A Study of NKTR-214 in Combination With Nivolumab Compared With the Investigator's Choice of a Tyrosine Kinase Inhibitor (TKI) Therapy (Either Sunitinib or Cabozantinib Monotherapy) for Advanced Metastatic Renal Cell Carcinoma (RCC)



Status:Recruiting
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/24/2019
Start Date:December 28, 2018
End Date:June 2024
Contact:Nektar Recruitment
Email:StudyInquiry@nektar.com
Phone:855-482-8676

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A Phase 3 Randomized Open Label Study to Compare NKTR-214 Combined With Nivolumab to the Investigator's Choice of Sunitinib or Cabozantinib in Patients With Previously Untreated Advanced Renal Cell Carcinoma

The main purpose of this study is to compare the overall response rate (ORR) and overall
survival (OS) of NKTR-214 combined with nivolumab to that of a tyrosine kinase inhibitor
(TKI) monotherapy (sunitinib or cabozantinib) in intermediate and poor-risk participants with
previously untreated advanced renal cell carcinoma (RCC).


Inclusion Criteria:

- Provide written, informed consent to participate in the study and follow the study
procedures

- Karnofsky Performance Status (KPS) of at least 70

- Measurable disease per RECIST 1.1 criteria

- Histological confirmation of advanced (not amenable to curative surgery or radiation
therapy) or metastatic RCC with clear cell component including patients who may have
sarcomatoid features

- At least one International Metastatic Renal Cell Carcinoma Database Consortium (IMDC)
prognostic factors must be present to qualify as either intermediate or poor risk
renal cell carcinoma

- No prior systemic therapy (including neoadjuvant, adjuvant, or vaccine therapy) for
RCC

- Patients with stable brain metastases may be enrolled if certain criteria are met

- Archival tumor tissue available

Exclusion Criteria:

- Patients who have an active, known or suspected autoimmune disease

- Patients who have a known additional malignancy that is progressing or requires active
treatment

- Any tumor invading the superior vena cava (SVC) or other major blood vessels

- Any tumor invading the gastrointestinal (GI) tract or any evidence of endotracheal or
endobronchial tumor within 30 days prior to randomization

Other protocol defined inclusion/exclusion criteria could apply
We found this trial at
7
sites
Whittier, California 90603
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Whittier, CA
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Goodyear, Arizona 85338
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Goodyear, AZ
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Houston, Texas 77030
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Houston, TX
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Kettering, Ohio 45429
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Kettering, OH
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Leesburg, Virginia 20176
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Leesburg, VA
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Portland, Oregon 97210
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Portland, OR
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Rosario, Santa Fe
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Rosario,
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