An Open Label Investigational Immuno-therapy Trial of Nivolumab in Cancers That Are Advanced or Have Spread

Study Overview
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Brief Summary
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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.

Official Title
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An Open Label Phase 2 Multi-cohort Trial of Nivolumab in Advanced or Metastatic Malignancies

Conditions
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Cancer

Intervention / Treatment
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* Biological: Nivolumab


Participation Criteria
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Eligibility Criteria
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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 apply

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nivolumab<br> | Biological: Nivolumab<br>* Specified dose on specified days<br>* Other names: Opdivo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (ORR) | 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. | From first dose to the date of objectively documented progression (per tumor-specific response criteria) or the date of subsequent therapy, whichever occurs first (up to approximately 24 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Response (DOR) | 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. Median DOR computed using Kaplan-Meier method | From the time of first confirmed response to the date of the first documented progression (up to approximately 22 months) | 
| Time to Objective Response (TTR) | 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. | From the first dosing date to the date of the first confirmed response (up to approximately 10 months) | 
| Clinical Benefit Rate (CBR) | 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). | From the first dosing date to the date of the last dose (approximately 24 months) | 
| Overall Survival Rate at 1 Year | 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 percent of participants still alive at 1 year after first dosing, measured from Kaplan-Meier curve of OS. | From the first dosing date to 1 year later | 
| Number of Participants Who Died | Number of participants who died for any cause | From first dose to 100 days following last dose (up approximately 27 months) | 
| Number of Participants Experiencing Adverse Events (AEs) | Number of participants who experienced any grade, any cause AEs | From first dose to 30 days following the last dose (up to approximately 25 months) | 
| Number of Participants Experiencing Serious Adverse Events (SAEs) | Number of participants who experienced any grade, any cause SAEs | From first dose to 100 days following the last dose (up to approximately 27 months) | 
| Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation | Number of participants who experienced AEs leading to discontinuation of study therapy | From first dose to 30 days following the last dose (up to approximately 25 months) | 
| Number of Participants Experiencing Immune-mediated Adverse Events (IMAEs) | 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. | From first dose to 100 days following the last dose (up to approximately 27 months) | 
| Number of Participants Experiencing Select Adverse Events | Number of participants who experienced Select Adverse Events. Select Adverse Events categories include: gastrointestinal, hepatic, pulmonary, renal, skin, hypersensitivity/infusion reaction. | From first dose to 30 days following the last dose (up to approximately 25 months) | 
| Number of Participants Experiencing Adverse Events (AEs) Leading to Dose Delay or Dose Reduction | Number of participants who experienced AEs leading to dose delay or dose reduction. 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) | From first dose to 30 days following the last dose (up to approximately 25 months) | 
| Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests | Number of participants who experienced the laboratory abnormalities in specific liver tests described in the individual categories. ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal | From first dose to 30 days following the last dose (up to approximately 25 months) | 
| Number of Participants Experiencing Laboratory Abnormalities in Specific Thyroid Tests | Number of participants who experienced the laboratory abnormalities in specific thyroid tests described in the individual categories. TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal | From first dose to 100 days following the last dose (up to approximately 27 months) |