Description:
The purpose of this study is to determine whether nivolumab is an effective treatment for
cancer that has advanced or has spread. Various tumor types may be eligible for enrollment.
Title
- Brief Title: An Open Label Phase 2 Multicohort Trial of Nivolumab in Advanced or Metastatic Malignancies
- Official Title: An Open Label Phase 2 Multi-cohort Trial of Nivolumab in Advanced or Metastatic Malignancies
Clinical Trial IDs
- ORG STUDY ID:
CA209-627
- SECONDARY ID:
2016-000461-23
- NCT ID:
NCT02832167
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| BMS936558 | | Nivolumab |
Purpose
The purpose of this study is to determine whether Nivolumab is an effective treatment for
advanced or metastatic cancer. The study will evaluate the clinical benefit rate of
Nivolumab in subjects at 16 weeks from enrollment. Various advanced or metastatic tumor
types are eligible for enrollment. Subjects must have received prior standard of care
treatment for their cancer before enrollment.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Nivolumab | Experimental | | |
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com
Inclusion Criteria:
- Diagnosed with advanced or metastatic malignancy
- Received standard of care treatment for primary malignancy and standard of care
treatment for relapsed cancer
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria:
- Prior treatment with an antiPD1, antiPDL1, antiPDL2, antiCD137, or antiCTLA4
antibody, or any other antibody or drug specifically targeting Tcell co-stimulation
or checkpoint pathways.
- Subjects previously treated with investigational anticancer therapies less than 6
weeks prior to the first dose of Nivolumab
- Subjects with an active, known, or suspected autoimmune disease
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: | Clinical Benefit Rate measured by radiologic tumor assessments |
| Time Frame: | Change from baseline to week 16 |
| Safety Issue: | |
| Description: | |
Secondary Outcome Measures
| Measure: | Overall Survival rate (OS) |
| Time Frame: | 1 Year |
| Safety Issue: | |
| Description: | |
| Measure: | Duration of clinical response |
| Time Frame: | Up to one year |
| Safety Issue: | |
| Description: | |
| Measure: | Incidence of adverse events (AEs) |
| Time Frame: | Up to one year |
| Safety Issue: | |
| Description: | Safety and Tolerability |
| Measure: | Grade of AEs |
| Time Frame: | Up to one year |
| Safety Issue: | |
| Description: | Safety and Tolerability |
| Measure: | Radiologic Tumor Assessments to characterize Pseudoprogression |
| Time Frame: | Up to one year |
| Safety Issue: | |
| Description: | |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Bristol-Myers Squibb |
Last Updated
April 17, 2017
