A Study to Test the Safety and Effectiveness of Nivolumab Combined With Daratumumab in Patients With Pancreatic, Non-Small Cell Lung or Triple Negative Breast Cancers, That Have Advanced or Have Spread
NCT ID: NCT03098550
Last Updated: 2021-07-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
105 participants
INTERVENTIONAL
2017-06-15
2020-07-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Immunotherapy Combination
TNBC and PAC participants who are deriving clinical benefit will continue to be treated with the nivolumab plus daratumumab combination therapy
Nivolumab
Specified dose on specified days
Daratumumab
Specified dose on specified days
Nivolumab Monotherapy
NSCLC patients who are deriving clinical benefit will be treated with nivolumab monotherapy
Nivolumab
Specified dose on specified days
Interventions
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Nivolumab
Specified dose on specified days
Daratumumab
Specified dose on specified days
Eligibility Criteria
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Inclusion Criteria
* Patients with metastatic or advanced solid tumors
* Women with histologically or cytologically confirmed triple negative breast carcinoma
* Participants with histologically or cytologically confirmed pancreatic adenocarcinoma
* Participants with histologically or cytologically confirmed Non Small Cell Lung Cancer (NSCLC)
Exclusion Criteria
* Any serious or uncontrolled medical disorder
* Prior malignancy active within the previous 3 years
18 Years
ALL
No
Sponsors
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Janssen Biotech, Inc.
INDUSTRY
Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Pacific Shores Medical Group
Long Beach, California, United States
University Of Colorado
Aurora, Colorado, United States
Moffitt Cancer Center
Tampa, Florida, United States
University Of Michigan
Ann Arbor, Michigan, United States
Providence Portland Medical Center
Portland, Oregon, United States
Local Institution
St Leonards, New South Wales, Australia
Local Institution
Edmonton, , Canada
Local Institution
Lyon, , France
Local Institution
Marseille, , France
Centre Paul Strauss
Strasbourg, , France
Universitaetsklinikum Carl Gustav Carus
Dresden, , Germany
Medizinische Universitaetsklinik Freiburg
Freiburg im Breisgau, , Germany
Universitaetsklinik Heidelberg
Heidelberg, , Germany
Local Institution
Milan, , Italy
Istituto Nazionale Tumori Fondazione Pascale
Napoli, , Italy
Fundacion De Investigacion
San Juan, , Puerto Rico
Hospital Gral. Univ. Gregorio Maranon
Madrid, , Spain
Local Institution
Majadahonda - Madrid, , Spain
Klinik Fur Onkologie
Basel, , Switzerland
University Hospital of Lausanne
Lausanne, , Switzerland
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
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2017-000367-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA209-9GW
Identifier Type: -
Identifier Source: org_study_id
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