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

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02832167
First received: July 8, 2016
Last updated: June 8, 2017
Last verified: May 2017
  Purpose
The purpose of this study is to determine whether Nivolumab is an effective treatment for cancer that has advanced or has spread. The study will evaluate the clinical benefit of Nivolumab in patients at 16 weeks from enrollment. Various tumor types may be eligible for enrollment. Patients must have received prior standard-of-care treatment for their cancer before enrollment.

Condition Intervention Phase
Cancer Biological: BMS936558 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: An Open Label Phase 2 Multi-cohort Trial of Nivolumab in Advanced or Metastatic Malignancies

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Clinical Benefit Rate measured by radiologic tumor assessments [ Time Frame: Change from baseline to week 16 ]

Secondary Outcome Measures:
  • Overall Survival rate (OS) [ Time Frame: 1 Year ]
  • Duration of clinical response [ Time Frame: Up to one year ]
  • Incidence of adverse events (AEs) [ Time Frame: Up to one year ]
    Safety and Tolerability

  • Grade of AEs [ Time Frame: Up to one year ]
    Safety and Tolerability

  • Radiologic Tumor Assessments to characterize Pseudoprogression [ Time Frame: Up to one year ]

Estimated Enrollment: 150
Actual Study Start Date: September 13, 2016
Estimated Study Completion Date: January 4, 2019
Estimated Primary Completion Date: January 21, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nivolumab Biological: BMS936558
Flat Dose

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 51 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

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 )
Study First Received: July 8, 2016
Last Updated: June 8, 2017

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

Additional relevant MeSH terms:
Nivolumab
Antineoplastic Agents

ClinicalTrials.gov processed this record on June 27, 2017