Description:
The purpose of this study is to investigate BMS-986226 administered alone or in combination
with nivolumab or ipilimumab.
Title
- Brief Title: A Dose Escalation and Combination Immunotherapy Study to Evaluate BMS-986226 Alone or in Combination With Nivolumab or Ipilimumab in Patients With Advanced Solid Tumors
- Official Title: A Phase 1/2 Dose Escalation and Combination Cohort Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Efficacy of BMS-986226 Alone or in Combination With Nivolumab or Ipilimumab in Patients With Advanced Solid Tumors
Clinical Trial IDs
- ORG STUDY ID:
CA021-002
- SECONDARY ID:
2017-000238-73
- NCT ID:
NCT03251924
Conditions
- Cancer
- Tumors
- Neoplasm
- Malignancy
Interventions
| Drug | Synonyms | Arms |
|---|
| BMS-986226 | | BMS-986226 |
| Nivolumab | BMS-936558, PD-1 receptor blocking monoclonal antibody [mAb], Opdivo | BMS-986226 and Nivolumab |
| Ipilimumab | BMS-734016, MDX010, Checkpoint blocking antibody that recognizes CTLA-4, Yervoy | BMS-986226 and Ipilimumab |
| Tetanus Vaccine | | BMS-986226 |
Purpose
The purpose of this study is to investigate BMS-986226 administered alone or in combination
with nivolumab or ipilimumab.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| BMS-986226 | Experimental | administered intravenously | - BMS-986226
- Tetanus Vaccine
|
| BMS-986226 and Nivolumab | Experimental | administered intravenously | - BMS-986226
- Nivolumab
- Tetanus Vaccine
|
| BMS-986226 and Ipilimumab | Experimental | administered intravenously | - BMS-986226
- Ipilimumab
- Tetanus Vaccine
|
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com
Inclusion Criteria:
- Advanced solid tumors
- Histological or cytological confirmation of a malignancy that is advanced (metastatic
and/or unresectable) with measureable disease as defined by Response Evaluation
Criteria In Solid Tumors (RECIST) v1.1 or PCWG3 (prostate only).
- At least 1 lesion accessible for biopsy in addition to the target lesion
- Participants must have received, and then progressed or been intolerant to, at least 1
standard treatment regimen
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2
Exclusion Criteria:
- Participants with active central nervous system (CNS) metastases, untreated CNS
metastases, or with the CNS as the only site of disease are excluded (controlled brain
metastases will be allowed to enroll)
- Participants with carcinomatous meningitis
- Prior malignancy active within the previous 2 years except for locally curable cancers
that have been apparently cured, such as basal or squamous cell skin cancer,
superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast
- Active, known, or suspected autoimmune disease
- Uncontrolled or significant cardiovascular disease
- Participants with known allergies to egg products, neomycin and tetanus toxoid.
- Prior adverse reaction to tetanus toxoid- containing vaccines.
Other protocol defined inclusion/exclusion criteria could 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 (AE) |
| Time Frame: | Approximately 2 years |
| Safety Issue: | |
| Description: | |
Secondary Outcome Measures
| Measure: | Objective response rate (ORR) measure by Clopper-Pearson method |
| Time Frame: | Approximately 2 years |
| Safety Issue: | |
| Description: | |
| Measure: | Median Duration of Response (mDOR) measured by Kaplan-Meier method |
| Time Frame: | Approximately 2 years |
| Safety Issue: | |
| Description: | |
| Measure: | Progression Free Survival (PFS) measured by Kaplan-Meier method |
| Time Frame: | At 24 weeks |
| Safety Issue: | |
| Description: | |
| Measure: | Maximum observed plasma concentration (Cmax) |
| Time Frame: | Approximately 2 years |
| Safety Issue: | |
| Description: | |
| Measure: | Time of maximum observed plasma concentration (Tmax) |
| Time Frame: | Approximately 2 years |
| Safety Issue: | |
| Description: | |
| Measure: | Area under the concentration-time curve from time 0 to the time of the last [AUC (0-T)] |
| Time Frame: | Approximately 2 years |
| Safety Issue: | |
| Description: | |
| Measure: | Area under the concentration-time curve in 1 dosing interval [AUC(TAU)] |
| Time Frame: | Approximately 2 years |
| Safety Issue: | |
| Description: | |
| Measure: | Incidence of anti-drug antibodies to BMS-986226 assessed by immunoassay |
| Time Frame: | Approximately 2 years |
| Safety Issue: | |
| Description: | |
| Measure: | Change from baseline in immunoassay for BMS-986226 |
| Time Frame: | Approximately 2 years |
| Safety Issue: | |
| Description: | |
Details
| Phase: | Phase 1/Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Active, not recruiting |
| Lead Sponsor: | Bristol-Myers Squibb |
Last Updated
September 10, 2020
