Pan Tumor Nivolumab Rollover Study

  • Interventional
  • Active
  • NCT03899155
Eligibility Details Visit Clinicaltrials.gov

Pan-Tumor Study for Long Term Follow-up of Cancer Survivors Who Have Participated in Trials Investigating Nivolumab

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

Gender
All

Age Group
18 Years and up

Accepting 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.

At a Glance

National Government IDNCT03899155

IRB#IRB19-2018

Lead SponsorBristol-Myers Squibb

Lead PhysicianEverett E. Vokes

Collaborator(s)N/A

EligibilityAll
18 Years and up
Active