parent AUC(INF), corrected for molecular weight (single dose in clinical pharmacology substudy only) [MR_AUC(INF)] of BMS-986205 |
| Time Frame: | Approximately 3 years |
| Safety Issue: | |
| Description: | measured by plasma concentration |
| Measure: | Anti-drug antibody (ADA) response to Nivolumab in combination with BMS-986205 |
| Time Frame: | Approximately 3 years |
| Safety Issue: | |
| Description: | measured by immunoassay and liquid chromatography- mass spectrometry |
| Measure: | Anti-drug antibody (ADA) response to Ipilimumab in combination with BMS-986205 |
| Time Frame: | Approximately 3 years |
| Safety Issue: | |
| Description: | measured by immunoassay and liquid chromatography- mass spectrometry |
Details
| Phase: | Phase 1/Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Bristol-Myers Squibb |
Last Updated
August 10, 2020
