Klinische Studien

Institute
Klinik für Dermatologie, LVR Kliniken-Essen - Klinik für Psychosomatische Medizin und Psychotherapie, Westdeutsches Tumorzentrum

Prüfarzt (AMG) / Studienleitung (BO)

Frau Madeleine Fink

+49 (0)201 7227-208
Madeleine.fink@uni-due.de

Virchowstr 174
45147 Essen

Indikation
Melanom

Medizinischer Befund
malignes Melanom

Institute
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

Alcedis GmbH, Giessen

Indikation
Melanom

Medizinischer Befund
melanoma

Institute
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

Universitätsklinik Essen (AöR)

+49 (0)201 723-0
info@uk-essen.de

Hufelandstraße 55
45147 Essen

Geschlecht
Divers, Männlich, Weiblich

Indikation
Melanom

Medizinischer Befund
Melanoma

Institute
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

Regeneron Pharmaceuticals, Inc, USA

Einschlusskriterien
- All patients must be either stage IIC, III, or stage IV per American Joint Committee on Cancer (AJCC) 8th edition and have histologically confirmed melanoma that is completely surgically resected in order to be eligible as defined by the protocol
- Complete surgical resection must be performed within 12 weeks prior to randomization, and enrollment may occur only after satisfactory wound healing from the surgery
- All patients must have disease-free status documented by a complete physical examination and imaging studies within 4 weeks prior to randomization, as described in the protocol
Note: Other Protocol Defined Inclusion Criteria Apply

Ausschlusskriterien
- Uveal melanoma
- Any evidence of residual disease after surgery by imaging, pathology, or cytology.
- Ongoing or recent (within 2 years) evidence of clinically significant autoimmune disease that required systemic treatment with immunosuppressive agents
- Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C (HCV) infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection, as described in the protocol
- Another malignancy that is currently progressing or that required active treatment in the past 5 years, as described in the protocol
- Adolescent patients (=12 to <18 years old) with body weight <40 kg
Note: Other Protocol Defined Exclusion Criteria Apply

Studienteilnehmende Mindestalter
12 Jahr(e)

Geschlecht
Männlich, Weiblich

Indikation
Melanom

Medizinischer Befund
Melanoma

Institute
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

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

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

Studienteilnehmende Mindestalter
18 Jahr(e)

Geschlecht
Männlich, Weiblich

Indikation
Melanom

Medizinischer Befund
Advanced Melanoma

Institute
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

Studienteilnehmende Mindestalter
18 Jahr(e)

Geschlecht
Männlich, Weiblich

Indikation
Melanom

Medizinischer Befund
Refractory Cancer\nRecurrent Cancer\nSolid Tumor, Adult\nCancer

Institute
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

Philogen S.p.A, Italien

Einschlusskriterien
- Patients with high-risk, locally advanced (non-metastatic, node negative, single or multifocal), BCC or cSCC amenable to intratumoral injection, not eligible to surgery according to the evaluation of a local interdisciplinary tumor board or who refuse surgery and for whom an histological evaluation is available according to international guidelines.
- Patients with injectable and measurable regional cutaneous or subcutaneous in-transit or satellite metastasis but without regional nodal involvement are also eligible.
- Male or female patients, age 18 - 100 years.
- ECOG Performance Status/WHO Performance Status ≤ 1.
- Hemoglobin > 10.0 g/dL.
- Platelets > 100 x 109/L.
- ALT and AST, GGT and Lipase ≤ 1.5 x the upper limit of normal (ULN).
- Serum creatinine 60 mL/min.
- All acute toxic effects (excluding alopecia) of any prior therapy must have resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v. 5.0) Grade ≤ 1 unless otherwise specified.
- Women of childbearing potential (WOCBP) must have negative pregnancy test results at screening. WOCBP must be using, from screening to three months following the last study drug administration, highly effective contraception methods, as defined by the "Recommendations for contraception and pregnancy testing in clinical trials" issued by the Head of Medicine Agencies' Clinical Trial Facilitation Group and which include, for instance, progesterone-only or combined (estrogen- and progesterone-containing) hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone-releasing systems, bilateral tubal occlusion, vasectomised partner.
- Male patients with WOCBP partners must agree to use simultaneously two acceptable methods of contraception (i.e. spermicidal gel plus condom) from the screening to three months following the last study drug administration.
- Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.

Ausschlusskriterien
- Previous or concurrent cancer type that is distinct from the cancers being evaluated in this study, except any cancer curatively treated more than 2 years prior to study entry.
- Patients may have previously received topical or systemic chemotherapy, immunotherapy or radiation therapy on the tumor sites. Such therapies must be completed at least 4 weeks prior to study drug administration.
- Patients with node positive BCC/cSCC who are candidate to SHH inhibitor or checkpoint inhibitor therapy.
- Presence of active severe bacterial or viral infections or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study. In particular a documented test for HIV, HBV and HCV excluding active infection is needed.
- History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris, inadequately treated cardiac arrhythmias and heart insufficiency (any grade, New York Heart Association (NYHA) criteria).
- Any abnormalities observed during baseline ECG investigations that are considered clinically significant by the investigator.
- Known arterial aneurysms.
- INR > 3.
- Uncontrolled hypertension.
- Known uncontrolled coagulopathy or bleeding disorder.
- Known hepatic cirrhosis or severe pre-existing hepatic impairment.
- Moderate to severe respiratory failure.
- Active autoimmune disease.
- Patient requires or is taking systemic corticosteroids (>5 mg/day) or other immunosuppressant drugs on a long-term basis. Limited use of corticosteroids to treat or prevent acute hypersensitivity reactions and asthma/COPD is not considered an exclusion criterion.
- Known history of allergy to IL2, TNF, or other human proteins/peptides/antibodies.
- Pregnancy or breast-feeding.
- Ischemic peripheral vascular disease (Grade IIb-IV).
- Severe diabetic retinopathy.
- Recovery from major trauma including surgery within 4 weeks prior to enrollment.
- Solid organ transplant recipient or patient with iatrogenic or pathologic severe immune suppression.
- Any conditions that in the opinion of the investigator could hamper compliance with the study protocol

Studienteilnehmende Mindestalter
18 Jahr(e)

Geschlecht
Männlich, Weiblich

Indikation
BCC - Basalzellkarzinom

Medizinischer Befund
Patients with high-risk, locally advanced (non-metastatic, node negative, single or multifocal), basal cell carcinoma (BCC) or cutaneous squamous cell carcinoma (cSCC) amenable to intratumoral injection, not eligible to surgery according to the evaluation of a local interdisciplinary tumor board or who refuse surgery and for whom an histological evaluation is available according to international guidelines

MedDRA Term
Basal cell carcinoma

Institute
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

Indikation
Melanom

Medizinischer Befund
maligne Melanome

Institute
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

IO Biotech ApS, Dänemark

Einschlusskriterien
- Measurable disease based on RECIST 1.1
- Candidate for surgical resection with curative intent
- Willing and able to provide written informed consent for the trial
- Age ≥18 years on the day of signing the informed consent form
- Willing for archival tissue to be submitted for analysis
- Willing to undergo tumor biopsies (core, punch, incisional or excisional) before and during trial treatment
- Willing to undergo dwMRI (if available)
- Willing to undergo PD-L1 status evaluation
- ECOG performance score status of 0 or 1
- Adequate organ function performed on screening labs obtained within 4 weeks before first dose.
- Women of childbearing potential: Negative urine or serum pregnancy within 72 hours prior to receiving the first dose of trial medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Women of childbearing potential: Willing to use highly effective contraception or abstain from heterosexual activity for the duration of the trial and for at least 120 days after the last dose of trial medication.
- Patients who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to start of trial intervention.
- Patients with a history of HCV infection are eligible if HCV viral load is undetectable at screening.

Ausschlusskriterien
- Currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks of the first dose of trial treatment. Note: Patients who have entered the follow-up phase of an investigational trial may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
- Any prior treatment for the tumor under study
- Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX40, CD137), and discontinued from that treatment due to a grade 3 or higher irAE
- Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to first dose of trial treatment. Note: Patients must have recovered from all AEs due to previous therapies (i.e., grade =1 at baseline). Patients with grade =2 neuropathy are eligible for the trial. Patients with endocrine-related AEs grade =2 requiring treatment or hormone replacement are also eligible. Note: If the patient has had major surgery, the patient must have recovered adequately from the procedure and/or complications from the surgery prior to starting trial treatment.
- Live or live-attenuated vaccine within 30 days prior to first dose of trial treatment. Note: Administration of inactivated vaccines, mRNA-based vaccines [e.g.,COVID-19] and vector-based vaccines are allowed.
- Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to first dose of trial treatment. Patients who are currently receiving steroids at a dose equivalent to >10mg/day of hydrocortisone or >5mg/day of prednisone equivalent do not need to discontinue steroids prior to enrollment. Patients who require topical, ophthalmologic and inhalational steroids will not be excluded from the trial. Patients with hypothyroidism stable on hormone replacement or Sjogren's syndrome will not be excluded from the trial.
- Active (i.e., symptomatic or growing) CNS metastases
- Additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
- History of an allogeneic tissue/solid organ transplant
- Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Patients with type I diabetes mellitus; hypothyroidism only requiring hormone replacement; skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment; or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- History or current evidence of non-infectious pneumonitis/ interstitial lung disease that required steroids.
- Active infection requiring systemic therapy.
- History of HIV infection.
- Has known active HBV(defined as HBsAg reactive and/or detectable HBV DNA) or known active HCV(defined as anti HCV Ab positive and detectable HCV RNA [qualitative]) infection.
- History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.
- Psychiatric or substance abuse disorders that would interfere with the patient's ability to cooperate with the trial requirements.
- Severe hypersensitivity (grade =3) to pembrolizumab and/or any of its excipients.
- Women of childbearing potential:Pregnant or breastfeeding, or expecting to conceive a child within the projected duration of the trial, from time of informed consent until at least 120 days after the last dose of trial treatment.

Studienteilnehmende Mindestalter
18 Jahr(e)

Geschlecht
Männlich, Weiblich

Indikation
Melanom

Medizinischer Befund
Melanoma\nSquamous Cell Carcinoma of Head and Neck

Institut
Klinik für Dermatologie

Prüfarzt (AMG) / Studienleitung (BO)

PD Dr. med. Wiebke Sondermann

+49 (0)201 723-2225
Hautklinik.Studienzentrum@uk-essen.de

Hufelandstr 55
45147 Essen

Indikation
AD - Atopische Dermatitis

Medizinischer Befund
Atopic Dermatitis

Institut
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

InflaRx GmbH, Jena

Einschlusskriterien
* clinical diagnosis of ulcerative PG

Ausschlusskriterien
* Women of childbearing potential (WOCBP) who have a positive serum pregnancy test result within 7 days before treatment or are breast feeding.

Studienteilnehmende Mindestalter
18 Jahr(e)

Indikation
Diverse

Medizinischer Befund
Pyoderma Gangrenosum

Institute
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

Indikation
Melanom

Institut
Klinik für Dermatologie

Prüfarzt (AMG) / Studienleitung (BO)

PD Dr. med. Wiebke Sondermann

+49 (0)201 723-2225
Hautklinik.Studienzentrum@uk-essen.de

Hufelandstr 55
45147 Essen

Sponsor

AstraZeneca GmbH

+49 (0)4103 708-0
service.center@astrazeneca.com

Tinsdaler Weg 183 183
22880 Wedel

Einschlusskriterien
* Participants must have a confirmed diagnosis of CLE. Diagnosis must be clinically and histologically confirmed with the following:
- CLASI-A total score ≥ 10 points at Screening and confirmed at randomization.
- CLA-IGA-R erythema score of ≥ 3 and CLA-IGA-R-OMC score of ≥ 1 at Screening and confirmed at randomization.
- Inadequate response or intolerant to antimalarial therapy.
* Participants should have no medical history or signs or symptoms of active or prior tuberculosis infection (TB) and the same should reflect in chest radiograph or a chest CT scan result.
* Contraceptive use by males and females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* Participants should have a coronavirus disease 2019 (COVID-19) negative PCR or antigen test result as per local policies at Screening.

Ausschlusskriterien
* History or evidence of suicidal ideation.
* Severe or life-threatening Systemic lupus erythematosus (SLE).
* Active SLE or Sjögren's Syndrome.
* Any active skin conditions other than CLE that may interfere with the study.
* History of recurrent infection requiring hospitalization and IV antibiotics.
* COVID-19 infection
* Any history of an anaphylactic reaction to human proteins, or monoclonal antibodies.
* At screening, if participants do not meet the eligibility criteria assessed based on laboratory test results e.g tests for total bilirubin, serum creatinine etc.

Studienteilnehmende Mindestalter
18 Jahr(e)

Studienteilnehmende Höchstalter
70 Jahr(e)

Geschlecht
Divers, Männlich, Weiblich

Indikation
Lupus Erythematodes

Medizinischer Befund
Cutaneous Lupus Erythematosus

Institut
Klinik für Dermatologie

Prüfarzt (AMG) / Studienleitung (BO)

PD Dr. med. Wiebke Sondermann

+49 (0)201 723-2225
Hautklinik.Studienzentrum@uk-essen.de

Hufelandstr 55
45147 Essen

Indikation
Hidradenitis suppurativa (HS)

Medizinischer Befund
moderate to severe hidradenitis suppurativa

Institut
Klinik für Dermatologie

Prüfarzt (AMG) / Studienleitung (BO)

PD Dr. med. Wiebke Sondermann

+49 (0)201 723-2225
Hautklinik.Studienzentrum@uk-essen.de

Hufelandstr 55
45147 Essen

Indikation
Palmoplantare Pustulose (PPP)

Medizinischer Befund
moderate-to-severe pustulosis palmoplantaris

Institut
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

Indikation
Diverse

Medizinischer Befund
CHRONIC VENOUS ULCERS

Institut
Klinik für Dermatologie

Prüfarzt (AMG) / Studienleitung (BO)

PD Dr. med. Wiebke Sondermann

+49 (0)201 723-2225
Hautklinik.Studienzentrum@uk-essen.de

Hufelandstr 55
45147 Essen

Indikation
Skabies