NCT03192943
Completed
Phase 1
A Phase 1 Study for Safety and Tolerability of BMS-986205 Administered in Combination With Nivolumab (BMS-936558) in Advanced Malignant Tumors
Overview
- Phase
- Phase 1
- Intervention
- BMS-986205
- Conditions
- Advanced Cancer
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Incidence of Laboratory Abnormalities
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this study is to assess the safety and tolerability for the combination therapy of BMS-986205 and Nivolumab in patients with advanced tumors
Investigators
Eligibility Criteria
Inclusion Criteria
- •For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
- •Participants must have histologic or cytological confirmation of a malignancy that is advanced (metastatic and/or unresectable) with measureable disease per Response Evaluation Criteria In Solid Tumors (RECIST v1.1)
- •Participants must have received, and then progressed or been intolerant to standard treatment regimen in the advanced or metastatic setting
- •Eastern Cooperative Oncology Group performance status of ≤ 1
Exclusion Criteria
- •Participants with known or suspected CNS metastases, untreated CNS metastases, or with the CNS as the only site of disease are excluded
- •History of congenital or autoimmune hemolytic disorders
- •History or presence of hypersensitivity or idiosyncratic reaction to methylene blue
- •Other protocol defined inclusion/exclusion criteria could apply
Arms & Interventions
Dose Escalation
monotherapy and combination therapy
Intervention: BMS-986205
Dose Escalation
monotherapy and combination therapy
Intervention: Nivolumab
Outcomes
Primary Outcomes
Incidence of Laboratory Abnormalities
Time Frame: 15 months
Safety and Tolerability
AEs leading to discontinuation
Time Frame: Up to one year
Safety and Tolerability
Incidence of Serious Adverse Events (SAEs)
Time Frame: 15 months
Safety and Tolerability
Incidence of Adverse Events (AEs)
Time Frame: 15 months
Safety and Tolerability
Incidence of Death
Time Frame: 15 months
Safety and Tolerability
Secondary Outcomes
- Apparent volume of distribution at steady-state (Vss/F)(Up to one year)
- Best Overall Response (BOR)(Up to one year)
- Time of maximum observed plasma concentration (Tmax)(Up to one year)
- Trough observed plasma concentration at the end of the dosing interval (Ctrough)(Up to one year)
- Percent urinary recovery over 24 hours (%UR24)(Up to 24 hours)
- Biomarker Availability(Up to one year)
- Maximum observed plasma concentration (Cmax)(Up to one year)
- Area under the plasma concentration-time curve in one dosing interval [AUC(TAU)](Up to one year)
- Apparent total body clearance (CLT/F)(Up to one year)
- Incidence of anti-drug antibody (ADA)(Up to one year)
- Duration of Response (DOR)(Up to one year)
Study Sites (1)
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