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An Open Label Investigational Immuno-therapy Trial of Nivolumab in Cancers That Are Advanced or Have Spread (CheckMate 627)

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ClinicalTrials.gov Identifier: NCT02832167
Recruitment Status : Recruiting
First Posted : July 14, 2016
Last Update Posted : May 22, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
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.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Phase 2 Multi-cohort Trial of Nivolumab in Advanced or Metastatic Malignancies
Actual Study Start Date : September 13, 2016
Estimated Primary Completion Date : June 16, 2019
Estimated Study Completion Date : December 20, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: Nivolumab Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo




Primary Outcome Measures :
  1. Objective Response Rate (ORR) as determined by investigator [ Time Frame: Change from baseline to week 28 ]

Secondary Outcome Measures :
  1. Overall Survival (OS) is defined as the time from the first dosing date to the date of death [ Time Frame: 1 Year ]
  2. Duration of clinical response [ Time Frame: Up to one year ]
  3. Incidence of adverse events (AEs) [ Time Frame: Up to one year ]
  4. Incidence of serious adverse events (SAEs) [ Time Frame: Up to one year ]
  5. Clinical Benefit Rate (CBR) defined as the number of participants with a best overall response of confirmed complete response (CR) or partial response (PR), or stable disease divided by the number of all treated participants [ Time Frame: Up to one year ]
  6. Time to Response (TTR) defined as the time from first dosing date to the date of the first confirmed response, as assessed by investigator [ Time Frame: Up to one year ]
  7. Programmed death-ligand 1 (PD-L1) expression as determined by biomarker analysis [ Time Frame: Up to one year ]
  8. MisMatch Repair (MMR) alterations as determined by biomarker analysis [ Time Frame: Up to one year ]


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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

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

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 could apply


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): NCT02832167


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

  Show 53 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02832167     History of Changes
Other Study ID Numbers: CA209-627
2016-000461-23 ( EudraCT Number )
First Posted: July 14, 2016    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Nivolumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs