Clinical Trials

Dermatologic Tumors

Recruitment stopped
Ongoing Recruitment

ADMEC-O/BMS CA184-205

(adjuvant)
Title:Prospective randomized trial of an adjuvant therapy of completely resected Merkel Cell Carcinoma (MCC) with 3mg/kg BW Ipilimumab (Yervoy®) every 3 weeks for 12 weeks versus observation
Indication:Merkelzellkarzinom nach operativer Entfernung des Tumors
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 NCT02196961
EudraCT: 2013-000043-78 (siehe EU klinisches Studienregister)

PIVOTAL/ PH-L19IL2TNF-02/15

(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:Malignes Melanom
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)

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:Malignes Melanom
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)

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:Malignes Melanom
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:Gehirnmetastasiertes Melanom
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:Fortgeschrittenes Melanom
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:Metastasiertes Melanom
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)

NCT-PMO-1603 TOP-ART

(second-line, BRCAness)
Title:A Randomized Phase-2 Study of Trabectedin/Olaparib Compared to Physician's Choice in Subjects With Previously Treated Advanced or Recurrent Solid Tumors Harboring DNA Repair Deficiencies
Indication:Krebs mit DNA-Reparatur-Defizite
Type of study:Phase II
Contact: Barbara Stöhr (Study Nurse)
[barbara.stoehr@nct-heidelberg.de]
Investigator: Prof. Dr. Stefan Fröhling (Leiter klinische Prüfung)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT03127215
EudraCT: 2017-001755-31 (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)

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.

CV-8102-008 [Rekrutierung nach Anfrage]

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:Plattenepithelkarzinomen des Kopf-Hals-Bereichs sowie Adenoid-zystisches Karzinom/Melanom
Type of study:Phase I
Contact: Anette Manka-Stuhlik (Kontaktperson)
[anette.manka-stuhlik@med.uni-heidelberg.de]
Investigator: Prof. Dr. 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)

CoveNis/ML39302

Title:A NON-INTERVENTIONAL STUDY TO INVESTIGATE THE EFFECTIVENESS, SAFETY AND UTILIZATION OF COBIMETINIB AND VEMURAFENIB IN PATIENTS WITH AND WITHOUT BRAIN METASTASIS WITH BRAF V600 MUTANT MELANOMA UNDER REAL WORLD CONDITIONS (coveNIS ) ML39302
Indication:Malignes Melanom
Type of study:Phase IV
Contact: Melanie Leierer (Study Nurse)
[melanie.leierer@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.

ILLUMINATE-301

Title:A Randomized Phase 3 Comparison of IMO-2125 With Ipilimumab Versus Ipilimumab Alone in Subjects With Anti-PD-1 Refractory Melanoma (ILLUMINATE-301)
Indication:Refraktäres Melanom
Type of study:Phase III
Contact: Melanie Leierer (Study Nurse)
[melanie.leierer@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 NCT03445533
EudraCT: Not stated. Non-interventional studies and studies not controlled by the Medicines Act do not have a EudraCT number.

IMCgp100-202

Title:A Phase II Randomized, Open-label, Multi-center Study of the Safety and Efficacy of IMCgp100 Compared with Investigator’s Choice in HLA-A*0201 Positive Patients with Previously Untreated Advanced Uveal Melanoma
Indication:Melanom der Aderhaut
Type of study:Phase II
Contact: Melanie Leierer (Study Nurse)
[melanie.leierer@med.uni-heidelberg.de]
Investigator: Dr. med. Jessica Hassel (Prüfer)
Trial Register: No trial registry number given.
EudraCT: 2015-003153-18 (siehe EU klinisches Studienregister)

IRINA

Title:Einfluss einer Bestrahlung auf die Immunantwort nach Immune Checkpoint Blockade in Patienten mit metastasiertem Melanom
Indication:Metastasiertes Melanom
Type of study:Phase N/A
Contact: Studienzentrale Dermatoonkologie NCT (Kontaktperson)
[studien-dermaonko.nct@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.

R2810-ONC-1620

Title:A PHASE 2 STUDY OF REGN2810, A FULLY HUMAN MONOCLONAL ANTIBODY TO PROGRAMMED DEATH-1, IN PATIENTS WITH ADVANCED BASAL CELL CARCINOMA WHO EXPERIENCED PROGRESSION OF DISEASE ON HEDGEHOG PATHWAY INHIBITOR THERAPY, OR WERE INTOLERANT OF PRIOR HEDGEHOG PATHWAY INHIBITOR THERAPY
Indication:Fortgeschrittenes Basalzellkarzinom
Type of study:Phase II
Contact: Melanie Leierer (Study Nurse)
[melanie.leierer@med.uni-heidelberg.de]
Investigator: Dr. med. Jessica Hassel (Prüfer)
Trial Register: No trial registry number given.
EudraCT: 2016-003122-16 (siehe EU klinisches Studienregister)

TUD-CoBRIM-067

Title:An open-label phase II multicenter study of vemurafenib (Zelboraf®) plus cobimetinib (Cotellic®) after radiosurgery in patients with active BRAF-V600-mutant melanoma brain metastases
Indication:Hirnmetastasen bei Melanom
Type of study:Phase II
Contact: Melanie Leierer (Study Nurse)
[melanie.leierer@med.uni-heidelberg.de]
Investigator: Dr. med. Jessica Hassel (Prüfer)
Trial Register: No trial registry number given.
EudraCT: 2017-000768-13 (siehe EU klinisches Studienregister)

Vaccibody (VBN-01) / [Rekrutierung nach Rücksprache]

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:Plattenepithelkarzinomen, Melanom, Kopf-/Hals Tumore, Nicht-kleinzelliger Lungenkrebs, Nierenzellkarzinom
Type of study:Phase I
Contact: Gabriele Bentz (Kontaktperson)
[gabriele.bentz@med.uni-heidelberg.de]
Investigator: Prof. Dr. Jürgen Krauss (Leiter klinische Prüfung)
Trial Register: No trial registry number given.
EudraCT: 2017-002474-39 (siehe EU klinisches Studienregister)