Studienzentrum
Willkommen auf den Seiten des klinischen Studienzentrums der Essener Universitäts-Hautklinik.
Das klinische Studienzentrum der Essener Universitäts-Hautklinik ermöglicht qualitativ hochwertige klinische Forschung, die zur Einführung neuer Medikamente, Geräte, Diagnostika, Therapieverfahren oder zu epidemiologischen und sozioökonomischen Fragestellungen beitragen. Durch unsere Arbeit wollen wir die Qualität von klinischen Studien fördern und verbessern. Dies erreichen wir durch qualifiziert ausgebildetes Personal, das sich um die Belange der Studienpatienten kümmert. Unser Ziel ist, den Patienten einen Zugang zu neuartigen Therapien und innovativen Forschungsmöglichkeiten zu bieten. Wir sind erfahren in Planung, Organisation und Management pharmazeutischer Phase I, II, III und IV-Studien in den unterschiedlichsten therapeutischen Bereichen der Dermatologie. Ergänzend können wir diagnostische Untersuchungen zur Therapie- und Sicherheitskontrolle während des Studienverlaufs anbieten. Alle Studien werden gemäß der aktuell gültigen GCP (Good Clinical Practice)-Guidelines durchgeführt.
Unser klinisches Studienzentrum besteht aus 3 Bereichen. Der Studienambulanz für Studien aus dem Bereich der allgemeinen Dermatologie, der Dermatoonkologie und Studien zum Thema HIV/AIDS/Geschlechtserkrankungen.
Einrichtung
Die Studienambulanz steht allen Bereichen der Hautklinik der Universitätsklinik Essen zur Verfügung. Die Einrichtung ist…
Erfahrung in klinischen Studien
Unsere Klinik verfügt über langjährige Erfahrung in der Durchführung klinischer Studien und Anwendungsbeobachtungen. Diese Expertise…
Allgemeine Dermatologie-Studien
Studienzentrum allgemeine Dermatologie Wir freuen uns, Patienten im Studienzentrum „allgemeine Dermatologie“ einen möglichst frühzeitig einen…
Dermatoonkologische Studien
Dermatoonkologische Studienambulanz In unserer onkologischen Studienambulanz werden zahlreiche multizentrische klinische Studien zur neoadjuvanten, adjuvanten und…
HIV/HPSTD Studien
HIV/HPSTD-Studienambulanz Sehr geehrter Websitebesucher,in der HIV Ambulanz der Universitätshautklinik Essen bieten wir viele klinische Studien…
Klinische Studien des Wundzentrums -Bereich Dermatologie
Neben der bestmöglichen Diagnostik und Therapie wie diese von Fachgesellschaften und aktuellen Leitlinien empfohlen wird,…
Prof. Dr. med.
Lisa Zimmer
Leitende Oberärztin,
Fachärztin für Haut- und Geschlechtskrankheiten,
Zusatzbezeichnung: Medikamentöse Tumortherapie
Prof. Dr. med.
Elisabeth Livingstone
Oberärztin,
Fachärztin für Haut- und Geschlechtskrankheiten,
Zusatzbezeichnung: Medikamentöse Tumortherapie
Prof. Dr. med.
Stefan Esser
Leitender Oberarzt,
Facharzt für Haut- und Geschlechtskrankheiten
Zusatzbezeichnung: Allergologie
Infektiologisch tätiger Venerologe
Prof. Dr. med.
Joachim Dissemond
Oberarzt,
Facharzt für Haut- und Geschlechtskrankheiten,
Zusatzbezeichnung: Allergologie, Sportmedizin
ARCHITECT
Non-Interventionelle ADOREG Registerstudie zur Charakterisierung einer Kombination aus Immuntherapie und Elektrochemotherapie beim malignen Melanom
Berufsordnung (BO) / Nicht-interventionell
Zurück
ARCHITECT
Studieninformationen
Studien-Code
UME-ID-11475
UME-ID-11475
Studien-Akronym
ARCHITECT
ARCHITECT
Studientitel
Non-Interventionelle ADOREG Registerstudie zur Charakterisierung einer Kombination aus Immuntherapie und Elektrochemotherapie beim malignen Melanom
Non-Interventionelle ADOREG Registerstudie zur Charakterisierung einer Kombination aus Immuntherapie und Elektrochemotherapie beim malignen Melanom
Aktueller Studienstatus
Aktiv, rekrutierend
Aktiv, rekrutierend
Studie aktiv in den Jahren
2015,2016,2017,2018,2019,2021,2022,2023,2025
2015,2016,2017,2018,2019,2021,2022,2023,2025
Beteiligte
Institute
Klinik für Dermatologie, Westdeutsches Tumorzentrum
Klinik für Dermatologie, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)
Prof. Dr. med. Selma Ugurel
+49 (0)201 723-2225
Hautklinik.Studienzentrum@uk-essen.de
Hufelandstr 55
45147 Essen
Studiendesign
Registerstudie
Registerstudie
Indikation
Melanom
Melanom
Medizinischer Befund
maligne Melanome
maligne Melanome
BI 1368-0140
A multi-centre, randomised, placebo-controlled, double-blind, parralelgroup trial to evaluate safety and efficacy of spesolimab (BI 655130) i.v. in adult patients with ulcerative pyoderma gangrenosum (PG) who require systemic therapy
Clinical Trial Regulation (CTR) / Interventionell, Multizentrisch
Zurück
BI 1368-0140
Studieninformationen
Studien-Code
UME-ID-12223
UME-ID-12223
Studien-Akronym
BI 1368-0140
BI 1368-0140
Studientitel
A multi-centre, randomised, placebo-controlled, double-blind, parralelgroup trial to evaluate safety and efficacy of spesolimab (BI 655130) i.v. in adult patients with ulcerative pyoderma gangrenosum (PG) who require systemic therapy
A multi-centre, randomised, placebo-controlled, double-blind, parralelgroup trial to evaluate safety and efficacy of spesolimab (BI 655130) i.v. in adult patients with ulcerative pyoderma gangrenosum (PG) who require systemic therapy
Aktueller Studienstatus
Aktiv, rekrutierend
Aktiv, rekrutierend
Studie aktiv in den Jahren
2025
2025
Beteiligte
Institut
Klinik für Dermatologie
Klinik für Dermatologie
Prüfarzt (AMG) / Studienleitung (BO)
Prof. Dr. med. Joachim Dissemond
+49 (0)201 723-2225
Hautklinik.Studienzentrum@uk-essen.de
Hufelandstr 55
45147 Essen
Sponsor
Boehringer Ingelheim Pharma GmbH & Co. KG
Studiendesign
randomisiert, doppelt verblindet, kontrolliert, Multizentrisch
randomisiert, doppelt verblindet, kontrolliert, Multizentrisch
Studienteilnehmende Mindestalter
18 Jahr(e)
18 Jahr(e)
Geschlecht
Divers, Männlich, Weiblich
Divers, Männlich, Weiblich
Indikation
Pyoderma gangraenosum (PG)
Pyoderma gangraenosum (PG)
Medizinischer Befund
Pyoderma gangraenosum (PG)
Pyoderma gangraenosum (PG)
BNT326-01
A Phase I/II, open-label, adaptive two-part Trial to evaluate the safety, efficacy, optimal dose and pharmacokinetics of BNT326 as monotherapy and in combination with Cancer immunotherapies in participants with advanced solid tumors
Clinical Trial Regulation (CTR) / Interventionell
Zurück
BNT326-01
Studieninformationen
Studien-Code
UME-ID-12655
UME-ID-12655
Studien-Akronym
BNT326-01
BNT326-01
Studientitel
A Phase I/II, open-label, adaptive two-part Trial to evaluate the safety, efficacy, optimal dose and pharmacokinetics of BNT326 as monotherapy and in combination with Cancer immunotherapies in participants with advanced solid tumors
A Phase I/II, open-label, adaptive two-part Trial to evaluate the safety, efficacy, optimal dose and pharmacokinetics of BNT326 as monotherapy and in combination with Cancer immunotherapies in participants with advanced solid tumors
Aktueller Studienstatus
Aktiv, rekrutierend
Aktiv, rekrutierend
Studie aktiv in den Jahren
2026
2026
Beteiligte
Institute
Klinik für Dermatologie, Westdeutsches Tumorzentrum
Klinik für Dermatologie, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)
Prof. Dr. med. Dirk Schadendorf
+49 (0)201 723-2225
Hautklinik.Studienzentrum@uk-essen.de
Hufelandstraße 55
45147 Essen
Studiendesign
offen
offen
Indikation
Solide Tumoren
Solide Tumoren
Medizinischer Befund
advanced solid tumors
advanced solid tumors
DICIT
Efficacy of diclofenac added to ongoing PD-1 inhibitor therapy in metastatic melanoma patients
Clinical Trial Regulation (CTR) / Interventionell
Efficacy of diclofenac added to an approved, ongoing PD-1 inhibitor therapy that achieved stable disease as best response in metastatic melanoma patients. A single arm phase II trial
Zurück
DICIT
Studieninformationen
Studien-Code
UME-ID-11602
UME-ID-11602
Studien-Akronym
DICIT
DICIT
Studientitel
Efficacy of diclofenac added to ongoing PD-1 inhibitor therapy in metastatic melanoma patients
Efficacy of diclofenac added to ongoing PD-1 inhibitor therapy in metastatic melanoma patients
Kurzbeschreibung
Efficacy of diclofenac added to an approved, ongoing PD-1 inhibitor therapy that achieved stable disease as best response in metastatic melanoma patients. A single arm phase II trial
Efficacy of diclofenac added to an approved, ongoing PD-1 inhibitor therapy that achieved stable disease as best response in metastatic melanoma patients. A single arm phase II trial
Aktueller Studienstatus
Aktiv, rekrutierend
Aktiv, rekrutierend
Studie aktiv in den Jahren
2024,2025
2024,2025
Beteiligte
Institute
Klinik für Dermatologie, Westdeutsches Tumorzentrum
Klinik für Dermatologie, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)
Prof. Dr. med. Lisa Zimmer
+49 (0)201 723-2225
Hautklinik.Studienzentrum@uk-essen.de
Hufelandstr 55
45147 Essen
Sponsor
Universitätsklinikum Regensburg
Studiendesign
Indikation
Melanom
Melanom
IMA203-301
A prospective, multicenter, open-label, randomized, actively controlled, parallel-group Phase 3 clinical trial to evaluate efficacy, safety, and tolerability of IMA203 versus investigator’s choice of treatment in patients with previously treated, unresectable or
Clinical Trial Regulation (CTR) / Interventionell, Multizentrisch
Zurück
IMA203-301
Studieninformationen
Studien-Code
UME-ID-12467
UME-ID-12467
Studien-Akronym
IMA203-301
IMA203-301
Studientitel
A prospective, multicenter, open-label, randomized, actively controlled, parallel-group Phase 3 clinical trial to evaluate efficacy, safety, and tolerability of IMA203 versus investigator’s choice of treatment in patients with previously treated, unresectable or
A prospective, multicenter, open-label, randomized, actively controlled, parallel-group Phase 3 clinical trial to evaluate efficacy, safety, and tolerability of IMA203 versus investigator’s choice of treatment in patients with previously treated, unresectable or
Aktueller Studienstatus
Aktiv, rekrutierend
Aktiv, rekrutierend
Studie aktiv in den Jahren
2025,2026
2025,2026
Beteiligte
Institute
Klinik für Dermatologie, Westdeutsches Tumorzentrum
Klinik für Dermatologie, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)
Prof. Dr. med. Dirk Schadendorf
+49 (0)201 723-2225
Hautklinik.Studienzentrum@uk-essen.de
Hufelandstraße 55
45147 Essen
Sponsor
Immatics US Inc.
Studiendesign
randomisiert, offen, kontrolliert, Multizentrisch
randomisiert, offen, kontrolliert, Multizentrisch
Einschlusskriterien
• Pathologically confirmed and documented cutaneous melanoma- CM patients (including acral melanoma) with unresectable or metastatic disease
• HLA-A*02:01 positive
• Adequate selected organ function per protocol
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Disease progression (resistance, toxicity) on or after at least one PD-1 inhibitor, applied either as monotherapy or in combination with other therapies as treatment for unresectable or metastatic cutaneous melanoma
• Patients with BRAF mutation should have been treated with one prior line of BRAF-directed therapy (with or without a MEK inhibitor) prior to initial eligibility assessment, unless deemed not clinically indicated at Investigator's discretion due to concurrent medical condition, prior toxicity, or if declined by the patient
• Life expectancy more than 6 months
• Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
• Female patient of childbearing potential must use adequate contraception from randomization until 12 months after the infusion of IMA203 or in line with the instructions provided for investigator's choice treatment (in the control arm)
• Male patient must agree to use effective contraception or be abstinent while on study and for 6 months after the infusion of IMA203 or in line with the instructions provided for investigator's choice treatment (in the control arm)
• The patient must have recovered from any side effects of prior therapy to Grade 1 or lower prior to randomization.
• Pathologically confirmed and documented cutaneous melanoma- CM patients (including acral melanoma) with unresectable or metastatic disease
• HLA-A*02:01 positive
• Adequate selected organ function per protocol
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Disease progression (resistance, toxicity) on or after at least one PD-1 inhibitor, applied either as monotherapy or in combination with other therapies as treatment for unresectable or metastatic cutaneous melanoma
• Patients with BRAF mutation should have been treated with one prior line of BRAF-directed therapy (with or without a MEK inhibitor) prior to initial eligibility assessment, unless deemed not clinically indicated at Investigator's discretion due to concurrent medical condition, prior toxicity, or if declined by the patient
• Life expectancy more than 6 months
• Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
• Female patient of childbearing potential must use adequate contraception from randomization until 12 months after the infusion of IMA203 or in line with the instructions provided for investigator's choice treatment (in the control arm)
• Male patient must agree to use effective contraception or be abstinent while on study and for 6 months after the infusion of IMA203 or in line with the instructions provided for investigator's choice treatment (in the control arm)
• The patient must have recovered from any side effects of prior therapy to Grade 1 or lower prior to randomization.
Ausschlusskriterien
• Primary mucosal or uveal melanoma and melanoma of unknown primary
• History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 3 years
• Serious autoimmune disease Note: At the discretion of the investigator, these patients may be included if their disease is well controlled without the use of immunosuppressive agents.
• History of cardiac conditions as per protocol
• Prior allogenic stem cell transplantation or solid organ transplantation
• Concurrent severe and/or uncontrolled medical disease that could compromise participation in the study
• History of or current immunodeficiency disease or prior treatment compromising immune function at the discretion of the treating physician
• History of hypersensitivity to CY, FLU, or IL-2 or presence of any contraindications and other limitations for planned treatment with investigator's choice as laid down in the current versions of the respective PIs / SmPCs
• Known hypersensitivity to any of the rescue medications
• History of or current immunodeficiency disease or prior treatment compromising immune function at the discretion of the investigator
• Positive for HIV infection or with active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection.
• Any condition contraindicating leukapheresis
• Pregnant or breastfeeding
• Any other condition that would, in the investigator's or sponsor's judgment, contraindicate the patient's participation in the clinical trial because of safety concerns or compliance with clinical trial procedures (e.g., psychiatric disorders or substance dependence, neurological impairment)
• Patient has received systemic corticosteroids within 2 weeks prior to leukapheresis,
• Patient has received surgery or other anti-cancer therapies, any agent that is likely to suppress bone marrow function, or investigational medicinal products within 7 days prior to leukapheresis.
• Patients with any active infection or ongoing reactivation of infection
• Patients who underwent non-myeloablative lymphodepletion prior to cell therapy within the last 6 months
• Prior treatment with IMA203
• Patients with ascites, pleural or pericardial effusion which requires repeated (2 within 4 weeks) or continuous paracentesis, thoracentesis or pericardiocentesis within last 2 months
• Patients with LDH greater than 2.0-fold ULN
• Concurrent treatment in another clinical trial or a device study that could interfere with the IMA203 treatment or planned investigator's choice treatment
• Patients with active brain metastases or leptomeningeal metastases
• Patient has received any investigational therapies, inactivated vaccines, chronic use of systemic corticosteroids or IV antibiotics within 1 week prior to randomization, or live vaccines within 4 weeks prior to randomization
• Patient has received any anti-cancer therapy (prior anti-cancer treatment or bridging therapy) or radiotherapy within 1 week prior to start of trial treatment
• Other protocol defined inclusion/exclusion criteria could apply
• Primary mucosal or uveal melanoma and melanoma of unknown primary
• History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 3 years
• Serious autoimmune disease Note: At the discretion of the investigator, these patients may be included if their disease is well controlled without the use of immunosuppressive agents.
• History of cardiac conditions as per protocol
• Prior allogenic stem cell transplantation or solid organ transplantation
• Concurrent severe and/or uncontrolled medical disease that could compromise participation in the study
• History of or current immunodeficiency disease or prior treatment compromising immune function at the discretion of the treating physician
• History of hypersensitivity to CY, FLU, or IL-2 or presence of any contraindications and other limitations for planned treatment with investigator's choice as laid down in the current versions of the respective PIs / SmPCs
• Known hypersensitivity to any of the rescue medications
• History of or current immunodeficiency disease or prior treatment compromising immune function at the discretion of the investigator
• Positive for HIV infection or with active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection.
• Any condition contraindicating leukapheresis
• Pregnant or breastfeeding
• Any other condition that would, in the investigator's or sponsor's judgment, contraindicate the patient's participation in the clinical trial because of safety concerns or compliance with clinical trial procedures (e.g., psychiatric disorders or substance dependence, neurological impairment)
• Patient has received systemic corticosteroids within 2 weeks prior to leukapheresis,
• Patient has received surgery or other anti-cancer therapies, any agent that is likely to suppress bone marrow function, or investigational medicinal products within 7 days prior to leukapheresis.
• Patients with any active infection or ongoing reactivation of infection
• Patients who underwent non-myeloablative lymphodepletion prior to cell therapy within the last 6 months
• Prior treatment with IMA203
• Patients with ascites, pleural or pericardial effusion which requires repeated (2 within 4 weeks) or continuous paracentesis, thoracentesis or pericardiocentesis within last 2 months
• Patients with LDH greater than 2.0-fold ULN
• Concurrent treatment in another clinical trial or a device study that could interfere with the IMA203 treatment or planned investigator's choice treatment
• Patients with active brain metastases or leptomeningeal metastases
• Patient has received any investigational therapies, inactivated vaccines, chronic use of systemic corticosteroids or IV antibiotics within 1 week prior to randomization, or live vaccines within 4 weeks prior to randomization
• Patient has received any anti-cancer therapy (prior anti-cancer treatment or bridging therapy) or radiotherapy within 1 week prior to start of trial treatment
• Other protocol defined inclusion/exclusion criteria could apply
Studienteilnehmende Mindestalter
18 Jahr(e)
18 Jahr(e)
Geschlecht
Divers, Männlich, Weiblich
Divers, Männlich, Weiblich
Indikation
Melanom
Melanom
Medizinischer Befund
Melanom
Melanom
IMA402-101
A Phase I/II First-In-Human Clinical Trial to Evaluate the Safety, Tolerability and Initial Anti-tumor Activity of IMA402, a Bispecific T Cell Engaging Receptor Molecule (TCER®) targeting PRAME, in Patients With Recurrent and/or Refractory Solid Tumors
Arzneimittelgesetz (AMG) / Phase 1, Interventionell, Multizentrisch
Zurück
IMA402-101
Studieninformationen
Studien-Code
UME-ID-11436
UME-ID-11436
Studien-Akronym
IMA402-101
IMA402-101
Studientitel
A Phase I/II First-In-Human Clinical Trial to Evaluate the Safety, Tolerability and Initial Anti-tumor Activity of IMA402, a Bispecific T Cell Engaging Receptor Molecule (TCER®) targeting PRAME, in Patients With Recurrent and/or Refractory Solid Tumors
A Phase I/II First-In-Human Clinical Trial to Evaluate the Safety, Tolerability and Initial Anti-tumor Activity of IMA402, a Bispecific T Cell Engaging Receptor Molecule (TCER®) targeting PRAME, in Patients With Recurrent and/or Refractory Solid Tumors
Aktueller Studienstatus
Aktiv, rekrutierend
Aktiv, rekrutierend
Studie aktiv in den Jahren
2023,2024,2025,2026
2023,2024,2025,2026
Beteiligte
Institute
Klinik für Dermatologie, Westdeutsches Tumorzentrum
Klinik für Dermatologie, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)
Prof. Dr. med. Dirk Schadendorf
+49 (0)201 723-2225
Hautklinik.Studienzentrum@uk-essen.de
Hufelandstraße 55
45147 Essen
Sponsor
immatics biotechnologies GmbH, Tübingen
Studiendesign
Multizentrisch, National
Multizentrisch, National
Studienteilnehmende Mindestalter
18 Jahr(e)
18 Jahr(e)
Geschlecht
Männlich, Weiblich
Männlich, Weiblich
Indikation
Melanom
Melanom
Medizinischer Befund
Refractory Cancer\nRecurrent Cancer\nSolid Tumor, Adult\nCancer
Refractory Cancer\nRecurrent Cancer\nSolid Tumor, Adult\nCancer
IMC-F106C-301
A Phase 3 Randomized, Controlled Study of IMC-F 106C Plus Nivolumab Versus Nivolumab Regimens in HLA-A*02:01-Positive Participants With Previously Untreated Advanced Melanoma (PRISM-MEL-301)
Clinical Trial Regulation (CTR) / Interventionell, Multizentrisch
Zurück
IMC-F106C-301
Studieninformationen
Studien-Code
UME-ID-11454
UME-ID-11454
Studien-Akronym
IMC-F106C-301
IMC-F106C-301
Studientitel
A Phase 3 Randomized, Controlled Study of IMC-F 106C Plus Nivolumab Versus Nivolumab Regimens in HLA-A*02:01-Positive Participants With Previously Untreated Advanced Melanoma (PRISM-MEL-301)
A Phase 3 Randomized, Controlled Study of IMC-F 106C Plus Nivolumab Versus Nivolumab Regimens in HLA-A*02:01-Positive Participants With Previously Untreated Advanced Melanoma (PRISM-MEL-301)
Aktueller Studienstatus
Aktiv, rekrutierend
Aktiv, rekrutierend
Studie aktiv in den Jahren
2024,2025,2026
2024,2025,2026
Beteiligte
Institute
Klinik für Dermatologie, Westdeutsches Tumorzentrum
Klinik für Dermatologie, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)
Prof. Dr. med. Dirk Schadendorf
+49 (0)201 723-2225
Hautklinik.Studienzentrum@uk-essen.de
Hufelandstraße 55
45147 Essen
Sponsor
Immunocore Limited, UK
Studiendesign
randomisiert, offen, kontrolliert, Multizentrisch, International
randomisiert, offen, kontrolliert, Multizentrisch, International
Einschlusskriterien
- Participants must be HLA-A*02:01-positive
- Participants must have histologically confirmed Stage IV or unresectable Stage III melanoma
- Archived or fresh tumor tissue sample that must be confirmed as adequate
- Participants must have measurable disease per RECIST 1.1
- Participant must have BRAF V600 mutation status determined
- Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Male and female participants of childbearing potential who are sexually active with a non-sterilized partner must agree to use highly effective methods of birth control from the study screening date until 5 months after the final dose of study intervention
- Participants must be HLA-A*02:01-positive
- Participants must have histologically confirmed Stage IV or unresectable Stage III melanoma
- Archived or fresh tumor tissue sample that must be confirmed as adequate
- Participants must have measurable disease per RECIST 1.1
- Participant must have BRAF V600 mutation status determined
- Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Male and female participants of childbearing potential who are sexually active with a non-sterilized partner must agree to use highly effective methods of birth control from the study screening date until 5 months after the final dose of study intervention
Ausschlusskriterien
- Participants with a history of a malignant disease other than those being treated in this study
- Participants with untreated, active, or symptomatic central nervous system (CNS) metastases or carcinomatous meningitis
- Hypersensitivity to IMC-F106C, nivolumab, relatlimab, or any associated excipients
- Participants with clinically significant pulmonary disease or impaired lung function
- Participants with clinically significant cardiac disease or impaired cardiac function
- Participants with active autoimmune disease requiring immunosuppressive treatment
- Participants with any medical condition that is poorly controlled or that would, in the Investigator's or Sponsor's judgment, adversely impact the participant's participation in the clinical study due to safety concerns, compliance with clinical study procedures, or interpretation of study results
- Participants who received prior systemic anticancer therapy for unresectable or metastatic melanoma
- Participants with a history of a life-threatening AE related to prior anti-PD-(L)1 or anti-LAG-3
- Participants with a history of a malignant disease other than those being treated in this study
- Participants with untreated, active, or symptomatic central nervous system (CNS) metastases or carcinomatous meningitis
- Hypersensitivity to IMC-F106C, nivolumab, relatlimab, or any associated excipients
- Participants with clinically significant pulmonary disease or impaired lung function
- Participants with clinically significant cardiac disease or impaired cardiac function
- Participants with active autoimmune disease requiring immunosuppressive treatment
- Participants with any medical condition that is poorly controlled or that would, in the Investigator's or Sponsor's judgment, adversely impact the participant's participation in the clinical study due to safety concerns, compliance with clinical study procedures, or interpretation of study results
- Participants who received prior systemic anticancer therapy for unresectable or metastatic melanoma
- Participants with a history of a life-threatening AE related to prior anti-PD-(L)1 or anti-LAG-3
Studienteilnehmende Mindestalter
18 Jahr(e)
18 Jahr(e)
Indikation
Melanom
Melanom
Medizinischer Befund
Advanced melanoma
Advanced melanoma
IMCgp100-203
EudraCT-Nummer: 2022-502732-39-00
Phase 2/3 Randomized Study of Tebentafusp as Monotherapy and in Combination With Pembrolizumab Versus Investigator's Choice in HLA-A*02:01-positive Participants With Previously Treated Advanced Melanoma (TEBE-AM)
Arzneimittelgesetz (AMG) / Phase 2, Interventionell, Multizentrisch
Zurück
IMCgp100-203
Studieninformationen
Studien-Code
UME-ID-11435
UME-ID-11435
Studien-Akronym
IMCgp100-203
IMCgp100-203
Studientitel
Phase 2/3 Randomized Study of Tebentafusp as Monotherapy and in Combination With Pembrolizumab Versus Investigator's Choice in HLA-A*02:01-positive Participants With Previously Treated Advanced Melanoma (TEBE-AM)
Phase 2/3 Randomized Study of Tebentafusp as Monotherapy and in Combination With Pembrolizumab Versus Investigator's Choice in HLA-A*02:01-positive Participants With Previously Treated Advanced Melanoma (TEBE-AM)
Aktueller Studienstatus
Aktiv, rekrutierend
Aktiv, rekrutierend
Studie aktiv in den Jahren
2024,2025,2026
EudraCT-Nummer: 2022-502732-39-00 2024,2025,2026
Beteiligte
Institute
Klinik für Dermatologie, Westdeutsches Tumorzentrum
Klinik für Dermatologie, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)
Prof. Dr. med. Dirk Schadendorf
+49 (0)201 723-2225
Hautklinik.Studienzentrum@uk-essen.de
Hufelandstraße 55
45147 Essen
Sponsor
Immunocore Limited, UK
Studiendesign
randomisiert, offen, Multizentrisch, International
randomisiert, offen, Multizentrisch, International
Einschlusskriterien
- HLA-A*02:01-positive.
- unresectable Stage III or Stage IV non-ocular melanoma
- archival tumor tissue sample or a newly obtained biopsy of a tumor lesion not previously irradiated has been provided.
- measurable or non-measurable disease per RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- If applicable, must agree to use highly effective contraception
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed Consent (ICF) and protocol
- HLA-A*02:01-positive.
- unresectable Stage III or Stage IV non-ocular melanoma
- archival tumor tissue sample or a newly obtained biopsy of a tumor lesion not previously irradiated has been provided.
- measurable or non-measurable disease per RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- If applicable, must agree to use highly effective contraception
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed Consent (ICF) and protocol
Ausschlusskriterien
- Pregnant or lactating women
- diagnosis of ocular or metastatic uveal melanoma
- history of a malignant disease other than those being treated in this study
- ineligible to be retreated with pembrolizumab due to a treatment-related AE
- known untreated or symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis
- previous severe hypersensitivity reaction to treatment with another monoclonal antibody (mAb)
-active autoimmune disease requiring immunosuppressive treatment
- clinically significant medical condition
- known psychiatric or substance abuse disorders
- received prior treatment with a licensed or investigative Immune-mobilizing monoclonal T-cell receptor Against Cancer (ImmTAC) medication
- received chemotherapy or biological cancer therapy (excluding anti-PD(L)1 mAb, ipilimumab, and BRAF TKI regimen) within 14 days of first dose
- received cellular therapies within 90 days of first dose
- received systemic treatment with steroids or any other immunosuppressive drug within 2 weeks of first dose
- have not progressed on treatment with an anti-PD(L)1 mAb
- have not received prior ipilimumab
- a BRAF V600 mutation, who have not received a prior BRAF/MEK TKI regimen
- currently participating or have participated in a study of an investigational agent or using an investigational device within 30 days of the first dose
- known history of chronic viral infections
- Out of range Laboratory values
- history of allogenic tissue/solid organ transplant
- Pregnant or lactating women
- diagnosis of ocular or metastatic uveal melanoma
- history of a malignant disease other than those being treated in this study
- ineligible to be retreated with pembrolizumab due to a treatment-related AE
- known untreated or symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis
- previous severe hypersensitivity reaction to treatment with another monoclonal antibody (mAb)
-active autoimmune disease requiring immunosuppressive treatment
- clinically significant medical condition
- known psychiatric or substance abuse disorders
- received prior treatment with a licensed or investigative Immune-mobilizing monoclonal T-cell receptor Against Cancer (ImmTAC) medication
- received chemotherapy or biological cancer therapy (excluding anti-PD(L)1 mAb, ipilimumab, and BRAF TKI regimen) within 14 days of first dose
- received cellular therapies within 90 days of first dose
- received systemic treatment with steroids or any other immunosuppressive drug within 2 weeks of first dose
- have not progressed on treatment with an anti-PD(L)1 mAb
- have not received prior ipilimumab
- a BRAF V600 mutation, who have not received a prior BRAF/MEK TKI regimen
- currently participating or have participated in a study of an investigational agent or using an investigational device within 30 days of the first dose
- known history of chronic viral infections
- Out of range Laboratory values
- history of allogenic tissue/solid organ transplant
Studienteilnehmende Mindestalter
18 Jahr(e)
18 Jahr(e)
Geschlecht
Männlich, Weiblich
Männlich, Weiblich
Indikation
Melanom
Melanom
Medizinischer Befund
Advanced Melanoma
Advanced Melanoma
NAZARÉ
NAZARÉ: Concurrent optical and magnetic stimulation (COMS) for treatment of patients with chroniculcers of vascular origin in a real-world Setting including care at patient's home, a prospective randomized, controlled, Assessor blinded, Phase IV, clinical trial
Medizinproduktegesetz (MPG) / Produktklasse III
Zurück
NAZARÉ
Studieninformationen
Studien-Code
UME-ID-12464
UME-ID-12464
Studien-Akronym
NAZARÉ
NAZARÉ
Studientitel
NAZARÉ: Concurrent optical and magnetic stimulation (COMS) for treatment of patients with chroniculcers of vascular origin in a real-world Setting including care at patient's home, a prospective randomized, controlled, Assessor blinded, Phase IV, clinical trial
NAZARÉ: Concurrent optical and magnetic stimulation (COMS) for treatment of patients with chroniculcers of vascular origin in a real-world Setting including care at patient's home, a prospective randomized, controlled, Assessor blinded, Phase IV, clinical trial
Aktueller Studienstatus
Aktiv, rekrutierend
Aktiv, rekrutierend
Studie aktiv in den Jahren
2026
2026
Beteiligte
Institut
Klinik für Dermatologie
Klinik für Dermatologie
Prüfarzt (AMG) / Studienleitung (BO)
Prof. Dr. med. Joachim Dissemond
+49 (0)201 723-2225
Hautklinik.Studienzentrum@uk-essen.de
Hufelandstr 55
45147 Essen
Studiendesign
randomisiert
randomisiert
Einschlusskriterien
* Diagnosed leg Ulcer of vascular origin (venous or mixed venous-arterial) without severe arterial insufficiency. Diagnosis of leg ulcer is based on angiological tests carried out at a given time, regardless of whether it is recent or older.
* Ulcer area between 2 - 50 cm2 after debridement
* Patients are older than 18 years of age.
* Chronic ulcer(s) with duration greater than 30 days and less than 2 years (continuous duration)
* If more than one ulcer is present, the target ulcer may be chosen based on the investigator's preference. However, the target ulcer must have a spatial distance of at least 5cm from all other ulcers so that measurements can be carried out accurately even in case an ulcer is growing in size.
+ For diabetic patients: well-controlled diabetic mellitus (HbA1c = 8%, historical results <3 months is acceptable)
* Adequate vascular perfusion as evidence by: ABI > 0.5 and < 1.30, ankle artery pressure >60 mmHg (historical results <3 months is acceptable).
* Women of childbearing age must agree to use adequate method of contraception
* Informed consent as documented by signature of the participant or a LAR, and being able to understand German or French language and follow the study protocol (cognition)
* Diagnosed leg Ulcer of vascular origin (venous or mixed venous-arterial) without severe arterial insufficiency. Diagnosis of leg ulcer is based on angiological tests carried out at a given time, regardless of whether it is recent or older.
* Ulcer area between 2 - 50 cm2 after debridement
* Patients are older than 18 years of age.
* Chronic ulcer(s) with duration greater than 30 days and less than 2 years (continuous duration)
* If more than one ulcer is present, the target ulcer may be chosen based on the investigator's preference. However, the target ulcer must have a spatial distance of at least 5cm from all other ulcers so that measurements can be carried out accurately even in case an ulcer is growing in size.
+ For diabetic patients: well-controlled diabetic mellitus (HbA1c = 8%, historical results <3 months is acceptable)
* Adequate vascular perfusion as evidence by: ABI > 0.5 and < 1.30, ankle artery pressure >60 mmHg (historical results <3 months is acceptable).
* Women of childbearing age must agree to use adequate method of contraception
* Informed consent as documented by signature of the participant or a LAR, and being able to understand German or French language and follow the study protocol (cognition)
Ausschlusskriterien
* Women who are pregnant or breastfeeding (Women of childbearing potential need to perform a pregnancy test (urine test) within 24 hours prior to the study intervention and need at least one simple acceptable contraceptive method)
* Suspected skin cancer, or documented history of skin cancer or any other localized cancer, precancerous lesions or large moles in the areas to be treated.
* Use of photosensitizing agents or medications
* The patient is undergoing severe endogenous or drug immunosuppression
* Decompensated heart failure (NYHA III-IV)
* Patient with chronic renal insufficiency currently undergoing dialysis.
* Wounds with >30% wound area reduction in the last 2 weeks while receiving optimal standard of care (SOC) prior to randomization
* The patient is receiving systemic antibiotic treatment or is receiving/needing antibiotic wound therapy in/near the wound at inclusion
* The patient has received one of the following treatments in the last 2 weeks:
- Arterial interventions such as angioplasty or vascular surgery. Venous Interventions including venous angioplasty, sclerotherapy, stenting, or endovenous thermal or non-thermal ablation.
* Cell and tissue based therapies such as punch & skin grafts in general, placental based allografts, autologous skin substitutes, cellular and acellular dermal matrix, platelet rich plasma and stem cell therapies
* Advanced wound care therapies such as shock wave, cold plasma, electric stimulation, ultrasound, negative pressure wound therapy, nanotechnologies, oxygen therapies
* Participants that were previously included in this clinical trial
* Women who are pregnant or breastfeeding (Women of childbearing potential need to perform a pregnancy test (urine test) within 24 hours prior to the study intervention and need at least one simple acceptable contraceptive method)
* Suspected skin cancer, or documented history of skin cancer or any other localized cancer, precancerous lesions or large moles in the areas to be treated.
* Use of photosensitizing agents or medications
* The patient is undergoing severe endogenous or drug immunosuppression
* Decompensated heart failure (NYHA III-IV)
* Patient with chronic renal insufficiency currently undergoing dialysis.
* Wounds with >30% wound area reduction in the last 2 weeks while receiving optimal standard of care (SOC) prior to randomization
* The patient is receiving systemic antibiotic treatment or is receiving/needing antibiotic wound therapy in/near the wound at inclusion
* The patient has received one of the following treatments in the last 2 weeks:
- Arterial interventions such as angioplasty or vascular surgery. Venous Interventions including venous angioplasty, sclerotherapy, stenting, or endovenous thermal or non-thermal ablation.
* Cell and tissue based therapies such as punch & skin grafts in general, placental based allografts, autologous skin substitutes, cellular and acellular dermal matrix, platelet rich plasma and stem cell therapies
* Advanced wound care therapies such as shock wave, cold plasma, electric stimulation, ultrasound, negative pressure wound therapy, nanotechnologies, oxygen therapies
* Participants that were previously included in this clinical trial
Studienteilnehmende Mindestalter
18 Jahr(e)
18 Jahr(e)
Geschlecht
Divers, Männlich, Weiblich
Divers, Männlich, Weiblich
Indikation
Diverse
Diverse
Medizinischer Befund
Venous Leg Ulcer\nWound Heal\nMagnetic Field Exposure
Venous Leg Ulcer\nWound Heal\nMagnetic Field Exposure
NeoMatryx
Neoadjuvant Merkel cell carcinoma therapy (Tx) with the PD-1 Inhibitor Cemiplimab - A randomized, double-blind, placebo-controlled, non-comparative Phase II study
Clinical Trial Regulation (CTR) / Interventionell
Zurück
NeoMatryx
Studieninformationen
Studien-Code
UME-ID-12891
UME-ID-12891
Studien-Akronym
NeoMatryx
NeoMatryx
Studientitel
Neoadjuvant Merkel cell carcinoma therapy (Tx) with the PD-1 Inhibitor Cemiplimab - A randomized, double-blind, placebo-controlled, non-comparative Phase II study
Neoadjuvant Merkel cell carcinoma therapy (Tx) with the PD-1 Inhibitor Cemiplimab - A randomized, double-blind, placebo-controlled, non-comparative Phase II study
Aktueller Studienstatus
Aktiv, rekrutierend
Aktiv, rekrutierend
Studie aktiv in den Jahren
2026
2026
Beteiligte
Institute
Klinik für Dermatologie, Westdeutsches Tumorzentrum
Klinik für Dermatologie, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)
Prof. Dr. med. Dirk Schadendorf
+49 (0)201 723-2225
Hautklinik.Studienzentrum@uk-essen.de
Hufelandstraße 55
45147 Essen
Studiendesign
randomisiert, doppelt verblindet, kontrolliert
randomisiert, doppelt verblindet, kontrolliert
Geschlecht
Divers, Männlich, Weiblich
Divers, Männlich, Weiblich
Indikation
MCC - Merkelzellkarzinom, Non-melanoma skin cancer (NMSC)
MCC - Merkelzellkarzinom, Non-melanoma skin cancer (NMSC)
Medizinischer Befund
Merkel cell carcinoma
Merkel cell carcinoma
SKABUP
Multizentrische, prospektive, randomisierte, doppelblinde Phase III-Studie zum Vergleich der Wirksamkeit und Sicherheit der Therapie der Skabies mit zwei unterschiedlich konzentrierten Permethrin-Cremes
Clinical Trial Regulation (CTR) / Interventionell, Multizentrisch
Zurück
SKABUP
Studieninformationen
Studien-Code
UME-ID-12252
UME-ID-12252
Studien-Akronym
SKABUP
SKABUP
Studientitel
Multizentrische, prospektive, randomisierte, doppelblinde Phase III-Studie zum Vergleich der Wirksamkeit und Sicherheit der Therapie der Skabies mit zwei unterschiedlich konzentrierten Permethrin-Cremes
Multizentrische, prospektive, randomisierte, doppelblinde Phase III-Studie zum Vergleich der Wirksamkeit und Sicherheit der Therapie der Skabies mit zwei unterschiedlich konzentrierten Permethrin-Cremes
Aktueller Studienstatus
Aktiv, rekrutierend
Aktiv, rekrutierend
Studie aktiv in den Jahren
2024,2025,2026
2024,2025,2026
Beteiligte
Institut
Klinik für Dermatologie
Klinik für Dermatologie
Prüfarzt (AMG) / Studienleitung (BO)
Prof. Dr. med. Wiebke Sondermann
+49 (0)201 723-2225
Hautklinik.Studienzentrum@uk-essen.de
Hufelandstr 55
45147 Essen
Studiendesign
randomisiert, doppelt verblindet, Multizentrisch
randomisiert, doppelt verblindet, Multizentrisch
Indikation
Skabies
Skabies
V940-012
A Phase 2, Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled Clinical Study of V940 (mRNA-4157) Plus Pembrolizumab Versus Placebo Plus Pembrolizumab in Participants With First-Line Advanced Melanoma (INTerpath-012)
Clinical Trial Regulation (CTR) / Interventionell
Zurück
V940-012
Studieninformationen
Studien-Code
UME-ID-12590
UME-ID-12590
Studien-Akronym
V940-012
V940-012
Studientitel
A Phase 2, Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled Clinical Study of V940 (mRNA-4157) Plus Pembrolizumab Versus Placebo Plus Pembrolizumab in Participants With First-Line Advanced Melanoma (INTerpath-012)
A Phase 2, Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled Clinical Study of V940 (mRNA-4157) Plus Pembrolizumab Versus Placebo Plus Pembrolizumab in Participants With First-Line Advanced Melanoma (INTerpath-012)
Aktueller Studienstatus
Aktiv, rekrutierend
Aktiv, rekrutierend
Studie aktiv in den Jahren
2025,2026
2025,2026
Beteiligte
Institute
Klinik für Dermatologie, Westdeutsches Tumorzentrum
Klinik für Dermatologie, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)
Prof. Dr. med. Dirk Schadendorf
+49 (0)201 723-2225
Hautklinik.Studienzentrum@uk-essen.de
Hufelandstraße 55
45147 Essen
Studiendesign
randomisiert, doppelt verblindet, kontrolliert
randomisiert, doppelt verblindet, kontrolliert
Studienteilnehmende Mindestalter
18 Jahr(e)
18 Jahr(e)
Geschlecht
Divers, Männlich, Weiblich
Divers, Männlich, Weiblich
Indikation
Melanom
Melanom
Medizinischer Befund
Melanom
Melanom