Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : Not yet recruiting
First Posted : April 2, 2019
Last Update Posted : July 2, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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 4

Detailed Description:
This is a continuation, rollover study of nivolumab for participants who are currently receiving nivolumab as monotherapy or have finished treatment and are now in follow up on a company-sponsored clinical trial selected by BMS of nivolumab or nivolumab combination (Parent Study). Each participant who is receiving study drug in the Parent Study will continue therapy in this rollover with nivolumab.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 4 Pan-Tumor Study of Long Term Follow up for Cancer Survivors Treated With Nivolumab or Nivolumab Combination Therapy
Estimated Study Start Date : June 28, 2019
Estimated Primary Completion Date : October 24, 2022
Estimated Study Completion Date : June 30, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: Nivolumab 480 mg IV Every 4 Weeks
Participants will receive 480 mg nivolumab as a 30-minute infusion on Day 1 of each treatment cycle every 4 weeks until progression, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first.
Drug: Nivolumab
Solution for IV Injection
Other Name: BMS-936558-01

Experimental: Nivolumab 240 mg IV Every 2 Weeks
Participants will receive 240 mg nivolumab as a 30-minute infusion on Day 1 of each treatment cycle every 2 weeks until progression, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first. Participants will be dosed at least 12 days from the previous dose.
Drug: Nivolumab
Solution for IV Injection
Other Name: BMS-936558-01




Primary Outcome Measures :
  1. Number of Participants with Adverse Events (AEs) [ Time Frame: From Day 1 up to 100 Days after discontinuation of treatment ]
  2. Number of Participants With AEs Related to Treatment [ Time Frame: From Day 1 up to 100 Days after discontinuation of treatment ]
  3. Number of Participants With AEs Leading to Discontinuation [ Time Frame: From Day 1 up to 100 Days after discontinuation of treatment ]
  4. Number of Participants With Serious AEs (SAEs) and Death [ Time Frame: From signature of Informed Consent up to 100 Days after discontinuation of treatment ]
  5. Number of Participants With Select AEs [ Time Frame: From Day 1 up to 100 Days after discontinuation of treatment ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 Protocol are not eligible to receive nivolumab in this study. These participants may be enrolled for safety and survival follow-up only.
  • Participant is eligible as per the Parent Protocol Exclusion Criteria: -
  • Participant ineligibility as per Parent Protocol.

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
Layout table for location contacts
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#

  Show 78 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Layout table for investigator information
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03899155     History of Changes
Other Study ID Numbers: CA209-8TT
2018-004362-34 ( EudraCT Number )
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: July 2019

Layout table for additional information
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:
Layout table for MeSH terms
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents