A Study of Bempegaldesleukin (NKTR-214: BEMPEG) 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
  • End date
    Jun 5, 2024
  • participants needed
    600
  • sponsor
    Nektar Therapeutics
Updated on 5 November 2020
Investigator
Nektar Recruitment
Primary Contact
Investigator Site - Sydney (1.3 mi away) Contact
+184 other location
tyrosine
sunitinib
systemic therapy
measurable disease
carcinoma
growth factor
karnofsky performance status
kinase inhibitor
metastasis
cabozantinib
brain metastases
vaccine therapy
pd-l1
brain metastasis
programmed cell death 1 ligand 1
nivolumab
curative surgery
metastatic renal cell carcinoma
advanced renal cell carcinoma

Summary

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

Details
Treatment Nivolumab, Sunitinib, Cabozantinib, NKTR-214, bempegaldesleukin
Clinical Study IdentifierNCT03729245
SponsorNektar Therapeutics
Last Modified on5 November 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Renal Cell Cancer or Kidney Cancer or Metastatic Renal Cell Carcinoma or Malignant neoplasm of kidney or Malignant Adenoma or Renal Cancer or Adenocar...?
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 mRECIST 1.1 criteria
Histologically confirmed RCC with a clear-cell component (may have sarcomatoid features); advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) RCC
Patients with any International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) score (favorable-, intermediate-, or poor-risk) are eligible. At least one IMDC prognostic factor 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 following local treatment may be enrolled if certain criteria are met
Tumor tissue (archival or fresh biopsy) identified and available for PD-L1 testing
Adequate organ function without growth factor or transfusion support

Exclusion Criteria

An active, known or suspected autoimmune disease that has required systemic treatment within the past 3 months (exceptions exist)
Patients who have a known additional malignancy that is progressing or requires active treatment (exceptions exist)
Any tumor invading the wall of a major blood vessels
Any tumor invading the gastrointestinal (GI) tract or any evidence of endotracheal or endobronchial tumor within 28 days prior to randomization
Need for >2 medications for management of hypertension (including diuretics)
History of pulmonary embolism, deep vein thrombosis (not including tumor thrombus), or clinically significant thromboembolic event within 3 months of randomization
Additional protocol defined inclusion/exclusion criteria and exceptions apply
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