Trial record 1 of 1 for:
NCT03785925
A Randomized Study of NKTR-214 Plus Nivolumab and of Reference Chemotherapy in Cisplatin Ineligible Patients Who Have Locally Advanced or Metastatic Urothelial Cancer With Low PD-L1 Expression (PIVOT-10)
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| ClinicalTrials.gov Identifier: NCT03785925 |
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Recruitment Status :
Not yet recruiting
First Posted : December 24, 2018
Last Update Posted : January 10, 2019
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Sponsor:
Nektar Therapeutics
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Nektar Therapeutics
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Brief Summary:
The main purpose of this study is to evaluate the anti-tumor activity of NKTR-214 in combination with nivolumab by assessing the objective response rate (ORR) in cisplatin ineligible, locally advanced or metastatic urothelial cancer patients with low PD-L1 expression. The efficacy will be assessed within the experimental Arm A, while Arm B will serve as a reference arm.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Urinary Bladder Neoplasm Neoplasm Metastasis | Biological: NKTR-214 Biological: Nivolumab Drug: Reference Gemcitabine Drug: Reference Carboplatin | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 165 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2, Randomized, Non-Comparative, Open-Label Study of NKTR-214 in Combination With Nivolumab and of Chemotherapy in Cisplatin Ineligible, Locally Advanced or Metastatic Urothelial Cancer Patients With Low PD-L1 Expression |
| Estimated Study Start Date : | January 2019 |
| Estimated Primary Completion Date : | June 2020 |
| Estimated Study Completion Date : | May 2022 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Bladder cancer
| Arm | Intervention/treatment |
|---|---|
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Experimental: Combination of NKTR-214 + nivolumab
Participants in Arm A will receive NKTR-214 in combination with nivolumab.
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Biological: NKTR-214
Specified dose on specified days
Other Names:
Biological: Nivolumab Specified dose on specified days
Other Names:
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Combination of gemcitabine + carboplatin
Participants in the reference Arm B will receive a combination of gemcitabine and carboplatin.
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Drug: Reference Gemcitabine
Specified dose on specified days
Other Name: Gemzar® Drug: Reference Carboplatin Specified dose on specified days
Other Name: Paraplatin® |
Primary Outcome Measures :
- Objective Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 per Blinded Independent Central Review (BICR) in patients with low programmed cell death ligand (PD-L1) expression [ Time Frame: Approximately 18 months ]
Secondary Outcome Measures :
- Duration of Response (DOR) by RECIST 1.1 per BICR [ Time Frame: Up to 5 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 |
Criteria
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
- Tumor must be PD-L1 low defined by a Combined Positive Score (CPS) of < 10 utilizing the Dako PD-L1 immunohistochemistry (IHC) 22C3 pharmDx assay
- 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
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, 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 randomization
Other protocol-defined inclusion/exclusion criteria could apply
Information from the National Library of Medicine
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
Contacts
| Contact: Nektar Recruitment | 855-482-8676 | StudyInquiry@nektar.com |
Locations
| United States, California | |
| Investigator Site - Whittier | Recruiting |
| Whittier, California, United States, 90603 | |
| United States, Texas | |
| Local Institution - Houston | Not yet recruiting |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
Nektar Therapeutics
Bristol-Myers Squibb
Investigators
| Study Director: | Erin Karski, MD | Nektar Therapeutics |
| Responsible Party: | Nektar Therapeutics |
| ClinicalTrials.gov Identifier: | NCT03785925 History of Changes |
| Other Study ID Numbers: |
18-214-10 CA045-012 ( Other Identifier: Bristol-Myers Squibb ) |
| First Posted: | December 24, 2018 Key Record Dates |
| Last Update Posted: | January 10, 2019 |
| Last Verified: | January 2019 |
| 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 | |
Keywords provided by Nektar Therapeutics:
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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 Carboplatin Gemcitabine Paraplatin® Gemzar® GemCarbo |
Additional relevant MeSH terms:
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Neoplasms Neoplasm Metastasis Urinary Bladder Neoplasms Neoplastic Processes Pathologic Processes Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Urinary Bladder Diseases Urologic Diseases Gemcitabine Nivolumab Cisplatin |
Carboplatin Antibodies, Monoclonal Antineoplastic Agents Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |