Description:
The main purpose of this study is to evaluate the anti-tumor activity of bempegaldesleukin
(NKTR-214) in combination with nivolumab by assessing the objective response rate (ORR) in
cisplatin ineligible, locally advanced or metastatic urothelial cancer patients.
Title
- Brief Title: A Single-Arm Study of Bempegaldesleukin (NKTR-214) Plus Nivolumab in Cisplatin Ineligible Patients Who Have Locally Advanced or Metastatic Urothelial Cancer
- Official Title: A Phase 2, Single-Arm Study of Bempegaldesleukin (NKTR-214) in Combination With Nivolumab in Cisplatin Ineligible, Locally Advanced or Metastatic Urothelial Cancer Patients
Clinical Trial IDs
- ORG STUDY ID:
18-214-10
- SECONDARY ID:
CA045-012
- SECONDARY ID:
2018-003636-79
- NCT ID:
NCT03785925
Conditions
- Urinary Bladder Neoplasm
- Neoplasm Metastasis
Interventions
Drug | Synonyms | Arms |
---|
Bempegaldesleukin | NKTR-214, BMS-986321 | Combination of bempegaldesleukin (NKTR-214) + nivolumab |
Nivolumab | Opdivo®, BMS-936658 | Combination of bempegaldesleukin (NKTR-214) + nivolumab |
Purpose
The main purpose of this study is to evaluate the anti-tumor activity of bempegaldesleukin
(NKTR-214) in combination with nivolumab by assessing the objective response rate (ORR) in
cisplatin ineligible, locally advanced or metastatic urothelial cancer patients.
Trial Arms
Name | Type | Description | Interventions |
---|
Combination of bempegaldesleukin (NKTR-214) + nivolumab | Experimental | Participants will receive bempegaldesleukin (NKTR-214) in combination with nivolumab. | - Bempegaldesleukin
- Nivolumab
|
Eligibility Criteria
Key Inclusion Criteria:
- Provide written, informed consent to participate in the study and follow the study
procedures
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
- Measurable disease per RECIST 1.1 criteria
- Histologically or cytologically documented inoperable, locally advanced or metastatic
urothelial cell carcinoma (also termed TCC)
- Fresh biopsy or archival tissue
- No prior systemic chemotherapy or investigational agent for inoperable locally
advanced or mUC
- Ineligible for cisplatin
Key Exclusion Criteria:
- Patients who have an active, known or suspected autoimmune disease
- Patients must not have received prior IL-2 therapy
- Prior treatment with an anti PD-1, anti PD-L1, or anti cytotoxic T lymphocyte
associated protein 4 (anti CTLA-4) antibody, agents that target IL-2 pathway, or any
other antibody or drug specifically targeting T-cell co-stimulation or immune
checkpoint pathways
- Patients with hypertension must be on a stable antihypertensive regimen for the 14
days prior to Cycle 1 Day 1
Additional protocol-defined inclusion/exclusion criteria will apply
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 per Blinded Independent Central Review (BICR) in patients whose tumors have low programmed cell death ligand (PD-L1) expression |
Time Frame: | Approximately 18 months |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | ORR by RECIST 1.1 per BICR in all treated patients |
Time Frame: | Approximately 18 months |
Safety Issue: | |
Description: | |
Measure: | Duration of Response (DOR) by RECIST 1.1 per BICR in all treated patients and patients whose tumors have low PD-L1 expression |
Time Frame: | Approximately 2 years |
Safety Issue: | |
Description: | |
Measure: | ORR and DOR by RECIST 1.1 per Investigator assessment in all treated patients and in patients whose tumors have low PD-L1 expression |
Time Frame: | Approximately 2 years |
Safety Issue: | |
Description: | |
Measure: | Incidence of treatment-related Adverse Events (AEs) |
Time Frame: | Up to 2 years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Nektar Therapeutics |
Trial Keywords
- Bladder
- Bladder Cancer
- CD122
- Cisplatin Ineligible
- Immuno-oncology
- Immunotherapy
- Locally Advanced Urothelial Cancer
- Metastatic Urothelial Cancer
- mUC
- Natural Killer Cells
- Nivolumab
- NKTR-214
- Opdivo®
- PD-L1
- Urothelial Cancer
- Urothelial
- Metastatic Urothelial Carcinoma
- Urothelial Carcinoma
- Bempegaldesleukin
- BEMPEG
- CPI Combination
- IL-2
Last Updated
August 26, 2021