Clinical Trials

Dermatologic Tumors

Recruitment stopped
Ongoing Recruitment

EORTC18081 (PEG-Interferon)

(adjuvant)
Title:Adjuvant Pegylated-Interferon-alpha2b (SylatronTM) for 2 Years Versus Observation in Patients With an Ulcerated Primary Cutaneous Melanoma With T(2-4)bN0M0: a Randomized Phase III Trial of the EORTC Melanoma Group.
Indication:Resected ulcerated primary cutaneous Melanoma
Type of study:Phase III
Contact: Silvia Körner (Study Nurse)
[silvia.koerner@med.uni-heidelberg.de]
Investigator: Dr. med. Jessica Hassel (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT01502696
EudraCT: 2009-010273-20 (siehe EU klinisches Studienregister)

IMMUNED

(adjuvant)
Title:A Phase II Randomized, Double-Blind Trial of Immunotherapy with Nivolumab or Nivolumab plus Ipilimumab versus Double-Placebo Control as a Post-Surgical/Post-Radiation Treatment for Stage IV Melanoma with No Evidence of Disease
Indication:Stage IV Melanoma with No Evidence of Disease
Type of study:Phase II
Contact: Silvia Körner (Study Nurse)
[silvia.koerner@med.uni-heidelberg.de]
Investigator: Dr. med. Jessica Hassel (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT02523313
EudraCT: 2014-001167-12 (siehe EU klinisches Studienregister)

NICCI

(neoadjuvant)
Title:A Phase II, single-armed, multicenter Trial of neoadjuvant vismodegib in patients with large and/or recurrent basal cell carcinoma (NICCI).
Indication:basal cell carcinoma
Type of study:Phase II
Contact: Silvia Körner (Study Nurse)
[silvia.koerner@med.uni-heidelberg.de]
Investigator: Dr. med. Jessica Hassel (Prüfer)
Trial Register: No trial registry number given.
EudraCT: 2016-002856-26 (siehe EU klinisches Studienregister)

PIVOTAL (PH-L19IL2TNF-02/15, neoadjuvant)

(neoadjuvant)
Title:A pivotal Phase III, open-label, randomized, controlled multi-center study of the efficacy of L19IL2/L19TNF neoadjuvant intratumoral treatment followed by surgery versus surgery alone in clinical stage III B/C melanoma patients.
Indication:Melanoma stage IIIB/C with presence of injectable cutaneous and/or subcutaneous or nodal lesions
Type of study:Phase III
Contact: Silvia Körner (Study Nurse)
[silvia.koerner@med.uni-heidelberg.de]
Investigator: Dr. med. Jessica Hassel (Prüfer)
Trial Register: No trial registry number given.
EudraCT: 2015-002549-72 (siehe EU klinisches Studienregister)

CA017-055

(first-line, metastatsiert)
Title:Anti-PD-1 Refractory Melanoma
Indication:Malignant Melanoma
Type of study:Phase III
Contact: Silvia Körner (Study Nurse)
[silvia.koerner@med.uni-heidelberg.de]
Investigator: Dr. med. Jessica Hassel (Prüfer)
Trial Register: No trial registry number given.
EudraCT: 2017-002499-14 (siehe EU klinisches Studienregister)

ImmunoCobiVem_2015

(first-line)
Title:A Phase II, Open-label, Randomized-controlled Trial Evaluating the Efficacy and Safety of a Sequencing Schedule of Cobimetinib Plus Vemurafenib Followed by Immunotherapy With an Anti- PD-L1 Antibody Atezolizumab for the Treatment in Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma
Indication:Melanoma
Type of study:Phase II
Contact: Silvia Körner (Study Nurse)
[silvia.koerner@med.uni-heidelberg.de]
Investigator: Dr. med. Jessica Hassel (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT02902029
EudraCT: 2015-005097-37 (siehe EU klinisches Studienregister)

T-VEC+Pembro (2011265)

(first-line)
Title:A Phase 1b/3, Multicenter, Trial of Talimogene Laherparepvec in Combination With Pembrolizumab (MK-3475) for Treatment of Unresectable Stage IIIB to IVM1c Melanoma (MASTERKEY-265)
Indication:Melanoma
Type of study:Phase II
Contact: Silvia Körner (Study Nurse)
[silvia.koerner@med.uni-heidelberg.de]
Investigator: Dr. med. Guy Ungerechts (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT02263508
EudraCT: 2014-000185-22 (siehe EU klinisches Studienregister)

TRILOGY (CO39262)

(first-line)
Title:A Phase III, Double-Blinded, Randomized, Placebo-Controlled Study of Atezolizumab Plus Cobimetinib and Vemurafenib Versus Placebo Plus Cobimetinib and Vemurafenib in Previously Untreated BRAFV600 Mutation-Positive Patients With Unresectable Locally Advanced or Metastatic Melanoma
Indication:Melanoma
Type of study:Phase III
Contact: Silvia Körner (Study Nurse)
[silvia.koerner@med.uni-heidelberg.de]
Investigator: Dr. med. Jessica Hassel (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT02908672
EudraCT: 2016-002482-54 (siehe EU klinisches Studienregister)

BMS CA 209-234 (Checkmate / Nivo-PASS)

(second-line, epidemiologisch)
Title:Pattern of Use and Safety/Effectiveness of Nivolumab in Routine Oncology Practice
Indication:melanoma
Type of study:Phase IV
Contact: Silvia Körner (Study Nurse)
[silvia.koerner@med.uni-heidelberg.de]
Investigator: Dr. med. Jessica Hassel (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT02847728
EudraCT: Not stated. Non-interventional studies and studies not controlled by the Medicines Act do not have a EudraCT number.

BOTTOM

(second-line)
Title:Biopsy- and biology-driven optimization of targeted therapy of metastatic melanoma in BRAF inhibitor non-pretreated and pretreated subjects with advanced, non-resectable (Stage IIIC) or metastatic (Stage IV) BRAF V600E/K mutation-positive melanoma
Indication:metastatic BRAF V600E/K mutation-positive melanoma
Type of study:Phase II
Contact: Silvia Körner (Study Nurse)
[silvia.koerner@med.uni-heidelberg.de]
Investigator: Dr. med. Jessica Hassel (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT02410863
EudraCT: 2012-005569-10 (siehe EU klinisches Studienregister)

COMBI-r / CDRB436BDE04

(second-line, epidemiologisch)
Title:Nicht-interventionelle Studie (NIS) COMBI-r bei Patienten mit fortgeschrittenem Melanom zur Bewertung der Kombinationstherapie mit Dabrafenib (Tafinlar®) und Trametinib (Mekinist®) in der klinischen Routine
Indication:melanoma
Type of study:Phase N/A
Contact: Silvia Körner (Study Nurse)
[silvia.koerner@med.uni-heidelberg.de]
Investigator: Dr. med. Jessica Hassel (Prüfer)
Trial Register: No trial registry number given.
EudraCT: Not stated. Non-interventional studies and studies not controlled by the Medicines Act do not have a EudraCT number.

ELEKTRA (Gehirn-Radiatio +/- Ipilimumab)

(second-line)
Title:Evaluation of the Radiotherapeutic and Immunemodulatory Response to Whole Brain Radiotherapy (WBRT) or Stereotactic Radiosurgery (SRS) in patients with brain metastases from Malignant Melanoma (MM) treated with or without Ipilimumab (IP)
Indication:Brain metastatic Melanoma
Type of study:Phase I/II
Contact: Silvia Körner (Study Nurse)
[silvia.koerner@med.uni-heidelberg.de]
Investigator: PD Dr. med. Stephanie Combs (Leiter klinische Prüfung)
Trial Register: No trial registry number given.
EudraCT: Not stated. Non-interventional studies and studies not controlled by the Medicines Act do not have a EudraCT number.

Immunocore (IMCgp100-201)

(second-line)
Title:A Phase Ib/II Open-label, Multi-center Study of the Safety and Efficacy of IMCgp100 in Combination With Durvalumab (MEDI4736) or Tremelimumab or the Combination of Durvalumab and Tremelimumab in Patients With Advanced Melanoma
Indication:Melanoma
Type of study:Phase I/II
Contact: Silvia Körner (Study Nurse)
[silvia.koerner@med.uni-heidelberg.de]
Investigator: Dr. med. Jessica Hassel (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT02535078
EudraCT: 2015-002971-12 (siehe EU klinisches Studienregister)

Lipo-MERIT (RB_0003-01)

(second-line)
Title:Clinical First-in-human Dose Escalation Study Evaluating the Safety and Tolerability of Intravenous Administration of a Tetravalent RNA-lipoplex Cancer Vaccine Targeting Four Tumour-associated Antigens in Patients With Advanced Melanoma
Indication:- advanced metastatic Melanoma - subjects not eligible or declining any other available approved therapy
Type of study:Phase I
Contact: Silvia Körner (Study Nurse)
[silvia.koerner@med.uni-heidelberg.de]
Investigator: Dr. med. Jessica Hassel (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT02410733
EudraCT: 2013-001646-33 (siehe EU klinisches Studienregister)

NIPAWILMA

(second-line)
Title:A Phase I/II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Nintedanib/Vargatef in Combination With Paclitaxel Chemotherapy for Treatment of Patients with BRAF Wildtype Metastatic Melanoma
Indication:BRAF Wildtype Metastatic Melanoma
Type of study:Phase I/II
Contact: Silvia Körner (Study Nurse)
[silvia.koerner@med.uni-heidelberg.de]
Investigator: Dr. med. Jessica Hassel (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT02308553
EudraCT: 2013-004458-34 (siehe EU klinisches Studienregister)

Sensitize

(second-line, metastatsiert)
Title:Unverblindete, multizentrische Studie der Phase Ib/II zu 4SC-202 in Kombination mit Pembrolizumab bei Patienten mit nicht resezierbarem kutanem Melanom im Stadium III / metastasiertem kutanem Melanom im Stadium IV mit primärer Refraktärität gegen / Nichtansprechen auf eine frühere Anti-PD-1-Therapie
Indication:Malignant Melanoma
Type of study:Phase I/II
Contact: Silvia Körner (Study Nurse)
[silvia.koerner@med.uni-heidelberg.de]
Investigator: Dr. med. Jessica Hassel (Prüfer)
Trial Register: No trial registry number given.
EudraCT: 2017-001050-33 (siehe EU klinisches Studienregister)

Minitub (EORTC 1208)

(epidemiologisch, chirurgisch)
Title:Minitub: Prospective Registry of Sentinel Node (SN) Positive Melanoma Patients With Minimal SN Tumor Burden Who Undergo Completion Lymph Node Dissection (CLND) or Nodal Observation
Indication:Melanoma
Type of study:Phase N/A
Contact: Silvia Körner (Study Nurse)
[silvia.koerner@med.uni-heidelberg.de]
Investigator: Dr. med. Jessica Hassel (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT01942603
EudraCT: Not stated. Non-interventional studies and studies not controlled by the Medicines Act do not have a EudraCT number.

BEXACOS / ADO-CTCL-4

Title:This is a non-interventional, open observational study to describe and analyse the mode of maintenance management, including medical treatment, of patients with the Mycosis fungoides subtype of cutaneous T-cell lymphoma after having achieved a partial remission from a PUVA-based treatment regimen. The study objective is to collect and evaluate field data on bexarotene and other treatment modalities to control cutaneous T-cell lymphoma after previous treatment with PUVA
Indication:Mycosis fungoides subtype of cutaneous T-cell lymphoma
Type of study:Phase N/A
Contact: Silvia Körner (Kontaktperson)
[silvia.koerner@med.uni-heidelberg.de]
Investigator: Dr. med. Jessica Hassel (Prüfer)
Trial Register: No trial registry number given.
EudraCT: Not stated. Non-interventional studies and studies not controlled by the Medicines Act do not have a EudraCT number.

CPDR001F2301 / Combi I

Title:A Randomized, Double-blind, Placebo-controlled, Phase III Study Comparing the Combination of PDR001, Dabrafenib and Trametinib Versus Placebo, Dabrafenib and Trametinib in Previously Untreated Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma
Indication:Melanoma
Type of study:Phase III
Contact: Silvia Körner (Kontaktperson)
[silvia.koerner@med.uni-heidelberg.de]
Investigator: Dr. med. Jessica Hassel (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT02967692
EudraCT: 2016-002794-35 (siehe EU klinisches Studienregister)

CV-8102-008

Title:Phase I Study of Intratumoral CV8102 in Patients With Advanced Melanoma, Squamous Cell Carcinoma of the Skin, Squamous Cell Carcinoma of the Head and Neck, or Adenoid Cystic Carcinoma
Indication:Carcinoma, Melanoma, Carcinoma, Squamous Cell, Skin Neoplasms, Head and Neck Neoplasms, Carcinoma, Adenoid Cystic
Type of study:Phase I
Contact: Anette Manka-Stuhlik (Kontaktperson)
[anette.manka-stuhlik@med.uni-heidelberg.de]
Investigator: PD Dr. med. Jürgen Krauss (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT03291002
EudraCT: 2016-003429-41 (siehe EU klinisches Studienregister)

Vaccibody (VBN-01)

Title:An open labelled first human dose phase 1/2a study to evaluate safety, feasibility and efficacy of multiple dosing with individualised VB10.NEO immunotherapy in patients with locally advanced or metastatic melanoma, NSCLC, clear renal cell carcinoma, urothelial cancer or squamous cell carcinoma of head and neck, who did not reach complete responses with current standard of care immune checkpoint blockade
Indication:Locally advanced or metastatic solid tumours including melanoma, NSCLC, clear renal cell carcinoma, urothelial cancer or SCCHN
Type of study:Phase I
Contact: Sebastian Schülke (Kontaktperson)
[Sebastian.Schuelke@med.uni-heidelberg.de]
Investigator: PD Dr. med. Jürgen Krauss (Leiter klinische Prüfung)
Trial Register: No trial registry number given.
EudraCT: 2017-002474-39 (siehe EU klinisches Studienregister)