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

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ClinicalTrials.gov Identifier: NCT02750514
Recruitment Status : Recruiting
First Posted : April 25, 2016
Last Update Posted : October 4, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
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 or disease Intervention/treatment Phase
Advanced Cancer Biological: Nivolumab Drug: Dasatinib Biological: Relatlimab Biological: Ipilimumab Drug: BMS-986205 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 504 participants
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)
Actual Study Start Date : May 6, 2016
Estimated Primary Completion Date : April 28, 2021
Estimated Study Completion Date : April 29, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arm Intervention/treatment
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




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

Secondary Outcome Measures :
  1. 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.

  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]


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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:

  • 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


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

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02750514     History of Changes
Other Study ID Numbers: CA018-001
First Posted: April 25, 2016    Key Record Dates
Last Update Posted: October 4, 2018
Last Verified: October 2018

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