Cutaneous T-Cell Lymphoma/Mycosis FungoidesPhase 2SOLARNCT03713320
SOLAR: Efficacy and Safety of Cobomarsen (MRG-106) vs. Active Comparator in Subjects With Mycosis Fungoides
A Phase 2 study testing Cobomarsen and Vorinostat in people with Cutaneous T-Cell Lymphoma/Mycosis Fungoides, run by miRagen Therapeutics, Inc. at 43 sites in 8 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. 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 and Vorinostat
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 43 sitesin 8 countries
- Study dates
- 2 Apr 2019to 1 Dec 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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
Who cannot join
- 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
Trial locations and contacts
43 sites in 8 countries.
43 sites in 8 countries
United States20 sites
The University of Alabama at Birmingham
Birmingham, Alabama, 35233
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
City of Hope
Duarte, California, 91010
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
Rochester Skin Lymphoma Medical Group
Fairport, New York, 14450
MD Anderson Cancer Center
Houston, Texas, 77030
Mayo Clinic
Jacksonville, Florida, 32224
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
UCLA
Los Angeles, California, 90404
Smilow Cancer Hospital at Yale-New Haven
New Haven, Connecticut, 06510
Columbia University Medical Center
New York, New York, 10032
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Chao Family Comprehensive Cancer Center at University of California, Irvine
Orange, California, 92868
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Mayo Clinic
Phoenix, Arizona, 85054
Mayo Clinic
Rochester, Minnesota, 55905
University of Washington
Seattle, Washington, 98109
Washington University School of Medicine
St Louis, Missouri, 63108
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
France5 sites
Hôpital Saint André, CHU de Bordeaux
Bordeaux, 33000
Hôpital Saint-Louis
Paris, 75010
Centre Hospitalier Lyon-Sud
Pierre-Bénite, 69310
Hôpital Robert Dubré, CHU de Reims
Reims, 51100
Centre Hospitalier Universitaire de Rouen
Rouen, 76031
Spain5 sites
Vall d'Hebron Institute of Oncology
Barcelona, 08035
Fundación Jiménez Diaz
Madrid, 28040
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario de Salamanca
Salamanca, 37007
Consorcio Hospital General Universitario Valencia
Valencia, 46014
United Kingdom4 sites
University Hospitals of Birmingham NHS Foundation Trust, Queen Elizabeth Hospital
Birmingham, B15 2TH
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN
Guy's and St. Thomas' NHS Foundation Trust, Cancer Center
London, SE1 9RT
The Christie NHS Foundation Trust
Manchester, M20 4BX
Australia3 sites
Concord Repatriation General Hospital
Concord, New South Wales, 2139
Linear Clinical Research
Nedlands, 6009
Westmead Hospital
Westmead, New South Wales, NSW 2145
Italy3 sites
Policlinico S. Orsola-Malpighi
Bologna, 40138
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, 20122
AOU Citta dell Salute e della Scienza di Torino
Torino, 10126
Canada2 sites
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Jewish General Hospital
Montreal, Quebec, H3T 1E2
About this study
Official title: SOLAR: A Phase 2, Randomized, Open-label, Parallel-group, Active Comparator, Multi-center Study to Investigate the Efficacy and Safety of Cobomarsen (MRG-106) in Subjects With Cutaneous T-Cell Lymphoma (CTCL), Mycosis Fungoides (MF) Subtype
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. 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 study will compare the effects of cobomarsen to vorinostat, a drug that has been approved for the treatment of CTCL in the United States and several other countries.
Participants in the clinical trial will be randomly assigned to receive either weekly doses of cobomarsen by injection into a vein or daily oral doses of vorinostat. Participants will continue on their assigned treatment as long as there is no evidence of progression of their cancer. The effects of treatment will be measured based on changes in skin lesion severity, 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.
Participants assigned to receive vorinostat who experience progression of their disease during their participation in this study may have the option to be treated with cobomarsen in an open-label, crossover arm of the same study if they meet the entry criteria for that part of the study.
Read the detailed description
Study Design:
Subjects will be randomly assigned in a 1:1 ratio to receive either cobomarsen or vorinostat. Approximately 126 subjects (63 per arm) are expected to be enrolled. Cobomarsen will be administered in the clinic by 2-hr intravenous infusion on Days 1, 3, 5 and 8, and weekly thereafter. Vorinostat will be dispensed to study subjects and taken as a daily oral dose according to the manufacturer's labeled dosing instructions. Treatment will continue until the subject becomes intolerant, develops clinically significant side effects, progresses, or the trial is terminated. An interim analysis will be conducted after approximately 40 subjects have been followed for a minimum of approximately 6 months. Enrollment will be suspended until the completion of the interim analysis.
- Being tested
- Cobomarsen, Vorinostat
- Keywords
- 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
- 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 doses of cobomarsen (282 mg) throughout study treatment period
VorinostatDrug
Daily doses of vorinostat throughout study treatment period
| Study group | Role | What they receive |
|---|---|---|
| Cobomarsen | Experimental | Cobomarsen will be administered by intravenous 2-hour infusion at a dose of 282 mg on Days 1, 3, 5, 8, and weekly thereafter Receives: Drug: Cobomarsen |
| Vorinostat | Active comparator | 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. Receives: Drug: Vorinostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects Achieving an Objective Skin Response of at Least 4 Months Duration (ORR4)
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.
Measured: 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
Secondary outcomes (10)
Progression-free Survival (PFS)
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.
Measured: Date of first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months
Complete Response Rate
Percentage of subjects with a complete response in the skin based on mSWAT
Measured: Date of first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months
Time to Progression
Time from date of randomization until the earliest date of confirmed progression
Measured: Date of first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months
Time to Maximal Effect in mSWAT
Time to greatest improvement in mSWAT score
Measured: Monthly from first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months
Objective Response Rate in the Skin of at Least 28-days Duration (ORR1)
Percentage of participants achieving ≥ 50% improvement in mSWAT of at least 28-days duration
Measured: Monthly from first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months
Percentage of Subjects Achieving ≥ 50% Improvement in mSWAT at 28 Days
Percentage of subjects achieving ≥ 50% improvement from baseline in mSWAT at 28 days after first dose
Measured: 28 days after first dose
Percentage of Subjects Achieving ≥ 50% Improvement in mSWAT at 4 Months
Percentage of subjects achieving ≥ 50% improvement from baseline in mSWAT at 4 months after first dose
Measured: 4 months after first dose
Time to ≥ 50% Improvement in mSWAT
Time from date of randomization until ≥ 50% improvement in mSWAT score
Measured: Monthly from first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months
Duration of Response in Skin
Duration of response in skin (no progression after achieving ≥ 50% improvement in mSWAT)
Measured: Monthly from first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months
Pruritus Medication Utilization
Change from baseline in number of pruritus medications taken per subject
Measured: Date of first dose through end of treatment or interim analysis data cut-off date of 12-Oct-2020, up to 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start2 Apr 2019
- Primary completion12 Oct 2020
- Study completion1 Dec 2020
Why it stopped: The study was terminated early for business reasons, and not due to concerns regarding safety or lack of efficacy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 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
- NCT03713320
- Sponsor's protocol ID
- MRG106-11-201
- Other IDs
- 2018-000727-13, 2018
- Acronym
- SOLAR
- Status last verified
- Mar 2022
- First submitted
- 17 Oct 2018
- Last updated
- 8 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ganguly K, Kishore U, Madan T. Interplay between C-type lectin receptors and microRNAs in cellular homeostasis and immune response. FEBS J. 2021 Jul;288(14):4210-4229. doi: 10.1111/febs.15603. Epub 2020 Nov 7.
PubMed 33085815Valipour A, Jager M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD008946. doi: 10.1002/14651858.CD008946.pub3.
PubMed 32632956
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SOLAR: A Phase 2, Randomized, Open-label, Parallel-group, Active Comparator, Multi-center Study to Investigate the Efficacy and Safety of Cobomarsen (MRG-106) in Subjects With Cutaneous T-Cell Lymphoma (CTCL), Mycosis Fungoides (MF) Subtype
- ClinicalTrials.gov ID
- NCT03713320
- Acronym / sponsor ID
- SOLAR / MRG106-11-201
- Keywords
- SOLAR, 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: The study was terminated early for business reasons, and not due to concerns regarding safety or lack of efficacy.
- Enrolment
- 37 participants (actual)
- Lead sponsor
- miRagen Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Apr 2019 (actual)
- Primary completion
- 12 Oct 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 19 Oct 2018 (actual)
- Results
- Posted 8 Apr 2022
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. 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 study will compare the effects of cobomarsen to vorinostat, a drug that has been approved for the treatment of CTCL in the United States and several other countries.
Participants in the clinical trial will be randomly assigned to receive either weekly doses of cobomarsen by injection into a vein or daily oral doses of vorinostat. Participants will continue on their assigned treatment as long as there is no evidence of progression of their cancer. The effects of treatment will be measured based on changes in skin lesion severity, 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.
Participants assigned to receive vorinostat who experience progression of their disease during their participation in this study may have the option to be treated with cobomarsen in an open-label, crossover arm of the same study if they meet the entry criteria for that part of the study.
Detailed description
Study Design:
Subjects will be randomly assigned in a 1:1 ratio to receive either cobomarsen or vorinostat. Approximately 126 subjects (63 per arm) are expected to be enrolled. Cobomarsen will be administered in the clinic by 2-hr intravenous infusion on Days 1, 3, 5 and 8, and weekly thereafter. Vorinostat will be dispensed to study subjects and taken as a daily oral dose according to the manufacturer's labeled dosing instructions. Treatment will continue until the subject becomes intolerant, develops clinically significant side effects, progresses, or the trial is terminated. An interim analysis will be conducted after approximately 40 subjects have been followed for a minimum of approximately 6 months. Enrollment will be suspended until the completion of the interim analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cobomarsen | Experimental | Drug: CobomarsenCobomarsen will be administered by intravenous 2-hour infusion at a dose of 282 mg on Days 1, 3, 5, 8, and weekly thereafter |
| Vorinostat | Active comparator | Drug: VorinostatVorinostat 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 (6 listed)
- 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
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 doses of cobomarsen (282 mg) throughout study treatment period | Drug | Cobomarsen |
| VorinostatDaily doses of vorinostat throughout study treatment period | Drug | Vorinostat |
Primary outcome
Percentage of Subjects Achieving an Objective Skin Response of at Least 4 Months Duration (ORR4)
Time frame: 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.
10 secondary outcomes
Progression-free Survival (PFS)
Time frame: Date of first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months
Complete Response Rate
Time frame: Date of first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months
Time to Progression
Time frame: Date of first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months
Time to Maximal Effect in mSWAT
Time frame: Monthly from first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months
Objective Response Rate in the Skin of at Least 28-days Duration (ORR1)
Time frame: Monthly from first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months
Percentage of Subjects Achieving ≥ 50% Improvement in mSWAT at 28 Days
Time frame: 28 days after first dose
Percentage of Subjects Achieving ≥ 50% Improvement in mSWAT at 4 Months
Time frame: 4 months after first dose
Time to ≥ 50% Improvement in mSWAT
Time frame: Monthly from first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months
Duration of Response in Skin
Time frame: Monthly from first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months
Pruritus Medication Utilization
Time frame: Date of first dose through end of treatment or interim analysis data cut-off date of 12-Oct-2020, up to 16 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33085815Ganguly K, Kishore U, Madan T. Interplay between C-type lectin receptors and microRNAs in cellular homeostasis and immune response. FEBS J. 2021 Jul;288(14):4210-4229. doi: 10.1111/febs.15603. Epub 2020 Nov 7.
- Derived from this study: PubMed 32632956Valipour A, Jager M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD008946. doi: 10.1002/14651858.CD008946.pub3.
- 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.
43 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cobomarsen and Vorinostat in people with Cutaneous T-Cell Lymphoma/Mycosis Fungoides, run by miRagen Therapeutics, Inc. at 43 sites in 8 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 4 inclusion and 6 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 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States, France, Spain, United Kingdom, Australia and 3 more countries. 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?
Yes. Results are posted in the registry (first posted 8 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Subjects Achieving an Objective Skin Response of at Least 4 Months Duration (ORR4) (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03713320, which also lists 2 linked publications.
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 8 Apr 2022.