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An Investigational Immuno-therapy Study to Test Combination Treatments in Patients With Advanced Non-Small Cell Lung Cancer (FRACTION-Lung)

This study is currently recruiting participants.
Verified November 2017 by Bristol-Myers Squibb
Sponsor:
ClinicalTrials.gov Identifier:
NCT02750514
First Posted: April 25, 2016
Last Update Posted: November 9, 2017
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.
Information provided by (Responsible Party):
Bristol-Myers Squibb
  Purpose
The purpose of this study is to determine whether Nivolumab, in combination with other therapies, is effective in patients with advanced Non-Small Cell lung cancer

Condition Intervention Phase
Advanced Cancer Biological: Nivolumab Drug: Dasatinib Biological: Relatlimab Biological: Ipilimumab Drug: BMS-986205 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Fast Real Time Assessment of Combination Therapies in Immuno-Oncology Study in Subjects With Advanced Non-Small Cell Lung Cancer (FRACTION-Lung)

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Objective Response Rate (ORR) [ Time Frame: 24 weeks ]
  • Duration of Response (DOR) [ Time Frame: 24 weeks ]
  • Progression-free Survival Rate (PFSR) [ Time Frame: 24 weeks ]

Secondary Outcome Measures:
  • Safety and tolerability of Nivolumab based on incidence of adverse events, serious adverse events, adverse events leading to discontinuation and deaths [ Time Frame: approximately 38 weeks ]
    Arm is closed. No longer active.

  • Safety and tolerability of Nivolumab & Dasatinib combination based on incidence of adverse events, serious adverse events, adverse events leading to discontinuation and deaths [ Time Frame: approximately 38 weeks ]
  • Safety and tolerability of Nivolumab & BMS-986016 combination based on incidence of adverse events, serious adverse events, adverse events leading to discontinuation and deaths [ Time Frame: approximately 38 weeks ]
  • Safety and tolerability of Nivolumab & Ipilimumab combination based on incidence of adverse events, serious adverse events, adverse events leading to discontinuation and deaths [ Time Frame: approximately 38 weeks ]
  • Safety and tolerability of Nivolumab & BMS-966205 combination based on incidence of adverse events, serious adverse events, adverse events leading to discontinuation and deaths [ Time Frame: Up to 38 weeks ]

Estimated Enrollment: 504
Actual Study Start Date: May 6, 2016
Estimated Study Completion Date: April 29, 2021
Estimated Primary Completion Date: April 28, 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Nivolumab
Nivolumab Monotherapy - Arm associated with this intervention is closed. Nivolumab is no longer given as an active comparator
Biological: Nivolumab
Arm associated with this intervention is closed. Nivolumab is no longer given as an active comparator.
Other Names:
  • BMS-936558
  • MDX-1106
  • OPDIVO
Experimental: Nivolumab & Dasatinib
Nivolumab in combination with Dasatinib
Biological: Nivolumab
Arm associated with this intervention is closed. Nivolumab is no longer given as an active comparator.
Other Names:
  • BMS-936558
  • MDX-1106
  • OPDIVO
Drug: Dasatinib
Other Names:
  • BMS-354825
  • SPRYCEL
Experimental: Nivolumab & Relatlimab
Nivolumab in combination with Relatlimab
Biological: Nivolumab
Arm associated with this intervention is closed. Nivolumab is no longer given as an active comparator.
Other Names:
  • BMS-936558
  • MDX-1106
  • OPDIVO
Biological: Relatlimab
Other Name: BMS-986016
Experimental: Nivolumab & Ipilimumab
Nivolumab in combination with Ipilimumab
Biological: Nivolumab
Arm associated with this intervention is closed. Nivolumab is no longer given as an active comparator.
Other Names:
  • BMS-936558
  • MDX-1106
  • OPDIVO
Biological: Ipilimumab
Other Names:
  • BMS-734016
  • Yervoy
Experimental: Nivolumab & BMS-986205
Nivolumab in combination with BMS- 986205
Biological: Nivolumab
Arm associated with this intervention is closed. Nivolumab is no longer given as an active comparator.
Other Names:
  • BMS-936558
  • MDX-1106
  • OPDIVO
Drug: BMS-986205
Specified dose on specified days

  Eligibility

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.


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:

  • Advanced Non Small Cell Lung Cancer (NSCLC)
  • Eastern Cooperative Oncology Group (ECOG) Performance status of ≤ 1
  • Life expectancy of at least 3 months from most recent chemotherapy or immunotherapy treatment
  • Must have at least 1 lesion with measurable disease

Exclusion Criteria:

  • Subjects with certain mutations that have not been treated with a targeted therapy prior to enrollment
  • Subjects who need daily oxygen therapy
  • People with autoimmune disease

Other protocol defined inclusion/exclusion criteria could apply

  Contacts and Locations
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): NCT02750514


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 57 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: NCT02750514     History of Changes
Other Study ID Numbers: CA018-001
First Submitted: April 21, 2016
First Posted: April 25, 2016
Last Update Posted: November 9, 2017
Last Verified: November 2017

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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Nivolumab
Dasatinib
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action