A Single-Arm Study of Bempegaldesleukin (NKTR-214) Plus Nivolumab in Cisplatin Ineligible Patients Who Have Locally Advanced or Metastatic Urothelial Cancer (PIVOT-10)
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ClinicalTrials.gov Identifier: NCT03785925 |
Recruitment Status :
Completed
First Posted : December 24, 2018
Last Update Posted : July 26, 2022
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Condition or disease | Intervention/treatment | Phase |
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Urinary Bladder Neoplasm Neoplasm Metastasis | Biological: Bempegaldesleukin Biological: Nivolumab | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 192 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | April 29, 2019 |
Actual Primary Completion Date : | February 9, 2022 |
Actual Study Completion Date : | June 30, 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Combination of bempegaldesleukin (NKTR-214) + nivolumab
Participants will receive bempegaldesleukin (NKTR-214) in combination with nivolumab.
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Biological: Bempegaldesleukin
Specified dose on specified days
Other Names:
Biological: Nivolumab Specified dose on specified days
Other Names:
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- 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 ]
- ORR by RECIST 1.1 per BICR in all treated patients [ Time Frame: Approximately 18 months ]
- 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 ]
- 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 ]
- Incidence of treatment-related Adverse Events (AEs) [ Time Frame: Up to 2 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03785925

Study Director: | Study Director | Nektar Therapeutics |
Responsible Party: | Nektar Therapeutics |
ClinicalTrials.gov Identifier: | NCT03785925 |
Other Study ID Numbers: |
18-214-10 CA045-012 ( Other Identifier: Bristol-Myers Squibb Protocol ID ) 2018-003636-79 ( EudraCT Number ) |
First Posted: | December 24, 2018 Key Record Dates |
Last Update Posted: | July 26, 2022 |
Last Verified: | June 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
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 |
Neoplasms Neoplasm Metastasis Urinary Bladder Neoplasms Neoplastic Processes Pathologic Processes Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site |
Urinary Bladder Diseases Urologic Diseases Nivolumab Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action |