Breast Cancer Clinical Trial

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

Summary

In this four-part study, NKTR-214 will be administered in combination with nivolumab in Part 1, in combination with nivolumab with or without various chemotherapies in Part 2, and with nivolumab in Parts 3 & 4. In Part 1, the Recommended Phase 2 Dose (RP2D) of NKTR-214 in combination with nivolumab will be determined. In Part 2, NKTR-214 with nivolumab at the RP2D will be evaluated as first-line therapy and/or as second or third line therapy in select patients with Melanoma, Renal Cell Carcinoma (RCC), Non-Small Cell Lung Cancer (NSCLC), Urothelial Carcinoma (UC), triple negative Breast Cancer (TNBC), HR+/HER2- breast cancer, gastric cancer, and Colorectal Cancer (CRC). In addition, in Part 2, the RP2D of NKTR-214 with nivolumab and various chemotherapies and regimens in select cohorts of NSCLC patients will be determined. In Part 3, several different regimens of the doublet combination of NKTR-214 plus nivolumab will be evaluated in select patients with RCC, NSCLC, Melanoma, and UC. In Part 4, the safety and efficacy of the doublet combination will be evaluated further in select patients with RCC, NSCLC, Melanoma and UC.

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Full Description

Part 1 enrolled patients with advanced or metastatic melanoma, renal cell carcinoma (RCC), non-small cell lung cancer (NSCLC), urothelial carcinoma, or triple negative breast cancer (TNBC) to determine the recommended Phase 2 dose (RP2D) or maximum tolerated dose (MTD) of NKTR 214 + nivolumab doublet therapy.

Part 2 enrolled patients with advanced or metastatic solid tumor malignancies (including 9 tumor types consisting of the same 5 tumor types as in Part 1, plus hormone receptor positive human epidermal growth factor receptor 2 [HER 2] negative breast cancer [HR+ HER2- BC], gastric cancer, colorectal carcinoma, and small cell lung cancer [SCLC]) to assess the efficacy of the RP2D.

Part 3 enrolled patients with advanced or metastatic melanoma, RCC, NSCLC, or urothelial carcinoma (UCC) in a first-line setting (1L) to assess the safety and tolerability of NKTR 214 + nivolumab + ipilimumab triplet therapy Three dosing schedules were evaluated to establish RP2D dosing schedules for Part 4 of the study.

Part 4 planned to enroll patients with advanced or metastatic melanoma, RCC, NSCLC, or UCC to further assess the efficacy of the RP2D triplet combination at the 3 dosing schedules from Part 3. Patients were enrolled simultaneously to each tumor cohort.

All patients enrolled in the study were closely monitored for safety, tolerability and response per RECIST criteria. The primary efficacy endpoint was objective response rate (ORR) using RECIST 1.1 at the RP2D doublet.

View Eligibility Criteria

Eligibility Criteria

INCLUSION CRITERIA - For Parts 1-4:

Histologically confirmed diagnosis of a locally advanced (not amenable to curative therapy such as surgical resection) or metastatic solid tumors
Life expectancy > 12 weeks
Patients must not have received prior interleukin-2 (IL-2) therapy
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Measurable disease per RECIST 1.1
Patients with stable brain metastases under certain criteria
Fresh and archival tumor tissue available Tumor specific inclusion criteria may apply.

EXCLUSION CRITERIA - For Parts 1-4:

Use of an investigational agent or an investigational device within 28 days before administration of first dose of NKTR--214
Females who are pregnant or breastfeeding
Participants who have an active autoimmune disease requiring systemic treatment within the past 3 months or have a documented history of clinically severe autoimmune disease that requires systemic steroids or immunosuppressive agents
History of organ transplant that requires use of immune suppressive agents
Active malignancy not related to the current diagnosed malignancy
Evidence of clinically significant interstitial lung disease or active, noninfectious pneumonitis
Participants who have had < 28 days since the last chemotherapy, biological therapy, or < 14 days from approved tyrosine kinase inhibitor (TKI) therapy, or systemic or inhaled steroid therapy at doses greater than 10mg of prednisone Tumor specific exclusion criteria may apply.

Other protocol defined inclusion/exclusion criteria may apply

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

557

Study ID:

NCT02983045

Recruitment Status:

Completed

Sponsor:

Nektar Therapeutics

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There are 55 Locations for this study

See Locations Near You

UCSD, Moores Cancer Center
La Jolla California, 92093, United States
UCLA
Los Angeles California, 90095, United States
Stanford Cancer Institute
Stanford California, 94305, United States
University of Colorado, Denver
Denver Colorado, 80045, United States
Yale School of Medicine
New Haven Connecticut, 06473, United States
University of Florida
Gainesville Florida, 32610, United States
Orlando Health Inc.
Orlando Florida, 32806, United States
Emory University Hospital
Atlanta Georgia, 30322, United States
Loyola University Medical Center, Chicago
Maywood Illinois, 60153, United States
Indiana University Health Melvin & Bren Simon Cancer Center
Indianapolis Indiana, 46202, United States
University of Kansas Cancer Center
Kansas City Kansas, 66205, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02115, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States
Washington University School of Medicine in St. Louis
Saint Louis Missouri, 63110, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
New York University Langone Medical Center - NYU Cancer Institute
New York New York, 10016, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10065, United States
Providence Portland Medical Center
Portland Oregon, 97213, United States
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
Inova Fairfax Hospital
Fairfax Virginia, 22031, United States
Virginia Cancer Specialists, PC
Fairfax Virginia, 22031, United States
Seattle Cancer Care Alliance
Seattle Washington, 98109, United States
Antwerp University Hospital
Edegem , 02650, Belgium
Vzw Az Groeninge
Kortrijk , 08500, Belgium
UZ Leuven
Leuven , 03000, Belgium
CHU de Liège
Liège , 04000, Belgium
GZA Ziekenhuizen Campus Sint-Augustinus
Wilrijk , 02610, Belgium
BC Cancer Agency Vancouver Centre
Vancouver British Columbia, H3T1E, Canada
Sunnybrook Health Sciences Centre
Toronto Ontario, M4N3M, Canada
Princess Margaret Cancer Centre
Toronto Ontario, M5G2M, Canada
Jewish General Hospital
Montréal Quebec, H3T1E, Canada
L'Institut Paoli - Calmettes
Marseille Brouches-duRhone, 13009, France
Institut de Cancerologie de l'Ouest
Saint-Herblain Loire-Atlantique, 44805, France
Centre Léon Bérard
Lyon , 69008, France
Assistance Publique Hopitaux de Marseille - Hopital Nord
Marseille Cedex 20 , 13915, France
Gustave Roussy
Villejuif , 94805, France
Fondazione IRCCS Istituto Nazionale dei Tumori
Milano , 20133, Italy
Istituto Europeo di Oncologia
Milano , 20141, Italy
Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"
Napoli , 80131, Italy
Azienda Ospedaliera San Camillo-Forlanini
Roma , 00152, Italy
Azienda Ospedaliera Universitaria Senese
Siena , 53100, Italy
Institute for Cancer Research and Treatment (IRCC)
Turin , 10060, Italy
Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny im. Ks. B. Markiewicza
Brzozów , , Poland
Szpitale Pomorskie Sp. z o.o.
Gdynia , 81519, Poland
Mazowieckie Centrum Leczenia Chorób Płuc i Gruźlicy
Otwock , 05400, Poland
Wielkopolskie Centrum Pulmonologii i Torakochirurgii
Poznań , 60569, Poland
Med-Polonia Sp. z o.o.
Poznań , 60693, Poland
Instytut Medyczny Santa Familia Sp. z o. o. w Łodzi
Łódź , 93509, Poland
Hospital Quirón Barcelona
Barcelona , 8023, Spain
Hospital Clínic de Barcelona
Barcelona , 8036, Spain
Hospital Universitario Ramón y Cajal
Madrid , 28034, Spain
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain
Centro Integral Oncológico Clara Campal (CIOCC)
Madrid , 28050, Spain
Clínica Universidad de Navarra
Pamplona , 31008, Spain
Campus Hospital Universitario Virgen del Rocío - Instituto de Biomedicina de Sevilla (IBIS)
Sevilla , 41013, Spain
The Royal Marsden NHS Trust
London , SM25P, United Kingdom
Mount Vernon Cancer Centre
Northwood , HA62R, United Kingdom
The Christie NHS Foundation Trust
Withington , M204B, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

557

Study ID:

NCT02983045

Recruitment Status:

Completed

Sponsor:


Nektar Therapeutics

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