A Dose Frequency Optimization,Trial of Nivolumab 240 mg Every 2 Weeks vs Nivolumab 480 mg Every 4 Weeks in Subjects With Advanced or Metastatic Non-small Cell Lung Cancer Who Received Up to 12 Months of Nivolumab at 3 mg/kg or 240 mg Every 2 Weeks
Status: | Active, not recruiting |
---|---|
Conditions: | Lung Cancer, Lung Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 9/19/2018 |
Start Date: | April 21, 2016 |
End Date: | June 30, 2022 |
A Dose Frequency Optimization, Phase IIIB/IV Trial of Nivolumab 240 mg Every 2 Weeks vs Nivolumab 480 mg Every 4 Weeks in Subjects With Advanced or Metastatic Non-small Cell Lung Cancer Who Received up to 12 Months of Nivolumab at 3 mg/kg or 240 mg Every 2 Weeks
The primary objective of this study is to compare PFS (progression-free survival) rate at 6
months and at 1 year after randomization, of Nivolumab 480 mg every 4 weeks with nivolumab
240 mg every 2 weeks in subjects with advanced/metastatic (Stage IIIb/IV) NSCLC (non-Sq and
Sq).
months and at 1 year after randomization, of Nivolumab 480 mg every 4 weeks with nivolumab
240 mg every 2 weeks in subjects with advanced/metastatic (Stage IIIb/IV) NSCLC (non-Sq and
Sq).
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com
Inclusion Criteria:
- Histologically or cytologically documented Squamous or non-Squamous Non-small cell
lung cancer (NSCLC) (Stage IIIB/IV), or recurrent or progressive disease following
multimodal therapy
- Patients must have received pre-study nivolumab for up to 12 months and have 2
consecutive tumor assessments confirming Complete response (CR), Partial response
(PR), or Stable disease (SD)
- Measurable disease before start of pre-study nivolumab treatment
- Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 0-2
Exclusion Criteria:
- Carcinomatous meningitis
- Untreated, symptomatic Central nervous system (CNS) metastases
- Symptomatic interstitial lung disease
Other protocol defined inclusion/exclusion criteria could apply
We found this trial at
69
sites
1831 Fifth Avenue
Columbus, Georgia 31904
Columbus, Georgia 31904
(706) 320-8700
Phone: 706-320-8752
John B. Amos Cancer Center The John B. Amos Cancer Center located in Columbus, Georgia,...
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3840 Broadway
Fort Myers, Florida 33901
Fort Myers, Florida 33901
(239) 275-6400
Phone: 239-274-9930
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1150 N 35th Ave # 330
Hollywood, Florida 33021
Hollywood, Florida 33021
Phone: 310-794-3424
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3900 W Avera Drive
Sioux Falls, South Dakota 57108
Sioux Falls, South Dakota 57108
(605) 322-4700
Phone: 605-322-3082
Avera Cancer Institute Avera, the health ministry of the Benedictine and Presentation Sisters, is a...
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6410 Rockledge Dr #660
Bethesda, Maryland 20817
Bethesda, Maryland 20817
(301) 571-0019
Phone: 301-571-2016
Center for Cancer & Blood Disorders Widely recognized for its compassionate, expert care, the Center...
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Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
Nashville, Tennessee 37023
615-320-5090
Phone: 615-524-4025
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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2603 Kentucky Avenue
Paducah, Kentucky 42003
Paducah, Kentucky 42003
Phone: 310-794-3424
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7901 Frost Street
San Diego, California 92123
San Diego, California 92123
858-939-3400
Phone: 858-939-5062
Sharp Memorial Hospital Sharp Memorial Hospital offers clinical excellence with the latest technology and patient-centered...
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818 N. Emporia, #403
Wichita, Kansas 67214
Wichita, Kansas 67214
(316) 262-4467
Phone: 310-206-0179
Cancer Center of Kansas The physicians of Cancer Center are hematologists and oncologists. The staff...
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2811 Tieton Drive
Yakima, Washington 98902
Yakima, Washington 98902
Phone: 281-863-4631
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