A Dose Escalation and Cohort Expansion Study of NKTR-214 in Combination With Nivolumab and Other Anti-Cancer Therapies in Patients With Select Advanced Solid Tumors
Public ClinicalTrials.gov record NCT02983045. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1/2, Open-label, Multicenter Study of the Combination of NKTR-214 and Nivolumab or the Combination of NKTR-214, Nivolumab, and Other Anti-Cancer Therapies in Patients With Select Locally Advanced or Metastatic Solid Tumor Malignancies
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
In this four-part study, NKTR-214 was administered in combination with nivolumab and with/without other anticancer therapies. Part 1 considered escalating doublet (NKTR 214 + nivolumab) doses to determine the RP2D. Part 2 considered dose expansion cohorts for the doublet (NKTR 214 + nivolumab ± chemotherapy). Part 3 was schedule-finding for a triplet therapy (NKTR 214 + nivolumab + ipilimumab). Part 4 dose expansion for the triplet (NKTR 214 + nivolumab + ipilimumab) was planned to further assess the efficacy of the RP2D triplet combination at dosing schedules from Part 3.
Study identification
- NCT ID
- NCT02983045
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 557 participants
Conditions and interventions
Conditions
Interventions
- Dose Escalation Doublet: Combination of NKTR-214 + nivolumab Drug
- Dose Expansion Doublet: Combination of NKTR-214 + nivolumab Drug
- Schedule Finding Triplet: Combination of NKTR-214+ nivolumab+ ipilimumab Drug
- Dose Expansion Triplet: Combination of NKTR-214+ nivolumab+ ipilimumab Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 18, 2016
- Primary completion
- Apr 27, 2022
- Completion
- Apr 27, 2022
- Last update posted
- Mar 12, 2023
2016 – 2022
United States locations
- U.S. sites
- 22
- U.S. states
- 16
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCSD, Moores Cancer Center | La Jolla | California | 92093 | — |
| UCLA | Los Angeles | California | 90095 | — |
| Stanford Cancer Institute | Stanford | California | 94305 | — |
| University of Colorado, Denver | Denver | Colorado | 80045 | — |
| Yale School of Medicine | New Haven | Connecticut | 06473 | — |
| University of Florida | Gainesville | Florida | 32610 | — |
| Orlando Health Inc. | Orlando | Florida | 32806 | — |
| Emory University Hospital | Atlanta | Georgia | 30322 | — |
| Loyola University Medical Center, Chicago | Maywood | Illinois | 60153 | — |
| Indiana University Health Melvin & Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | — |
| University of Kansas Cancer Center | Kansas City | Kansas | 66205 | — |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | — |
| Henry Ford Hospital | Detroit | Michigan | 48202 | — |
| Washington University School of Medicine in St. Louis | St Louis | Missouri | 63110 | — |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | — |
| New York University Langone Medical Center - NYU Cancer Institute | New York | New York | 10016 | — |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | — |
| Providence Portland Medical Center | Portland | Oregon | 97213 | — |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| Inova Fairfax Hospital | Fairfax | Virginia | 22031 | — |
| Virginia Cancer Specialists, PC | Fairfax | Virginia | 22031 | — |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 36 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02983045, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 12, 2023 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02983045 live on ClinicalTrials.gov.