A Phase 3 Randomized Double-blind Study of Adjuvant Pembrolizumab With or Without V940 in Participants With Resectable Stage II to IIIB (N2) NSCLC Not Achieving pCR After Receiving Neoadjuvant Pembrolizumab With Platinum-based Doublet Chemotherapy (INTerpath-009)

Status: Recruiting
Location: See all (205) locations...
Intervention Type: Drug, Other, Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The goal of this study is to learn if people who receive intismeran autogene and pembrolizumab after surgery are cancer-free longer than people who receive placebo and pembrolizumab. Researchers want to know if giving intismeran autogene and pembrolizumab after surgery can help prevent the cancer from coming back in people with non-small cell lung cancer (NSCLC) whose tumors did not respond completely to treatment before surgery (neoadjuvant treatment).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ The main inclusion criteria include but are not limited to the following:

• Has histologically/cytologically confirmed diagnosis of previously untreated and pathologically confirmed resectable Stage II, IIIA, or IIIB (N2) non-small cell lung cancer (NSCLC) \[American Joint Committee on Cancer (AJCC) 8th Edition\]

• Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before the first dose of study intervention

• Participants who have not achieved a pathological complete response (pCR) following completion of neoadjuvant chemotherapy and pembrolizumab followed by surgery will be eligible

• Confirmation that epidermal growth factor receptor (EGFR)-directed therapy is not indicated as primary therapy (documentation of absence of tumor-activating EGFR mutations \[eg, DEL19 or L858R\])

• Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART)

• Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization

• Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening

Locations
United States
Arizona
Banner MD Anderson Cancer Center ( Site 0181)
RECRUITING
Gilbert
California
Providence St. Jude Medical Center ( Site 0106)
RECRUITING
Fullerton
VA Long Beach Healthcare System ( Site 0199)
RECRUITING
Long Beach
USC Norris Comprehensive Cancer Center ( Site 0205)
RECRUITING
Los Angeles
UCSF Medical Center at Mission Bay ( Site 0178)
RECRUITING
San Francisco
Colorado
UCHealth Memorial Hospital Central ( Site 0125)
RECRUITING
Colorado Springs
Banner MD Anderson Cancer Center at North Colorado Medical Center ( Site 0207)
RECRUITING
Greeley
Centura Health - St. Anthony North Health Campus ( Site 0189)
RECRUITING
Westminster
Connecticut
Yale University School of Medicine ( Site 0201)
RECRUITING
New Haven
Eastern CT Hematology & Oncology Associates ( Site 0202)
RECRUITING
Norwich
Florida
The Oncology Institute of Hope and Innovation - Fort Lauderdale ( Site 0156)
RECRUITING
Fort Lauderdale
Idaho
Beacon Cancer Care ( Site 0127)
RECRUITING
Post Falls
Illinois
The University of Chicago Medical Center ( Site 0118)
RECRUITING
Chicago
Massachusetts
Dana Farber Cancer Hospital ( Site 0155)
RECRUITING
Boston
Massachusetts General Hospital ( Site 0136)
RECRUITING
Boston
Maryland
Maryland Oncology Hematology (MOH) ( Site 8102)
RECRUITING
Rockville
Missouri
Ellis Fischel Cancer Center ( Site 0133)
RECRUITING
Columbia
Lake Regional Hospital-Cancer Center ( Site 0123)
RECRUITING
Osage Beach
New York
Roswell Park Cancer Institute ( Site 0184)
RECRUITING
Buffalo
Hematology-Oncology Associates of CNY ( Site 0164)
RECRUITING
East Syracuse
Icahn School of Medicine at Mount Sinai ( Site 0116)
RECRUITING
New York
Memorial Sloan Kettering Cancer Center ( Site 0137)
RECRUITING
New York
The Blavatnik Family- Chelsea Medical Center at Mount Sinai ( Site 0216)
RECRUITING
New York
SUNY Upstate Cancer Center ( Site 0140)
RECRUITING
Syracuse
Montefiore Medical Center ( Site 0160)
RECRUITING
The Bronx
Westchester Medical Center ( Site 0196)
RECRUITING
Valhalla
Ohio
University of Cincinnati Medical Center ( Site 0119)
RECRUITING
Cincinnati
Pennsylvania
St. Lukes Hospital and Health Network ( Site 0186)
RECRUITING
Bethlehem
Tennessee
Thompson Cancer Survival Center ( Site 0168)
RECRUITING
Knoxville
Elliston Place Medical Oncology & Hematology ( Site 0215)
RECRUITING
Nashville
Texas
Texas Oncology - DFW ( Site 8103)
RECRUITING
Dallas
Houston Methodist Cancer Center ( Site 0191)
RECRUITING
Houston
MD Anderson Cancer Center ( Site 0150)
RECRUITING
Houston
Memorial Hermann Cancer Center ( Site 0172)
RECRUITING
Houston
O'Quinn Medical Tower at McNair Campus ( Site 0131)
RECRUITING
Houston
The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center ( Site 0148)
RECRUITING
Tyler
Virginia
Virginia Cancer Specialists ( Site 0167)
RECRUITING
Fairfax
Washington
Swedish Cancer Institute ( Site 0143)
RECRUITING
Seattle
Virginia Mason Franciscan Health - St. Michael Cancer Center ( Site 0192)
RECRUITING
Silverdale
Other Locations
Argentina
Fundacion Intecnus ( Site 2456)
RECRUITING
Bariloche
Instituto Medico Especializado Alexander Fleming ( Site 2457)
RECRUITING
Buenos Aires
CEMIC ( Site 2454)
RECRUITING
Caba.
Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 2459)
RECRUITING
Ciudad Autonoma De Buenos Aires.
Instituto Oncologico de Cordoba -IONC ( Site 2455)
RECRUITING
Córdoba
Centro Médico IPAM ( Site 2452)
RECRUITING
Rosario
Australia
Grampians Health ( Site 2101)
RECRUITING
Ballarat
One Clinical Research ( Site 2103)
RECRUITING
Nedlands
Tasman Oncology Research ( Site 2104)
RECRUITING
Southport
Calvary Mater Newcastle ( Site 2106)
RECRUITING
Waratah
Princess Alexandra Hospital ( Site 2102)
RECRUITING
Wooloongabba
Belgium
Cliniques Universitaires Saint-Luc ( Site 1203)
RECRUITING
Brussels
UZ Gent ( Site 1201)
RECRUITING
Ghent
Jessa Ziekenhuis ( Site 1204)
RECRUITING
Hasselt
Brazil
Hospital de Amor - Barretos ( Site 2511)
RECRUITING
Barretos
Hospital Tacchini ( Site 2506)
RECRUITING
Bento Gonçalves
CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA ( Site 2502)
RECRUITING
Fortaleza
Liga Norte Riograndense Contra o Cancer ( Site 2513)
RECRUITING
Natal
Hospital de Clínicas de Passo Fundo ( Site 2504)
RECRUITING
Passo Fundo
Hospital Moinhos de Vento ( Site 2510)
RECRUITING
Porto Alegre
Hospital Nossa Senhora Da Conceicao ( Site 2512)
RECRUITING
Porto Alegre
Instituto Nacional de Câncer - INCA ( Site 2501)
RECRUITING
Rio De Janeiro
Instituto de Oncologia Saint Gallen ( Site 2507)
RECRUITING
Santa Cruz Do Sul
Bulgaria
MBAL Uni Hospital ( Site 1253)
RECRUITING
Panagyurishte
MHAT - Heart and Brain ( Site 1252)
RECRUITING
Pleven
Canada
Queen Elizabeth II Health Sciences Centre ( Site 1101)
RECRUITING
Halifax
Hamilton Health Sciences - Juravinski Site ( Site 1104)
RECRUITING
Hamilton
Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 1105)
RECRUITING
Kingston
McGill University Health Centre ( Site 1103)
RECRUITING
Montreal
Lakeridge Health ( Site 1107)
RECRUITING
Oshawa
IUCPQ ( Site 1112)
RECRUITING
Québec
Sunnybrook Research Institute ( Site 1106)
RECRUITING
Toronto
Chile
Bradfordhill ( Site 2552)
RECRUITING
Santiago
Clínica RedSalud Vitacura ( Site 2556)
RECRUITING
Santiago
FALP ( Site 2551)
RECRUITING
Santiago
Orlandi Oncologia ( Site 2555)
RECRUITING
Santiago
ONCOCENTRO APYS ( Site 2554)
RECRUITING
Viña Del Mar
Colombia
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 2604)
RECRUITING
Bogotá
FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 2603)
RECRUITING
Bogotá
Hospital Universitario San Ignacio ( Site 2610)
RECRUITING
Bogotá
Fundacion Valle del Lili- CIC ( Site 2601)
RECRUITING
Cali
IMAT S.A.S ( Site 2602)
RECRUITING
Montería
Oncologos del Occidente ( Site 2608)
RECRUITING
Pereira
Finland
Oulun yliopistollinen sairaala ( Site 1301)
RECRUITING
Oulu
Turku University Hospital ( Site 1303)
RECRUITING
Turku
France
CHU Besançon ( Site 1358)
RECRUITING
Besançon
Institut Cœur Poumon -CHU Lille ( Site 1352)
RECRUITING
Lille
CENTRE LEON BERARD ( Site 1351)
RECRUITING
Lyon
Institut De Cancerologie De L Ouest ( Site 1357)
RECRUITING
Saint-herblain
Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau ( Site 1354)
RECRUITING
Tours
Germany
St.-Antonius-Hospital ( Site 1411)
RECRUITING
Eschweiler
UKGM Gießen/Marburg ( Site 1404)
RECRUITING
Giessen
Klinikverbund Allgäu gGmbH ( Site 1408)
RECRUITING
Kempten (allgäu)
Marienhaus Klinikum Mainz ( Site 1403)
RECRUITING
Mainz
Universitätsklinikum Münster - Albert Schweitzer Campus ( Site 1405)
RECRUITING
Münster
Pius Hospital Oldenburg ( Site 1407)
RECRUITING
Oldenburg
Robert-Bosch-Krankenhaus ( Site 1401)
RECRUITING
Stuttgart
Greece
Errikos Dunant Hospital Center ( Site 1457)
RECRUITING
Athens
Metropolitan Hospital ( Site 1459)
RECRUITING
Athens
THORACIC GENERAL HOSPITAL OF ATHENS I SOTIRIA-3rd Dept of Internal Medicine and Laboratory, Oncol ( Site 1451)
RECRUITING
Athens
ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 1460)
RECRUITING
Chaïdári
University General Hospital of Herakleion ( Site 1458)
RECRUITING
Heraklion
University General Hospital of Larissa-Oncology Clinic ( Site 1453)
RECRUITING
Larissa
UNIVERSITY HOSPITAL OF PATRAS-DIVISION OF ONCOLOGY ( Site 1452)
RECRUITING
Pátrai
Papageorgiou General Hospital of Thessaloniki ( Site 1454)
RECRUITING
Thessaloniki
Hungary
Orszagos Koranyi Pulmonologiai Intezet ( Site 1501)
RECRUITING
Budapest
Debreceni Egyetem Altalanos Orvostudomanyi Kar Tudogyogyaszati Tanszek ( Site 1508)
RECRUITING
Debrecen
Petz Aladár Megyei Oktató Kórház ( Site 1502)
RECRUITING
Győr
Somogy Vármegyei Kaposi Mór Oktató Kórház-Oncology center ( Site 1507)
RECRUITING
Kaposvár
Mátrai Gyógyintézet ( Site 1504)
RECRUITING
Mátraháza
Fejér Megyei Szent György Egyetemi Oktató Kórház ( Site 1506)
RECRUITING
Székesfehérvár
Reformatus Pulmonologiai Centrum-Onkopulmonologiai Jarobeteg Centrum ( Site 1505)
RECRUITING
Törökbálint
Ireland
Cork University Hospital ( Site 1553)
RECRUITING
Cork
St. James's Hospital ( Site 1554)
RECRUITING
Dublin
Tallaght University Hospital ( Site 1551)
RECRUITING
Dublin
Israel
Rambam Health Care Campus ( Site 1603)
RECRUITING
Haifa
Hadassah Medical Center ( Site 1605)
RECRUITING
Jerusalem
Shaare Zedek Medical Center ( Site 1601)
RECRUITING
Jerusalem
Meir Medical Center ( Site 1606)
RECRUITING
Kfar Saba
Sheba Medical Center ( Site 1602)
RECRUITING
Ramat Gan
Italy
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1656)
RECRUITING
Milan
IEO Istituto Europeo di Oncologia ( Site 1655)
RECRUITING
Milan
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1657)
RECRUITING
Napoli
Ospedale Santa Maria delle Croci ( Site 1652)
RECRUITING
Ravenna
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1653)
RECRUITING
Rome
Fondazione Policlinico Universitario Campus Bio-Medico ( Site 1660)
RECRUITING
Rome
Istituto Nazionale Tumori Regina Elena ( Site 1651)
RECRUITING
Rome
Centro Ricerche Cliniche di Verona ( Site 1659)
RECRUITING
Verona
Japan
Chiba University Hospital ( Site 1154)
RECRUITING
Chiba
National Cancer Center Hospital ( Site 1156)
RECRUITING
Chūō
National Hospital Organization Kyushu Cancer Center ( Site 1167)
RECRUITING
Fukuoka
Fukushima Medical University Hospital ( Site 1151)
RECRUITING
Fukushima
Hiroshima University Hospital ( Site 1165)
RECRUITING
Hiroshima
St. Marianna University Hospital ( Site 1159)
RECRUITING
Kawasaki
Hospital of the University of Occupational and Environmental Health, Japan ( Site 1166)
RECRUITING
Kitakyushu
Okayama University Hospital ( Site 1164)
RECRUITING
Okayama
Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 1161)
RECRUITING
Osaka
Kindai University Hospital ( Site 1162)
RECRUITING
Sakai
Dokkyo Medical University Hospital ( Site 1152)
RECRUITING
Shimotsuga-gun
Tokyo Medical University Hospital ( Site 1157)
RECRUITING
Shinjuku
Shizuoka Cancer Center ( Site 1160)
RECRUITING
Sunto-gun
Wakayama Medical University Hospital ( Site 1163)
RECRUITING
Wakayama
Kanagawa Cancer Center ( Site 1158)
RECRUITING
Yokohama
Netherlands
Jeroen Bosch Hospital ( Site 1701)
RECRUITING
's-hertogenbosch
Medisch Centrum Leeuwarden ( Site 1702)
RECRUITING
Leeuwarden
Maastricht UMC+ ( Site 1705)
RECRUITING
Maastricht
Radboudumc ( Site 1706)
RECRUITING
Nijmegen
New Zealand
Dunedin Hospital ( Site 2202)
RECRUITING
Dunedin
Waikato Hospital ( Site 2204)
RECRUITING
Hamilton
Tauranga Hospital-Bay of Plenty Clinical Trials Unit ( Site 2201)
RECRUITING
Tauranga
Peru
Aliada ( Site 2753)
RECRUITING
Lima
Clínica Internacional - Sede San Borja ( Site 2752)
RECRUITING
Lima
Detecta Clínica ( Site 2751)
RECRUITING
Lima
Poland
Uniwersyteckie Centrum Kliniczne ( Site 1758)
RECRUITING
Gdansk
Swietokrzyskie Centrum Onkologii. ( Site 1754)
RECRUITING
Kielce
Krakowski Szpital Specjalistyczny im. Jana Pawla II ( Site 1756)
RECRUITING
Krakow
Warmińsko - Mazurskie Centrum Chorób Płuc w Olsztynie ( Site 1760)
RECRUITING
Olsztyn
Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 1763)
RECRUITING
Poznan
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1759)
RECRUITING
Przemyśl
Instytut Gruźlicy i Chorób Płuc w Warszawie ( Site 1764)
RECRUITING
Warsaw
Republic of Korea
National Cancer Center ( Site 2305)
RECRUITING
Goyang-si
Samsung Medical Center ( Site 2304)
RECRUITING
Seoul
Seoul National University Hospital ( Site 2303)
RECRUITING
Seoul
Seoul St. Mary's Hospital ( Site 2307)
RECRUITING
Seoul
Severance Hospital Yonsei University Health System ( Site 2302)
RECRUITING
Seoul
Ajou University Hospital ( Site 2306)
RECRUITING
Suwon
The Catholic University of Korea St. Vincent s Hospital ( Site 2301)
RECRUITING
Suwon
Romania
Centrul Medical Medicover Victoria ( Site 1802)
RECRUITING
Bucharest
Institutul Regional de Oncologie ( Site 1804)
RECRUITING
Iași
Cabinet Medical Oncomed ( Site 1803)
RECRUITING
Timișoara
Singapore
National Cancer Centre Singapore ( Site 2251)
RECRUITING
Singapore
Tan Tock Seng Hospital ( Site 2252)
RECRUITING
Singapore
Spain
Complejo Hospitalario Universitario A Coruna ( Site 1916)
RECRUITING
A Coruña
Hospital Clinic de Barcelona ( Site 1919)
RECRUITING
Barcelona
Hospital Universitari Vall D Hebron ( Site 1910)
RECRUITING
Barcelona
Hospital Insular de Gran Canaria ( Site 1911)
RECRUITING
Canarias
Hospital General Universitario Gregorio Maranon ( Site 1912)
RECRUITING
Madrid
Hospital Quiron Malaga ( Site 1914)
RECRUITING
Málaga
Hospital Universitario Quiron Madrid ( Site 1913)
RECRUITING
Pozuelo De Alarcón
Sweden
Karolinska Universitetssjukhuset Solna ( Site 1951)
RECRUITING
Stockholm
Taiwan
China Medical University Hospital ( Site 2358)
RECRUITING
Taichung
Chung Shan Medical University Hospital ( Site 2351)
RECRUITING
Taichung
National Cheng Kung University Hospital ( Site 2354)
RECRUITING
Tainan
Koo Foundation Sun Yat-Sen Cancer Center ( Site 2359)
RECRUITING
Taipei
Mackay Memorial Hospital ( Site 2355)
RECRUITING
Taipei
National Taiwan University Cancer Center (NTUCC) ( Site 2360)
RECRUITING
Taipei
Taipei Medical University Hospital ( Site 2352)
RECRUITING
Taipei
Taipei Veterans General Hospital ( Site 2357)
RECRUITING
Taipei
Chang Gung Memorial Hospital ( Site 2361)
RECRUITING
Taoyuan District
Turkey
Sakarya Universitesi Tip Fakultesi Hastanesi ( Site 2006)
RECRUITING
Adapazarı
Ankara Bilkent Sehir Hastanesi ( Site 2002)
RECRUITING
Ankara
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi ( Site 2003)
RECRUITING
Istanbul
Hacettepe Universite Hastaneleri ( Site 2001)
RECRUITING
Sıhhiye
Namık Kemal University Medical Faculty ( Site 2007)
RECRUITING
Tekirdağ
Karadeniz Technical University ( Site 2008)
RECRUITING
Trabzon
United Kingdom
Bristol Haematology and Oncology Centre ( Site 2072)
RECRUITING
Bristol
St James University Hospital ( Site 2055)
RECRUITING
Leeds
Leicester Royal Infirmary ( Site 2051)
RECRUITING
Leicester
Guys Hospital ( Site 2057)
RECRUITING
London
Royal Free Hospital ( Site 2074)
RECRUITING
London
ROYAL MARSDEN HOSPITAL (CHELSEA)-Lung Unit ( Site 2075)
RECRUITING
London
Royal Marsden Hospital (Sutton) ( Site 2076)
RECRUITING
London
St Bartholomews Hospital ( Site 2052)
RECRUITING
London
The Clatterbridge Cancer Centre ( Site 2069)
RECRUITING
Metropolitan Borough Of Wirral
Nottingham City Hospital ( Site 2058)
RECRUITING
Nottingham
Queen Alexandra Hospital ( Site 2059)
RECRUITING
Portsmouth
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2024-10-21
Estimated Completion Date: 2038-01-26
Participants
Target number of participants: 680
Treatments
Experimental: Pembrolizumab + Intismeran autogene
For neoadjuvant treatment, participants will receive pembrolizumab 200 mg via intravenous (IV) infusion every 3-week cycle for up to 4 cycles PLUS background chemotherapy via IV infusion (cisplatin 75 mg/m\^2 or carboplatin area under the curve \[AUC\] 5 or 6 mg/mL/min, pemetrexed 500 mg/m\^2, gemcitabine 1000 mg/m\^2, paclitaxel 175 mg/m\^2 or 200 mg/m\^2 given at a dose and combination per investigator's choice) every 3-week cycle for up to 4 cycles (total neoadjuvant treatment duration of up to \~12 weeks). After surgical resection, for adjuvant treatment, participants will receive pembrolizumab 400 mg via IV infusion every 6-week cycle for up to 7 cycles PLUS intismeran autogene 1 mg via intramuscular (IM) injection every 3 weeks for up to 9 doses (total adjuvant treatment duration of up to \~42 weeks).
Active_comparator: Pembrolizumab + Placebo
For neoadjuvant treatment, participants will receive pembrolizumab 200 mg via IV infusion every 3-week cycle for up to 4 cycles PLUS background chemotherapy via IV infusion (cisplatin 75 mg/m\^2 or carboplatin AUC 5 or 6 mg/mL/min, pemetrexed 500 mg/m\^2, gemcitabine 1000 mg/m\^2, paclitaxel 175 mg/m\^2 or 200 mg/m\^2 given at a dose and combination per investigator's choice) every 3-week cycle for up to 4 cycles (total neoadjuvant treatment duration of up to \~12 weeks). After surgical resection, for adjuvant treatment, participants will receive pembrolizumab 400 mg via IV infusion every 6-week cycle for up to 7 cycles PLUS matching placebo via IM injection every 3 weeks for up to 9 doses (total adjuvant treatment duration of up to \~42 weeks).
Sponsors
Collaborators: ModernaTX, Inc.
Leads: Merck Sharp & Dohme LLC

This content was sourced from clinicaltrials.gov

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