Lymphoma, T-Cell, PeripheralPhase 1/2NCT02535247
Study of MK-3475 Alone or in Combination With Copanlisib in Relapsed or Refractory NK and T-cell Non-Hodgkin Lymphoma
A Phase 1/2 study testing MK-3475 and Copanlisib in people with Lymphoma, T-Cell, Peripheral, run by Fox Chase Cancer Center at 1 site in United States.
Trial summary
This is a multicenter, single-arm, open label, study consisting of two cohorts. Cohort 2 explores the combination of copanlisib and pembrolizumab in patients with relapsed or refractory NKTCL, who have received at least 1 prior systemic therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, T-Cell, Peripheral
- What is being tested?
- MK-3475 and Copanlisib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2016to 25 Feb 2020
- Phase
- Phase 1/2
- 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
- Have a histologically or cytologically confirmed relapsed/refractory mature T-cell lymphoma that has progressed after a minimum of 1 systemic therapy with any of the following T-cell histologies:
- Peripheral T-cell NHL, not other wise specified (PTCL, NOS)
- Anaplastic large cell T-cell lymphoma (ALCL)
- Anaplastic lymphoma kinase positive or negative
- Angioimmunoblastic T-cell lymphoma
- Subcutaneous panniculitis like T-cell lymphoma
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- Follicular T-cell lymphoma
- Nodal peripheral T-cell lymphoma with TFH phenotype
- Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL)
- Enteropathy associated T-cell lymphoma
- Hepatosplenic T-cell lymphoma
- Extranodal NK/T-cell lymphoma, nasal type
- Unclassifiable PTCL
- Transformed cutaneous T-cell lymphoma (CTCL) to PTCL with systemic involvement (not local skin transformation).
- Be willing and able to sign written informed consent for the trial.
- Be at least 18 years of age on day of signing informed consent.
- Have measurable disease based as defined by at least one lesion that can be measured in least 2 perpendicular dimensions and measures at least 1.5 cm in its long axis.
- Have provided tissue from an archival tissue sample or newly obtained core or excisional biopsy of a tumor lesion obtained within 28 days prior to study enrollment.
- Have a performance status of 0, 1 or 2 on the ECOG Performance Scale.
- Demonstrate adequate organ function as defined below, all screening labs should be performed within 10 days of treatment initiation.
- Absolute neutrophil count (ANC) Greater than or equal to 1,500 /mcL, OR Greater than or equal to1,000 /mcL if lymphomatous bone marrow involvement Patients with documented marrow involvement may receive GCSF to achieve this value
- Platelets greater than or equal to 100,000 / mcL, OR greater than or equal to 75,000 / mcL if lymphomatous bone marrow involvement Patients with documented marrow involvement may be transfused to this value.
- Hemoglobin greater than or equal to 9 g/dL or greater than or equal to 5.6 mmol/L Patients with documented marrow involvement may be transfused to this value.
- Serum creatinine OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) less than or equal to1.5 X upper limit of normal (ULN) OR greater than or equal to 40 mL/min for subject with creatinine levels greater than 1.5 X institutional ULN
- Serum total bilirubin less than 1.5 X ULN OR Direct bilirubin less than the ULN for subjects with total bilirubin levels greater than 1.5 ULN
- AST (SGOT) and ALT (SGPT) less than or equal to 2.5 X ULN OR less than or equal to 5 X ULN for subjects with liver involvement by lymphoma
- Lipase less than or equal to 1.5 X ULN
- International Normalized Ratio (INR) or Prothrombin Time (PT) less than or equal to 1.5 X ULN unless subject is receiving anticoagulant therapy
- Activated Partial Thromboplastin Time (aPTT) less than or equal to 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
- Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication (Reference Section 5.5.2). Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for greater than 1 year.
- Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.
Who cannot join
- Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 2 weeks of the first dose of treatment.
- Patients diagnosed with Adult T-cell Leukemia/Lymphoma (ATLL) or T-cell PLL
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
- Has had a prior monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (i.e., worse than Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
- Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
- Note: Subjects with worse than Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
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- Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
- Has known active intraparenchymal lymphomatous central nervous system (CNS) lesions and/or lymphomatous meningitis. Subjects with previously treated CNS involvement by lymphoma may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain lesions, and are not using steroids for at least 7 days prior to trial treatment.
- Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjoegren's syndrome will not be excluded from the study.
- Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
- Has an active infection requiring systemic therapy.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
- Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
- Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
- Has received a live vaccine within 30 days prior to the first dose of trial treatment.
- Cohort 2a: Has received an allogeneic stem cell transplant. For cohort 2b, patients within the first 100 days of having undergone an allogeneic stem cell transplant will be excluded. Otherwise, patients who have received an allogeneic stem cell transplant are allowed as long as they have no evidence of active GVHD or are on immunosuppressive therapy
- Uncontrolled arterial hypertension despite optimal medical management
- Uncontrolled Type I or II diabetes mellitus as deemed appropriate by the investigator. Suggested guidelines for uncontrolled diabetes: HbA1c> 8.5%
- Anti-arrhythmic therapy (beta blockers or digoxin are permitted)
- Use of CYP3A4 inhibitors and inducers. Copanlisib is primarily metabolized by CYP3A4. Therefore concomitant use of strong inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir, nelfinavir and saquinavir), and strong inducers of CYP3A (e.g. rifampin, phenytoin, carbamazepine, phenobarbital, St. John's Wort) are not permitted from Day -14 of Cycle 1 until the Safety follow up visit. See Table in Appendix 5 for complete list
- Concurrent diagnosis of pheochromocytoma
- Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 3 months before the start of study medication
- Prior exposure to PI3K inhibitors, unless on PI3K inhibitor therapy more than 6 months ago AND reason for discontinuation of prior PI3K inhibitor therapy was other than progression or toxicity.
- Patients with detectable CMV viremia are excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
About this study
Official title: A Phase I/II Study to Determine Feasibility and Safety MK-3475 Alone or in Combination With Copanlisib in Relapsed or Refractory NK and T-cell Non-Hodgkin Lymphoma
This is a multicenter, single-arm, open label, study consisting of two cohorts. Cohort 2 explores the combination of copanlisib and pembrolizumab in patients with relapsed or refractory NKTCL, who have received at least 1 prior systemic therapy. Cohort 2 will include a phase 1 portion (cohort 2a) to determine the recommended phase 2 dose (RP2D) utilizing a standard 3+3 design, followed by a phase II portion where patients will be treated at the RP2D (cohort 2b). The primary endpoint for cohort 1 was progression-free survival; the primary endpoint for cohort 2a will be to determine RP2D for the combination therapy; and overall response rate at the end of 4 treatment cycles for cohort 2b. Patients will be assessed for response with PET CT or CT every 12 weeks using the revised Cheson criteria. Correlative endpoints will be exploratory and assess PD-1 expression on peripheral blood lymphocytes; peripheral blood T-cell and NK-cell functional assays; PD-1 and PD-L1 expression on tumor tissue; tumor infiltrating lymphocytes and gene expression panels using the nanostring technology as prognostic and predictive biomarkers, as well as monitoring of minimal residual disease via high-throughput sequencing of cell free tumor DNA, and exosome analysis.
Read the detailed description
Patients with relapsed or refractory (RR) NK and T-cell Lymphoma (NKTCL), who have received at least 1 prior systemic therapy, were enrolled in cohort 1. The study design for cohort 1 was a single arm phase II 2-stage design, to explore monotherapy with the PD-1 antibody pembrolizumab (or MK-3475) given intravenously at a fixed dose of 200mg every 3 weeks for up to 36 cycles. Enrollment to this cohort has been completed.
- Conditions
- Lymphoma, T-Cell, Peripheral
- Being tested
- MK-3475, Copanlisib
- Medical subject headings
- Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-3475Drug
Also called Pembrolizumab
CopanlisibDrug
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | MK-3475 given intravenously at a fixed dose of 200mg every 3 weeks for up to 36 cycles Receives: Drug: MK-3475 |
| Combination | Active comparator | MK-3475 is given intravenously at a fixed dose of 200mg every 3 weeks Copanlisib is given intravenously at RP2D determined from Phase I study Receives: Drug: MK-3475; Drug: Copanlisib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Based on RECIST v1.1
Measured: 3 Months
Recommended Phase II Dose of the Combination of Pembrolizumab and Copanlisib
Measured: 6 months
Determine Overall Response Rate by 4 Cycles of Combination of Pembrolizumab and Copanlisib
Measured: 6 months
Secondary outcomes (3)
Overall Survival
Measured: 6 Months
Maximum Tolerated Dose of Pembrolizumab and Copanlisib
Defined as the highest dose tested in which none or only one patient experienced dose-limiting toxicity (DLT) attributable to the study drug(s), when 6 patients have been treated at that dose and are evaluable for toxicity.
Measured: 6 months
Expression of PD-1, PD-L1 and Tumor Infiltrating Lymphocytes (TIL) in Pre-treatment Tumor Specimens
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2015 (estimated)
- Study start5 Jan 2016
- Primary completion25 Feb 2020
- Study completion25 Feb 2020
Why it stopped: Merck no longer providing drug for study
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 (1)Papers the sponsor has linked to this study.
- Other trials for Lymphoma, T-Cell, PeripheralStudies of the same condition, open and under way.
- More trials run by Fox Chase Cancer CenterThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- MK-3475 is given intravenously at a fixed dose of 200mg every 3 weeks. Copanlisib is given intravenously at RP2D determined from Phase I study 18 in cohort 1 (pembrolizumab alone; completed); 27 in Cohort 2; 4-12 in cohort 2a (phase I); 18 in cohort 2b (phase II). Total up to 48
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Henry Fung, MD, Principal investigator, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02535247
- Sponsor's protocol ID
- HM-075
- Status last verified
- Jun 2022
- First submitted
- 26 Aug 2015
- Last updated
- 8 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Barta SK, Zain J, MacFarlane AW 4th, Smith SM, Ruan J, Fung HC, Tan CR, Yang Y, Alpaugh RK, Dulaimi E, Ross EA, Campbell KS, Khan N, Siddharta R, Fowler NH, Fisher RI, Oki Y. Phase II Study of the PD-1 Inhibitor Pembrolizumab for the Treatment of Relapsed or Refractory Mature T-cell Lymphoma. Clin Lymphoma Myeloma Leuk. 2019 Jun;19(6):356-364.e3. doi: 10.1016/j.clml.2019.03.022. Epub 2019 Apr 3.
PubMed 31029646
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study to Determine Feasibility and Safety MK-3475 Alone or in Combination With Copanlisib in Relapsed or Refractory NK and T-cell Non-Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT02535247
- Acronym / sponsor ID
- HM-075
- Conditions
- Lymphoma, T-Cell, Peripheral
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Merck no longer providing drug for study
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 5 Jan 2016 (actual)
- Primary completion
- 25 Feb 2020 (actual)
- Study completion
- 25 Feb 2020 (actual)
- First posted
- 28 Aug 2015 (estimated)
- Results
- Posted 8 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, single-arm, open label, study consisting of two cohorts. Cohort 2 explores the combination of copanlisib and pembrolizumab in patients with relapsed or refractory NKTCL, who have received at least 1 prior systemic therapy. Cohort 2 will include a phase 1 portion (cohort 2a) to determine the recommended phase 2 dose (RP2D) utilizing a standard 3+3 design, followed by a phase II portion where patients will be treated at the RP2D (cohort 2b). The primary endpoint for cohort 1 was progression-free survival; the primary endpoint for cohort 2a will be to determine RP2D for the combination therapy; and overall response rate at the end of 4 treatment cycles for cohort 2b. Patients will be assessed for response with PET CT or CT every 12 weeks using the revised Cheson criteria. Correlative endpoints will be exploratory and assess PD-1 expression on peripheral blood lymphocytes; peripheral blood T-cell and NK-cell functional assays; PD-1 and PD-L1 expression on tumor tissue; tumor infiltrating lymphocytes and gene expression panels using the nanostring technology as prognostic and predictive biomarkers, as well as monitoring of minimal residual disease via high-throughput sequencing of cell free tumor DNA, and exosome analysis.
Detailed description
Patients with relapsed or refractory (RR) NK and T-cell Lymphoma (NKTCL), who have received at least 1 prior systemic therapy, were enrolled in cohort 1. The study design for cohort 1 was a single arm phase II 2-stage design, to explore monotherapy with the PD-1 antibody pembrolizumab (or MK-3475) given intravenously at a fixed dose of 200mg every 3 weeks for up to 36 cycles. Enrollment to this cohort has been completed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- MK-3475 is given intravenously at a fixed dose of 200mg every 3 weeks. Copanlisib is given intravenously at RP2D determined from Phase I study 18 in cohort 1 (pembrolizumab alone; completed); 27 in Cohort 2; 4-12 in cohort 2a (phase I); 18 in cohort 2b (phase II). Total up to 48
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: MK-3475MK-3475 given intravenously at a fixed dose of 200mg every 3 weeks for up to 36 cycles |
| Combination | Active comparator | Drug: MK-3475, Drug: CopanlisibMK-3475 is given intravenously at a fixed dose of 200mg every 3 weeks Copanlisib is given intravenously at RP2D determined from Phase I study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (31 listed)
- Have a histologically or cytologically confirmed relapsed/refractory mature T-cell lymphoma that has progressed after a minimum of 1 systemic therapy with any of the following T-cell histologies:
- Be willing and able to sign written informed consent for the trial.
- Be at least 18 years of age on day of signing informed consent.
- Have measurable disease based as defined by at least one lesion that can be measured in least 2 perpendicular dimensions and measures at least 1.5 cm in its long axis.
- Have provided tissue from an archival tissue sample or newly obtained core or excisional biopsy of a tumor lesion obtained within 28 days prior to study enrollment.
Key exclusion criteria (28 listed)
- Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 2 weeks of the first dose of treatment.
- Patients diagnosed with Adult T-cell Leukemia/Lymphoma (ATLL) or T-cell PLL
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
- Has had a prior monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (i.e., worse than Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
- Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
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 |
|---|---|---|
| MK-3475Also: Pembrolizumab | Drug | Combination, Treatment |
| Copanlisib | Drug | Combination |
Primary outcome
Progression Free Survival
Time frame: 3 Months
Based on RECIST v1.1
Recommended Phase II Dose of the Combination of Pembrolizumab and Copanlisib
Time frame: 6 months
Determine Overall Response Rate by 4 Cycles of Combination of Pembrolizumab and Copanlisib
Time frame: 6 months
3 secondary outcomes
Overall Survival
Time frame: 6 Months
Maximum Tolerated Dose of Pembrolizumab and Copanlisib
Time frame: 6 months
Expression of PD-1, PD-L1 and Tumor Infiltrating Lymphocytes (TIL) in Pre-treatment Tumor Specimens
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 31029646Barta SK, Zain J, MacFarlane AW 4th, Smith SM, Ruan J, Fung HC, Tan CR, Yang Y, Alpaugh RK, Dulaimi E, Ross EA, Campbell KS, Khan N, Siddharta R, Fowler NH, Fisher RI, Oki Y. Phase II Study of the PD-1 Inhibitor Pembrolizumab for the Treatment of Relapsed or Refractory Mature T-cell Lymphoma. Clin Lymphoma Myeloma Leuk. 2019 Jun;19(6):356-364.e3. doi: 10.1016/j.clml.2019.03.022. Epub 2019 Apr 3.
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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.
Henry Fung, MD principal investigator
Fox Chase Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MK-3475 and Copanlisib in people with Lymphoma, T-Cell, Peripheral, run by Fox Chase Cancer Center at 1 site in United States.
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 31 inclusion and 28 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 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Jul 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?
Progression Free Survival (time frame: 3 Months). The study lists 3 primary outcomes in all. 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 NCT02535247, which also lists 1 linked publication.
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 Jul 2022.