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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 (PIVOT-02)

Primary Purpose

Melanoma, Renal Cell Carcinoma, Non Small Cell Lung Cancer

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Dose Escalation Doublet: Combination of NKTR-214 + nivolumab
Dose Expansion Doublet: Combination of NKTR-214 + nivolumab
Schedule Finding Triplet: Combination of NKTR-214+ nivolumab+ ipilimumab
Dose Expansion Triplet: Combination of NKTR-214+ nivolumab+ ipilimumab
Sponsored by
Nektar Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma focused on measuring NKTR-214, Bempegaldesleukin, Nivolumab, Paclitaxel, Carboplatin, Cisplatin, Pemetrexed, Melanoma, Renal Cell Carcinoma, Non Small Cell Lung Cancer, Urothelial Carcinoma, Triple Negative Breast Cancer, HR+/HER2- Breast Cancer, Gastric Cancer, Colorectal Cancer, Metastatic, Advanced, Immunotherapy, Anti-PD-1, anti-CTLA-4

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCSD, Moores Cancer Center
  • UCLA
  • Stanford Cancer Institute
  • University of Colorado, Denver
  • Yale School of Medicine
  • University of Florida
  • Orlando Health Inc.
  • Emory University Hospital
  • Loyola University Medical Center, Chicago
  • Indiana University Health Melvin & Bren Simon Cancer Center
  • University of Kansas Cancer Center
  • Dana-Farber Cancer Institute
  • Henry Ford Hospital
  • Washington University School of Medicine in St. Louis
  • Roswell Park Cancer Institute
  • New York University Langone Medical Center - NYU Cancer Institute
  • Memorial Sloan-Kettering Cancer Center
  • Providence Portland Medical Center
  • The University of Texas MD Anderson Cancer Center
  • Inova Fairfax Hospital
  • Virginia Cancer Specialists, PC
  • Seattle Cancer Care Alliance
  • Antwerp University Hospital
  • Vzw Az Groeninge
  • UZ Leuven
  • CHU de Liège
  • GZA Ziekenhuizen Campus Sint-Augustinus
  • BC Cancer Agency Vancouver Centre
  • Sunnybrook Health Sciences Centre
  • Princess Margaret Cancer Centre
  • Jewish General Hospital
  • L'Institut Paoli - Calmettes
  • Institut de Cancerologie de l'Ouest
  • Centre Léon Bérard
  • Assistance Publique Hopitaux de Marseille - Hopital Nord
  • Gustave Roussy
  • Fondazione IRCCS Istituto Nazionale dei Tumori
  • Istituto Europeo di Oncologia
  • Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"
  • Azienda Ospedaliera San Camillo-Forlanini
  • Azienda Ospedaliera Universitaria Senese
  • Institute for Cancer Research and Treatment (IRCC)
  • Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny im. Ks. B. Markiewicza
  • Szpitale Pomorskie Sp. z o.o.
  • Mazowieckie Centrum Leczenia Chorób Płuc i Gruźlicy
  • Wielkopolskie Centrum Pulmonologii i Torakochirurgii
  • Med-Polonia Sp. z o.o.
  • Instytut Medyczny Santa Familia Sp. z o. o. w Łodzi
  • Hospital Quirón Barcelona
  • Hospital Clínic de Barcelona
  • Hospital Universitario Ramón y Cajal
  • Hospital Universitario 12 de Octubre
  • Centro Integral Oncológico Clara Campal (CIOCC)
  • Clínica Universidad de Navarra
  • Campus Hospital Universitario Virgen del Rocío - Instituto de Biomedicina de Sevilla (IBIS)
  • The Royal Marsden NHS Trust
  • Mount Vernon Cancer Centre
  • The Christie NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Dose Escalation: Combination of NKTR-214 + nivolumab

Dose Expansion: Combination of NKTR-214 + nivolumab

Experimental: Combination of NKTR-214 + nivolumab + ipilimumab

Experimental: Dose Expansion of Part 3

Arm Description

NKTR 214 + nivolumab at 5 dosage levels to determine the RP2D Part 1 of RP2D in patients with advanced or metastatic melanoma, RCC, NSCLC, urothelial carcinoma, or TNBC.

NKTR-214+nivolumab in patients with advanced or metastatic solid tumor malignancies to assess the efficacy of the RP2D.

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

To further assess the RP2D triplet combination dosing schedules from Part 3 in 1L NSCLC and 1L RCC patients.

Outcomes

Primary Outcome Measures

Part 1 Dose Escalation: Incidence of Dose-limiting Toxicity (DLT) During the DLT Evaluation Window
Part 1of the study was a dose-escalation phase that evaluated the safety and tolerability and defined the maximum tolerated dose or recommended Phase 2 dose of the NKTR-214/nivolumab doublet across 5 dosage/schedule levels. The results presented are for the DLT Population.
Part 3 Schedule Finding: Incidence of Dose-limiting Toxicity (DLT) During the DLT Evaluation Window
Part 3 of the study was a schedule finding phase to establish the recommended phase 2 dosing schedules for Part 4 and assess the safety and tolerability for the NKTR-214/nivolumab/ipilimumab triplet combination. The results presented are for the DLT Population.
Part 2 and Part 4: Objective Response Rate (ORR) Per RECIST 1.1 at Recommended Phase 2 Dose (RP2D)
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) at Recommended Phase 2 Dose (RP2D). ORR is defined as the percentage of enrolled participants who achieved a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR). CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to <10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR is calculated as the sum of CR and PR.

Secondary Outcome Measures

Full Information

First Posted
November 23, 2016
Last Updated
March 9, 2023
Sponsor
Nektar Therapeutics
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT02983045
Brief Title
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
Acronym
PIVOT-02
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
December 19, 2016 (Actual)
Primary Completion Date
April 28, 2022 (Actual)
Study Completion Date
April 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nektar Therapeutics
Collaborators
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma, Renal Cell Carcinoma, Non Small Cell Lung Cancer, Urothelial Carcinoma, Triple Negative Breast Cancer, HR+/HER2- Breast Cancer, Gastric Cancer
Keywords
NKTR-214, Bempegaldesleukin, Nivolumab, Paclitaxel, Carboplatin, Cisplatin, Pemetrexed, Melanoma, Renal Cell Carcinoma, Non Small Cell Lung Cancer, Urothelial Carcinoma, Triple Negative Breast Cancer, HR+/HER2- Breast Cancer, Gastric Cancer, Colorectal Cancer, Metastatic, Advanced, Immunotherapy, Anti-PD-1, anti-CTLA-4

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
557 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dose Escalation: Combination of NKTR-214 + nivolumab
Arm Type
Experimental
Arm Description
NKTR 214 + nivolumab at 5 dosage levels to determine the RP2D Part 1 of RP2D in patients with advanced or metastatic melanoma, RCC, NSCLC, urothelial carcinoma, or TNBC.
Arm Title
Dose Expansion: Combination of NKTR-214 + nivolumab
Arm Type
Experimental
Arm Description
NKTR-214+nivolumab in patients with advanced or metastatic solid tumor malignancies to assess the efficacy of the RP2D.
Arm Title
Experimental: Combination of NKTR-214 + nivolumab + ipilimumab
Arm Type
Experimental
Arm Description
To assess the safety and tolerability of NKTR 214 + nivolumab + ipilimumab triplet therapy and establish RP2D dosing schedules for Part 4 in patients with advanced or metastatic melanoma, RCC, NSCLC, or UCC in a first-line setting (1L).
Arm Title
Experimental: Dose Expansion of Part 3
Arm Type
Experimental
Arm Description
To further assess the RP2D triplet combination dosing schedules from Part 3 in 1L NSCLC and 1L RCC patients.
Intervention Type
Drug
Intervention Name(s)
Dose Escalation Doublet: Combination of NKTR-214 + nivolumab
Other Intervention Name(s)
Bempegaldesleukin + Opdivo®
Intervention Description
NKTR 214 + nivolumab at 5 dosage levels.
Intervention Type
Drug
Intervention Name(s)
Dose Expansion Doublet: Combination of NKTR-214 + nivolumab
Other Intervention Name(s)
Bempegaldesleukin+ Opdivo®, Carboplatin (Paraplatin®), Cisplatin (Platinol®), Pemetrexed (Alimta®), Paclitaxel (Taxol®)
Intervention Description
Select patient cohorts with select tumor types will be dosed with NKTR-214 + nivolumab at the RP2D + other anti-cancer therapies per institution standard.
Intervention Type
Drug
Intervention Name(s)
Schedule Finding Triplet: Combination of NKTR-214+ nivolumab+ ipilimumab
Other Intervention Name(s)
Bempegaldesleukin+ Opdivo®+ Yervoy®
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Dose Expansion Triplet: Combination of NKTR-214+ nivolumab+ ipilimumab
Other Intervention Name(s)
Bempegaldesleukin+ Opdivo®+ Yervoy®
Intervention Description
Combination of NKTR-214 + nivolumab + ipilimumab was administered at RP2D dose/schedules in select tumor types
Primary Outcome Measure Information:
Title
Part 1 Dose Escalation: Incidence of Dose-limiting Toxicity (DLT) During the DLT Evaluation Window
Description
Part 1of the study was a dose-escalation phase that evaluated the safety and tolerability and defined the maximum tolerated dose or recommended Phase 2 dose of the NKTR-214/nivolumab doublet across 5 dosage/schedule levels. The results presented are for the DLT Population.
Time Frame
Includes DLTs that occurred within the DLT window of at least 21 days after the first dose of study treatment (28 days for every 2 weeks dosing; 21 days for every 3 weeks dosing). Patients were counted only once under each preferred term.
Title
Part 3 Schedule Finding: Incidence of Dose-limiting Toxicity (DLT) During the DLT Evaluation Window
Description
Part 3 of the study was a schedule finding phase to establish the recommended phase 2 dosing schedules for Part 4 and assess the safety and tolerability for the NKTR-214/nivolumab/ipilimumab triplet combination. The results presented are for the DLT Population.
Time Frame
Dose-limiting toxicities (DLTs) were assessed during a 3-week (21-day) DLT evaluation period beginning with the first dose of ipilimumab.
Title
Part 2 and Part 4: Objective Response Rate (ORR) Per RECIST 1.1 at Recommended Phase 2 Dose (RP2D)
Description
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) at Recommended Phase 2 Dose (RP2D). ORR is defined as the percentage of enrolled participants who achieved a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR). CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to <10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR is calculated as the sum of CR and PR.
Time Frame
Tumor assessment at Screening then every 8 weeks (± 7 days) from Cycle 1 Day 1 and end of treatment (unless scan done within 4 weeks) up to approximately 27 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Nektar Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
UCSD, Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Stanford Cancer Institute
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of Colorado, Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Yale School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06473
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Orlando Health Inc.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Loyola University Medical Center, Chicago
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Indiana University Health Melvin & Bren Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Kansas Cancer Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Washington University School of Medicine in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
New York University Langone Medical Center - NYU Cancer Institute
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Inova Fairfax Hospital
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Virginia Cancer Specialists, PC
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Antwerp University Hospital
City
Edegem
ZIP/Postal Code
02650
Country
Belgium
Facility Name
Vzw Az Groeninge
City
Kortrijk
ZIP/Postal Code
08500
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
03000
Country
Belgium
Facility Name
CHU de Liège
City
Liège
ZIP/Postal Code
04000
Country
Belgium
Facility Name
GZA Ziekenhuizen Campus Sint-Augustinus
City
Wilrijk
ZIP/Postal Code
02610
Country
Belgium
Facility Name
BC Cancer Agency Vancouver Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
H3T1E2
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N3M5
Country
Canada
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G2M10
Country
Canada
Facility Name
Jewish General Hospital
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3T1E2
Country
Canada
Facility Name
L'Institut Paoli - Calmettes
City
Marseille
State/Province
Brouches-duRhone
ZIP/Postal Code
13009
Country
France
Facility Name
Institut de Cancerologie de l'Ouest
City
Saint-Herblain
State/Province
Loire-Atlantique
ZIP/Postal Code
44805
Country
France
Facility Name
Centre Léon Bérard
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Assistance Publique Hopitaux de Marseille - Hopital Nord
City
Marseille Cedex 20
ZIP/Postal Code
13915
Country
France
Facility Name
Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Istituto Europeo di Oncologia
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Azienda Ospedaliera San Camillo-Forlanini
City
Roma
ZIP/Postal Code
00152
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Senese
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Institute for Cancer Research and Treatment (IRCC)
City
Turin
ZIP/Postal Code
10060
Country
Italy
Facility Name
Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny im. Ks. B. Markiewicza
City
Brzozów
Country
Poland
Facility Name
Szpitale Pomorskie Sp. z o.o.
City
Gdynia
ZIP/Postal Code
81519
Country
Poland
Facility Name
Mazowieckie Centrum Leczenia Chorób Płuc i Gruźlicy
City
Otwock
ZIP/Postal Code
05400
Country
Poland
Facility Name
Wielkopolskie Centrum Pulmonologii i Torakochirurgii
City
Poznań
ZIP/Postal Code
60569
Country
Poland
Facility Name
Med-Polonia Sp. z o.o.
City
Poznań
ZIP/Postal Code
60693
Country
Poland
Facility Name
Instytut Medyczny Santa Familia Sp. z o. o. w Łodzi
City
Łódź
ZIP/Postal Code
93509
Country
Poland
Facility Name
Hospital Quirón Barcelona
City
Barcelona
ZIP/Postal Code
8023
Country
Spain
Facility Name
Hospital Clínic de Barcelona
City
Barcelona
ZIP/Postal Code
8036
Country
Spain
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Centro Integral Oncológico Clara Campal (CIOCC)
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Clínica Universidad de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Campus Hospital Universitario Virgen del Rocío - Instituto de Biomedicina de Sevilla (IBIS)
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
The Royal Marsden NHS Trust
City
London
ZIP/Postal Code
SM25PT
Country
United Kingdom
Facility Name
Mount Vernon Cancer Centre
City
Northwood
ZIP/Postal Code
HA62RN
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust
City
Withington
ZIP/Postal Code
M204BX
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35643589
Citation
Siefker-Radtke AO, Cho DC, Diab A, Sznol M, Bilen MA, Balar AV, Grignani G, Puente E, Tang L, Chien D, Hoch U, Choudhury A, Yu D, Currie SL, Tagliaferri MA, Zalevsky J, Hurwitz ME, Tannir NM. Bempegaldesleukin plus Nivolumab in First-line Metastatic Urothelial Carcinoma: Results from PIVOT-02. Eur Urol. 2022 Oct;82(4):365-373. doi: 10.1016/j.eururo.2022.05.002. Epub 2022 May 25.
Results Reference
derived
PubMed Identifier
34255535
Citation
Diab A, Tykodi SS, Daniels GA, Maio M, Curti BD, Lewis KD, Jang S, Kalinka E, Puzanov I, Spira AI, Cho DC, Guan S, Puente E, Nguyen T, Hoch U, Currie SL, Lin W, Tagliaferri MA, Zalevsky J, Sznol M, Hurwitz ME. Bempegaldesleukin Plus Nivolumab in First-Line Metastatic Melanoma. J Clin Oncol. 2021 Sep 10;39(26):2914-2925. doi: 10.1200/JCO.21.00675. Epub 2021 Jul 13.
Results Reference
derived
PubMed Identifier
33298619
Citation
Veatch JR, Singhi N, Jesernig B, Paulson KG, Zalevsky J, Iaccucci E, Tykodi SS, Riddell SR. Mobilization of pre-existing polyclonal T cells specific to neoantigens but not self-antigens during treatment of a patient with melanoma with bempegaldesleukin and nivolumab. J Immunother Cancer. 2020 Dec;8(2):e001591. doi: 10.1136/jitc-2020-001591. Erratum In: J Immunother Cancer. 2021 Feb;9(2):
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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

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