- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03837457
PRISM: Efficacy and Safety of Cobomarsen (MRG-106) in Subjects With Mycosis Fungoides Who Have Completed the SOLAR Study (PRISM)
PRISM: An Open-label, Multi-Center Extension Study to Investigate the Efficacy and Safety of Cobomarsen (MRG-106) Following Systemic Treatment in Subjects With Cutaneous T-Cell Lymphoma (CTCL), Mycosis Fungoides (MF) Subtype, Who Have Completed the SOLAR Study
The main objective of this clinical trial is to study the efficacy and safety of cobomarsen (also known as MRG-106) for the treatment of cutaneous T-cell lymphoma (CTCL), mycosis fungoides (MF) subtype in subjects who have confirmed disease progression following treatment with vorinostat in the SOLAR clinical study (MRG106-11-201). Cobomarsen is designed to inhibit the activity of a molecule called miR-155 that may be important to the growth and survival of MF cancer cells.
The effects of treatment will be measured based on changes in skin lesion severity, disease-associated symptoms, and quality of life, as well as the length of time that the subject's disease remains stable or improved, without evidence of disease progression. The safety and tolerability of cobomarsen will be assessed based on the frequency and severity of observed side effects.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Design:
Up to 60 subjects are expected to be enrolled after discontinuation from the SOLAR clinical study (MRG106-11-201). Cobomarsen will be administered in the clinic by 2-hr intravenous infusion on Days 1, 3, 5 and 8, and weekly thereafter. Treatment will continue until the subject becomes intolerant, develops clinically significant side effects, progresses, or the trial is terminated.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Leuven, Belgium, B3000
- University Hospital Leuven
-
-
-
-
-
Bordeaux, France, 33076
- Hôpital Saint André, CHU de Bordeaux
-
Paris, France, 75475
- Hôpital Saint-Louis
-
Rouen, France, 76031
- Hôpital Charles Nicolle, CHU de Rouen
-
-
-
-
Arizona
-
Phoenix, Arizona, United States, 85054
- Mayo Clinic Hospital
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Dana-Farber Cancer Institute
-
-
Missouri
-
Saint Louis, Missouri, United States, 63108
- Washington University School of Medicine
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- The Ohio State University and Wexner Medical Center
-
-
Washington
-
Seattle, Washington, United States, 98109
- University of Washington/Seattle Cancer Care Alliance
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Key Inclusion Criteria:
- Must have participated in the comparator arm of the SOLAR clinical trial and completed the study (confirmed disease progression).
Key Exclusion Criteria:
- 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.
- Visceral involvement related to MF at screening.
- Unresolved toxicities from prior vorinostat treatment, defined as having not resolved to CTCAE v5.0 grade 0 or 1.
- Any CTCL systemic therapy after completion of the SOLAR study and prior to Day 1 for PRISM.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Cobomarsen
|
At least weekly intravenous infusions of cobomarsen (282 mg) throughout study treatment period
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of subjects achieving an objective response of at least 4 months duration (ORR4)
Time Frame: Up to approximately 36 months (estimated study duration)
|
Based on composite global response criteria including radiological imaging, flow cytometry, and the modified Severity Weighted Assessment Tool (mSWAT).
|
Up to approximately 36 months (estimated study duration)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival
Time Frame: Up to approximately 36 months (estimated study duration)
|
Time from date of first dose of cobomarsen until the date of earliest documented progression or death from any cause.
|
Up to approximately 36 months (estimated study duration)
|
Pruritis Numerical Rating Scale
Time Frame: Daily for up to 6 months, then weekly up to approximately 36 months (estimated study duration)
|
Measures the patient's degree of itch related to mycosis fungoides based on an 11-point scale (from 0-10), with 0 being no itch and 10 being worst imaginable itch.
|
Daily for up to 6 months, then weekly up to approximately 36 months (estimated study duration)
|
Skindex-29 Dermatological Survey
Time Frame: Monthly, up to approximately 36 months (estimated study duration)
|
Measures the effects of skin disease on quality of life based on a 30-item questionnaire.
The patient's responses are transformed to a linear scale from 0 to 100 and averaged to determine a subscore in three domains (Symptoms, Emotions and Functioning), as well as a total score.
Lower scores indicate a lesser degree of skin disease interference with quality of life.
|
Monthly, up to approximately 36 months (estimated study duration)
|
Pain Numerical Rating Scale
Time Frame: Daily, for up to 6 months, then weekly up to approximately 36 months (estimated study duration)
|
Measures the patient's intensity of pain related to mycosis fungoides based on an 11-point scale (from 0-10), with 0 being no pain and 10 being worst imaginable pain.
|
Daily, for up to 6 months, then weekly up to approximately 36 months (estimated study duration)
|
Difference in drug tolerability by Patient Impression of Treatment Side Effects
Time Frame: Weekly, up to approximately 36 months (estimated study duration)
|
Weekly, up to approximately 36 months (estimated study duration)
|
|
Duration of composite global response for responding subjects
Time Frame: Up to approximately 36 months (estimated study duration)
|
Up to approximately 36 months (estimated study duration)
|
|
Complete response rate
Time Frame: Up to approximately 36 months (estimated study duration)
|
Based on composite global response criteria including radiological imaging, flow cytometry, and mSWAT.
|
Up to approximately 36 months (estimated study duration)
|
Skin disease severity based on modified Severity-weighted Assessment Tool (mSWAT)
Time Frame: Monthly, up to approximately 36 months (estimated study duration)
|
Measures skin disease severity based on the percentage of skin within each body region with patches, plaques, or tumors.
Total scores are calculated by adding the total percent for each category of lesion (patch, plaque, or tumor) and multiplying by a weighting factor.
Weighted subtotals are added together to obtain the total score.
Lower scores indicate a lower degree of skin disease severity.
|
Monthly, up to approximately 36 months (estimated study duration)
|
Time to progression
Time Frame: Up to approximately 36 months (estimated study duration)
|
Time from date of first dose of cobomarsen until the earliest date of confirmed progression.
|
Up to approximately 36 months (estimated study duration)
|
Overall survival
Time Frame: Up to approximately 36 months (estimated study duration)
|
Time from date of first dose of cobomarsen until the date of death from any cause.
|
Up to approximately 36 months (estimated study duration)
|
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time Frame: Up to approximately 36 months (estimated study duration)
|
Up to approximately 36 months (estimated study duration)
|
|
Plasma concentration of cobomarsen
Time Frame: Day 1, Day 29 and monthly or every other month thereafter until End of Treatment visit, up to approximately 36 months (estimated study duration)
|
Sparse pharmacokinetic samples will be collected to monitor for accumulation of cobomarsen.
|
Day 1, Day 29 and monthly or every other month thereafter until End of Treatment visit, up to approximately 36 months (estimated study duration)
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants with anti-drug antibody generation
Time Frame: Up to approximately 36 months (estimated study duration)
|
Up to approximately 36 months (estimated study duration)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infections
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Bacterial Infections and Mycoses
- Lymphoma
- Mycoses
- Lymphoma, T-Cell
- Lymphoma, T-Cell, Peripheral
- Lymphoma, T-Cell, Cutaneous
- Mycosis Fungoides
Other Study ID Numbers
- MRG106-11-203
- 2018-003748-22 (EUDRACT_NUMBER)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cutaneous T-Cell Lymphoma/Mycosis Fungoides
-
Northwestern UniversityAmgenTerminatedRecurrent Cutaneous T-cell Non-Hodgkin Lymphoma | Recurrent Mycosis Fungoides/Sezary Syndrome | Stage III Cutaneous T-cell Non-Hodgkin Lymphoma | Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma | Stage I Cutaneous T-cell Non-Hodgkin Lymphoma | Stage IA Mycosis Fungoides/Sezary Syndrome | Stage... and other conditionsUnited States
-
Rochester Skin Lymphoma Medical Group, PLLCRochester General HospitalCompletedMycosis Fungoides | Cutaneous T-cell Lymphoma | Transformed Mycosis Fungoides | Cutaneous T-cell Lymphoma Stage I | Folliculotropic Mycosis Fungoides | Granulomatous Slack Skin | Syringotropic Mycosis Fungoides | Mycosis Fungoides VariantUnited States
-
Northwestern UniversityNational Cancer Institute (NCI); CelgeneActive, not recruitingPeripheral T-cell Lymphoma | Anaplastic Large Cell Lymphoma | Angioimmunoblastic T-cell Lymphoma | Adult Nasal Type Extranodal NK/T-cell Lymphoma | Hepatosplenic T-cell Lymphoma | Stage III Cutaneous T-cell Non-Hodgkin Lymphoma | Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma | Stage I Cutaneous... and other conditionsUnited States
-
National Cancer Institute (NCI)TerminatedRecurrent Cutaneous T-cell Non-Hodgkin Lymphoma | Recurrent Mycosis Fungoides/Sezary Syndrome | Stage III Cutaneous T-cell Non-Hodgkin Lymphoma | Stage III Mycosis Fungoides/Sezary Syndrome | Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma | Stage IV Mycosis Fungoides/Sezary Syndrome | Stage I... and other conditionsUnited States
-
miRagen Therapeutics, Inc.TerminatedCutaneous T-Cell Lymphoma/Mycosis FungoidesUnited States, France, Spain, Canada, United Kingdom, Australia, Italy, Belgium
-
SoligenixCompletedCutaneous T-Cell Lymphoma/Mycosis FungoidesUnited States
-
Moleculin Biotech, Inc.CompletedCutaneous T-Cell Lymphoma/Mycosis FungoidesPoland
-
Kevin Cooper MDNational Cancer Institute (NCI)CompletedRecurrent Cutaneous T-cell Non-Hodgkin Lymphoma | Recurrent Mycosis Fungoides/Sezary Syndrome | Stage I Cutaneous T-cell Non-Hodgkin Lymphoma | Stage IA Mycosis Fungoides/Sezary Syndrome | Stage IB Mycosis Fungoides/Sezary Syndrome | Stage II Cutaneous T-cell Non-Hodgkin Lymphoma | Stage IIA Mycosis...United States
-
Fondazione Italiana Linfomi - ETSNot yet recruitingCutaneous T Cell Lymphoma | Cutaneous T-Cell Lymphoma/Mycosis Fungoides | Cutaneous T-Cell Lymphoma/Sezary SyndromeItaly
-
National Cancer Institute (NCI)CompletedAnaplastic Large Cell Lymphoma | Angioimmunoblastic T-cell Lymphoma | Recurrent Adult T-cell Leukemia/Lymphoma | Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma | Recurrent Mycosis Fungoides/Sezary Syndrome | Small Intestine Lymphoma | Stage III Cutaneous T-cell Non-Hodgkin Lymphoma | Stage III Mycosis... and other conditionsUnited States
Clinical Trials on Cobomarsen
-
miRagen Therapeutics, Inc.CompletedChronic Lymphocytic Leukemia (CLL) | Cutaneous T-cell Lymphoma (CTCL) | Mycosis Fungoides (MF) | Diffuse Large B-Cell Lymphoma (DLBCL), ABC Subtype | Adult T-Cell Leukemia/Lymphoma (ATLL)United States
-
miRagen Therapeutics, Inc.TerminatedCutaneous T-Cell Lymphoma/Mycosis FungoidesUnited States, France, Spain, Canada, United Kingdom, Australia, Italy, Belgium