Trial purpose
Cancer treatment
Tumor type
Genitourinary
Age
18+
Clinical summary
Summary
This is a randomised trial with a experimental and active comparator arms that is assessing the objective response rate and overall survival of different treatments in people with IMDC intermediate- or poor-risk patients and IMDC all-risk patients with previously untreated advanced renal cell carcinoma (RCC). In the Experimental Arm, participants will receive bempegaldesleukin in combination with nivolumab. In the Active Comparator Arm, participants will receive the Investigator's choice of either sunitinib or cabozantinib).
Conditions
This trial is treating people with renal cell carcinoma
Eligibility
Inclusion
- 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
Exclusion
- 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
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- Your cancer has not spread to other parts of the body (localised).
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Nektar Therapeutics
Scientific Title
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
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