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

Last updated: March 9, 2023
Sponsor: Nektar Therapeutics
Overall Status: Completed

Phase

1/2

Condition

Melanoma

Stomach Cancer

Kidney Cancer

Treatment

N/A

Clinical Study ID

NCT02983045
16-214-02
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 Design

Total Participants: 557
Study Start date:
December 19, 2016
Estimated Completion Date:
April 28, 2022

Study 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.

Connect with a study center

  • Antwerp University Hospital

    Edegem, 02650
    Belgium

    Site Not Available

  • Vzw Az Groeninge

    Kortrijk, 08500
    Belgium

    Site Not Available

  • UZ Leuven

    Leuven, 03000
    Belgium

    Site Not Available

  • CHU de Liège

    Liège, 04000
    Belgium

    Site Not Available

  • GZA Ziekenhuizen Campus Sint-Augustinus

    Wilrijk, 02610
    Belgium

    Site Not Available

  • BC Cancer Agency Vancouver Centre

    Vancouver, British Columbia H3T1E2
    Canada

    Site Not Available

  • Local Institution - Ottawa

    Ottawa, Ontario K1H8L6
    Canada

    Site Not Available

  • Princess Margaret Cancer Centre

    Toronto, Ontario M5G2M10
    Canada

    Site Not Available

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario M4N3M5
    Canada

    Site Not Available

  • Jewish General Hospital

    Montréal, Quebec H3T1E2
    Canada

    Site Not Available

  • L'Institut Paoli - Calmettes

    Marseille, Brouches-duRhone 13009
    France

    Site Not Available

  • Institut de Cancerologie de l'Ouest

    Saint-Herblain, Loire-Atlantique 44805
    France

    Site Not Available

  • Centre Léon Bérard

    Lyon, 69008
    France

    Site Not Available

  • Assistance Publique Hopitaux de Marseille - Hopital Nord

    Marseille Cedex 20, 13915
    France

    Site Not Available

  • Gustave Roussy

    Villejuif, 94805
    France

    Site Not Available

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milano, 20133
    Italy

    Site Not Available

  • Istituto Europeo di Oncologia

    Milano, 20141
    Italy

    Site Not Available

  • Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"

    Napoli, 80131
    Italy

    Site Not Available

  • Azienda Ospedaliera San Camillo-Forlanini

    Roma, 00152
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Senese

    Siena, 53100
    Italy

    Site Not Available

  • Institute for Cancer Research and Treatment (IRCC)

    Turin, 10060
    Italy

    Site Not Available

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

    Brzozów,
    Poland

    Site Not Available

  • Szpitale Pomorskie Sp. z o.o.

    Gdynia, 81519
    Poland

    Site Not Available

  • Local Institution - Kraków

    Kraków, 31115
    Poland

    Site Not Available

  • Mazowieckie Centrum Leczenia Chorób Płuc i Gruźlicy

    Otwock, 05400
    Poland

    Site Not Available

  • Med-Polonia Sp. z o.o.

    Poznań, 60693
    Poland

    Site Not Available

  • Wielkopolskie Centrum Pulmonologii i Torakochirurgii

    Poznań, 60569
    Poland

    Site Not Available

  • Instytut Medyczny Santa Familia Sp. z o. o. w Łodzi

    Łódź, 93509
    Poland

    Site Not Available

  • Hospital Clínic de Barcelona

    Barcelona, 8036
    Spain

    Site Not Available

  • Hospital Quirón Barcelona

    Barcelona, 8023
    Spain

    Site Not Available

  • Centro Integral Oncológico Clara Campal (CIOCC)

    Madrid, 28050
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034
    Spain

    Site Not Available

  • Clínica Universidad de Navarra

    Pamplona, 31008
    Spain

    Site Not Available

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

    Sevilla, 41013
    Spain

    Site Not Available

  • Local Institution - Dnipropetrovsk

    Dnipropetrovsk, 49102
    Ukraine

    Site Not Available

  • Local Institution - Ivano-Frankivs'k

    Ivano-Frankivs'k, 76018
    Ukraine

    Site Not Available

  • Local Institution - Lviv

    L'viv, 79031
    Ukraine

    Site Not Available

  • Local Institution - Odessa

    Odessa, 65055
    Ukraine

    Site Not Available

  • Local Institution - Belmont

    Belmont, SM25PT
    United Kingdom

    Site Not Available

  • Local Institution - Bradford

    Bradford, BD71DP
    United Kingdom

    Site Not Available

  • Local Institution - West Yorkshire (Bradford)

    Leeds, LS97TF
    United Kingdom

    Site Not Available

  • The Royal Marsden NHS Trust

    London, SM25PT
    United Kingdom

    Site Not Available

  • Mount Vernon Cancer Centre

    Northwood, HA62RN
    United Kingdom

    Site Not Available

  • The Christie NHS Foundation Trust

    Withington, M204BX
    United Kingdom

    Site Not Available

  • UCSD, Moores Cancer Center

    La Jolla, California 92093
    United States

    Site Not Available

  • UCLA

    Los Angeles, California 90095
    United States

    Site Not Available

  • Stanford Cancer Institute

    Stanford, California 94305
    United States

    Site Not Available

  • Local Institution - Aurora

    Aurora, Colorado 80045
    United States

    Site Not Available

  • University of Colorado, Denver

    Denver, Colorado 80045
    United States

    Site Not Available

  • Yale School of Medicine

    New Haven, Connecticut 06473
    United States

    Site Not Available

  • University of Florida

    Gainesville, Florida 32610
    United States

    Site Not Available

  • Orlando Health Inc.

    Orlando, Florida 32806
    United States

    Site Not Available

  • Local Institution - Tampa

    Tampa, Florida 33612
    United States

    Site Not Available

  • Emory University Hospital

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Loyola University Medical Center, Chicago

    Maywood, Illinois 60153
    United States

    Site Not Available

  • Indiana University Health Melvin & Bren Simon Cancer Center

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • University of Kansas Cancer Center

    Kansas City, Kansas 66205
    United States

    Site Not Available

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Washington University School of Medicine in St. Louis

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Roswell Park Cancer Institute

    Buffalo, New York 14263
    United States

    Site Not Available

  • Memorial Sloan-Kettering Cancer Center

    New York, New York 10065
    United States

    Site Not Available

  • New York University Langone Medical Center - NYU Cancer Institute

    New York, New York 10016
    United States

    Site Not Available

  • Local Institution - Cleveland

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Providence Portland Medical Center

    Portland, Oregon 97213
    United States

    Site Not Available

  • Local Institution - Nashville

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Local Institution - Dallas

    Dallas, Texas 72501
    United States

    Site Not Available

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Inova Fairfax Hospital

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • Seattle Cancer Care Alliance

    Seattle, Washington 98109
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.