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 Investigational Immuno-therapy Trial of Nivolumab in Cancers That Are Advanced or Have Spread
- 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 |
|---|
| Nivolumab | BMS-936558, Opdivo | Nivolumab |
Purpose
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.
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: | Objective Response Rate (ORR) |
| Time Frame: | From first dose to the date of objectively documented progression (per tumor-specific response criteria) or the date of subsequent therapy, whichever occurs first (approximately 24 months) |
| Safety Issue: | |
| Description: | ORR is defined as the percentage of participants with a best overall response (BOR) of confirmed Complete Response (CR) or Partial Response (PR). Best overall response is defined as the best response designation, as determined by investigator, recorded in the specified timeframe, according to the RECIST 1.1 criteria. |
Secondary Outcome Measures
| Measure: | Duration of Response (DOR) |
| Time Frame: | From the time of first confirmed response to the date of the first documented progression (approximately 20 months) |
| Safety Issue: | |
| Description: | DOR is defined as the time from first confirmed response (Complete Response, CR or Partial Response, PR) to the date of the first documented tumor progression (as determined by investigator) or death due to any cause, whichever occurs first. |
| Measure: | Time to Objective Response (TTR) |
| Time Frame: | From the first dosing date to the date of the first confirmed response (approximately 10 months) |
| Safety Issue: | |
| Description: | TTR is defined as the time from first dosing date to the date of the first confirmed response (Complete Response, CR or Partial Response, PR), as assessed by investigator. |
| Measure: | Clinical Benefit Rate (CBR) |
| Time Frame: | From the first dosing date to the date of the last dose (approximately 24 months) |
| Safety Issue: | |
| Description: | CBR is defined as the percentage of participants with a best overall response of confirmed Complete Response (CR) or Partial Response (PR) or Stable Disease (SD). |
| Measure: | Overall Survival Rate at 1 Year |
| Time Frame: | From the first dosing date to 1 year later |
| Safety Issue: | |
| Description: | Overall Survival (OS) is defined as the time from the first dosing date to the date of death. A participant who has not died will be censored at last known date alive. OS rate at 1 year is measured as the proportion of participants still alive at 1 year after first dosing, measured from Kaplan-Meier curve of OS. |
| Measure: | Number of Participants Who Died |
| Time Frame: | From first dose to 100 days following last dose (approximately 27 months) |
| Safety Issue: | |
| Description: | Number of participants who died for any cause |
| Measure: | Number of Participants Experiencing Adverse Events (AEs) |
| Time Frame: | From first dose to 30 days following the last dose (approximately 25 months) |
| Safety Issue: | |
| Description: | Number of participants who experienced any grade, any cause AEs |
| Measure: | Number of Participants Experiencing Serious Adverse Events (SAEs) |
| Time Frame: | From first dose to 30 days following the last dose (approximately 25 months) |
| Safety Issue: | |
| Description: | Number of participants who experienced any grade, any cause SAEs |
| Measure: | Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation |
| Time Frame: | From first dose to 30 days following the last dose (approximately 25 months) |
| Safety Issue: | |
| Description: | Number of participants who experienced AEs leading to discontinuation of study therapy |
| Measure: | Number of Participants Experiencing Immune-mediated Adverse Events (IMAEs) |
| Time Frame: | From first dose to 30 days following the last dose (approximately 25 months) |
| Safety Issue: | |
| Description: | Number of participants who experienced IMAEs. IMAEs are AEs consistent with an immune-mediated mechanism or immune-mediated component for which non-inflammatory etiologies (eg, infection or tumor progression) have been ruled out. IMAEs can include events with an alternate etiology which were exacerbated by the induction of autoimmunity. |
| Measure: | Number of Participants Experiencing Select Adverse Events |
| Time Frame: | From first dose to 30 days following the last dose (approximately 25 months) |
| Safety Issue: | |
| Description: | Number of participants who experienced Select Adverse Events. Select Adverse Events categories include: any select AEs, drug-related select AEs, serious select AEs, drug related serious select AEs, any select AEs leading to discontinuation, drug-related select AEs leading to discontinuation |
| Measure: | Number of Participants Experiencing Adverse Events (AEs) Leading to Dose Delay |
| Time Frame: | From first dose to 30 days following the last dose (approximately 25 months) |
| Safety Issue: | |
| Description: | Number of participants who experienced AEs leading to dose delay. A dose will be considered as delayed if the delay is exceeding 3 days after the intended dose date (i.e., greater than or equal to 4 days from scheduled dosing date) |
| Measure: | Number of Participants Experiencing Specific Laboratory Abnormalities |
| Time Frame: | From first dose to 30 days following the last dose (approximately 25 months) |
| Safety Issue: | |
| Description: | Number of participants who experienced specific laboratory abnormalities (measured as change from baseline) in the following disciplines: Hematology, Serum Chemistry, Electrolytes, Abnormal Thyroid Function Test, Abnormal Hepatic Function Test |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Active, not recruiting |
| Lead Sponsor: | Bristol-Myers Squibb |
Last Updated
December 17, 2020
