Description:
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).
Title
- Brief Title: 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)
- Official 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
Clinical Trial IDs
- ORG STUDY ID:
17-214-09
- SECONDARY ID:
CA045002
- NCT ID:
NCT03729245
Conditions
- Renal Cell Carcinoma
- Metastatic Renal Cell Carcinoma
Interventions
Drug | Synonyms | Arms |
---|
bempegaldesleukin | BEMPEG, BMS-986321 | Combination of bempegaldesleukin + nivolumab |
sunitinib | Sutent® | sunitinib or cabozantinib |
nivolumab | Opdivo®, BMS-936558 | Combination of bempegaldesleukin + nivolumab |
cabozantinib | Cabometyx® | sunitinib or cabozantinib |
Purpose
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).
Trial Arms
Name | Type | Description | Interventions |
---|
Combination of bempegaldesleukin + nivolumab | Experimental | Patients in Arm A will receive bempegaldesleukin in combination with nivolumab. | - bempegaldesleukin
- nivolumab
|
sunitinib or cabozantinib | Active Comparator | Patients in Arm B will receive the Investigator's choice of either one of two treatment options. | |
Eligibility Criteria
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
- 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
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | ORR using mRECIST 1.1 by BICR in IMDC intermediate- or poor-risk patients |
Time Frame: | Approximately 32 months |
Safety Issue: | |
Description: | Objective response rate (ORR) using modified Response Evaluation Criteria in Solid Tumors (mRECIST) 1.1 by Blinded Independent Central Review (BICR) in International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) intermediate- or poor-risk patients |
Secondary Outcome Measures
Measure: | Progression-free survival (PFS) per mRECIST 1.1 by BICR in IMDC intermediate- or poor-risk patients |
Time Frame: | 32-59 months |
Safety Issue: | |
Description: | |
Measure: | PFS per mRECIST 1.1 by BICR in IMDC all risk-patients |
Time Frame: | 32-59 months |
Safety Issue: | |
Description: | |
Measure: | Incidence of treatment-related Adverse Events (AEs) |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | |
Measure: | ORR per mRECIST 1.1 by BICR in biomarker population |
Time Frame: | 32-59 months |
Safety Issue: | |
Description: | |
Measure: | PFS per mRECIST 1.1 by BICR in biomarker population |
Time Frame: | 32-59 months |
Safety Issue: | |
Description: | |
Measure: | OS in biomarker population |
Time Frame: | 32-59 months |
Safety Issue: | |
Description: | |
Measure: | Changes in cancer-related symptoms and quality-of-life in patients using the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy (NCCN/FACT) Symptom Index for Kidney Cancer (FKSI-19) |
Time Frame: | 32-59 months |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Nektar Therapeutics |
Trial Keywords
- Kidney Cancer
- Kidney Neoplasms
- Renal Cancer
- Renal Neoplasms
- CD122
- CD122-Biased Agonist
- CD122-Biased Cytokine
- IL-2 receptor agonist
- Immuno-oncology therapy
- NKTR-214
- Nivolumab
- Opdivo®
- PD-L1
- PD-1
- Bempegaldesleukin
- IL-2
- BEMPEG
- CD122-Preferential
- IL-2 pathway agonist
- Checkpoint inhibition
- Immune checkpoint inhibitor
Last Updated
August 26, 2021