Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02143999
Other study ID # ML29031
Secondary ID
Status Completed
Phase N/A
First received May 19, 2014
Last updated June 26, 2017
Start date June 27, 2014
Est. completion date December 30, 2016

Study information

Verified date June 2017
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This observational study will evaluate the effectiveness of BRAF inhibitors and current therapies in patients with newly diagnosed metastatic melanoma with or without BRAF V600 mutation. Patients will be treated per the locally approved therapeutic options in clinical practice. The observation period for each patient will be up to 24 months.


Recruitment information / eligibility

Status Completed
Enrollment 403
Est. completion date December 30, 2016
Est. primary completion date December 30, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adult patients, >/= 18 years of age at diagnosis

- Histologically confirmed new diagnosis of unresectable or metastatic melanoma

- Patients with tumor samples available for assessment of BRAF V600 mutation

Exclusion Criteria:

- Prior systemic therapy for metastatic disease

- Participation in interventional clinical trials

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Italy Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari Bari Puglia
Italy Asst Papa Giovanni XXIII; Oncologia Medica Bergamo Lombardia
Italy Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica Bologna Emilia-Romagna
Italy Az. Osp. Spedali Civili; Divisione Di Oncologia - Iii Medicina Brescia Lombardia
Italy Fondazione Del Piemonte Per L'oncologia IRCC Di Candiolo Candiolo Piemonte
Italy Policlinico Ospedaliero Ss Annunziata; U.O. Di Clinica Oncologica Chieti Abruzzo
Italy Azienda Ospedaliero Universitaria di Ferrara - U.O. Di Oncologia Cona (FE) Veneto
Italy Azienda Sanitaria Ospedaliera s. Croce e Carle; Oncologia Medica Cuneo Piemonte
Italy Azienda Sanitaria di Firenze Presidio Palagi - SC Dermatologia II e Fisioterapia Dermatologica Firenze Toscana
Italy IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A Genova Liguria
Italy Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST);U.O. di Immunoterapia Meldola Emilia-Romagna
Italy Irccs Istituto Europeo Di Oncologia (Ieo); Unita' Di Ricerca Traslazionale Del Melanoma Milano Lombardia
Italy Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2 Milano Lombardia
Italy IRCCS IST. Tumori Fondaz. Pascale; S.C. Oncologia Medica,Melanoma,Immunoterapia E Terapie Innovative Napoli Campania
Italy Ospedale Maggiore Della Carita; Oncologia Medica Novara Piemonte
Italy Policlinico P. Giaccone; Istituto Di Oncologia, Clinica Medica 1 Palermo Sicilia
Italy Azlenda Ospendaliero-Universitaria Pisana; C.O. Oncologia 2 Pisa Toscana
Italy Arcispedale Santa Maria Nuova; Oncologia Reggio Emilia Emilia-Romagna
Italy Policlinico Umberto i di Roma; dip. Scienze Radiologiche, Oncologiche, Anatomopatologiche Roma Lazio
Italy Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica Roma Lazio
Italy Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica Siena Toscana
Italy Ospedale S. Vincenzo; Oncologia Medica Taormina Sicilia
Italy Azienda Ospedaliera Città della Salute e della Scienza di Torino Torino Piemonte
Italy Azienda Ospedaliera di Verona-Policlinico G.B. Rossi; Oncologia Medica Verona Veneto

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall survival 2 years
Secondary Progression-free survival 2 years
Secondary Best Overall Response Rate (BORR) 2 years
Secondary Time to response 2 years
Secondary Duration of response 2 years
Secondary ECOG performance status 2 years
Secondary Safety: Incidence of adverse events 2 years
See also
  Status Clinical Trial Phase
Completed NCT04229277 - Fast Track Diagnosis of Skin Cancer by Advanced Imaging N/A
Completed NCT03653819 - High Intensity Interval Training (HIIT) for Patients With Cancer-related Lymphedema in the Lower Limbs N/A
Active, not recruiting NCT04074096 - Binimetinib Encorafenib Pembrolizumab +/- Stereotactic Radiosurgery in BRAFV600 Melanoma With Brain Metastasis Phase 2
Completed NCT02935790 - Selective HDAC6 Inhibitor ACY-241 in Combination With Ipilimumab and Nivolumab Phase 1
Recruiting NCT05478876 - Carbon Ion Radiation Therapy in the Treatment of Mucous Melanomas of the Female Lower Genital Tract N/A
Completed NCT01211262 - Study to Assess the Tolerability of a Bispecific Targeted Biologic IMCgp100 in Malignant Melanoma Phase 1
Recruiting NCT03649529 - Treatment of Malignant Melanoma With GPA-TriMAR-T Cell Therapy Early Phase 1
Completed NCT03278665 - 4SC-202 in Combination With Pembrolizumab in Patients Primary Refractory/Non-responding to Prior Anti-PD-1 Therapy Phase 1/Phase 2
Completed NCT04452214 - A Study of the Safety and Tolerance of CAN04 and Pembrolizumab in Combination With and Without Carboplatin and Pemetrexed in Subjects With Solid Tumors Phase 1
Terminated NCT02709889 - Rovalpituzumab Tesirine in Delta-Like Protein 3-Expressing Advanced Solid Tumors Phase 1/Phase 2
Completed NCT01455259 - Phase I/IIa AdCD40L Immunogene Therapy for Malignant Melanoma and Other Solid Tumors Phase 1/Phase 2
Completed NCT00978913 - Transfected Dendritic Cell Based Therapy for Patients With Breast Cancer or Malignant Melanoma Phase 1
Completed NCT00232726 - Clinical Study of Previously Untreated Patients With Malignant Melanoma Phase 2
Completed NCT00336986 - Efficacy Study of IL-21 to Treat Metastatic Melanoma Phase 2
Completed NCT00350597 - GM-CSF as Adjuvant Therapy of Melanoma Phase 2
Completed NCT02523313 - Immunotherapy With Nivolumab or Nivolumab Plus Ipilimumab vs. Double Placebo for Stage IV Melanoma w. NED Phase 2
Completed NCT03545334 - Lymph Node Identification in Skin Malignancy Using ICG Transcutaneously Study N/A
Completed NCT04253574 - Comparison of PET/CT and Ultrasound in Staging of Malignant Melanoma
Completed NCT00179608 - Study of the Combination of Lenalidomide and DTIC (Dacarbazine) in Patients With Metastatic Malignant Melanoma Previously Untreated With Systemic Chemotherapy Phase 1
Terminated NCT00104884 - FR901228 in Treating Patients With Unresectable Stage III or Stage IV Malignant Melanoma Phase 2