PIVOT-12: Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined With Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence
Sponsor
Nektar Therapeutics (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04410445
Collaborator
Bristol-Myers Squibb (Industry)
775
212
2
83.1
3.7
0
Study Details
Study Description
Brief Summary
The main purpose of this study is to compare the efficacy of bempegaldesleukin plus nivolumab versus nivolumab in patients with completely resected Stage IIIA/B/C/D, or Stage IV cutaneous melanoma who are at high risk for recurrence.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
The main purpose of this study is to compare the efficacy, as measured by recurrence-free survival (RFS) by blinded independent central review (BICR), of bempegaldesleukin plus nivolumab versus nivolumab in patients with completely resected Stage IIIA (lymph node [LN] metastasis > 1 mm), Stage IIIB/C/D, or Stage IV (American Joint Committee on Cancer [AJCC] 8th edition) cutaneous melanoma with no evidence of disease (NED) who are at high risk for recurrence.
Study Design
Study Type:
Interventional
Actual Enrollment
:
775 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Patients will be randomized in a 1:1 ratio to one of two treatment armsPatients will be randomized in a 1:1 ratio to one of two treatment arms
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 3, Randomized, Open-label Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined With Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence (PIVOT-12)
Actual Study Start Date
:
Jul 27, 2020
Anticipated Primary Completion Date
:
Jul 1, 2027
Anticipated Study Completion Date
:
Jul 1, 2027
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Combination of bempegaldesleukin (NKTR-214) + nivolumab Arm A: Participants will receive bempegaldesleukin (NKTR-214) IV in combination with nivolumab every 3 weeks. |
Biological: Bempegaldesleukin
Specified dose on specified days
Other Names:
Biological: Nivolumab
Specified dose on specified days
Other Names:
|
| Active Comparator: Nivolumab Arm B: Participants will receive nivolumab IV alone every 4 weeks. |
Biological: Nivolumab
Specified dose on specified days
Other Names:
|
Outcome Measures
Primary Outcome Measures
- RFS of bempegaldesleukin plus nivolumab versus nivolumab alone by BICR, is defined as the time between date of randomization and date of first recurrence, new primary melanoma, or all-cause death [Approximately up to 60 months]
Secondary Outcome Measures
- Overall Survival (OS) defined as the time between the date of randomization and the date of death due to any cause [Approximately up to 83 months]
- Distant metastasis-free survival (DMFS) by BICR and by Investigator in patients who have Stage IIIA (LN metastasis > 1 mm) or IIIB/C/D melanoma at study entry. [Approximately up to 60 months]
To evaluate distant metastasis-free survival (DMFS) by BICR and by Investigator in patients who have Stage IIIA (LN metastasis > 1 mm) or IIIB/C/D melanoma at study entry. Distant Metastasis Free Survival is defined as the time between the date of randomization and the date of first distant metastasis or date of death due to any cause.
- Overall safety and tolerability of bempegaldesleukin plus nivolumab will be measured by the incidence of AEs, SAEs, deaths, and laboratory abnormalities using CTCAE Version 5.0 criteria [Approximately up to 60 months]
- Patient Reported Outcomes will be measured by changes from baseline in scores for the global health/quality of life and physical functioning subscales of the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire [Approximately up to 60 months]
- The predictive strength of PD-L1 expression as a biomarker will be measured by the endpoint RFS by BICR based on PD-L1 expression level [Approximately up to 60 months]
- RFS by Investigator will be measured similarly to the primary endpoint, but recurrence and new primary melanoma will be decided by the Investigator [Approximately up to 60 months]
- Time to disease progression after the next line of treatment for study patients following discontinuation of bempegaldesleukin plus nivolumab versus nivolumab [Approximately up to 60 months]
To evaluate time to disease progression after the next line of treatment for study patients following discontinuation of bempegaldesleukin plus nivolumab versus nivolumab
Eligibility Criteria
Criteria
Ages Eligible for Study:
12 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Male or female patients, age 12 years or older at the time of signing the informed consent form (age 18 years or older where local regulations, countries, and/or institutional policies do not allow for patients < 18 years of age (adolescents) to participate). In regions where adolescents are not allowed to participate in the study due to age restrictions, enrolled patients must be ≥ 18 years of age.
-
Histologically confirmed Stage IIIA (LN metastasis > 1 mm), IIIB/C/D, or IV (M1a/b/c/d) cutaneous melanoma by AJCC (8th edition) at study entry that has been completely surgically resected within 12 weeks prior to randomization.
-
Tumor tissue available from biopsy or resected disease must be provided to central laboratory for PD-L1 status analysis. Must have PD-L1 expression classification for stratification purposes.
-
Disease-free status documented by a complete physical examination and imaging studies within 28 days prior to randomization.
Exclusion Criteria:
-
History of ocular/uveal melanoma or mucosal melanoma.
-
Active, known or suspected autoimmune disease. Patients with Type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
-
Conditions requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
-
Prior therapy for melanoma except surgery for the melanoma lesion(s) and/or adjuvant radiation therapy for central nervous system lesions.
-
Prior therapy with interferon, talimogene laherparepvec (Imylgic®), interleukin-2 (IL-2) directed therapy, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T lymphocyte-associated protein 4 antibody (including ipilimumab or any other antibody or drug specifically targeting T cell co-stimulation or checkpoint pathways).
-
Prior malignancy active within the previous 3 years except for locally potentially curable cancers that have been apparently cured.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Honor Health | Scottsdale | Arizona | United States | 85258 |
| 2 | Banner MD Anderson Cancer Center | Little Rock | Arkansas | United States | 72205 |
| 3 | Kaiser Foundation Hospital, Inpatient Pharmacy | Anaheim | California | United States | 92805 |
| 4 | Kaiser Permanente | Fontana | California | United States | 92335 |
| 5 | St. Joseph Heritage Healthcare | Fullerton | California | United States | 92835 |
| 6 | Hematology Oncology Medical Group of Orange County, Inc. | Orange | California | United States | 92868 |
| 7 | University of California Irvine | Orange | California | United States | 92868 |
| 8 | Emad Ibrahim, MD, Inc | Redlands | California | United States | 92373 |
| 9 | Kaiser Permanente | Riverside | California | United States | 92505 |
| 10 | Southern California Permanente Medical Group | Riverside | California | United States | 92505 |
| 11 | San Francisco Oncology Associates | San Francisco | California | United States | 94115 |
| 12 | California Cancer Associates for Research and Excellence | San Marcos | California | United States | 92069 |
| 13 | Kaiser Permanente | San Marcos | California | United States | 92078 |
| 14 | Angeles Clinic and Research Institute | Santa Monica | California | United States | 90404 |
| 15 | John Wayne Cancer Institute | Santa Monica | California | United States | 90404 |
| 16 | Rocky Mountain Cancer Centers (Littleton) - USOR | Aurora | Colorado | United States | 80012 |
| 17 | University of Colorado - Cancer Center - PPDS | Aurora | Colorado | United States | 80045 |
| 18 | MedStar Georgetown University Hospital | Washington | District of Columbia | United States | 20007 |
| 19 | Orlando Health Cancer Institute | Longwood | Florida | United States | 32750 |
| 20 | Rush University Medical Center | Chicago | Illinois | United States | 60612 |
| 21 | Goshen Center For Cancer Care | Goshen | Indiana | United States | 46526 |
| 22 | University of Kentucky | Lexington | Kentucky | United States | 40536 |
| 23 | Ochsner Clinic Foundation | New Orleans | Louisiana | United States | 70121 |
| 24 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
| 25 | Mayo Clinic - PIN | Rochester | Minnesota | United States | 55905 |
| 26 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
| 27 | Frontier Cancer Center and Blood Institute | Billings | Montana | United States | 59102 |
| 28 | Nebraska Cancer Specialists | Omaha | Nebraska | United States | 68130 |
| 29 | Nebraska Methodist Hospital | Omaha | Nebraska | United States | 68130 |
| 30 | University of Nebraska Medical Center | Omaha | Nebraska | United States | 68198 |
| 31 | Hackensack University Medical Center | Hackensack | New Jersey | United States | 07601 |
| 32 | Atlantic Health System | Morristown | New Jersey | United States | 07960 |
| 33 | NYU Langone Medical Center | New York | New York | United States | 10016 |
| 34 | Columbia University Medical Center - PIN | New York | New York | United States | 10021 |
| 35 | Icahn School of Medicine at Mount Sinai | New York | New York | United States | 10029 |
| 36 | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | United States | 32750 |
| 37 | Duke Cancer Institute | Durham | North Carolina | United States | 27710 |
| 38 | University Hospitals Cleveland Medical Center | Cleveland | Ohio | United States | 44106 |
| 39 | The Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
| 40 | Providence Cancer Institute, Franz Clinic | Portland | Oregon | United States | 97213 |
| 41 | Oregon Health and Science University | Portland | Oregon | United States | 97216 |
| 42 | Lehigh Valley Physician Group (LVPG) - Hematology Oncology | Allentown | Pennsylvania | United States | 18103 |
| 43 | Penn State Milton S Hershey Medical Center | Hershey | Pennsylvania | United States | 17033 |
| 44 | Jefferson University Hospital | Philadelphia | Pennsylvania | United States | 19107 |
| 45 | H Lee Moffitt Cancer Center and Research Institute | Pittsburgh | Pennsylvania | United States | 15232 |
| 46 | Hillman Cancer Center | Pittsburgh | Pennsylvania | United States | 15232 |
| 47 | Prisma Health Cancer Institute | Greenville | South Carolina | United States | 29605 |
| 48 | SCRI Tennessee Oncology Chattanooga | Chattanooga | Tennessee | United States | 37404 |
| 49 | University of Tennessee Medical Center | Knoxville | Tennessee | United States | 37920 |
| 50 | SCRI Tennessee Oncology Nashville | Nashville | Tennessee | United States | 37203 |
| 51 | Vanderbilt University Medical Center | Nashville | Tennessee | United States | 37232 |
| 52 | Department of Pharmacy Investigational Drug Services | Dallas | Texas | United States | 75235 |
| 53 | Texas Oncology (Loop) - USOR | Dallas | Texas | United States | 75246 |
| 54 | University of Texas Southwestern Medical Center | Dallas | Texas | United States | 75390 |
| 55 | MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
| 56 | Utah Cancer Specialists (Salt Lake City) | Salt Lake City | Utah | United States | 90603 |
| 57 | University of Virginia Cancer Center | Charlottesville | Virginia | United States | 22903 |
| 58 | Inova Schar Cancer Institute | Fairfax | Virginia | United States | 22031 |
| 59 | Blue Ridge Cancer Care - USOR | Roanoke | Virginia | United States | 24014 |
| 60 | Seattle Cancer Care Alliance | Seattle | Washington | United States | 98109 |
| 61 | Northwest Medical Specialties | Tacoma | Washington | United States | 98405 |
| 62 | University of Wisconsin | Madison | Wisconsin | United States | 53792 |
| 63 | Royal Adelaide Hospital | Adelaide | Australia | 5000 | |
| 64 | Cairns Hospital | Cairns | Australia | 4870 | |
| 65 | Icon Cancer Care Wesley | Chermside | Australia | 4032 | |
| 66 | Gallipoli Medical Research Foundation | Greenslopes | Australia | 4120 | |
| 67 | Austin Health | Heidelberg | Australia | 3084 | |
| 68 | Alfred Hospital | Melbourne | Australia | 3004 | |
| 69 | Affinity Clinical Research | Nedlands | Australia | 6009 | |
| 70 | Sir Charles Gairdner Hospital | Nedlands | Australia | 6009 | |
| 71 | Melanoma Institute Australia | North Sydney | Australia | 2000 | |
| 72 | Gold Coast University Hospital | Southport | Australia | 4215 | |
| 73 | Tasman Oncology Research | Southport | Australia | 4215 | |
| 74 | Blacktown Hospital | Westmead | Australia | 2145 | |
| 75 | Princess Alexandra Hospital | Woolloongabba | Australia | 4102 | |
| 76 | Medizinische Universität Graz | Graz | Austria | 8036 | |
| 77 | Ordensklinikum Linz, Krankenhaus der Elisabethinen GmbH | Lienz | Austria | ||
| 78 | Landeskrankenhaus Feldkirch | Rankweil | Austria | 6830 | |
| 79 | Salzburger Landeskliniken | Salzburg | Austria | ||
| 80 | Universitätsklinikum St. Pölten | St.Pölten | Austria | 3100 | |
| 81 | Allgemeines Krankenhaus der Stadt Wien | Vienna | Austria | 1090 | |
| 82 | Mou/Mmci - Ppds | Brno | Czechia | 65653 | |
| 83 | Fakultni nemocnice Hradec Kralove | Hradec Králové | Czechia | ||
| 84 | Krajska nemocnice Liberec, a.s. | Liberec | Czechia | 46063 | |
| 85 | Fakultni nemocnice Olomouc | Olomouc | Czechia | 79900 | |
| 86 | Fakultni nemocnice Ostrava | Ostrava Poruba | Czechia | 70852 | |
| 87 | Nemocnice Na Bulovce | Prague | Czechia | 16000 | |
| 88 | Vseobecna Fakultni Nemocnice V Praze | Praha | Czechia | 12808 | |
| 89 | Centre Hospitalier Universitaire (CHU) Amiens-Picardie - Hopital Sud | Amiens | France | 80054 | |
| 90 | CHU Angers | Angers | France | 49100 | |
| 91 | Hôpital Saint-André | Bordeau | France | ||
| 92 | CHRU de Tours | Chambray-lès-Tours | France | ||
| 93 | CHU Estaing | Clermont-Ferrand | France | 63003 | |
| 94 | Hôpital Albert Michallon La Tronche | La Tronche | France | 38043 | |
| 95 | CHRU Lille | Lille | France | 59037 | |
| 96 | Hôtel Dieu - Nantes | Nantes | France | 44093 | |
| 97 | CHU de Nice | Nice | France | 6202 | |
| 98 | Hôpital Saint Louis | Paris | France | 75475 | |
| 99 | Groupe Hospitalier Bichat Claude Bernard | Paris | France | 75877 | |
| 100 | Hospices Civils de Lyon | Pierre-Bénite | France | 69310 | |
| 101 | EDOG - Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer - PPDS | Rennes | France | 35042 | |
| 102 | Hôpital Charles Nicolle | Rouen | France | 76031 | |
| 103 | Centre Hospitalier Universitaire de Saint Etienne | Saint-Priest-en-Jarez | France | 42055 | |
| 104 | Institut Gustave Roussy | Villejuif | France | 94801 | |
| 105 | Charité - Universitätsmedizin Berlin | Berlin | Germany | 10117 | |
| 106 | Ruhr Universität Bochum | Bochum | Germany | 44791 | |
| 107 | Elben Klinken Stade - Buxtehude | Buxtehude | Germany | 21614 | |
| 108 | Universitätsklinikum Carl Gustav Carus an der TU Dresden | Dresden | Germany | 81307 | |
| 109 | Helios Klinikum Erfurt | Erfurt | Germany | 99089 | |
| 110 | Universitätsklinikum Essen | Essen | Germany | 45147 | |
| 111 | SRH Wald-Klinikum Gera GmbH | Gera | Germany | 7548 | |
| 112 | Universitatsklinikum Halle (Saale) | Halle | Germany | 6097 | |
| 113 | Universitätsklinikum Hamburg Eppendorf | Hamburg | Germany | 20246 | |
| 114 | Medizinische Hochschule Hannover | Hannover | Germany | 30625 | |
| 115 | University Clinic Heidelberg | Heidelberg | Germany | 69120 | |
| 116 | SLK Kliniken Heilbronn GmbH | Heilbronn | Germany | 74078 | |
| 117 | Universitatsklinikum Schleswig-Holstein | Kiel | Germany | 24105 | |
| 118 | Uniklinik Köln | Köln | Germany | 50937 | |
| 119 | Universitatsklinikum Leipzig | Leipzig | Germany | 04103 | |
| 120 | Klinikum der Stadt Ludwigshafen gGmbH | Ludwigshafen | Germany | 67063 | |
| 121 | Universitätsklinik Magdeburg | Magdeburg | Germany | 39014 | |
| 122 | Klinikum Mannheim Universitätsklinikum gGmbH | Mannheim | Germany | 76297 | |
| 123 | Universitatsklinikum Munster | Münster | Germany | 48149 | |
| 124 | Fachklinik Hornheide | Münster | Germany | 48157 | |
| 125 | University Clinic Regensburg | Regensburg | Germany | 93053 | |
| 126 | Helios Klinikum Schwerin | Schwerin | Germany | 19049 | |
| 127 | Universitätsklinikum Tübingen | Tübingen | Germany | 76297 | |
| 128 | Universitätsklinikum Ulm | Ulm | Germany | 89081 | |
| 129 | Universitätsklinikum Würzburg | Würzburg | Germany | 97080 | |
| 130 | Laiko General Hospital of Athens | Ampelokipoi | Greece | 11526 | |
| 131 | Henry Dunant Hospital | Athens | Greece | 11526 | |
| 132 | Metropolitan Hospital - First Oncology Clinic | Athens | Greece | 18547 | |
| 133 | Metropolitan Hospital - Fourth Oncology Clinic | Athens | Greece | 18547 | |
| 134 | Pepagni Hospital | Heraklion | Greece | 71110 | |
| 135 | Medical Center of Athens | Maroúsi | Greece | 15125 | |
| 136 | Interbalkan Medical Center of Thessaloniki | Pylaía | Greece | TK57001 | |
| 137 | Theageneio Anticancer Oncology Hospital of Thessaloniki | Thessaloníki | Greece | 54645 | |
| 138 | Papageorgiou General Hospital of Thessaloniki | Thessaloníki | Greece | 56429 | |
| 139 | Bioclinic Thessaloniki (Galinos clinic) | Thessaloníki | Greece | 86 | |
| 140 | HaEmek Medical Center | Afula | Israel | 18101 | |
| 141 | Soroka University Medical Centre | Be'er Sheva | Israel | 8410501 | |
| 142 | Rambam Medical Center - PPDS | Haifa | Israel | 31096 | |
| 143 | Hadassah Medical Center - PPDS | Jerusalem | Israel | 9574425 | |
| 144 | Rabin Medical Center - PPDS | Petah tikva | Israel | 49100 | |
| 145 | Sheba Medical Center - PPDS | Ramat Gan | Israel | ||
| 146 | IRCCS Giovanni Paolo II Istituto Oncologico | Bari | Italy | 70124 | |
| 147 | ASST Papa Giovanni XXIII - Azienda Ospedaliera Papa Giovanni XXIII | Bergamo | Italy | ||
| 148 | Fondazione del Piemonte per l'Oncologia (IRCCS) | Candiolo | Italy | 10060 | |
| 149 | Ospedale Policlinico San Martino | Genova | Italy | ||
| 150 | Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS | Meldola | Italy | 47014 | |
| 151 | Istituto Europeo Di Oncologia | Milano | Italy | 20141 | |
| 152 | Istituto Nazionale Dei Tumori | Milano | Italy | ||
| 153 | Azienda Ospedaliero Universitaria Di Modena Policlinico | Modena | Italy | 41100 | |
| 154 | Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale | Napoli | Italy | 80131 | |
| 155 | Istituto Oncologico Veneto - I.R.C.C.S. | Padova | Italy | 35128 | |
| 156 | Azienda Ospedaliera Universitaria Senese | Siena | Italy | 53100 | |
| 157 | VU Medisch Centrum | Amsterdam | Netherlands | 1081HV | |
| 158 | Zuyderland Medisch Centrum | Heerlen | Netherlands | 6419 | |
| 159 | Medisch Centrum Leeuwarden | Leeuwarden | Netherlands | 8934 | |
| 160 | Leiden University Medical Center | Leiden | Netherlands | 2333ZA | |
| 161 | Radboud University Nijmegen Medical Centre | Nijmegen | Netherlands | 6525GA | |
| 162 | Universitair Medisch Centrum Utrecht | Utrecht | Netherlands | 3584 | |
| 163 | Maxima Medisch Centrum | Veldhoven | Netherlands | ||
| 164 | Isala Klinieken | Zwolle | Netherlands | 8025AB | |
| 165 | Christchurch Hospital | Christchurch | New Zealand | 8140 | |
| 166 | Dunedin Hospital | Dunedin | New Zealand | 9054 | |
| 167 | Auckland City Hospital | Heidelberg | New Zealand | 3084 | |
| 168 | Tauranga Hospital | Tauranga | New Zealand | 3143 | |
| 169 | Wellington Hospital | Wellington | New Zealand | 6021 | |
| 170 | Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie w Bialymstoku | Białystok | Poland | 15-027 | |
| 171 | Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy | Bydgoszcz | Poland | 85796 | |
| 172 | Uniwersyteckie Centrum Kliniczne | Gdańsk | Poland | 80952 | |
| 173 | NZOZ NEUROMED M. I M. Nastaj Spolka Partnerska | Lublin | Poland | 20064 | |
| 174 | Szpital Kliniczny im. Heliodora Swiecickiego w Poznaniu | Poznań | Poland | 60780 | |
| 175 | Centro Hospitalar E Universitário de Coimbra EPE | Coimbra | Portugal | 3004-561 | |
| 176 | Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria | Lisboa | Portugal | 1649-035 | |
| 177 | Hospital CUF Tejo | Lisboa | Portugal | 1649-035 | |
| 178 | Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E. | Lisbon | Portugal | 1099-023 | |
| 179 | Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS | Porto | Portugal | 4200-072 | |
| 180 | Onco Clinic Consult SA | Bucharest | Romania | 022328 | |
| 181 | Oncology Center Sfantul Nectarie | Cluj-Napoca | Romania | 400641 | |
| 182 | Medisprof SRL | Craiova | Romania | 200396 | |
| 183 | Affidea Romania SRL | Dolj | Romania | 200008 | |
| 184 | Chelyabinsk Regional Clinical Oncology Dispensary | Chelyabinsk | Russian Federation | 454087 | |
| 185 | Clinical Oncology Centre #1 | Krasnodar | Russian Federation | 350040 | |
| 186 | Krasnoyarsk Regional Oncology Center n.a. A.I. Kryzhanovskiy | Krasnoyarsk | Russian Federation | 660133 | |
| 187 | Kursk Regional Oncology Centre | Kursk | Russian Federation | 305524 | |
| 188 | PMI Euromedservice | Pushkin | Russian Federation | 196603 | |
| 189 | Ryazan Regional Clinical Oncology Dispensary | Ryazan' | Russian Federation | 390011 | |
| 190 | FSBI National Medical Research Center of Oncology n.a. N.N.Petrov of MHRF | Saint Petersburg | Russian Federation | 191758 | |
| 191 | Railway Clinical Hospital JSC RZhD | Saint Petersburg | Russian Federation | 195271 | |
| 192 | Regional Clinical Oncology Hospital | Yaroslavl | Russian Federation | 150040 | |
| 193 | Hospital Universitario A Coruña | A Coruña | Spain | 15006 | |
| 194 | Hospital Universitario Germans Trias i Pujol | Badalona | Spain | 08911 | |
| 195 | Hospital de La Santa Creu i Sant Pau | Barcelona | Spain | 08025 | |
| 196 | Hospital Universitari Dexeus - Grupo Quironsalud | Barcelona | Spain | 08028 | |
| 197 | Hospital Universitario Vall d'Hebron - PPDS | Barcelona | Spain | 08035 | |
| 198 | ICO l'Hospitalet - Hospital Duran i Reynals | Córdoba | Spain | 14004 | |
| 199 | Hospital Universitario Virgen de La Arrixaca | El Palmar | Spain | ||
| 200 | Hospital Universitario de Jaen | Jaén | Spain | 23007 | |
| 201 | C.H. Regional Reina Sofia - PPDS | L'Hospitalet De Llobregat | Spain | 08904 | |
| 202 | Hospital Universitario 12 de Octubre | Madrid | Spain | 28041 | |
| 203 | Hospital Universitario HM Sanchinarro - CIOCC | Madrid | Spain | 28050 | |
| 204 | Hospital General Universitario Gregorio Maranon | Madrid | Spain | 4628007 | |
| 205 | Hospital Universitario Virgen de la Victoria | Málaga | Spain | 29789 | |
| 206 | Hospital Universitario Virgen Macarena | Sevilla | Spain | 41009 | |
| 207 | Consorcio Hospital General Universitario de Valencia | Valencia | Spain | ||
| 208 | Addenbrooke's Hospital | Cambridge | United Kingdom | CB20QQ | |
| 209 | Castle Hill Hospital | Cottingham | United Kingdom | HU165JQ | |
| 210 | Leicester Royal Infirmary | Leicester | United Kingdom | LE15WW | |
| 211 | Nottingham City Hospital | Nottingham | United Kingdom | BG72UH | |
| 212 | Royal Cornwall Hospital | Truro | United Kingdom | TR13LJ |
Sponsors and Collaborators
- Nektar Therapeutics
- Bristol-Myers Squibb
Investigators
- Study Director: Study Director, Nektar Therapeutics
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Nektar Therapeutics
ClinicalTrials.gov Identifier:
NCT04410445
Other Study ID Numbers:
- 20-214-29/CA045-022
First Posted:
Jun 1, 2020
Last Update Posted:
Apr 11, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Nektar Therapeutics
Additional relevant MeSH terms: