Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 4
Study Type
Interventional
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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)

Recruiting Locations

Alabama Oncology
Birmingham, Alabama 35243
Contact:
Ira Gore, Site 0121
205-263-9746

Arizona Oncology Assoc, Pc-Hal
Phoenix, Arizona 85016
Contact:
Abhimanyu Ghose, Site 0148
928-204-4198

Arizona Oncol Assoc Dba (Hem Onc Physicians&Extenders) Hope
Tucson, Arizona 85704
Contact:
Richard Rosenberg, Site 0085
520-797-4468

University Of Arkansas For Medical Sciences
Little Rock, Arkansas 72205
Contact:
Issam Makhoul, Site 0164
501-686-8274

CBCC Global Research, Inc.
Bakersfield, California 93309
Contact:
Pradip Rustagi, Site 0146
310-206-0179

Marin Cancer Care, Inc
Greenbrae, California 94904
Contact:
Alex Metzger, Site 0177

Los Angeles Hematology/Oncology Medical Group
Los Angeles, California 90017
Contact:
Lasika Seneviratne, Site 0106
213-977-1214

Ucla
Los Angeles, California 90095
Contact:
Jonathan Goldman, Site 0115
310-206-8309

Torrance Health Association
Redondo Beach, California 90277
Contact:
Thomas Lowe, Site 0107
310-750-3376

Coastal Integrative Cancer Care
San Luis Obispo, California 93401
Contact:
Brian Dicarlo, Site 0143
310-206-0179

Central Coast Medical Oncology Corporation
Santa Maria, California 93454
Contact:
Robert Dichmann, Site 0144
310-206-0179

Gene Upshaw Memorial Tahoe Forest Cancer Center
Truckee, California 96161
Contact:
Ahrin Koppel, Site 0145
530-582-6438

Innovative Clinical Research Institute
Whittier, California 90603
Contact:
Michael Chung, Site 0161
562-693-4477

Rocky Mountain Cancer Center
Denver, Colorado 80218
Contact:
Robert Jotte, Site 0083
303-388-4876

St. Mary's Hospital Regional Cancer Center
Grand Junction, Colorado 81501
Contact:
Kimberly Mcgregor, Site 0141
310-206-0179

Memorial Cancer Institute
Hollywood, Florida 33021
Contact:
Luis Raez, Site 0147
310-206-0179

Cancer Specialists of North FL
Jacksonville, Florida 32207
Contact:
Bijoy Telivala, Site 0155
904-363-7462

Florida Cancer Affiliates - Ocala
Ocala, Florida 34471
Contact:
Rama Balaraman, Site 0082
352-732-4938

University Cancer Blood Ctr
Athens, Georgia 30607
Contact:
Petros Nikolinakos, Site 0163
706-353-2990

Winship Cancer Institute.
Atlanta, Georgia 30322
Contact:
Rathi Pillai, Site 0002

Northside Hospital, Inc
Atlanta, Georgia 30342
Contact:
Sreekanth Reddy, Site 0166
770-496-9457

Illinois Cancer Specialists
Niles, Illinois 60714
Contact:
David Hakimian, Site 0088
847-827-9060

Cancer Center Of Kansas
Wichita, Kansas 67214
Contact:
Shaker Dakhil, Site 0108
316-262-4467

Kentucky One Health St. Joseph East Cancer Center
Lexington, Kentucky 40509
Contact:
Jessica Croley, Site 0081
720-874-1346

Maryland Oncology Hematology, P.A.
Columbia, Maryland 21044
Contact:
Mohit Narang, Site 0091
410-964-2212

Minnesota Oncology Hematology, Pa
Edina, Minnesota 55435-2150
Contact:
Paul Thurmes, Site 0089
612-884-6300

St. Francis Cancer Treatment Center
Grand Island, Nebraska 68803
Contact:
Ryan Ramaekers, Site 0077
308-398-6518

Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada 89148
Contact:
Oscar Goodman, Site 0087
702-952-3400

Cancer Care Specialists
Reno, Nevada 89511
Contact:
Tejvir Singh, Site 0170

Essex Oncology Of North Jersey P.A.
Belleville, New Jersey 07109
Contact:
James Orsini, Site 0156
973-751-8880

Saint Barnabas Medical Cancer Center
Livingston, New Jersey 07039
Contact:
Andrew Brown, Site 0142
973-322-5325

Dumc
Durham, North Carolina 27710
Contact:
Neal Ready, Site 0004

Wake Forest Baptist Health
Winston-Salem, North Carolina 27157
Contact:
Stefan Grant, Site 0012

Oncology Hematology Care, Inc.
Cincinnati, Ohio 45242
Contact:
Patrick John Ward, Site 0100
513-751-2273

MetroHealth Medical Center
Cleveland, Ohio 44109
Contact:
Michelle Treasure, Site 0134
216-778-4568

Willamette Valley Cancer Center
Springfield, Oregon 97477
Contact:
Matthew Lonergan, Site 0096
541-988-0656

Lehigh Valley Health Network
Allentown, Pennsylvania 18103
Contact:
Brian Patson, Site 0139
610-402-1642

Allegheny Health Network
Pittsburgh, Pennsylvania 15224
Contact:
Mohammed Islam, Site 0137
412-235-1316

Guthrie Medical Group, Pc
Sayre, Pennsylvania 18840
Contact:
Philip Lowry, Site 0001
570-887-2141

Charleston Hematology Oncology Associates, Pa
Charleston, South Carolina 29414
Contact:
Gene Saylors, Site 0123

Tennessee Oncology, PLLC
Chattanooga, Tennessee 37404
Contact:
Davey Daniel, Site 0066
877-691-7274

Tennessee Oncology, Pc
Nashville, Tennessee 37203
Contact:
David Spigel, Site 0067
877-691-7274

Texas Oncology, PA - South Austin Cancer Center
Austin, Texas 78745
Contact:
James Uyeki, Site 0090
512-447-2202

Texas Oncology, P.A.
Dallas, Texas 75230
Contact:
Jay Courtright, Site 0150
972-566-4363

Texas Oncology
Dallas, Texas 75231
Contact:
Kristi McIntyre, Site 0149
214-265-2080

Texas Oncology-Fort Worth 12th Ave
Fort Worth, Texas 76104
Contact:
Stephen Richey, Site 0094
817-850-2011

Texas Oncology-Longview
Longview, Texas 75601
Contact:
Matei Socoteanu, Site 0093
903-579-9800

Texas Oncology-Plano East
Plano, Texas 75075-7787
Contact:
Carlos Taboada, Site 0098
972-867-3577

Texas Oncology Cancer Care And Research Center
Waco, Texas 76712
Contact:
Carl Chakmakjian, Site 0086
254-399-0741

Virginia Cancer Specialists, Pc
Fairfax, Virginia 22031
Contact:
Alexander Spira, Site 0097
703-208-5390

Virginia Cancer Institute
Richmond, Virginia 23226
Contact:
Will Voelzke, Site 0044
804-288-7159

Providence Regional Cancer Partnership
Everett, Washington 98201
Contact:
Jason Lukas, Site 0135

More Details

NCT ID
NCT02869789
Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:
Clinical.Trials@bms.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.