Melanoma Clinical Trial
Official title:
A Phase 3, Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled Clinical Study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants With High-Risk Stage II-IV Melanoma (INTerpath-001)
The purpose of this study is to learn if V940 which is an individualized neoantigen therapy (INT; formerly, called messenger ribonucleic acid [mRNA]-4157) with pembrolizumab (MK-3475) is safe and prevents cancer from returning in people with high-risk melanoma. Researchers want to know if V940 with pembrolizumab is better than receiving pembrolizumab alone at preventing the cancer from returning.
| Status | Recruiting |
| Enrollment | 1089 |
| Est. completion date | September 26, 2030 |
| Est. primary completion date | October 26, 2029 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: The main inclusion criteria include but are not limited to the following: - Has surgically resected and histologically/pathologically confirmed diagnosis of Stage IIB or IIC, III, or IV cutaneous melanoma - Has not received any prior systemic therapy for their melanoma beyond surgical resection - No more than 13 weeks have passed between final surgical resection that rendered the participant disease-free and the first dose of pembrolizumab - Is disease free at the time of providing documented consent for the study - Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART) Exclusion Criteria: The main exclusion criteria include but are not limited to the following: - Has ocular or mucosal melanoma - Has cancer that has spread to other parts of the body and cannot be removed with surgery - Has heart failure within the past 6 months - Has received prior cancer therapy or another cancer vaccine - Has another known cancer that that has spread to other parts of the body or has required treatment within the past 3 years - Has severe reaction to study medications or any of their substance used to prepare a drug - Have not recovered from major surgery or have ongoing surgical complications |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Hospital Aleman ( Site 2200) | Buenos Aires | Caba |
| Argentina | Sanatorio Finochietto ( Site 2205) | Buenos Aires | |
| Argentina | Clinica Adventista Belgrano-Oncology ( Site 2204) | Caba | |
| Argentina | Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 2202) | Caba | Buenos Aires |
| Argentina | Centro Privado de RMI Río Cuarto S.A. II ( Site 2201) | Río Cuarto | Cordoba |
| Australia | Princess Alexandra Hospital ( Site 1003) | Brisbane | Queensland |
| Australia | Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 1005) | Melbourne | Victoria |
| Australia | The Alfred Hospital-Medical Oncology Alfred Cancer Trials ( Site 1004) | Melbourne | Victoria |
| Australia | One Clinical Research ( Site 1002) | Nedlands | Western Australia |
| Australia | Westmead Hospital-Department of Medical Oncology ( Site 1001) | Westmead | New South Wales |
| Australia | Melanoma Institute Australia-Clinical Trials Unit ( Site 1000) | Wollstonecraft | New South Wales |
| Belgium | UZ Brussel-Medische oncologie ( Site 3405) | Brussels | Bruxelles-Capitale, Region De |
| Belgium | Ziekenhuis Oost-Limburg, Campus St.-Jan ( Site 3402) | Genk | Limburg |
| Belgium | UZ Gent ( Site 3403) | Gent | Oost-Vlaanderen |
| Belgium | AZ Groeninge Campus Kennedylaan-Oncology ( Site 3401) | Kortrijk | West-Vlaanderen |
| Belgium | UZ Leuven ( Site 3400) | Leuven | Vlaams-Brabant |
| Brazil | Centro Avançado de Tratamento Oncológico- CENANTRON ( Site 2303) | Belo Horizonte | Minas Gerais |
| Brazil | ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 2302) | Ijui | Rio Grande Do Sul |
| Brazil | Instituto Nacional de Câncer - INCA-Pesquisa Clinica HC II ( Site 2305) | Rio de Janeiro | |
| Brazil | ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 2300) | São Paulo | Sao Paulo |
| Canada | William Osler Health System ( Site 1105) | Brampton | Ontario |
| Canada | Cross Cancer Institute ( Site 1104) | Edmonton | Alberta |
| Canada | Centre Hospitalier de l'Université de Montréal-Unité de Recherche Clinique en Oncologie et Hématolo | Montréal | Quebec |
| Canada | Centre intégré de cancérologie du CHU de Québec Université L-Hemato-Oncology ( Site 1101) | Quebec City | Quebec |
| Canada | Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 1102) | Toronto | Ontario |
| Canada | Sunnybrook Research Institute ( Site 1103) | Toronto | Ontario |
| Canada | BC Cancer Vancouver-Clinical Trials Unit ( Site 1106) | Vancouver | British Columbia |
| Chile | Bradfordhill-Clinical Area ( Site 2401) | Santiago | Region M. De Santiago |
| Chile | Clínica UC San Carlos de Apoquindo-Hemato-Oncology ( Site 2402) | Santiago | Region M. De Santiago |
| Chile | FALP-UIDO ( Site 2400) | Santiago | Region M. De Santiago |
| Colombia | Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 2500) | Bogota | Distrito Capital De Bogota |
| Colombia | Fundación Valle del Lili ( Site 2505) | Cali | Valle Del Cauca |
| Colombia | Oncomédica S.A.S-Oncomedica S.A ( Site 2503) | Montería | Cordoba |
| Colombia | Clinica Somer-Unidad de Investigacion y Docencia ( Site 2506) | Rionegro | Antioquia |
| Denmark | Aalborg Universitetshospital, Syd ( Site 3302) | Aalborg | Nordjylland |
| Denmark | Herlev and Gentofte Hospital ( Site 3301) | Copenhagen | Hovedstaden |
| Denmark | Odense Universitetshospital ( Site 3300) | Odense | Syddanmark |
| France | CHU d'Amiens-Picardie - Hôpital Sud-Dermatologie ( Site 1208) | Amiens | Somme |
| France | CHU Besançon ( Site 1209) | Besançon | Doubs |
| France | CHU de Bordeaux Hop St ANDRE-Service de Dermatologie ( Site 1204) | Bordeaux | Gironde |
| France | Centre Georges François Leclerc ( Site 1210) | Dijon | Cote-d Or |
| France | Hopital Claude Huriez - CHU de Lille ( Site 1207) | Lille | Nord |
| France | Assistance Publique Hôpitaux de Marseille - Hôpital de la Ti-Service de Dermatologie et Cancérologi | Marseille | Bouches-du-Rhone |
| France | Centre Hospitalier Universitaire de Nice - Hôpital l'Archet-Dermatology Department ( Site 1211) | Nice cedex 3 | Alpes-Maritimes |
| France | Hôpital Saint-Louis ( Site 1200) | Paris | |
| France | centre hospitalier lyon sud-Service de dermatologie ( Site 1202) | Pierre-Bénite | Rhone |
| France | Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 1206) | Rennes | Ille-et-Vilaine |
| France | Gustave Roussy-Dermatologie ( Site 1201) | Villejuif | Val-de-Marne |
| Germany | Universitaetsklinikum Augsburg ( Site 1312) | Augsburg | Bayern |
| Germany | Charité Universitaetsmedizin Berlin - Campus Mitte-Hauttumorcentrum Charité (HTCC) ( Site 1302) | Berlin | |
| Germany | Universitaetsklinikum Essen-Klinik für Dermatologie, Venerologie und Allergologie ( Site 1300) | Essen | Nordrhein-Westfalen |
| Germany | SRH Wald-Klinikum Gera-Zentrum für klinische Studien ( Site 1306) | Gera | Thuringen |
| Germany | Universitätsmedizin Göttingen - Georg-August-Universität-Dermatology ( Site 1308) | Göttingen | Niedersachsen |
| Germany | Universitaetsklinikum Hamburg-Eppendorf ( Site 1309) | Hamburg | |
| Germany | Universitaetsklinikum des Saarlandes ( Site 1313) | Homburg | Saarland |
| Germany | Universitaetsklinikum Koeln ( Site 1307) | Köln | Nordrhein-Westfalen |
| Germany | Universitätsmedizin Mannheim ( Site 1305) | Mannheim | Baden-Wurttemberg |
| Germany | Johannes Wesling Klinikum Minden-Skin Cancer Center Minden ( Site 1301) | Minden | Nordrhein-Westfalen |
| Germany | Klinik und Poliklinik für Dermatologie und Allergologie-Dermato-oncology ( Site 1315) | München | Bayern |
| Germany | Universitätsmedizin Rostock-Klinik und Poliklinik für Dermatologie und Venerologie ( Site 1310) | Rostock | Mecklenburg-Vorpommern |
| Greece | General Hospital of Athens "Laiko"-First Department of Internal Medicine ( Site 3700) | Athens | Attiki |
| Greece | Metropolitan Hospital-A' Oncology Dpt ( Site 3701) | Neo Faliro | Attiki |
| Greece | Bioclinic Thessalonikis Private Clinic Single Member S.A.-Oncology ( Site 3703) | Thessaloniki | Kentriki Makedonia |
| Greece | European Interbalkan Medical Center-Oncology Department ( Site 3702) | Thessaloniki | |
| Israel | Emek Medical Center ( Site 2003) | Afula | |
| Israel | Hadassah Medical Center ( Site 2004) | Jerusalem | |
| Israel | Rabin Medical Center ( Site 2000) | Petah Tikva | |
| Israel | Sheba Medical Center ( Site 2001) | Ramat Gan | |
| Italy | Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1401) | Milan | Lombardia |
| Italy | Istituto Europeo di Oncologia IRCCS ( Site 1404) | Milano | |
| Italy | Istituto Nazionale Tumori IRCCS Fondazione Pascale-s.c. melanoma, immunoterapia oncologica e terapi | Napoli | |
| Italy | AO Santa Maria della Misericordia ( Site 1403) | Perugia | Umbria |
| Italy | Azienda Ospedaliero Universitaria Senese-U.O.C. Immunoterapia Oncologica ( Site 1402) | Siena | Toscana |
| Japan | Nagoya University Hospital ( Site 4201) | Nagoya | Aichi |
| New Zealand | Harbour Cancer & Wellness ( Site 1500) | Auckland | |
| New Zealand | Capital, Coast and Hutt Valley District - Wellington Regional Hospital ( Site 1502) | Newtown | Wellington |
| Poland | Bialostockie Centrum Onkologii ( Site 2905) | Bialystok | Podlaskie |
| Poland | Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2908) | Bydgoszcz | Kujawsko-pomorskie |
| Poland | Uniwersyteckie Centrum Kliniczne-Klinika Chirurgii Onkologicznej, Transplantacyjnej i Ogólnej ( Site | Gdansk | Pomorskie |
| Poland | Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2907) | Gliwice | Slaskie |
| Poland | Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Onkologii Klinicznej, Dzial Ch | Kielce | Swietokrzyskie |
| Poland | Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2903) | Siedlce | Mazowieckie |
| Poland | Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( | Warszawa | Mazowieckie |
| Portugal | Centro Hospitalar de Lisboa Ocidental - Hospital De Sao Francisco Xavier ( Site 3602) | Lisbon | Lisboa |
| Portugal | Centro Hospitalar Universitário Lisboa Norte, E.P.E. - Hospital de Santa Maria ( Site 3603) | Lisbon | Lisboa |
| Portugal | Instituto Português de Oncologia de Lisboa Francisco Gentil ( Site 3601) | Lisbon | Lisboa |
| Portugal | Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 3604) | Porto | |
| South Africa | Cape Town Oncology Trials ( Site 4100) | Cape Town | Western Cape |
| South Africa | Medical Oncology Centre of Rosebank ( Site 4106) | Johannesburg | Gauteng |
| South Africa | Wilgers Oncology Centre ( Site 4103) | Pretoria | Gauteng |
| Spain | HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Sit | Barcelona | Cataluna |
| Spain | Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1601) | Barcelona | |
| Spain | Hospital Universitario Ramón y Cajal ( Site 1602) | Madrid | Madrid, Comunidad De |
| Spain | H.R.U Málaga - Hospital General-Oncology ( Site 1605) | Málaga | Malaga |
| Spain | HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 1603) | Pozuelo de Alarcon | Madrid |
| Spain | HOSPITAL CLINICO DE VALENCIA ( Site 1604) | Valencia | Valenciana, Comunitat |
| Sweden | Sahlgrenska Universitetssjukhuset ( Site 3200) | Gothenburg | Vastra Gotalands Lan |
| Sweden | Skånes Universitetssjukhus Lund ( Site 3201) | Lund | Skane Lan |
| Switzerland | Kantonsspital Graubünden-Medizin ( Site 1703) | Chur | Grisons |
| Switzerland | UniversitätsSpital Zürich-Dermatology ( Site 1700) | Zürich Flughafen | Zurich |
| Taiwan | Chang Gung Memorial Hospital at Kaohsiung ( Site 4000) | Kaohsiung | |
| Taiwan | National Cheng Kung University Hospital-Clinical Trial Center ( Site 4004) | Tainan | |
| Taiwan | National Taiwan University Hospital ( Site 4001) | Taipei | |
| Taiwan | Chang Gung Medical Foundation-Linkou Branch ( Site 4003) | Taoyuan | |
| Turkey | Ankara Bilkent Sehir Hastanesi-Medical Oncology ( Site 3002) | Ankara | |
| Turkey | Hacettepe Universite Hastaneleri ( Site 3006) | Ankara | |
| Turkey | Memorial Ankara Hastanesi-Medical Oncology ( Site 3010) | Ankara | |
| Turkey | Acibadem Universitesi Atakent Hastanesi-Medical Oncology ( Site 3008) | Istanbul | |
| Turkey | TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 3003) | Istanbul | |
| Turkey | I.E.U. Medical Point Hastanesi-Oncology ( Site 3005) | Izmir | |
| United Kingdom | Bristol Haematology and Oncology Centre ( Site 1811) | Bristol | Bristol, City Of |
| United Kingdom | Addenbrooke's Hospital ( Site 1800) | Cambridge | Cambridgeshire |
| United Kingdom | Norfolk and Norwich University Hospitals NHS Foundation Trust ( Site 1813) | Cringleford | England |
| United Kingdom | Western General Hospital ( Site 1806) | Edinburgh | Midlothian |
| United Kingdom | St James's University Hospital-Leeds Cancer Centre ( Site 1808) | Leeds | |
| United Kingdom | ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 1804) | London | Kensington And Chelsea |
| United Kingdom | University College London Hospital ( Site 1807) | London | London, City Of |
| United Kingdom | The Christie NHS Foundation Trust ( Site 1814) | Manchester | |
| United Kingdom | The Churchill Hospital ( Site 1805) | Oxford | Oxfordshire |
| United States | University of Michigan ( Site 1915) | Ann Arbor | Michigan |
| United States | Winship Cancer Institute of Emory University ( Site 1940) | Atlanta | Georgia |
| United States | Texas Oncology - Austin ( Site 1903) | Austin | Texas |
| United States | Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - Melanoma ( Site 1912) | Baltimore | Maryland |
| United States | University of North Carolina Medical Center-Lineberger Comprehensive Cancer Center ( Site 1949) | Chapel Hill | North Carolina |
| United States | Medical University of South Carolina-Hollings Cancer Center ( Site 1934) | Charleston | South Carolina |
| United States | Texas Oncology - Dallas (Sammons) ( Site 1902) | Dallas | Texas |
| United States | Duke Cancer Institute ( Site 1911) | Durham | North Carolina |
| United States | Inova Schar Cancer Institute ( Site 1900) | Fairfax | Virginia |
| United States | Cancer and Hematology Centers of Western Michigan ( Site 1932) | Grand Rapids | Michigan |
| United States | John Theurer Cancer Center at Hackensack University Medical Center ( Site 1944) | Hackensack | New Jersey |
| United States | University of Texas MD Anderson Cancer Center ( Site 1920) | Houston | Texas |
| United States | University of Iowa-Holden Comprehensive Cancer Center ( Site 1935) | Iowa City | Iowa |
| United States | UCLA Hematology/Oncology - Westwood (Building 100) ( Site 1918) | Los Angeles | California |
| United States | Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 1950) | Marietta | Georgia |
| United States | Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 1958) | Mineola | New York |
| United States | Atlantic Health System ( Site 1925) | Morristown | New Jersey |
| United States | Yale-New Haven Hospital-Yale Cancer Center ( Site 1933) | New Haven | Connecticut |
| United States | Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical | New York | New York |
| United States | Memorial Sloan Kettering Cancer Center ( Site 1914) | New York | New York |
| United States | NYU Langone Health-Perlmutter Cancer Center ( Site 1917) | New York | New York |
| United States | Orlando Health Cancer Institute ( Site 1937) | Orlando | Florida |
| United States | Hospital of the University of Pennsylvania Perelman Center for Advanced Medicine ( Site 1905) | Philadelphia | Pennsylvania |
| United States | UPMC Hillman Cancer Center ( Site 1909) | Pittsburgh | Pennsylvania |
| United States | Valley Health Systems - Ridgewood Campus ( Site 1947) | Ridgewood | New Jersey |
| United States | UCSF Medical Center at Mission Bay ( Site 1929) | San Francisco | California |
| United States | Fred Hutchinson Cancer Center ( Site 1901) | Seattle | Washington |
| United States | Sanford Cancer Center ( Site 1951) | Sioux Falls | South Dakota |
| United States | Highlands Oncology Group ( Site 1943) | Springdale | Arkansas |
| United States | Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center ( Site 1945) | Tampa | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Merck Sharp & Dohme LLC | ModernaTX, Inc. |
United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia, Denmark, France, Germany, Greece, Israel, Italy, Japan, New Zealand, Poland, Portugal, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Recurrence-Free Survival (RFS) | RFS is defined as the length of time from when the participant starts the study until either the cancer comes back, or the cancer spreads as assessed by the investigator, or death due to any cause. | Up to approximately 74 months | |
| Secondary | Distant Metastasis-Free Survival (DMFS) | DMFS is the length of time from when the participant starts the study until either the cancer spreads from where it started to other parts of the body as assessed by the investigator, or death due to any cause. | Up to approximately 85 months | |
| Secondary | Overall-Survival (OS) | OS is the length of time that people are alive after joining the study. | Up to approximately 85 months | |
| Secondary | Number of Participants Who Experience an Adverse Event (AE) | An AE is a health problem that happens or worsens during a study. Number of participants who experience an AE will be reported. | Up to approximately 68 weeks | |
| Secondary | Number of Participants Who Discontinue Study Treatment Due to an AE | An AE is a health problem that happens or worsens during a study. Number of participants who discontinue study treatment will be reported. | Up to approximately 56 weeks | |
| Secondary | Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Combined Score | The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" will be scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores will be standardized, so that scores range from 0 to 100. Higher scores indicate a better overall health status. Per protocol, the change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score will be presented. | Baseline and up to approximately 85 months | |
| Secondary | Change from Baseline in the EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 | The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning will be scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores will be standardized, so that scores range from 0 to 100. Higher scores indicate a better level of physical functioning. The change from baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) combined score will be presented. | Baseline and up to approximately 85 months | |
| Secondary | Change from Baseline in the EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score on the EORTC QLQ-C30 | The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "Were you limited in doing either your work or other daily activities during the past week?" and " Were you limited in pursuing your hobbies or other leisure time activities during the past week?" will be scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a more impaired level of role functioning. Change from baseline in the role functioning (EORTC QLQ-C30 Items 6-7) combined score will be presented. | Baseline and up to approximately 85 months |
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