Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

A Phase 1/2a Study of BMS-986179 Administered Alone and in Combination With Nivolumab (BMS-936558) in Subjects With Advanced Solid Tumors

ID
Name
CA013-004
Description
The purpose of this study is to assess the safety and tumor-shrinking ability of experimental medication BMS-986179 alone and when combined with Nivolumab, in patients with solid cancers that are advanced or have spread.
Trial arms
Trial start
2016-06-21
Estimated PCD
2021-10-12
Trial end
2021-10-12
Status
Completed
Phase
Early phase I
Treatment
BMS-986179
Specified dose on specified days
Arms:
Arm A-Monotherapy, Arm B- Combination Therapy, Arm C-Combination Therapy
Nivolumab
Specified dose on specified days
Arms:
Arm B- Combination Therapy
Other names:
BMS-936558, Opdivo
rHuPH20
Specified dose on specified days
Arms:
Arm C-Combination Therapy
Size
235
Primary endpoint
Number of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.
From first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months.
Eligibility criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Solid cancers that are advanced or have spread (for which alternative therapies were deemed not effective) * Eastern Cooperative Oncology Group (ECOG) 0-1 * Acceptable lab testing results * Allow biopsies Exclusion Criteria: * Central nervous system (CNS) tumors * Uncontrolled or significant cardiovascular diseases * Active or known autoimmune disease * Organ transplant Other protocol defined inclusion/exclusion criteria could apply
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 235, 'type': 'ACTUAL'}}
Updated at
2023-04-05

1 organization

3 products

1 indication

Product
BMS-986179
Indication
Malignant Solid Tumor
Product
Nivolumab
Organization
Bristol-Myers Squibb
Product
rHuPH20