Trial of Therapeutic Cancer Vaccine OSE2101 in Patients With Non-Small Cell Lung Cancer and Secondary Resistance to Immune Checkpoint Inhibitor
NCT ID: NCT06472245
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
363 participants
INTERVENTIONAL
2024-12-03
2028-12-15
Brief Summary
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Patients will be randomized into 2 arms (randomization 2:1): experimental Arm A with OSE2101 monotherapy or control Arm B SoC with docetaxel monotherapy. Stratification factors will be histology (squamous versus non squamous) and ECOG Performance Status (0 versus 1).
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: OSE2101
Unit dose: 1 mL corresponding to a total of 5 mg of the combination of peptides Mode/Route: Subcutaneous injection Regimen: One injection every three weeks for six cycles, then every eight weeks for the remainder of year one and, finally every twelve weeks until the end of second year.
OSE2101
OSE2101 is a peptidic cancer vaccine composed of nine epitopes restricted to HLA-A2 phenotype targeting the tumor associated antigens of P53, HER-2, CEA, MAGE-2 and MAGE-3, and one pan-HLA DR binding epitope (PADRE), all epitopes emulsified in Montanide ISA 51TM adjuvant.
NGS HLAA2 assay
Amp-HLA-A-CDx Tedopi for amplification of human genomic DNA (gDNA), LFK-CDx Tedopi kit (library full kit) for library preparation, NGSengine-CDx Tedopi software for analysis of NGS data files.
Arm B: Docetaxel
Unit dose: 75 mg/m2 Mode/Route: Intravenous infusion over 1 hour Regimen: One infusion every three weeks.
Docetaxel
Docetaxel is an antineoplastic agent that acts by disrupting the microtubular network in cells that is essential for mitotic and interphase cellular functions.
NGS HLAA2 assay
Amp-HLA-A-CDx Tedopi for amplification of human genomic DNA (gDNA), LFK-CDx Tedopi kit (library full kit) for library preparation, NGSengine-CDx Tedopi software for analysis of NGS data files.
GenDx CDx Tedopi
System of qualitative companion diagnostic devices, consisting of a polymerase chain reaction (PCR) assay Amp-HLA-A-CDx Tedopi, a DNA library preparation assay, LFK-CDx Tedopi and the software NGSengine-CDx Tedopi.
NGS HLAA2 assay
Amp-HLA-A-CDx Tedopi for amplification of human genomic DNA (gDNA), LFK-CDx Tedopi kit (library full kit) for library preparation, NGSengine-CDx Tedopi software for analysis of NGS data files.
Interventions
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OSE2101
OSE2101 is a peptidic cancer vaccine composed of nine epitopes restricted to HLA-A2 phenotype targeting the tumor associated antigens of P53, HER-2, CEA, MAGE-2 and MAGE-3, and one pan-HLA DR binding epitope (PADRE), all epitopes emulsified in Montanide ISA 51TM adjuvant.
Docetaxel
Docetaxel is an antineoplastic agent that acts by disrupting the microtubular network in cells that is essential for mitotic and interphase cellular functions.
NGS HLAA2 assay
Amp-HLA-A-CDx Tedopi for amplification of human genomic DNA (gDNA), LFK-CDx Tedopi kit (library full kit) for library preparation, NGSengine-CDx Tedopi software for analysis of NGS data files.
Eligibility Criteria
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Inclusion Criteria
2. Patients expressing HLA-A2 phenotype in blood by pre-screening central laboratory
3. Patients with histologically or cytologically squamous or non-squamous documented NSCLC, metastatic stage at study entry, not eligible for definite surgery or radiation, without EGFR, ALK and ROS1 gene alterations eligible for targeted therapy; for patients with squamous NSCLC, the molecular tests are not mandatory if age ≥ 50 years old and smoker ≥ 15 pack years; other sensitizing mutations known to be immunosensitive are eligible in case of lack of local access to targeted therapy (i.e.; KRAS G12C and BRAF mutations) after Sponsor' agreement.
4. Patients with secondary resistance to ICI;
18 Years
ALL
No
Sponsors
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Exystat
OTHER
Genome Diagnostics (GenDx)
UNKNOWN
OSE Immunotherapeutics
INDUSTRY
Responsible Party
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Locations
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Clinical Research Advisors, LLC
Beverly Hills, California, United States
Clinical Research Advisors - Encino
Encino, California, United States
Clinical Research Advisors - West Hollywood
Los Angeles, California, United States
Clinical Research Advisors - Korea Town
Los Angeles, California, United States
SCL Health - Saint Joseph Hospital Cancer Center
Littleton, Colorado, United States
Lutheran Medical Center - Cancer Centers of Colorado
Wheat Ridge, Colorado, United States
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, United States
Georgetown Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, United States
Comprehensive Hematology Oncology - Bradenton Clinic
Bradenton, Florida, United States
Comprehensive Hematology Oncology - Brandon Clinic
Brandon, Florida, United States
Cancer Specialists of North Florida - Fleming Island
Fleming Island, Florida, United States
Cancer Specialists of North Florida - Riverside
Jacksonville, Florida, United States
Cancer Specialists of North Florida Southside
Jacksonville, Florida, United States
Cancer Specialists of North Florida - Northside
Jacksonville, Florida, United States
Cancer Specialists of North Florida - Southpoint
Jacksonville, Florida, United States
Cancer Specialists of North Florida - Baptist South
Jacksonville, Florida, United States
Cancer Specialists of North Florida
Jacksonville Beach, Florida, United States
Comprehensive Hematology Oncology - Largo Clinic
Largo, Florida, United States
Cancer Specialists of North Florida - Beaches
Neptune Beach, Florida, United States
Comprehensive Hematology Oncology - Palm Harbor Clinic
Palm Harbor, Florida, United States
Cancer Specialists Of North Florida - St. Augustine
Saint Augustine, Florida, United States
Comprehensive Hematology Oncology - Bayfront Clinic
St. Petersburg, Florida, United States
Comprehensive Hematology Oncology
St. Petersburg, Florida, United States
Comprehensive Hematology Oncology - Trinity Clinic
Trinity, Florida, United States
University of Illinois Cancer Center
Chicago, Illinois, United States
Alliance for Multispecialty Research (AMR) - Kansas City Oncology
Merriam, Kansas, United States
Mary Bird Perkins Cancer Center - Baton Rouge
Baton Rouge, Louisiana, United States
Pontchartrain Cancer Center - Covington Office
Covington, Louisiana, United States
Pontchartrain Cancer Center - Hammond Office
Hammond, Louisiana, United States
Ascension Saint Agnes Hospital
Baltimore, Maryland, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States
Nebraska Hematology-Oncology - Revive Research Institute LLC
Lincoln, Nebraska, United States
New York Cancer & Blood Specialists - Babylon Medical Oncology
Babylon, New York, United States
Optum Medical Care - Carmel/Brewster Campus
Brewster, New York, United States
Brooklyn Radiation Oncology
Brooklyn, New York, United States
Optum Medical Care - Fishkill Westage Campus
Fishkill, New York, United States
Clinical Research Alliance
Lake Success, New York, United States
Optum Medical Care - Mount Kisco Campus 90
Mount Kisco, New York, United States
New York Cancer & Blood Specialists - New Hyde Park
New Hyde Park, New York, United States
Optum Hematology Oncology - Lake Success
New Hyde Park, New York, United States
New York Cancer & Blood Specialists - Cancer Center - Research Headquarters
New York, New York, United States
New York Cancer & Blood Specialists - Central Park Medical Oncology
New York, New York, United States
New York Cancer & Blood Specialists - Patchogue Medical Oncology
Patchogue, New York, United States
New York Cancer & Blood Specialists - Port Jefferson Medical Oncology
Port Jefferson Station, New York, United States
New York Cancer & Blood Specialists - Port Jefferson Station Medical Oncology
Port Jefferson Station, New York, United States
Optum Medical Care - Poughkeepsie
Poughkeepsie, New York, United States
New York Cancer & Blood Specialists - Eastchester Cancer Care Center
The Bronx, New York, United States
New York Cancer & Blood Specialists - Riverhead Medical Oncology
The Bronx, New York, United States
Mercy Health - Perrysburg Cancer Center
Perrysburg, Ohio, United States
Mercy Health - St. Anne Cancer Center
Toledo, Ohio, United States
Bon Secours Hematology and Oncology
Greenville, South Carolina, United States
Tennessee Oncology - Chattanooga - Medical Park II
Chattanooga, Tennessee, United States
Tennessee Oncology - Chattanooga - Downtown
Chattanooga, Tennessee, United States
Tennessee Oncology - Chattanooga - GHCR Site I
Chattanooga, Tennessee, United States
Tennessee Oncology - Chattanooga - Memorial Plaza
Chattanooga, Tennessee, United States
Tennessee Oncology - Cleveland Clinic
Cleveland, Tennessee, United States
Tennessee Oncology - Cookeville Clinic
Cookeville, Tennessee, United States
Tennessee Oncology - Dickson Clinic
Dickson, Tennessee, United States
Tennessee Oncology - Franklin Clinic
Franklin, Tennessee, United States
Tennessee Oncology - Gallatin Clinic
Gallatin, Tennessee, United States
Tennessee Oncology - Hendersonville Clinic
Hendersonville, Tennessee, United States
Tennessee Oncology - Hermitage - Summit Clinic
Hermitage, Tennessee, United States
Tennessee Oncology - Lebanon Clinic
Lebanon, Tennessee, United States
Tennessee Oncology - Murfreesboro Clinic
Murfreesboro, Tennessee, United States
Tennessee Oncology - Nashville - Centennial Center for Blood Cancers Clinic
Nashville, Tennessee, United States
Tennessee Oncology - Nashville - Centennial Clinic - Medical Oncology
Nashville, Tennessee, United States
Tennessee Oncology - Nashville - Midtown Center for Blood Cancers
Nashville, Tennessee, United States
Tennessee Oncology - Nashville - St. Thomas Midtown Clinic
Nashville, Tennessee, United States
Tennessee Oncology - Nashville - St. Thomas West Clinic
Nashville, Tennessee, United States
Tennessee Oncology - Nashville - Skyline Clinic
Nashville, Tennessee, United States
Tennessee Oncology - Nashville - Southern Hills Clinic
Nashville, Tennessee, United States
Greco-Hainsworth Tennessee Oncology Centers for Research (GHCR) - Corporate
Nashville, Tennessee, United States
Tennessee Oncology - Shelbyville Clinic
Shelbyville, Tennessee, United States
Tennessee Oncology - Smyrna Clinic
Smyrna, Tennessee, United States
Northwest Medical Specialties - Bonney Lake
Bonney Lake, Washington, United States
Northwest Medical Specialties - Federal Way
Federal Way, Washington, United States
Northwest Medical Specialties - Gig Harbor
Gig Harbor, Washington, United States
Northwest Medical Specialties - Puyallup Medical Oncology
Puyallup, Washington, United States
Northwest Medical Specialties - Tacoma
Tacoma, Washington, United States
Algemeen Ziekenhuis Klina
Brasschaat, Antwerpen, Belgium
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven, Flemish Brabant, Belgium
Jessa Ziekenhuis - Campus Virga Jesse
Hasselt, Limburg, Belgium
Algemeen Ziekenhuis Maria Middelares
Ghent, Oost-Vlaaderen, Belgium
Centre Hospitalier Universitaire Université Catholique de Louvain Namur - Site Sainte-Elisabeth
Namur, Wallonia, Belgium
Algemeen Ziekenhuis Groeninge - Campus Kennedylaan
Kortrijk, West-Vlaanderen, Belgium
Algemeen Ziekenhuis Delta - Campus Rembert Torhout
Roeselare, West-Vlaanderen, Belgium
Algemeen Ziekenhuis Delta - Campus Rumbeke
Roeselare, West-Vlaanderen, Belgium
Algemeen Ziekenhuis Delta - Campus Menen
Roeselare, West-Vlaanderen, Belgium
Centre Intégré Universitaire de Santé et de Services Sociaux du Saguenay - Lac-Saint-Jean
Chicoutimi, Quebec, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Centre Intégré de Santé et de Services Sociaux du Bas-Saint-Laurent
Rimouski, Quebec, Canada
Hôpital d'Instruction des Armées Sainte-Anne
Toulon, Alpes-de-Haute-Provence, France
Nouvel Hôpital Civil
Strasbourg, Alsace, France
Hôpital Louis Pradel
Bron, Auvergne-Rhône-Alpes, France
Centre Hospitalier Lyon-Sud
Lyon, Auvergne-Rhône-Alpes, France
Hôpital de la Croix Rousse
Lyon, Auvergne-Rhône-Alpes, France
Institut Paoli-Calmettes
Marseille, Bouches-du-Rhône, France
Centre Hospitalier Régional et Universitaire de Besançon - Hôpital Jean-Minjoz
Besançon, Doubs, France
Centre Hospitalier Regional Universitaire Brest - Hopital de la Cavale Blanche
Brest, Finistère, France
Hôpital Emile Muller
Mulhouse, Grand Est, France
Centre Hospitalier Universitaire Dupuytren 1
Limoges, Haute-Vienne, France
Hôpital Arnaud de Villeneuve
Montpellier, Hérault, France
Hôpital Pontchaillou
Rennes, Ille-et-Vilaine, France
Institut de Cancérologie de l'Ouest - Saint-Herblain - Site René Gauducheau
Saint-Herblain, Loire-Atlantique, France
Centre Hospitalier (Ch) De Cholet
Cholet, Maine-et-Loire, France
Hôpital Larrey
Toulouse, Midi-pyrenees, France
Hôpital Nord de Marseille
Marseille, Provence-Alpes-Côte d'Azur Region, France
Centre Hospitalier de la Côte Basque
Bayonne, Pyrénées-Atlantiques, France
Hôpital Michallon
La Tronche, Rhône, France
Gustave Roussy
Villejuif, Val-de-Marne, France
Institut Sainte Catherine
Avignon, Vaucluse, France
Centre Hospitalier Universitaire de Poitiers
Poitiers, Vienne, France
Centre Hospitalier Départemental Vendée
La Roche-sur-Yon, , France
Centre Hospitalier Le Mans
Le Mans, , France
Centre Hospitalier Universitaire De Nantes - Hôpital Nord Laennec
Nantes, , France
Hôpital Avicenne
Bobigny, Île-de-France Region, France
Centre Hospitalier Intercommunal de Créteil
Créteil, Île-de-France Region, France
Groupe Hospitalier Paris Saint-Joseph
Paris, Île-de-France Region, France
Hôpital Cochin
Paris, Île-de-France Region, France
Hôpital Tenon
Paris, Île-de-France Region, France
Thoraxklinik-Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
Robert-Bosch-Krankenhaus
Stuttgart, Baden-Wurttemberg, Germany
Asklepios Fachkliniken München-Gauting
Gauting, Bavaria, Germany
München Klinik Bogenhausen
München, Bavaria, Germany
Klinikum Kassel
Kassel, Hesse, Germany
Universitätsklinikum Aachen
Aachen, North Rhine-Westphalia, Germany
Universitätsklinikum Bonn
Bonn, North Rhine-Westphalia, Germany
Universitätsklinikum Essen
Essen, North Rhine-Westphalia, Germany
Universitätsklinikum Gießen und Marburg - Gießen
Homburg, Saarland, Germany
Krankenhaus Martha-Maria Halle-Dölau
Halle, Saxony-Anhalt, Germany
LungenClinic Grosshansdorf
Großhansdorf, Schleswig-Holstein, Germany
Charité - Universitätsmedizin Berlin
Berlin, , Germany
Metropolitan Hospital
Piraeus, Athens, Greece
Saint Savvas Anticancer - Oncological Hospital of Athens
Athens, Attica, Greece
Henry Dunant Hospital Center
Athens, Attica, Greece
General Hospital for Thoracic Diseases Sotiria
Athens, Attica, Greece
Agii Anargiri Cancer Hospital
Nea Kifissia, Attica, Greece
Clinic Agios Loukas
Thessaloniki, Central Macedonia, Greece
University General Hospital of Heraklion (PAGNI)
Heraklion, Crete, Greece
General Hospital of Thessaloniki Papageorgiou
Thessaloniki, Macedoni, Greece
University General Hospital of Patras
Patra, Peloponnese, Greece
Theagenio Anti-Cancer Hospital of Thessaloniki
Thessaloniki, Thessaloniki, Greece
University General Hospital of Larissa
Larissa, Thessaly, Greece
Mátrai Gyógyintézet
Gyöngyös, Heves County, Hungary
Országos Korányi Pulmonológiai Intézet
Budapest, , Hungary
Clinexpert Kft. telephelye, Bugát Pál Kórház - Phase I. Clinical Trial Site
Gyöngyös, , Hungary
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST
Meldola, Forlì-Cesena, Italy
Presidio Ospedaliero di Lucca
San Filippo, Lucca, Italy
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Istituto Clinico Humanitas
Rozzano, Milan, Italy
Azienda Ospedaliera Universitaria - Università degli Studi della Campania Luigi Vanvitelli
Napoli, Naples, Italy
Azienda Ospedaliero - Universitaria San Luigi Gonzaga
Orbassano, Torino, Italy
Ospedale P. Pederzoli - Casa di Cura Privata S.p.A.
Legnago, Verona, Italy
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale Policlinico San Martino
Genova, , Italy
Ospedale Vito Fazzi Lecce
Lecce, , Italy
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele
Milan, , Italy
Fondazione IRCCS - Istituto Nazionale dei Tumori
Milan, , Italy
Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara
Novara, , Italy
Ospedale Busonera - Istituto Oncologico Veneto (IOV) - Padua
Padua, , Italy
Azienda Ospedaliero-Universitaria Pisana
Pisa, , Italy
Azienda Unità Sanitaria Locale della Romagna - Ospedale Infermi di Rimini
Rimini, , Italy
IRCCS Istituto Nazionale Tumori Regina Elena
Roma, , Italy
Azienda Ospedaliera San Camillo Forlanini
Rome, , Italy
Azienda Ospedaliera Universitaria Senese - L'ospedale Santa Maria alle Scotte
Siena, , Italy
Radboud Universitair Medisch Centrum
Nijmegen, Gelderland, Netherlands
Erasmus Medisch Centrum
Rotterdam, South Holland, Netherlands
Universitair Medisch Centrum Groningen
Groningen, , Netherlands
Przychodnia Lekarska KOMED Roman Karaszewski
Konin, Greater Poland Voivodeship, Poland
Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandów
Poznan, Greater Poland Voivodeship, Poland
Centrum Onkologii Im. Prof. F. Łukaszczyka w Bydgoszczy
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie
Lublin, Lublin Voivodeship, Poland
Instytut Centrum Zdrowia Matki Polki
Lodz, Lódzkie, Poland
Uniwersyteckie Centrum Kliniczne w Gdańsku
Gdansk, Pomeranian Voivodeship, Poland
Unidade Local de Saúde de Coimbra
Coimbra, , Portugal
Hospital CUF Descobertas
Lisbon, , Portugal
Unidade Local de Saúde de Santa Maria, E. P. E. - Hospital Pulido Valente
Lisbon, , Portugal
Hospital CUF Porto
Porto, , Portugal
Unidade Local de Saúde de Gaia/Espinho, E. P. E
Vila Nova de Gaia, , Portugal
Institutul Oncologic Prof. Dr. Ion Chiricuta
Cluj-Napoca, Cluj, Romania
Centrul de Oncologie Sf Nectarie
Craiova, Dolj, Romania
SC OncoMed SRL
Timișoara, Timiș County, Romania
Hospital Son Llàtzer
Palma de Mallorca, Balearic Islands, Spain
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)
L'Hospitalet de Llobregat, Barcelona, Spain
Biocruces Bizkaia Instituto de Investigación Sanitaria
Barakaldo, Biscay, Spain
Complejo Hospitalario Universitario A Coruña
A Coruña, La Coruña, Spain
Complejo Hospitalario Universitario Insular Materno Infantil
Las Palmas de Gran Canaria, Las Palmas, Spain
Hospital Universitario Puerta de Hierro - Majadahonda
Majadahonda, Madrid, Spain
HC Marbella
Marbella, Malaga, Spain
Clínica Mi Tres Torres
Barcelona, , Spain
Hospital Universitari Dexeus
Barcelona, , Spain
Hospital Universitari Vall d'Hebrón
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Universitario Reina Sofía
Córdoba, , Spain
Hospital Universitari de Girona Dr. Josep Trueta
Girona, , Spain
Hospital Universitario Lucus Augusti
Lugo, , Spain
Hospital General Universitario Gregorio Marañón
Madrid, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Regional Universitario de Málaga - Hospital General
Málaga, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
University Hospitals of Leicester NHS Trust
Leicester, England, United Kingdom
The Christie NHS Foundation Trust
Manchester, England, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
Metropolitan Borough of Wirral, England, United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton, England, United Kingdom
NHS Grampian
Aberdeen, Scotland, United Kingdom
Countries
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Central Contacts
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References
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Besse B, Felip E, Garcia Campelo R, Cobo M, Mascaux C, Madroszyk A, Cappuzzo F, Hilgers W, Romano G, Denis F, Viteri S, Debieuvre D, Galetta D, Baldini E, Razaq M, Robinet G, Maio M, Delmonte A, Roch B, Masson P, Schuette W, Zer A, Remon J, Costantini D, Vasseur B, Dziadziuszko R, Giaccone G; ATALANTE-1 study group. Randomized open-label controlled study of cancer vaccine OSE2101 versus chemotherapy in HLA-A2-positive patients with advanced non-small-cell lung cancer with resistance to immunotherapy: ATALANTE-1. Ann Oncol. 2023 Oct;34(10):920-933. doi: 10.1016/j.annonc.2023.07.006. Epub 2023 Sep 11.
Other Identifiers
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OSE2101C302
Identifier Type: -
Identifier Source: org_study_id