Trial · NCT03713320
SOLAR: Efficacy and Safety of Cobomarsen (MRG-106) vs. Active Comparator in Subjects With Mycosis Fungoides
NCT03713320, Phase 2, Terminated, miRagen Therapeutics, Inc.; results first posted 2022-04-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. SOLAR: Efficacy and Safety of Cobomarsen (MRG-106) vs. Active Comparator in Subjects With Mycosis Fungoides. Trials, record NCT03713320. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03713320
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- SOLAR: Efficacy and Safety of Cobomarsen (MRG-106) vs. Active Comparator in Subjects With Mycosis Fungoides
- NCT number
- NCT03713320
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 37 participants, actual
- Lead sponsor
- miRagen Therapeutics, Inc.
- Conditions
- Cutaneous T-Cell Lymphoma/Mycosis Fungoides
- Interventions
- Cobomarsen, Vorinostat
- First posted
- 2018-10-19
- Last updated
- 2022-04-08
- Other registries' IDs
- eudract:2018-000727-13
- Results first posted
- 2022-04-08
- Limitations and caveats
The study was terminated early for business reasons, and not due to concerns regarding safety or lack of efficacy. Because the study was terminated early, enrollment was ended at 37 participants instead of the initially planned 126 participants, and a planned interim analysis based on these 37 participants was the only analysis performed for the study. The study duration was also shortened from an estimated 36 months to 20 months overall.
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Subjects Achieving an Objective Skin Response of at Least 4 Months Duration (ORR4) | Date of first dose through the earlier of last study visit or interim analysis data cut-off date of 12-Oct-2020, up to 16 months | ORR4 is the percentage of subjects with a complete response (CR) or partial response (PR) in the skin for 4 consecutive months confirmed by repeat assessments no less than 28 days (± 3 days) later. The modified Severity Weighted Assessment Tool (mSWAT) is used to measure skin disease severity based on the percentage of body surface area (BSA) with patches, plaques, or tumors. Total scores are calculated by multiplying the BSA percentage for each category of lesion (patch, plaque, or tumor) by a weighting factor and adding the three sub-scores. Lower scores indicate a lower degree of skin disease severity. CR corresponds to 100% clearance of skin lesions present at baseline (mSWAT score of 0). PR corresponds to 50-99% clearance of skin disease present at baseline (at least 50% reduction in mSWAT score), without new tumors. |
| Secondary | Progression-free Survival (PFS) | Date of first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months | Time from date of randomization until the date of earliest documented progression or death from any cause. The duration of PFS was censored at the date of the last mSWAT assessment if the subject was alive and had no documented progression. Disease progression in the skin is defined as ≥ 25% increase in mSWAT score from baseline or, in participants with complete or partial response, increase in mSWAT score of greater than the sum of the nadir plus 50% baseline score. |
| Secondary | Complete Response Rate | Date of first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months | Percentage of subjects with a complete response in the skin based on mSWAT |
| Secondary | Time to Progression | Date of first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months | Time from date of randomization until the earliest date of confirmed progression |
| Secondary | Time to Maximal Effect in mSWAT | Monthly from first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months | Time to greatest improvement in mSWAT score |
| Secondary | Objective Response Rate in the Skin of at Least 28-days Duration (ORR1) | Monthly from first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months | Percentage of participants achieving ≥ 50% improvement in mSWAT of at least 28-days duration |
| Secondary | Percentage of Subjects Achieving ≥ 50% Improvement in mSWAT at 28 Days | 28 days after first dose | Percentage of subjects achieving ≥ 50% improvement from baseline in mSWAT at 28 days after first dose |
| Secondary | Percentage of Subjects Achieving ≥ 50% Improvement in mSWAT at 4 Months | 4 months after first dose | Percentage of subjects achieving ≥ 50% improvement from baseline in mSWAT at 4 months after first dose |
| Secondary | Time to ≥ 50% Improvement in mSWAT | Monthly from first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months | Time from date of randomization until ≥ 50% improvement in mSWAT score |
| Secondary | Duration of Response in Skin | Monthly from first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months | Duration of response in skin (no progression after achieving ≥ 50% improvement in mSWAT) |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Subjects Achieving an Objective Skin Response of at Least 4 Months Duration (ORR4) | Date of first dose through the earlier of last study visit or interim analysis data cut-off date of 12-Oct-2020, up to 16 months | Intent to treat population (includes all randomized subjects who received at least one dose of study treatment (cobomarsen or vorinostat) and had at least one post-baseline assessment. Assignment of subjects to treatment group is based on the planned treatment assignment. | Percentage of participants | NUMBER |
| SECONDARY | Progression-free Survival (PFS) | Date of first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months | Intent to treat population (includes all randomized subjects who received at least one dose of study treatment \[cobomarsen or vorinostat\] and had at least one post-baseline assessment). Assignment of subjects to treatment group is based on the planned treatment assignment. | months | MEDIAN |
| SECONDARY | Complete Response Rate | Date of first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months | Intent to treat population (includes all randomized subjects who received at least one dose of study treatment (cobomarsen or vorinostat) and had at least one post-baseline assessment. Assignment of subjects to treatment group is based on the planned treatment assignment. | Percentage of participants | NUMBER |
| SECONDARY | Time to Progression | Date of first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months | Intent to treat population (includes all randomized subjects who received at least one dose of study treatment (cobomarsen or vorinostat) and had at least one post-baseline assessment. Assignment of subjects to treatment group is based on the planned treatment assignment. | Months | MEAN |
| SECONDARY | Time to Maximal Effect in mSWAT | Monthly from first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months | Participants with improvement in mSWAT score | Months | MEAN |
| SECONDARY | Objective Response Rate in the Skin of at Least 28-days Duration (ORR1) | Monthly from first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months | Intent to treat population (includes all randomized subjects who received at least one dose of study treatment (cobomarsen or vorinostat) and had at least one post-baseline assessment. Assignment of subjects to treatment group is based on the planned treatment assignment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Subjects Achieving ≥ 50% Improvement in mSWAT at 28 Days | 28 days after first dose | Intent to treat population (includes all randomized subjects who received at least one dose of study treatment (cobomarsen or vorinostat) and had at least one post-baseline assessment. Assignment of subjects to treatment group is based on the planned treatment assignment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Subjects Achieving ≥ 50% Improvement in mSWAT at 4 Months | 4 months after first dose | Intent to treat population (includes all randomized subjects who received at least one dose of study treatment (cobomarsen or vorinostat) and had at least one post-baseline assessment. Assignment of subjects to treatment group is based on the planned treatment assignment. | percentage of participants | NUMBER |
| SECONDARY | Time to ≥ 50% Improvement in mSWAT | Monthly from first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months | Subjects who achieved an objective response in skin (≥ 50% improvement in mSWAT) | Months | MEAN |
| SECONDARY | Duration of Response in Skin | Monthly from first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months | Subjects who achieved an objective response in skin (≥ 50% improvement in mSWAT) | Months | MEDIAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group25
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Subjects Achieving an Objective Skin Response of at Least 4 Months Duration (ORR4) | Cobomarsen (Randomized) | 15.8 | Percentage of participants | ||
| Percentage of Subjects Achieving an Objective Skin Response of at Least 4 Months Duration (ORR4) | Vorinostat (Randomized) | 16.7 | Percentage of participants | ||
| Progression-free Survival (PFS) | Cobomarsen (Randomized) | NA | 95% Confidence Interval 9.26 to NA | months | |
| Progression-free Survival (PFS) | Vorinostat (Randomized) | 6.01 | 95% Confidence Interval 2.89 to 8.90 | months | |
| Complete Response Rate | Cobomarsen (Randomized) | 0 | Percentage of participants | ||
| Complete Response Rate | Vorinostat (Randomized) | 5.6 | Percentage of participants | ||
| Time to Progression | Cobomarsen (Randomized) | NA | 95% Confidence Interval 9.26 to NA | Months | |
| Time to Progression | Vorinostat (Randomized) | 6.01 | 95% Confidence Interval 2.89 to 8.90 | Months | |
| Time to Maximal Effect in mSWAT | Cobomarsen (Randomized) | 4.5 | Standard Deviation 3.7 | Months | |
| Time to Maximal Effect in mSWAT | Vorinostat (Randomized) | 3.0 | Standard Deviation 2.7 | Months |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Randomized Period | STARTED | Cobomarsen (Randomized) | 19 | |
| Randomized Period | STARTED | Vorinostat (Randomized) | 18 | |
| Randomized Period | STARTED | Cobomarsen (Crossover) | 0 | |
| Randomized Period | COMPLETED | Cobomarsen (Randomized) | 4 | |
| Randomized Period | COMPLETED | Vorinostat (Randomized) | 8 | |
| Randomized Period | COMPLETED | Cobomarsen (Crossover) | 0 | |
| Randomized Period | NOT COMPLETED | Cobomarsen (Randomized) | 15 | |
| Randomized Period | NOT COMPLETED | Vorinostat (Randomized) | 10 | |
| Randomized Period | NOT COMPLETED | Cobomarsen (Crossover) | 0 | |
| Cobomarsen Crossover Period | STARTED | Cobomarsen (Randomized) | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events441
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Cobomarsen (Randomized) | 0 | 19 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Vorinostat (Randomized) | 1 | 18 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Cobomarsen (Crossover) | 0 | 7 | 0 |
| other | Abdominal pain upper | Gastrointestinal disorders | Cobomarsen (Randomized) | 0 | 19 | 0 |
| other | Abdominal pain upper | Gastrointestinal disorders | Vorinostat (Randomized) | 2 | 18 | 2 |
| other | Abdominal pain upper | Gastrointestinal disorders | Cobomarsen (Crossover) | 0 | 7 | 0 |
| other | Alanine aminotransferase increased | Investigations | Cobomarsen (Randomized) | 1 | 19 | 2 |
| other | Alanine aminotransferase increased | Investigations | Vorinostat (Randomized) | 1 | 18 | 1 |
| other | Alanine aminotransferase increased | Investigations | Cobomarsen (Crossover) | 0 | 7 | 0 |
| other | Alopecia | Skin and subcutaneous tissue disorders | Cobomarsen (Randomized) | 1 | 19 | 1 |
1 to 10 of 441Source ClinicalTrials.gov
See all 441 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cobomarsen (Randomized) | 0 | 19 |
| Total, all-cause mortality | Vorinostat (Randomized) | 0 | 18 |
| Total, all-cause mortality | Cobomarsen (Crossover) | 0 | 7 |
| Total, other adverse events | Cobomarsen (Randomized) | 18 | 19 |
| Total, other adverse events | Vorinostat (Randomized) | 18 | 18 |
| Total, other adverse events | Cobomarsen (Crossover) | 5 | 7 |
| Total, serious adverse events | Cobomarsen (Randomized) | 2 | 19 |
| Total, serious adverse events | Vorinostat (Randomized) | 1 | 18 |
| Total, serious adverse events | Cobomarsen (Crossover) | 0 | 7 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03713320
GET https://conductscience.org/api/trials/v1/NCT03713320/results?page=2