Purpose

Main Objective of this study is to examine long-term safety of nivolumab in participants on treatment and in follow up.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Signed Written Informed Consent
  • Participants who have completed treatment with nivolumab, progressed on prior nivolumab treatment or discontinued nivolumab due to toxicity in the Parent Study are not eligible to receive nivolumab in this study. These participants may be enrolled for safety and survival follow-up only.
  • Participant is eligible for nivolumab treatment as per the Parent Study, and/or Investigator assessed clinical benefit, or
  • Participant is in or has completed the follow-up phase of the Parent Study i) Participant has completed or discontinued treatment, or ii) Participant has progressed on treatment, and/or iii) Participant is on subsequent therapy

Exclusion Criteria

  • Participant is not eligible for nivolumab treatment as per the Parent Study
  • Participants not receiving clinical benefit as assessed by the Investigator (participant is still eligible for study if entering survival follow-up only)
  • Any clinical adverse event (AE), laboratory abnormality, or intercurrent illness which, in the opinion of the Investigator, indicates that participation in the study is not in the best interest of the participant
  • Participants in survival follow-up have no exclusion criteria.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Nivolumab Dose 1
Specified Dose on Specified Days
  • Drug: Nivolumab
    Solution for IV Injection
    Other names:
    • BMS-936558-01
Experimental
Nivolumab Dose 2
Specified Dose on Specified Days
  • Drug: Nivolumab
    Solution for IV Injection
    Other names:
    • BMS-936558-01

Recruiting Locations

Georgetown-Lombardi Comprehnsive Cancer Center
Washington, District of Columbia 20007-2113
Contact:
Michael Atkins, Site 0088
202-444-4807

More Details

Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

Recruiting sites have contact information. Please contact the sites directly. If there is no contact information available,
please email
Clinical.Trials@bms.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.