Description:
The purpose of this study is to evaluate the safety, tolerability, drug effects, drug levels
and preliminary antitumor activity of BMS-986416 when administered alone and in combination
with Nivolumab in participants with select advanced solid tumors.
Title
- Brief Title: A Study of BMS-986416 With and Without Nivolumab in Select Solid Tumors
- Official Title: A Phase 1 Study of BMS-986416 Alone and in Combination With Nivolumab in Select Solid Tumors
Clinical Trial IDs
- ORG STUDY ID:
CA102-003
- NCT ID:
NCT04943900
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| BMS-986416 | | Part 1A: Monotherapy (BMS-986416) |
| Nivolumab | BMS-936558, Opdivo | Part 1B: Combination Therapy (BMS-986416 + Nivolumab) |
Purpose
The purpose of this study is to evaluate the safety, tolerability, drug effects, drug levels
and preliminary antitumor activity of BMS-986416 when administered alone and in combination
with Nivolumab in participants with select advanced solid tumors.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Part 1A: Monotherapy (BMS-986416) | Experimental | | |
| Part 1B: Combination Therapy (BMS-986416 + Nivolumab) | Experimental | | |
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit:
www.BMSStudyConnect.com
Inclusion Criteria:
- Participants with histologically or cytologically confirmed locally advanced
unresectable, metastatic, or recurrent select solid tumor
- Eligible tumor types Non-small cell lung cancer (NSCLC), Urothelial carcinoma (UC),
Squamous cell carcinoma of the head and neck (SCCHN), Hepatocellular carcinoma (HCC),
Microsatellite-stable colorectal carcinoma (MSS CRC), or Pancreatic ductal
adenocarcinoma (PDAC)
- Resistant/refractory to or intolerant of existing standard therapies known to provide
clinical benefit
- Measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1
(RECIST v 1.1)
- Disease amenable to serial biopsy
Exclusion Criteria:
- Uncontrolled or significant cardiovascular disease
- Known connective tissue disease such as Marfan, Ehlers-Danlos, or Loeys-Dietz syndrome
- Medical requirement for chronic anticoagulant or antiplatelet agents (except low-dose
aspirin, which is permitted)
Other protocol-defined inclusion/exclusion criteria apply
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Incidence of Adverse Events (AEs) |
| Time Frame: | Up to 100 days after the last treatment of study intervention(s) |
| Safety Issue: | |
| Description: | |
Secondary Outcome Measures
| Measure: | Maximum observed serum concentration (Cmax) of BMS-986416 |
| Time Frame: | Up to 100 days after the last treatment of study intervention(s) |
| Safety Issue: | |
| Description: | |
| Measure: | Time of maximum observed serum concentration (Tmax) of BMS-986416 |
| Time Frame: | Up to 100 days after the last treatment of study intervention(s) |
| Safety Issue: | |
| Description: | |
| Measure: | Trough observed serum concentration (Ctrough) of BMS-986416 |
| Time Frame: | Up to 100 days after the last treatment of study intervention(s) |
| Safety Issue: | |
| Description: | |
| Measure: | Overall Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) per Investigator assessment |
| Time Frame: | Up to 2 years |
| Safety Issue: | |
| Description: | |
| Measure: | Duration of Response (DOR) using RECIST 1.1 per Investigator assessment |
| Time Frame: | Up to 2 years |
| Safety Issue: | |
| Description: | |
| Measure: | Incidence of clinically significant changes in ECG parameters: QTcF |
| Time Frame: | Up to 100 days after the last treatment of study intervention(s) |
| Safety Issue: | |
| Description: | QTcF = Corrected QT interval using the Fridericia formula. QT interval is the time from the start of the Q wave to the end of the T wave |
Details
| Phase: | Phase 1 |
| Primary Purpose: | Interventional |
| Overall Status: | Not yet recruiting |
| Lead Sponsor: | Bristol-Myers Squibb |
Trial Keywords
- BMS-986416
- Nivolumab
- Opdivo
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma (UC)
- Squamous cell carcinoma of the head and neck (SCCHN)
- Hepatocellular carcinoma (HCC)
- Microsatellite-stable colorectal carcinoma (MSS CRC)
- Pancreatic ductal adenocarcinoma (PDAC)
Last Updated
June 29, 2021
