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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00796445
Other study ID # 111482
Secondary ID 2008-002447-16
Status Terminated
Phase Phase 3
First received
Last updated
Start date December 1, 2008
Est. completion date January 27, 2016

Study information

Verified date February 2021
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this clinical trial is to evaluate the benefit of the immunotherapeutic product GSK 2132231A in preventing disease relapse when given to melanoma patients, after surgical removal of their tumor. This Protocol Posting has been updated following Amendments 1 of the Protocol, March 2010. The impacted sections are outcome measures and entry criteria.


Recruitment information / eligibility

Status Terminated
Enrollment 1351
Est. completion date January 27, 2016
Est. primary completion date January 27, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Written informed consent signed. - Male or female patient with histologically proven stage IIIB or IIIC cutaneous melanoma presenting with macroscopic lymph node involvement suitable for surgery. - The patient must have been surgically rendered free of disease before the randomization. - Patient is = 18 years old at the time of signing the informed consent form. - The patient's lymph node tumor shows expression of the MAGE-A3 gene. - The patient has fully recovered from surgery. - ECOG performance status of 0 or 1 at the time of randomization. - The patient must have adequate organ functions as assessed by standard laboratory criteria. - If the patient is female, she must be of non-childbearing potential, or practice adequate contraception. - In the opinion of the investigator, the patient can and will comply with all the requirements of the protocol. Exclusion Criteria: - The patient suffers from a mucosal or ocular melanoma. - The patient has or has had any history of in-transit metastases - The patient has been treated or is scheduled to be treated with an adjuvant anticancer therapy after the surgery that qualifies the patient for inclusion in the present trial. - The patient requires concomitant chronic treatment with systemic corticosteroids or any other immunosuppressive agents. - Use of any investigational or non-registered product (drug or vaccine) other than the study treatment. - The patient has a history of autoimmune disease. - The patient has a family history of congenital or hereditary immunodeficiency. - The patient is known to be positive for Human Immunodeficiency Virus (HIV) or has another confirmed or suspected immunosuppressive or immunodeficient condition. - History of allergic disease or reactions likely to be exacerbated by any component of the treatments. - The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent or to comply with the trial procedures. - The patient has concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk. - The patient has previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers or carcinoma in situ of the cervix or effectively treated malignancy that has been in remission for over 5 years and is highly likely to have been cured. - The patient has an uncontrolled bleeding disorder. - For female patients: the patient is pregnant or lactating.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
GSK 2132231A
IM solution, a course of 13 injections administered over 27 months
Placebo
IM solution, a course of 13 injections administered over 27 months

Locations

Country Name City State
Argentina GSK Investigational Site Cipolletti Río Negro
Argentina GSK Investigational Site Ciudad Autónoma de Buenos Aires Buenos Aires
Argentina GSK Investigational Site Ciudad Autónoma de Buenos Aires
Argentina GSK Investigational Site Rosario Santa Fe
Australia GSK Investigational Site Adelaide South Australia
Australia GSK Investigational Site Brisbane Queensland
Australia GSK Investigational Site Camperdown New South Wales
Australia GSK Investigational Site East Melbourne Victoria
Australia GSK Investigational Site Heidelberg Victoria
Australia GSK Investigational Site Hobart Tasmania
Australia GSK Investigational Site North Sydney New South Wales
Australia GSK Investigational Site Waratah New South Wales
Australia GSK Investigational Site Westmead New South Wales
Austria GSK Investigational Site Feldkirch
Austria GSK Investigational Site Graz
Austria GSK Investigational Site Linz
Austria GSK Investigational Site Salzburg
Austria GSK Investigational Site Wels
Austria GSK Investigational Site Wien
Austria GSK Investigational Site Wien
Austria GSK Investigational Site Wien
Belgium GSK Investigational Site Bruxelles
Belgium GSK Investigational Site Bruxelles
Belgium GSK Investigational Site Bruxelles
Belgium GSK Investigational Site Liège
Belgium GSK Investigational Site Wilrijk
Brazil GSK Investigational Site Belo Horizonte Minas Gerais
Brazil GSK Investigational Site Porto Alegre Rio Grande Do Sul
Brazil GSK Investigational Site São Paulo
Bulgaria GSK Investigational Site Plovdiv
Bulgaria GSK Investigational Site Sofia
Canada GSK Investigational Site Ottawa Ontario
Canada GSK Investigational Site Winnipeg Manitoba
Czechia GSK Investigational Site Brno
Czechia GSK Investigational Site Hradec Kralove
Czechia GSK Investigational Site Ostrava
Czechia GSK Investigational Site Praha 10
Czechia GSK Investigational Site Praha 2
Estonia GSK Investigational Site Tallinn
Estonia GSK Investigational Site Tartu
France GSK Investigational Site Besançon cedex
France GSK Investigational Site Bordeaux
France GSK Investigational Site Boulogne
France GSK Investigational Site Brest
France GSK Investigational Site Dijon
France GSK Investigational Site Grenoble
France GSK Investigational Site Le Mans
France GSK Investigational Site Lille
France GSK Investigational Site Limoges cedex
France GSK Investigational Site Marseille Cedex 5
France GSK Investigational Site Montpellier
France GSK Investigational Site Nantes
France GSK Investigational Site Nice
France GSK Investigational Site Paris
France GSK Investigational Site Paris
France GSK Investigational Site Paris Cedex 10
France GSK Investigational Site Pierre-Bénite cedex
France GSK Investigational Site Poitiers
France GSK Investigational Site Reims
France GSK Investigational Site Rennes
France GSK Investigational Site Rouen
France GSK Investigational Site Saint-Etienne
France GSK Investigational Site Toulouse cedex 9
France GSK Investigational Site Tours
France GSK Investigational Site Villejuif
Germany GSK Investigational Site Berlin
Germany GSK Investigational Site Berlin
Germany GSK Investigational Site Berlin
Germany GSK Investigational Site Bonn Nordrhein-Westfalen
Germany GSK Investigational Site Buxtehude Niedersachsen
Germany GSK Investigational Site Dresden Sachsen
Germany GSK Investigational Site Erfurt Thueringen
Germany GSK Investigational Site Essen Nordrhein-Westfalen
Germany GSK Investigational Site Frankfurt Hessen
Germany GSK Investigational Site Freiburg Baden-Wuerttemberg
Germany GSK Investigational Site Greifswald Mecklenburg-Vorpommern
Germany GSK Investigational Site Hannover Niedersachsen
Germany GSK Investigational Site Heidelberg Baden-Wuerttemberg
Germany GSK Investigational Site Homburg Saarland
Germany GSK Investigational Site Jena Thueringen
Germany GSK Investigational Site Kassel Hessen
Germany GSK Investigational Site Kiel Schleswig-Holstein
Germany GSK Investigational Site Koeln Nordrhein-Westfalen
Germany GSK Investigational Site Leipzig Sachsen
Germany GSK Investigational Site Ludwigshafen Rheinland-Pfalz
Germany GSK Investigational Site Luebeck Schleswig-Holstein
Germany GSK Investigational Site Magdeburg Sachsen-Anhalt
Germany GSK Investigational Site Mainz Rheinland-Pfalz
Germany GSK Investigational Site Mannheim Baden-Wuerttemberg
Germany GSK Investigational Site Marburg Hessen
Germany GSK Investigational Site Minden Nordrhein-Westfalen
Germany GSK Investigational Site Muenchen Bayern
Germany GSK Investigational Site Muenchen Bayern
Germany GSK Investigational Site Muenster Nordrhein-Westfalen
Germany GSK Investigational Site Nuernberg Bayern
Germany GSK Investigational Site Oldenburg Niedersachsen
Germany GSK Investigational Site Quedlinburg Sachsen-Anhalt
Germany GSK Investigational Site Regensburg Bayern
Germany GSK Investigational Site Tuebingen Baden-Wuerttemberg
Germany GSK Investigational Site Ulm Baden-Wuerttemberg
Germany GSK Investigational Site Wiesbaden Hessen
Germany GSK Investigational Site Wuerzburg Bayern
Greece GSK Investigational Site Athens
Greece GSK Investigational Site Athens
Ireland GSK Investigational Site Cork
Ireland GSK Investigational Site Dublin
Ireland GSK Investigational Site Dublin
Ireland GSK Investigational Site Dublin
Ireland GSK Investigational Site Dublin
Ireland GSK Investigational Site Galway
Israel GSK Investigational Site Haifa
Israel GSK Investigational Site Petach Tikva
Israel GSK Investigational Site Ramat Gan
Italy GSK Investigational Site Aviano (PN) Friuli-Venezia-Giulia
Italy GSK Investigational Site Bari Puglia
Italy GSK Investigational Site Genova Liguria
Italy GSK Investigational Site Meldola (FC) Emilia-Romagna
Italy GSK Investigational Site Milano Lombardia
Italy GSK Investigational Site Milano Lombardia
Italy GSK Investigational Site Modena Emilia-Romagna
Italy GSK Investigational Site Napoli Campania
Italy GSK Investigational Site Padova Veneto
Italy GSK Investigational Site Pisa Toscana
Italy GSK Investigational Site Roma Lazio
Italy GSK Investigational Site Siena Toscana
Japan GSK Investigational Site Shizuoka
Japan GSK Investigational Site Tokyo
Korea, Republic of GSK Investigational Site Seoul
Korea, Republic of GSK Investigational Site Seoul
Mexico GSK Investigational Site Monterrey Nuevo León
Netherlands GSK Investigational Site Nijmegen
Netherlands GSK Investigational Site Rotterdam
New Zealand GSK Investigational Site Auckland
New Zealand GSK Investigational Site Christchurch
New Zealand GSK Investigational Site Wellington
Norway GSK Investigational Site Oslo
Poland GSK Investigational Site Bydgoszcz
Poland GSK Investigational Site Gdansk
Poland GSK Investigational Site Kraków
Poland GSK Investigational Site Olsztyn
Poland GSK Investigational Site Poznan
Poland GSK Investigational Site Slupsk
Poland GSK Investigational Site Warszawa
Poland GSK Investigational Site Warszawa
Romania GSK Investigational Site Baia Mare
Romania GSK Investigational Site Cluj-Napoca
Romania GSK Investigational Site Craiova, Dolj
Russian Federation GSK Investigational Site Chelyabinsk
Russian Federation GSK Investigational Site Kursk
Russian Federation GSK Investigational Site Moscow
Russian Federation GSK Investigational Site Omsk
Russian Federation GSK Investigational Site St. Petersburg
Russian Federation GSK Investigational Site St. Petersburg
Russian Federation GSK Investigational Site Stavropol
Serbia GSK Investigational Site Belgrad
Serbia GSK Investigational Site Belgrad
Serbia GSK Investigational Site Sremska Kamenica
Spain GSK Investigational Site Barcelona
Spain GSK Investigational Site Madrid
Spain GSK Investigational Site Pamplona
Spain GSK Investigational Site Sevilla
Spain GSK Investigational Site Valencia
Sweden GSK Investigational Site Göteborg
Sweden GSK Investigational Site Malmö
Sweden GSK Investigational Site Uppsala
Switzerland GSK Investigational Site Basel
Switzerland GSK Investigational Site Zürich
Taiwan GSK Investigational Site Kaohsiung
Taiwan GSK Investigational Site Taipei
Taiwan GSK Investigational Site Taoyuan Hsien
Ukraine GSK Investigational Site Dnipropetrovsk
Ukraine GSK Investigational Site Dnipropetrovsk
Ukraine GSK Investigational Site Donetsk
Ukraine GSK Investigational Site Krivoy Rog
Ukraine GSK Investigational Site Kyiv
Ukraine GSK Investigational Site Lviv
United Kingdom GSK Investigational Site Belfast, Northern Ireland
United Kingdom GSK Investigational Site Chelmsford Essex
United Kingdom GSK Investigational Site Colchester
United Kingdom GSK Investigational Site Dundee
United Kingdom GSK Investigational Site London
United Kingdom GSK Investigational Site Poole, Dorset
United Kingdom GSK Investigational Site Salisbury
United States GSK Investigational Site Albany New York
United States GSK Investigational Site Amarillo Texas
United States GSK Investigational Site Ann Arbor Michigan
United States GSK Investigational Site Atlanta Georgia
United States GSK Investigational Site Atlanta Georgia
United States GSK Investigational Site Aurora Colorado
United States GSK Investigational Site Austin Texas
United States GSK Investigational Site Baltimore Maryland
United States GSK Investigational Site Baltimore Maryland
United States GSK Investigational Site Bedford Texas
United States GSK Investigational Site Birmingham Alabama
United States GSK Investigational Site Boston Massachusetts
United States GSK Investigational Site Boston Massachusetts
United States GSK Investigational Site Chapel Hill North Carolina
United States GSK Investigational Site Charleston South Carolina
United States GSK Investigational Site Charleston South Carolina
United States GSK Investigational Site Charlotte North Carolina
United States GSK Investigational Site Charlottesville Virginia
United States GSK Investigational Site Chicago Illinois
United States GSK Investigational Site Chicago Illinois
United States GSK Investigational Site Chicago Illinois
United States GSK Investigational Site Chicago Illinois
United States GSK Investigational Site Cincinnati Ohio
United States GSK Investigational Site Cleveland Ohio
United States GSK Investigational Site Dallas Texas
United States GSK Investigational Site Dallas Texas
United States GSK Investigational Site Durham North Carolina
United States GSK Investigational Site Fort Worth Texas
United States GSK Investigational Site Fridley Minnesota
United States GSK Investigational Site Grand Rapids Michigan
United States GSK Investigational Site Hackensack New Jersey
United States GSK Investigational Site Houston Texas
United States GSK Investigational Site Indianapolis Indiana
United States GSK Investigational Site Jacksonville Florida
United States GSK Investigational Site Jacksonville Florida
United States GSK Investigational Site La Jolla California
United States GSK Investigational Site Las Vegas Nevada
United States GSK Investigational Site Latham New York
United States GSK Investigational Site Little Rock Arkansas
United States GSK Investigational Site Los Angeles California
United States GSK Investigational Site Los Angeles California
United States GSK Investigational Site Louisville Kentucky
United States GSK Investigational Site Lubbock Texas
United States GSK Investigational Site Memphis Tennessee
United States GSK Investigational Site Metairie Louisiana
United States GSK Investigational Site Miami Florida
United States GSK Investigational Site Milwaukee Wisconsin
United States GSK Investigational Site Minneapolis Minnesota
United States GSK Investigational Site Morgantown West Virginia
United States GSK Investigational Site Morristown New Jersey
United States GSK Investigational Site Murray Utah
United States GSK Investigational Site Nashville Tennessee
United States GSK Investigational Site New York New York
United States GSK Investigational Site Orange California
United States GSK Investigational Site Orange Park Florida
United States GSK Investigational Site Orlando Florida
United States GSK Investigational Site Philadelphia Pennsylvania
United States GSK Investigational Site Philadelphia Pennsylvania
United States GSK Investigational Site Philadelphia Pennsylvania
United States GSK Investigational Site Pittsburgh Pennsylvania
United States GSK Investigational Site Plano Texas
United States GSK Investigational Site Portland Oregon
United States GSK Investigational Site Riverside California
United States GSK Investigational Site Saint Louis Missouri
United States GSK Investigational Site Saint Louis Park Minnesota
United States GSK Investigational Site San Francisco California
United States GSK Investigational Site Santa Rosa California
United States GSK Investigational Site Sayre Pennsylvania
United States GSK Investigational Site Seattle Washington
United States GSK Investigational Site Stuart Florida
United States GSK Investigational Site Tucson Arizona
United States GSK Investigational Site Tyler Texas
United States GSK Investigational Site Vancouver Washington
United States GSK Investigational Site Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  Czechia,  Estonia,  France,  Germany,  Greece,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  New Zealand,  Norway,  Poland,  Romania,  Russian Federation,  Serbia,  Spain,  Sweden,  Switzerland,  Taiwan,  Ukraine,  United Kingdom, 

References & Publications (2)

Dizier B, Callegaro A, Debois M, Dreno B, Hersey P, Gogas HJ, Kirkwood JM, Vansteenkiste JF, Sequist LV, Atanackovic D, Goeman J, van Houwelingen H, Salceda S, Wang F, Therasse P, Debruyne C, Spiessens B, Brichard VG, Louahed J, Ulloa-Montoya F. A Th1/IFN? Gene Signature Is Prognostic in the Adjuvant Setting of Resectable High-Risk Melanoma but Not in Non-Small Cell Lung Cancer. Clin Cancer Res. 2020 Apr 1;26(7):1725-1735. doi: 10.1158/1078-0432.CCR-18-3717. Epub 2019 Nov 15. — View Citation

Dreno B, Thompson JF, Smithers BM, Santinami M, Jouary T, Gutzmer R, Levchenko E, Rutkowski P, Grob JJ, Korovin S, Drucis K, Grange F, Machet L, Hersey P, Krajsova I, Testori A, Conry R, Guillot B, Kruit WHJ, Demidov L, Thompson JA, Bondarenko I, Jaroszek J, Puig S, Cinat G, Hauschild A, Goeman JJ, van Houwelingen HC, Ulloa-Montoya F, Callegaro A, Dizier B, Spiessens B, Debois M, Brichard VG, Louahed J, Therasse P, Debruyne C, Kirkwood JM. MAGE-A3 immunotherapeutic as adjuvant therapy for patients with resected, MAGE-A3-positive, stage III melanoma (DERMA): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2018 Jul;19(7):916-929. doi: 10.1016/S1470-2045(18)30254-7. Epub 2018 Jun 13. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Disease Free Survival (DFS) DFS = time to event from randomization to the date of first disease recurrence (as assessed by investigator) or the date of death (whatever cause), whichever occurred first. DFS was expressed as the person-year rate i.e. the number of patients with at least one event (n) over the sum of the follow-up periods in years (T), until the first occurrence of a recurrence/death. Types of recurrence to be considered as an event included loco-regional and distant metastases. Any death occurring without prior documentation of tumor recurrence was considered as an event (not censored in the stat. analysis) as this approach was less prone to introduce bias. If no event occurred by the time of analysis, then the time to event was censored at the last assessment date (tumor assessment/visit) of the patient. Any new primary cancer at another site, including second primary melanoma, was not considered as a recurrence and had to be reported as a Serious Adverse Event (SAE). At Final analysis (Month 30 = Year 2.5)
Primary Disease Free Survival (DFS) DFS = time to event from randomization to the date of first disease recurrence (as assessed by investigator) or the date of death (whatever cause), whichever occurred first. DFS was expressed as the person-year rate i.e. the number of patients with at least one event (n) over the sum of the follow-up periods in years (T), until the first occurrence of a recurrence/death. Types of recurrence to be considered as an event included loco-regional and distant metastases. Any death occurring without prior documentation of tumor recurrence was considered as an event (not censored in the stat. analysis) as this approach was less prone to introduce bias. If no event occurred by the time of analysis, then the time to event was censored at the last assessment date (tumor assessment/visit) of the patient. Any new primary cancer at another site, including second primary melanoma, was not considered as a recurrence and had to be reported as a Serious Adverse Event (SAE). At follow-up analysis (up to Year 5)
Secondary Overall Survival (OS) Overall Survival (OS) was defined as the time to event from randomization to the date of death, irrespective of the cause of death. OS was expressed as the person-year rate i.e. the number of patients with death (n) over the sum of the follow-up periods in years (T). Patients alive at the time of the analysis were censored on the date last known to be alive. At Final analysis (Month 30 = Year 2.5) and at follow-up analysis (up to Year 5)
Secondary Disease-free Specific Survival (DFSS) Disease Free Specific Survival (DFSS) was defined as the time to event from randomization to the date of first recurrence of disease or date of death due to melanoma (cause as assessed by investigator), whichever occurred first. DFSS was expressed as the person-year rate i.e. the number of patients with at least one event (n) over the sum of the follow-up periods in years (T), until the first occurrence of a recurrence/death. Patients who died due to a cause other than the disease under study and patients alive at the time of analysis were censored on the date of last assessment (visit or tumor assessment). At Final analysis (Month 30 = Year 2.5)
Secondary Distant Metastasis-free Survival (DMFS) Distant Metastasis Free Survival (DMFS) was defined as the time to event from randomization to the date of first distant metastasis or date of death, whichever occurred first. DMFS was expressed as the person-year rate i.e. the number of patients with at least one event (n) over the sum of the follow-up periods in years (T), until the first occurrence of distant metastasis/death. Patients alive and without distant metastases were censored at the date of last assessment (visit or tumor assessment, or date of last tumor assessment as documented during the yearly contact follow-up period). At Final analysis (Month 30 = Year 2.5)
Secondary Health-related Quality of Life The assessment of health-related quality of life was restricted to patients who consented to study participation after Protocol Amendment 1 became effective at their study site, and for whom a validated version of the Euro Quality of Life-5D (EQ-5D) questionnaire was available in their native language. The EQ-5D comprises a 5-dimensional descriptive system (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), where each item has 3 levels and together they define 243 possible health states. For each health state, a value (utility) was determined by using an additive algorithm. These utility scores were calculated for each patient at each timepoint at which an EQ-5D questionnaire was completed. The score had a maximum value of 1.0 corresponding to full health level, while lower scores, down to a minimum value of 0.0 reflected degradation in the health-related quality of life. At Weeks 0, 6, 12 [on the day of and the day after treatment administration (TA)], at Month 6, 9, 12, 24, at the Concluding visit (Month 30) + 6 months and +12 Months and at disease recurrence
Secondary Number of Subjects With Anti-MAGE-A3 Antibody Concentrations Above the Cut-off Value The cut-off value was 27 Enzyme-Linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL). At Weeks 0, 6, 12, 36, 48 72, 120 (Concluding visit) and at Week 120 + 6 months
Secondary Anti-MAGE-A3 Antibody Geometric Mean Concentrations Anti-MAGE-A3 antibody concentrations were presented as geometric mean concentrations (GMC) and expressed in EL.U/mL. At Weeks 0, 6, 12, 36, 48 72, 120 (Concluding visit) and at Month 120 + 6 months
Secondary Number of Subjects With Anti-MAGE-A3 Antibody Response Treatment response defined as: - For initially seronegative patients: post-treatment antibody concentration = 27 EL.U/mL; - For initially seropositive patients: post-treatment antibody concentration = 2 fold the pre-treatment antibody concentration. At Weeks 6, 12, 36, 48 72, 120 (Concluding visit) and at Month 120 + 6 months
Secondary Number of Subjects With Abnormal Haematological and Biochemical Parameters Laboratory abnormalities belong to hematological and biochemical parameters such as: alanine aminotransferase [ALT], asparatate aminostransferase [AST], alkaline phoshatase [AP], bilirubin [BIL], creatinine [CREA], hemoglobin [HGB], leukocytes [LEU], lymphopenia [LYMPH], neutrophils [NEU], platelets [PLA]. Parameter grades (Grade [G] 0, 1, 2, 3, 4, Unknown) were compared to each baseline parameter grade (G Unknown, 0, 1, 2, 3), as defined by the Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 of August 9, 2006. Within the 31-day (Days 0-30) post-treatment period
Secondary Number of Subjects With Any Adverse Events (AEs) An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Within the 31-day (Days 0-30) follow-up period after treatment
Secondary Number of Subjects With Any Serious Adverse Events (SAEs) Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. From Day 0 up to study end (up to 5 years)
Secondary Number of Subjects With Potential Immune-mediated Diseases (pIMDs) Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. From Day 0 up to study end (up to 5 years)
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