An Investigational Immuno-therapy Study of Nivolumab, or Nivolumab in Combination With Ipilimumab, or Placebo in Patients With Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) After Completion of Platinum-based Chemotherapy
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Lung Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/6/2018 |
| Start Date: | September 30, 2015 |
| End Date: | November 20, 2019 |
A Randomized, Multicenter, Double-Blind, Phase 3 Study of Nivolumab, Nivolumab in Combination With Ipilimumab, or Placebo as Maintenance Therapy in Subjects With Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) After Completion of Platinum-based First Line Chemotherapy (CheckMate 451: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 451)
In this study, all patients must have already completed first-line chemotherapy to treat
extensive-stage disease small cell lung cancer. The purpose of this study is to show that
nivolumab, or nivolumab plus ipilimumab followed by nivolumab by itself, will prolong overall
survival when administered as consolidation treatment in patients that are stable or
responding after chemotherapy. Patients receiving treatment will be compared with patients
taking placebo.
extensive-stage disease small cell lung cancer. The purpose of this study is to show that
nivolumab, or nivolumab plus ipilimumab followed by nivolumab by itself, will prolong overall
survival when administered as consolidation treatment in patients that are stable or
responding after chemotherapy. Patients receiving treatment will be compared with patients
taking placebo.
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com
Inclusion Criteria:
- Subjects with histologically or cytologically confirmed extensive stage disease SCLC
- Ongoing response of stable disease or better following 4 cycles of platinum-based
first line chemotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria:
- Subjects with symptomatic Central Nervous System (CNS) metastases
- Subjects receiving consolidative chest radiation
- Subjects with active, known, or suspected autoimmune disease are excluded
- All side effects attributed to prior anti-cancer therapy must have resolved to Grade 1
or baseline
We found this trial at
29
sites
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Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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4805 Northeast Glisan Street
Portland, Oregon 97213
Portland, Oregon 97213
(503) 215-1111
Phone: 503-215-2699
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Baltimore, Maryland 21231
Phone: 443-287-9377
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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Phone: 843-792-8795
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
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Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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1275 York Ave
New York, New York 10021
New York, New York 10021
(212) 639-2000
Phone: 646-888-4203
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Phone: 314-362-4140
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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818 N. Emporia, #403
Wichita, Kansas 67214
Wichita, Kansas 67214
(316) 262-4467
Phone: 316-268-8566
Cancer Center of Kansas The physicians of Cancer Center are hematologists and oncologists. The staff...
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