SOLAR: Efficacy and Safety of Cobomarsen (MRG-106) vs. Active Comparator in Subjects With Mycosis Fungoides (SOLAR)
Cutaneous T-Cell Lymphoma/Mycosis Fungoides
About this trial
This is an interventional treatment trial for Cutaneous T-Cell Lymphoma/Mycosis Fungoides focused on measuring SOLAR, Cutaneous T-cell Lymphoma, CTCL, Mycosis Fungoides, Lymphoma, Lymphoma, T-cell, Lymphoma, T-cell, cutaneous, Lymphoma, Non-Hodgkin, Lymphoproliferative Disorders, Lymphatic Diseases, Immunoproliferative Disorders, Immune System Diseases, Neoplasms, MicroRNAs, Vorinostat, Histone Deacetylase Inhibitors
Eligibility Criteria
Key Inclusion Criteria:
- Biopsy-proven CTCL, MF subtype
- Clinical stage IB, II, or III, with staging based on screening assessments
- Minimum mSWAT score of 10 at screening
- Receipt of at least one prior therapy for CTCL
Key Exclusion Criteria:
- Previous enrollment in a cobomarsen study
- Prior therapy with vorinostat or other HDAC inhibitors, or contraindication to an HDAC inhibitor
- Sézary syndrome or mycosis fungoides with B2 involvement, defined as documented history of B2 and/or B2 staging at screening
- Evidence of large cell transformation
- Lymph node involvement at screening, unless radiologically or histologically confirmed to be nonmalignant
- Visceral involvement related to MF at screening
Sites / Locations
- The University of Alabama at Birmingham
- Mayo Clinic
- City of Hope
- UCLA
- Chao Family Comprehensive Cancer Center at University of California, Irvine
- Smilow Cancer Hospital at Yale-New Haven
- Mayo Clinic
- H. Lee Moffitt Cancer Center and Research Institute
- Dana Farber Cancer Institute
- Mayo Clinic
- Washington University School of Medicine
- Dartmouth Hitchcock Medical Center
- Rochester Skin Lymphoma Medical Group
- Columbia University Medical Center
- Memorial Sloan Kettering Cancer Center
- The Ohio State University Comprehensive Cancer Center
- Thomas Jefferson University
- MD Anderson Cancer Center
- Inova Schar Cancer Institute
- University of Washington
- Concord Repatriation General Hospital
- Westmead Hospital
- Linear Clinical Research
- University Clinic UZ Leuven
- Cross Cancer Institute
- Jewish General Hospital
- Hôpital Saint André, CHU de Bordeaux
- Hôpital Saint-Louis
- Centre Hospitalier Lyon-Sud
- Hôpital Robert Dubré, CHU de Reims
- Centre Hospitalier Universitaire de Rouen
- Policlinico S. Orsola-Malpighi
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
- AOU Citta dell Salute e della Scienza di Torino
- Vall d'Hebron Institute of Oncology
- Fundación Jiménez Diaz
- Hospital Universitario 12 de Octubre
- Hospital Universitario de Salamanca
- Consorcio Hospital General Universitario Valencia
- University Hospitals of Birmingham NHS Foundation Trust, Queen Elizabeth Hospital
- Beatson West of Scotland Cancer Centre
- Guy's and St. Thomas' NHS Foundation Trust, Cancer Center
- The Christie NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Cobomarsen
Vorinostat
Cobomarsen will be administered by intravenous 2-hour infusion at a dose of 282 mg on Days 1, 3, 5, 8, and weekly thereafter
Vorinostat will be administered orally at a dose of 400 mg (four 100-mg capsules) once daily with food, at approximately the same time each day.