Clinical trial · Interventional
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)
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor decision
Summary
Brief summary (as posted)
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 intermediate- or poor-risk patients and IMDC all-risk patients with previously untreated advanced renal cell carcinoma (RCC).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bempegaldesleukin | Biological | — | UNRESOLVED |
| cabozantinib | Drug | Cabozantinib | ALIAS |
| nivolumab | Biological | Nivolumab | ALIAS |
| sunitinib | Drug | Sunitinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Combination of bempegaldesleukin + nivolumab
- description
- Patients in Arm A will receive bempegaldesleukin in combination with nivolumab.
- interventionNames
- Biological: bempegaldesleukin
- Biological: nivolumab
- type
- ACTIVE_COMPARATOR
- label
- sunitinib or cabozantinib
- description
- Patients in Arm B will receive the Investigator's choice of either one of two treatment options.
- interventionNames
- Drug: sunitinib
- Drug: cabozantinib
Primary outcomes (2)
- measure
- Objective Response Rate (ORR) Per mRECIST 1.1 by BICR in IMDC All-risk Patients and Intermediate- or Poor (I/P)-Risk Patients With Previously Untreated Advanced RCC
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key 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 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 Key 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
References
Publications (1)
- DERIVEDTannir NM, Formiga MN, Penkov K, Kislov N, Vasiliev A, Gunnar Skare N, Hong W, Dai S, Tang L, Qureshi A, Zalevsky J, Tagliaferri MA, George D, Agarwal N, Pal S. Bempegaldesleukin Plus Nivolumab Versus Sunitinib or Cabozantinib in Previously Untreated Advanced Clear Cell Renal Cell Carcinoma: A Phase III Randomized Study (PIVOT-09). J Clin Oncol. 2024 Aug 10;42(23):2800-2811. doi: 10.1200/JCO.23.02082. Epub 2024 Jun 5. PMID 38838287