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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

557

Participants

Timeline

Start Date

December 19, 2016

Primary Completion Date

April 28, 2022

Study Completion Date

April 28, 2022

Conditions
MelanomaRenal Cell CarcinomaNon Small Cell Lung CancerUrothelial CarcinomaTriple Negative Breast CancerHR+/HER2- Breast CancerGastric Cancer
Interventions
DRUG

Dose Escalation Doublet: Combination of NKTR-214 + nivolumab

NKTR 214 + nivolumab at 5 dosage levels.

DRUG

Dose Expansion Doublet: Combination of NKTR-214 + nivolumab

Select patient cohorts with select tumor types will be dosed with NKTR-214 + nivolumab at the RP2D + other anti-cancer therapies per institution standard.

DRUG

Schedule Finding Triplet: Combination of NKTR-214+ nivolumab+ ipilimumab

1L patients with RCC, NSCLC, UCC, and melanoma received NKTR-214 0.006 mg/kg q3w in combination with nivolumab and ipilimumab according to 3 dosing schedules.

DRUG

Dose Expansion Triplet: Combination of NKTR-214+ nivolumab+ ipilimumab

Combination of NKTR-214 + nivolumab + ipilimumab was administered at RP2D dose/schedules in select tumor types

Trial Locations (58)

8023

Hospital Quirón Barcelona, Barcelona

8036

Hospital Clínic de Barcelona, Barcelona

10016

New York University Langone Medical Center - NYU Cancer Institute, New York

10060

Institute for Cancer Research and Treatment (IRCC), Turin

10065

Memorial Sloan-Kettering Cancer Center, New York

13009

L'Institut Paoli - Calmettes, Marseille

13915

Assistance Publique Hopitaux de Marseille - Hopital Nord, Marseille

14263

Roswell Park Cancer Institute, Buffalo

20133

Fondazione IRCCS Istituto Nazionale dei Tumori, Milan

20141

Istituto Europeo di Oncologia, Milan

22031

Inova Fairfax Hospital, Fairfax

Virginia Cancer Specialists, PC, Fairfax

28034

Hospital Universitario Ramón y Cajal, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28050

Centro Integral Oncológico Clara Campal (CIOCC), Madrid

30322

Emory University Hospital, Atlanta

31008

Clínica Universidad de Navarra, Pamplona

32610

University of Florida, Gainesville

32806

Orlando Health Inc., Orlando

41013

Campus Hospital Universitario Virgen del Rocío - Instituto de Biomedicina de Sevilla (IBIS), Seville

44805

Institut de Cancerologie de l'Ouest, Saint-Herblain

46202

Indiana University Health Melvin & Bren Simon Cancer Center, Indianapolis

48202

Henry Ford Hospital, Detroit

53100

Azienda Ospedaliera Universitaria Senese, Siena

60153

Loyola University Medical Center, Chicago, Maywood

60569

Wielkopolskie Centrum Pulmonologii i Torakochirurgii, Poznan

60693

Med-Polonia Sp. z o.o., Poznan

63110

Washington University School of Medicine in St. Louis, St Louis

66205

University of Kansas Cancer Center, Kansas City

69008

Centre Léon Bérard, Lyon

77030

The University of Texas MD Anderson Cancer Center, Houston

80045

University of Colorado, Denver, Denver

80131

"Istituto Nazionale Tumori IRCCS Fondazione G. Pascale", Napoli

81519

Szpitale Pomorskie Sp. z o.o., Gdynia

90095

UCLA, Los Angeles

92093

UCSD, Moores Cancer Center, La Jolla

93509

Instytut Medyczny Santa Familia Sp. z o. o. w Łodzi, Lodz

94305

Stanford Cancer Institute, Stanford

94805

Gustave Roussy, Villejuif

97213

Providence Portland Medical Center, Portland

98109

Seattle Cancer Care Alliance, Seattle

06473

Yale School of Medicine, New Haven

02115

Dana-Farber Cancer Institute, Boston

02650

Antwerp University Hospital, Edegem

08500

Vzw Az Groeninge, Kortrijk

03000

UZ Leuven, Leuven

04000

CHU de Liège, Liège

02610

GZA Ziekenhuizen Campus Sint-Augustinus, Wilrijk

H3T1E2

BC Cancer Agency Vancouver Centre, Vancouver

Jewish General Hospital, Montreal

M4N3M5

Sunnybrook Health Sciences Centre, Toronto

M5G2M10

Princess Margaret Cancer Centre, Toronto

00152

Azienda Ospedaliera San Camillo-Forlanini, Roma

Unknown

Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny im. Ks. B. Markiewicza, Brzozów

05400

Mazowieckie Centrum Leczenia Chorób Płuc i Gruźlicy, Otwock

SM25PT

The Royal Marsden NHS Trust, London

HA62RN

Mount Vernon Cancer Centre, Northwood

M204BX

The Christie NHS Foundation Trust, Withington

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

Nektar Therapeutics

INDUSTRY