A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma
| Status: | Recruiting |
|---|---|
| Conditions: | Skin Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 12 - Any |
| Updated: | 4/5/2019 |
| Start Date: | September 14, 2018 |
| End Date: | March 15, 2025 |
| Contact: | Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, |
| Email: | Clinical.Trials@bms.com |
| Phone: | please email |
A Phase 3, Randomized, Open-label Study of NKTR-214 Combined With Nivolumab Versus Nivolumab in Participants With Previously Untreated Unresectable or Metastatic Melanoma
The purpose of the study is to test the effectiveness (how well the drug works), safety, and
tolerability of the investigational drug called NKTR-214, when combined with nivolumab versus
nivolumab given alone in participants with previously untreated melanoma skin cancer that is
either unable to be surgically removed or has spread
tolerability of the investigational drug called NKTR-214, when combined with nivolumab versus
nivolumab given alone in participants with previously untreated melanoma skin cancer that is
either unable to be surgically removed or has spread
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com
Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤1 (adults 18 years or
older)/Lansky Performance Score ≥ 80% (minors ages 12-17 only)
- Histologically confirmed stage III (unresectable) or stage IV melanoma
- Treatment-naive participants (ie, no prior systemic anticancer therapy for
unresectable or metastatic melanoma) with the exception of prior adjuvant treatment
Exclusion Criteria:
- Active brain metastases or leptomeningeal metastases
- Uveal melanoma
- Participants with an active, known or suspected autoimmune disease
Other protocol defined inclusion/exclusion criteria could apply
We found this trial at
23
sites
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
Phone: 503-418-1208
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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12902 USF Magnolia Dr
Tampa, Florida 33612
Tampa, Florida 33612
(888) 663-3488
Phone: 813-745-7361
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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1365 Clifton Rd NE
Atlanta, Georgia 30322
Atlanta, Georgia 30322
(404) 778-1900
Phone: 404-778-4520
Winship Cancer Institute at Emory University Winship Cancer Institute of Emory University is Georgia
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3855 Health Sciences Dr,
La Jolla, California 92093
La Jolla, California 92093
(858) 822-6100
Phone: 858-246-1093
UC San Diego Moores Cancer Center Established in 1978, UC San Diego Moores Cancer Center...
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660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Phone: 314-273-2779
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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