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Trial record 1 of 7 for:    Ipilimumab | Bakersfield, California, U.S.
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An Investigational Immuno-therapy Study for Safety of Nivolumab in Combination With Ipilimumab to Treat Advanced Cancers

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02869789
Recruitment Status : Active, not recruiting
First Posted : August 17, 2016
Last Update Posted : August 11, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
A study to evaluate the safety of Nivolumab given in combination with Ipilimumab in patients with advanced cancers. The initial group will enroll patients with newly diagnosed Stage 4 or non-small cell lung cancer that has come back.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: Nivolumab in combination with Ipilimumab Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1036 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3b/4 Safety Trial of Flat Dose Nivolumab In Combination With Ipilimumab in Participants With Non-Small Cell Lung Cancer
Actual Study Start Date : October 5, 2016
Estimated Primary Completion Date : October 14, 2020
Estimated Study Completion Date : October 4, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nivolumab in combination with Ipilimumab
Specified dose on specified days
Drug: Nivolumab in combination with Ipilimumab
Specified dose on specified days
Other Names:
  • BMS-936558 (Nivolumab)
  • Opdivo (Nivolumab)
  • BMS-734016 (Ipilimumab)
  • Yervoy (Ipilimumab)




Primary Outcome Measures :
  1. Number of participants who experience high grade AEs (Adverse Events) [ Time Frame: Up to 40 months ]
    Cohorts A, B, and C

  2. Percentage of participants who experience high grade AEs [ Time Frame: Up to 40 months ]
    Cohorts A, B, and C


Secondary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: Up to 40 months ]
    Cohorts A, B, and C

  2. ORR [ Time Frame: Up to 40 months ]
    Cohorts A, B, and C

  3. Duration of Response (DOR) [ Time Frame: Up to 40 months ]
    Cohorts A, B, and C

  4. Functional Assessment of Cancer Therapy-Lung (FACT-L) [ Time Frame: Up to 40 months ]
    Cohorts A, A1, B, and C

  5. Overall Survival (OS) [ Time Frame: Up to 40 months ]
    Cohorts A, B, and C



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.


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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:

  • Histologically confirmed Stage 4 or recurrent non-small cell lung cancer
  • Eastern Cooperative Oncology Group (ECOG) score 0-1 (Physically able to carry out light housework or office work through to being fully active as you were before cancer)
  • No prior systemic anticancer therapy (including EGFR and ALK inhibitors)
  • Tissue or Programmed death-ligand 1 (PD-L1) results available

Cohort 1A Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) score 2 or
  • Eastern Cooperative Oncology Group (ECOG) score 0-1 and one disease specific criteria as listed in the protocol

Cohort C Inclusion Criteria:

  • High Tumor Mutation Burden

Exclusion Criteria:

  • Untreated brain metastases
  • An active malignancy that requires concurrent intervention
  • Active, known or suspected autoimmune disease
  • Carcinomatous meningitis, which means there is inflammation of the covering of the brain, caused by cancer

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): NCT02869789


Locations
Hide Hide 135 study locations
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United States, Alabama
Alabama Oncology
Birmingham, Alabama, United States, 35205
United States, Arizona
Arizona Oncology Assoc, Pc-Hal
Phoenix, Arizona, United States, 85016
Arizona Oncol Assoc Dba (Hem Onc Physicians&Extenders) Hope
Tucson, Arizona, United States, 85704
United States, Arkansas
University Of Arkansas For Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
CBCC Global Research, Inc.
Bakersfield, California, United States, 93309
Marin Cancer Care, Inc
Greenbrae, California, United States, 94904
Los Angeles Hematology/Oncology Medical Group
Los Angeles, California, United States, 90017
Ucla
Los Angeles, California, United States, 90095
Torrance Health Association
Redondo Beach, California, United States, 90277
Va San Diego Healthcare System
San Diego, California, United States, 92161
Coastal Integrative Cancer Care
San Luis Obispo, California, United States, 93401
Central Coast Medical Oncology Corporation
Santa Maria, California, United States, 93454
Gene Upshaw Memorial Tahoe Forest Cancer Center
Truckee, California, United States, 96161
Innovative Clinical Research Institute
Whittier, California, United States, 90603
United States, Colorado
Rocky Mountain Cancer Center
Denver, Colorado, United States, 80218
St. Mary's Hospital Regional Cancer Center
Grand Junction, Colorado, United States, 81501
United States, Florida
Memorial Cancer Institute
Hollywood, Florida, United States, 33021
Cancer Specialists of North FL
Jacksonville, Florida, United States, 32207
Florida Cancer Affiliates - Ocala
Ocala, Florida, United States, 34474
United States, Georgia
University Cancer Blood Ctr
Athens, Georgia, United States, 30607
Winship Cancer Institute.
Atlanta, Georgia, United States, 30322
Northside Hospital, Inc
Atlanta, Georgia, United States, 30342
United States, Illinois
Illinois Cancer Specialists
Niles, Illinois, United States, 60714
United States, Kansas
Cancer Center Of Kansas
Wichita, Kansas, United States, 67214
United States, Kentucky
Kentucky One Health St. Joseph East Cancer Center
Lexington, Kentucky, United States, 40509
United States, Maryland
Maryland Oncology Hematology, P.A.
Columbia, Maryland, United States, 21044
United States, Minnesota
Minnesota Oncology Hematology, Pa
Edina, Minnesota, United States, 55435-2150
United States, Mississippi
Jackson Oncology Associates, Pllc
Jackson, Mississippi, United States, 39202
United States, Nebraska
St. Francis Cancer Treatment Center
Grand Island, Nebraska, United States, 68803
United States, Nevada
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89148
Cancer Care Specialists
Reno, Nevada, United States, 89511
United States, New Jersey
Essex Oncology Of North Jersey P.A.
Belleville, New Jersey, United States, 07109
Summit Medical Group
Florham Park, New Jersey, United States, 07932
Saint Barnabas Medical Cancer Center
Livingston, New Jersey, United States, 07039
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10461
United States, North Carolina
Dumc
Durham, North Carolina, United States, 27710
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Oncology Hematology Care, Inc.
Cincinnati, Ohio, United States, 45242
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109-1998
United States, Oregon
Good Samaritan Hospital Corvallis
Corvallis, Oregon, United States, 97330
Willamette Valley Cancer Center
Eugene, Oregon, United States, 97401
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Lehigh Valley Health Network
Allentown, Pennsylvania, United States, 18103
Allegheny Health Network
Pittsburgh, Pennsylvania, United States, 15224
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Guthrie Medical Group, Pc
Sayre, Pennsylvania, United States, 18840
United States, South Carolina
Charleston Hematology Oncology Associates, Pa
Charleston, South Carolina, United States, 29414
United States, Tennessee
Tennessee Oncology, PLLC
Chattanooga, Tennessee, United States, 37404
Tennessee Oncology, Pc
Nashville, Tennessee, United States, 37203
United States, Texas
Texas Oncology, PA - South Austin Cancer Center
Austin, Texas, United States, 78745
Texas Oncology, P.A.
Dallas, Texas, United States, 75230
Texas Oncology
Dallas, Texas, United States, 75231
Texas Oncology-Fort Worth 12th Ave
Fort Worth, Texas, United States, 76104
Texas Oncology-Longview
Longview, Texas, United States, 75601
Texas Oncology-Plano East
Plano, Texas, United States, 75075-7787
Texas Oncology Cancer Care And Research Center
Waco, Texas, United States, 76712
United States, Virginia
Virginia Cancer Specialists, Pc
Fairfax, Virginia, United States, 22031
Virginia Cancer Institute
Richmond, Virginia, United States, 23230
United States, Washington
Providence Regional Cancer Partnership
Everett, Washington, United States, 98201
Valley Medical Center
Renton, Washington, United States, 98055
Medical Oncology Associates
Spokane, Washington, United States, 99208
Argentina
Instituto Medico Especializado Alexander Fleming
Capital Federal, Buenos Aires, Argentina, 1426
Clinica Viedma S.A.
Viedma, RIO Negro, Argentina, 8500
Hospital Italiano De Buenos Aires
Caba, Argentina, 1199
Instituto Oncologico De Cordoba
Cordoba, Argentina, 5000
Centro Medico San Roque
Tucuman, Argentina, 4000
Belgium
Local Institution
Gent, Belgium, B-9000
Local Institution
Liege, Belgium, 4000
Local Institution
Sint-Niklaas, Belgium, 9100
Brazil
Local Institution
Ijui, RIO Grande DO SUL, Brazil, 98700-000
Local Institution
Porto Alegre, RIO Grande DO SUL, Brazil, 90610-000
Local Institution
Porto Alegre, RIO Grande DO SUL, Brazil, 91350-200
Local Institution
Barretos, SAO Paulo, Brazil, 14780-070
Canada, Quebec
Local Institution
Greenfield Park, Quebec, Canada, J4V 2H1
Hopital Du Sacre-Coeur De Montreal
Montreal, Quebec, Canada, H4J 1C5
CISSS du Bas-Saint-Laurent Hopital Regional de Rimouski
Rimouski, Quebec, Canada, G5L 5T1
Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-Centre-du-Quebec
Trois-Rivieres, Quebec, Canada, G8Z 3R9
Chile
Centro Internacional de Estudios Clinicos
Recoleta, Santiago DE Chile, Chile
Fundacion Arturo Lopez Perez
Santiago, Chile
Czechia
Komplexni onkologicke centrum
Novy Jicin, Czechia, 741 01
Onkologicka klinika VFN a 1. LF UK
Praha 2, Czechia, 128 08
France
Local Institution
Bordeaux, France, 33076
Local Institution
Dijon Cedex, France, 21079
Local Institution
Marseille Cedex 20, France, 13915
Local Institution
Paris, France, 75018
Local Institution
Pessac cedex, France, 33604
Local Institution
Rennes Cedex 9, France, 35033
Local Institution
Saint Herblain, France, 44805
Local Institution
Strasbourg Cedex, France, 67091
Local Institution
Toulon Cedex, France, 83056
Germany
Local Institution
Frankfurt, Germany, 60488
Local Institution
Gera, Germany, 07548
Local Institution
Kassel, Germany, 34125
Local Institution
Loewenstein, Germany, 74245
Local Institution
Wiesbaden, Germany, 65199
Greece
Sotiria General Hospital
Athens, Greece, 11527
Metropolitan Hospital
Neo Faliro, Greece, 18547
Papageorgiou General Hospital
Thessaloniki, Greece, 56429
Hungary
Local Institution
Budapest, Hungary, 1083
Local Institution
Matrahaza, Hungary, 3233
Italy
Local Institution
Genova, Italy, 16132
IRST Meldola
Meldola, Italy, 47014
Local Institution
Milan, Italy, 20141
Local Institution
Napoli, Italy, 80131
Ospedale Degli Infermi
Rimini, Italy, 47923
Local Institution
Siena, Italy, 53100
Azienda Ospedaliera Santa Maria Terni
Terni, Italy, 05100
Mexico
Local Institution
Monterrey, NL, Mexico, 64060
Netherlands
Local Institution
Groningen, Netherlands, 9713 GZ
Local Institution
Rotterdam, Netherlands, 3014 GD
Poland
Ambulatorium Chemioterapii
Bydgoszcz, Poland, 85-796
Oddzial Wewnetrzny
Sucha Beskidzka, Poland, 34-200
Klinika Nowotworow Pluca i Klatki Piersiowej
Warszawa, Poland, 02-781
Romania
Focus Lab Plus SRL
Bucuresti, Romania, 021389
Sf. Nectarie Oncology Center
Craiova, Romania, 200347
Prof. Dr. Ion Chiricuta Institute Of Oncology Day Care Dep
Romania, Romania, 400015
Russian Federation
Local Institution
Moscow, Russian Federation, 115478
Local Institution
Moscow, Russian Federation, 121309
Local Institution
St Petersburg, Russian Federation, 198255
Spain
Local Institution
A Coru?a, Spain, 15006
Local Institution
Barcelona, Spain, 08035
Local Institution
Jaen, Spain, 23007
Local Institution
Madrid, Spain, 28041
Local Institution
Majadahonda - Madrid, Spain, 28222
Local Institution
Sevilla, Spain, 41013
Local Institution
Valencia, Spain, 46026
Local Institution
Zaragoza, Spain, 50009
Switzerland
University Hospital Basel
Basel, Switzerland, 4031
University Hospital Zuerich
Zuerich, Switzerland, 8091
Turkey
Local Institution
Antalya, Turkey, 07070
United Kingdom
Local Institution
London, Greater London, United Kingdom, SE1 9RT
Local Institution
Leicester, Leicestershire, United Kingdom, LE1 5WW
Local Institution
Edinburgh, Midlothian, United Kingdom, EH4 2XU
Local Institution
Newcastle Upon Tyne, United Kingdom, NE7 7DN
Local Institution
Wirral, United Kingdom, CH63 4JY
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02869789    
Other Study ID Numbers: CA209-817
2016-002621-10 ( EudraCT Number )
First Posted: August 17, 2016    Key Record Dates
Last Update Posted: August 11, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ipilimumab
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents