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Pan Tumor Nivolumab Rollover Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03899155
Recruitment Status : Recruiting
First Posted : April 2, 2019
Last Update Posted : June 9, 2023
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
Cancer Drug: Nivolumab Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pan-Tumor Study for Long Term Follow-up of Cancer Survivors Who Have Participated in Trials Investigating Nivolumab
Actual Study Start Date : August 9, 2019
Estimated Primary Completion Date : August 25, 2025
Estimated Study Completion Date : August 25, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Nivolumab Dose 1
Specified Dose on Specified Days
 Drug: Nivolumab
Solution for IV Injection
Other Name: BMS-936558-01
Experimental: Nivolumab Dose 2
Specified Dose on Specified Days
 Drug: Nivolumab
Solution for IV Injection
Other Name: BMS-936558-01


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Adverse Events (AEs) [ Time Frame: From Day 1 up to 100 Days after discontinuation of treatment ]
  2. Incidence of drug related AEs [ Time Frame: From Day 1 up to 100 Days after discontinuation of treatment ]
  3. Incidence of AEs leading to Discontinuation [ Time Frame: From Day 1 up to 100 Days after discontinuation of treatment ]
  4. Incidence of Serious Adverse Events (SAEs) [ Time Frame: From signature of Informed Consent up to 100 Days after discontinuation of treatment ]
  5. Incidence of Select AEs [ Time Frame: From Day 1 up to 100 Days after discontinuation of treatment ]
  6. Incidence of Immune-Mediated AEs [ Time Frame: From Day 1 up to 100 Days after discontinuation of treatment ]
  7. Incidence of Death [ Time Frame: From signature of Informed Consent up to 100 Days after discontinuation of treatment ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03899155


Contacts
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Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information available, please email Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site#

Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03899155    
Other Study ID Numbers: CA209-8TT
2018-004362-34 ( EudraCT Number )
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: June 9, 2023
Last Verified: June 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action