Cutaneous T-Cell Lymphoma/Mycosis FungoidesPhase 2PRISMNCT03837457
PRISM: Efficacy and Safety of Cobomarsen (MRG-106) in Subjects With Mycosis Fungoides Who Have Completed the SOLAR Study
A Phase 2 study testing Cobomarsen in people with Cutaneous T-Cell Lymphoma/Mycosis Fungoides, run by miRagen Therapeutics, Inc. at 9 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous T-Cell Lymphoma/Mycosis Fungoides
- What is being tested?
- Cobomarsen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 1 Oct 2019to 27 Jul 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have participated in the comparator arm of the SOLAR clinical trial and completed the study (confirmed disease progression).
Who cannot join
- 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.
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
United States5 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
The Ohio State University and Wexner Medical Center
Columbus, Ohio, 43210
Mayo Clinic Hospital
Phoenix, Arizona, 85054
University of Washington/Seattle Cancer Care Alliance
Seattle, Washington, 98109
Washington University School of Medicine
St Louis, Missouri, 63108
France3 sites
Hopital Saint Andre, CHU de Bordeaux
Bordeaux, 33076
Hopital Saint-Louis
Paris, 75475
Hopital Charles Nicolle, CHU de Rouen
Rouen, 76031
About this study
Official title: 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.
Read the 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.
- Being tested
- Cobomarsen
- 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
- Medical subject headings
- Mycosis Fungoides, Lymphoma, T-Cell, Cutaneous, Lymphoma, Lymphoma, T-Cell, Lymphoma, Non-Hodgkin, Lymphoproliferative Disorders, Lymphatic Diseases, Immunoproliferative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CobomarsenDrug
Also called MRG-106
At least weekly intravenous infusions of cobomarsen (282 mg) throughout study treatment period
| Study group | Role | What they receive |
|---|---|---|
| Cobomarsen | Experimental | Not described Receives: Drug: Cobomarsen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to approximately 36 months (estimated study duration)
Secondary outcomes (12)
Progression-free survival
Time from date of first dose of cobomarsen until the date of earliest documented progression or death from any cause.
Measured: Up to approximately 36 months (estimated study duration)
Pruritis Numerical Rating Scale
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.
Measured: Daily for up to 6 months, then weekly up to approximately 36 months (estimated study duration)
Skindex-29 Dermatological Survey
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.
Measured: Monthly, up to approximately 36 months (estimated study duration)
Pain Numerical Rating Scale
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.
Measured: 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
Measured: Weekly, up to approximately 36 months (estimated study duration)
Duration of composite global response for responding subjects
Measured: Up to approximately 36 months (estimated study duration)
Complete response rate
Based on composite global response criteria including radiological imaging, flow cytometry, and mSWAT.
Measured: Up to approximately 36 months (estimated study duration)
Skin disease severity based on modified Severity-weighted Assessment Tool (mSWAT)
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.
Measured: Monthly, up to approximately 36 months (estimated study duration)
Time to progression
Time from date of first dose of cobomarsen until the earliest date of confirmed progression.
Measured: Up to approximately 36 months (estimated study duration)
Overall survival
Time from date of first dose of cobomarsen until the date of death from any cause.
Measured: Up to approximately 36 months (estimated study duration)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: Up to approximately 36 months (estimated study duration)
Plasma concentration of cobomarsen
Sparse pharmacokinetic samples will be collected to monitor for accumulation of cobomarsen.
Measured: Day 1, Day 29 and monthly or every other month thereafter until End of Treatment visit, up to approximately 36 months (estimated study duration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start1 Oct 2019
- Primary completion24 Jul 2020
- Study completion27 Jul 2020
Why it stopped: Study no longer needed because eligible subjects may receive treatment with cobomarsen in a crossover arm of the SOLAR clinical trial (NCT03713320)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous T-Cell Lymphoma/Mycosis FungoidesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- miRagen Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Diana M. Escolar, MD, FAAN, Study director, miRagen Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03837457
- Sponsor's protocol ID
- MRG106-11-203
- Other IDs
- 2018-003748-22, 2018
- Acronym
- PRISM
- Status last verified
- Nov 2020
- First submitted
- 8 Feb 2019
- Last updated
- 19 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03837457
- Acronym / sponsor ID
- PRISM / MRG106-11-203
- Keywords
- PRISM, Cutaneous T-cell Lymphoma, CTCL, Mycosis Fungoides, Lymphoma, Lymphoma, T-cell, Lymphoma, T-cell, cutaneous, Lymphoma, Non-Hodgkin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study no longer needed because eligible subjects may receive treatment with cobomarsen in a crossover arm of the SOLAR clinical trial (NCT03713320)
- Enrolment
- 8 participants (actual)
- Lead sponsor
- miRagen Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 24 Jul 2020 (actual)
- Study completion
- 27 Jul 2020 (actual)
- First posted
- 12 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cobomarsen | Experimental | Drug: Cobomarsen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Must have participated in the comparator arm of the SOLAR clinical trial and completed the study (confirmed disease progression).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CobomarsenAlso: MRG-106At least weekly intravenous infusions of cobomarsen (282 mg) throughout study treatment period | Drug | Cobomarsen |
Primary outcome
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).
12 secondary outcomes
Progression-free survival
Time frame: 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)
Skindex-29 Dermatological Survey
Time frame: 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)
Difference in drug tolerability by Patient Impression of Treatment Side Effects
Time frame: 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)
Complete response rate
Time frame: 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)
Time to progression
Time frame: Up to approximately 36 months (estimated study duration)
Overall survival
Time frame: 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)
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)
Results and safety
The study was stopped early (reason given: Study no longer needed because eligible subjects may receive treatment with cobomarsen in a crossover arm of the SOLAR clinical trial (NCT03713320)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diana M. Escolar, MD, FAAN study director
miRagen Therapeutics, Inc.
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cobomarsen in people with Cutaneous T-Cell Lymphoma/Mycosis Fungoides, run by miRagen Therapeutics, Inc. at 9 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, France, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study no longer needed because eligible subjects may receive treatment with cobomarsen in a crossover arm of the SOLAR clinical trial (NCT03713320)). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects achieving an objective response of at least 4 months duration (ORR4) (time frame: Up to approximately 36 months (estimated study duration)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2020.