Status:
TERMINATED
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
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Cancer
Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to investigate BMS-986226 administered alone or in combination with nivolumab or ipilimumab.
Eligibility Criteria
Inclusion
- For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
- 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
- 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
Key Trial Info
Start Date :
September 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2021
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03251924
Start Date
September 1 2017
End Date
December 20 2021
Last Update
February 28 2023
Active Locations (13)
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1
Local Institution - 0005
Boston, Massachusetts, United States, 02215
2
Local Institution - 0012
St Louis, Missouri, United States, 63110
3
Local Institution - 0002
Hackensack, New Jersey, United States, 07601
4
Local Institution - 0001
Philadelphia, Pennsylvania, United States, 19111