PRISM: Efficacy and Safety of Cobomarsen (MRG-106) in Subjects With Mycosis Fungoides Who Have Completed the SOLAR Study

NCT03837457 | Terminated Phase 2 DMC FDA Drug

• 2 other identifiers: MRG106-11-2032018-003748-22
• Study Type: interventional
• Target: 8
• Locations: 3 countries
• Sites: 9

Brief Summary

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.

Conditions

Cutaneous T-Cell Lymphoma/Mycosis Fungoides

Keywords

PRISM; 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

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects achieving an objective response of at least 4 months duration (ORR4)

  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 Outcomes (12)

• Progression-free survival

  Up to approximately 36 months (estimated study duration)

• Pruritis Numerical Rating Scale

  Daily for up to 6 months, then weekly up to approximately 36 months (estimated study duration)

• Skindex-29 Dermatological Survey

  Monthly, up to approximately 36 months (estimated study duration)

• Pain Numerical Rating Scale

  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

  Weekly, up to approximately 36 months (estimated study duration)

Other Outcomes (1)

• Number of participants with anti-drug antibody generation

  Up to approximately 36 months (estimated study duration)

Study Arms (1)

Cobomarsen

EXPERIMENTAL

Drug: Cobomarsen

Interventions

Cobomarsen DRUG

At least weekly intravenous infusions of cobomarsen (282 mg) throughout study treatment period

Also known as: MRG-106

Cobomarsen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have participated in the comparator arm of the SOLAR clinical trial and completed the study (confirmed disease progression).

You may not qualify if:

• 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.

Sponsors & Collaborators

• miRagen Therapeutics, Inc.: lead

Study Sites (9)

Mayo Clinic Hospital

Phoenix, Arizona, 85054, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63108, United States

Location

The Ohio State University and Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

University of Washington/Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

University Hospital Leuven

Leuven, B3000, Belgium

Location

Hopital Saint Andre, CHU de Bordeaux

Bordeaux, 33076, France

Location

Hopital Saint-Louis

Paris, 75475, France

Location

Hopital Charles Nicolle, CHU de Rouen

Rouen, 76031, France

Location

MeSH Terms

Conditions

Mycosis Fungoides; Lymphoma, T-Cell, Cutaneous; Lymphoma; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms

Interventions

cobomarsen

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Hemic and Lymphatic Diseases

Study Officials

• Diana M. Escolar, MD, FAAN

  miRagen Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2019
• First Posted: February 12, 2019
• Study Start: October 1, 2019
• Primary Completion: July 24, 2020
• Study Completion: July 27, 2020
• Last Updated: November 19, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (5); BE (1); FR (3)