Advanced MalignanciesPhase 1/2NCT02697591
A Study of INCAGN01876 in Participants With Advanced or Metastatic Solid Tumors
A Phase 1/2 study testing INCAGN01876 in people with Advanced Malignancies and Metastatic Cancer, run by Incyte Biosciences International Sàrl at 8 sites in United States.
Trial summary
This was an open-label, non-randomized Phase 1/2 safety study of INCAGN01876 in participants with advanced or metastatic solid tumors that was conducted in 2 parts. Part 1 is dose escalation and safety expansion which determines the optimal dose and maximum number of tolerated doses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignancies, Metastatic Cancer
- What is being tested?
- INCAGN01876
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 8 sitesUnited States
- Study dates
- 20 Jun 2016to 16 Dec 2019
- 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
- Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent.
- Part 1: Participants with advanced or metastatic solid tumors.
- Part 2: Participants with advanced or metastatic adenocarcinoma of endometrium, melanoma, non-small cell lung cancer, and renal cell carcinoma.
- Participants who have disease progression after treatment with available therapies that are known to confer clinical benefit, or who are intolerant to treatment, or participants who refuse standard treatment.
- Presence of measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
Who cannot join
- Laboratory and medical history parameters not within the protocol-defined range.
- Receipt of anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug.
- Has not recovered to ≤ Grade 1 from toxic effects of prior therapy and/or complications from prior surgical intervention before starting therapy.
- Receipt of a live vaccine within 30 days of planned start of study therapy.
- Active autoimmune disease.
- Prior treatment with any tumor necrosis factor super family agonist.
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- Known active central nervous system metastases and/or carcinomatous meningitis.
- Evidence of active, non-infectious pneumonitis or history of interstitial lung disease.
- Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
MSK Westchester
Harrison, New York, 10604
The Angeles Clinic and Research Institute
Los Angeles, California, 90025
Memorial Sloan Kettering at Monmouth
Middletown, New Jersey, 07748
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Yale University
New Haven, Connecticut, 06511
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCAGN01876 in Subjects With Advanced or Metastatic Solid Tumors
This was an open-label, non-randomized Phase 1/2 safety study of INCAGN01876 in participants with advanced or metastatic solid tumors that was conducted in 2 parts. Part 1 is dose escalation and safety expansion which determines the optimal dose and maximum number of tolerated doses. Part 2 is dose expansion in which Part 1 recommended dose will be evaluated.
- Conditions
- Advanced Malignancies, Metastatic Cancer
- Being tested
- INCAGN01876
- Keywords
- Solid tumor, adenocarcinoma of the endometrium, melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), glucocorticoid-induced tumor necrosis factor receptor (GITR)
- Medical subject headings
- Neoplasm Metastasis, Melanoma, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCAGN01876Drug
Initial cohort dose of INCAGN01876 monotherapy at the protocol-defined starting dose, with subsequent cohort escalations based on protocol-specific criteria. The recommended dose will be taken forward into expansion cohorts.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1: 20.0 Milligram Per Kilograms (mg/kg) Every 2 Weeks (Q2W) | Experimental | Participants received IV infusion of study drug at a dose of 20.0 mg/kg every Q2W starting on Day 1 of each cycle for up to 15 months. Receives: Drug: INCAGN01876 |
| Phase 1: 0.03 mg/kg Q2W | Experimental | Participants received intravenous (IV) infusion of study drug at a dose of 0.03 mg/kg every Q2W starting on Day 1 of each cycle for up to 15 months. Receives: Drug: INCAGN01876 |
| Phase 1: 0.1 mg/kg Q2W | Experimental | Participants received IV infusion of study drug at a dose of 0.1 mg/kg every Q2W starting on Day 1 of each cycle for up to 15 months. Receives: Drug: INCAGN01876 |
| Phase 1: 0.3 mg/kg Q2W | Experimental | Participants received IV infusion of study drug at a dose of 0.3 mg/kg every Q2W starting on Day 1 of each cycle for up to 15 months. Receives: Drug: INCAGN01876 |
| Phase 1: 1.0 mg/kg Q2W | Experimental | Participants received IV infusion of study drug at a dose of 1.0 mg/kg every Q2W starting on Day 1 of each cycle for up to 15 months. Receives: Drug: INCAGN01876 |
| Phase 1: 3.0 mg/kg Q2W | Experimental | Participants received IV infusion of study drug at a dose of 3.0 mg/kg every Q2W starting on Day 1 of each cycle for up to 15 months. Receives: Drug: INCAGN01876 |
| Phase 1: 5.0 mg/kg Q2W | Experimental | Participants received IV infusion of study drug at a dose of 5.0 mg/kg every Q2W starting on Day 1 of each cycle for up to 15 months. Receives: Drug: INCAGN01876 |
| Phase 1: 10.0 mg/kg Q2W | Experimental | Participants received IV infusion of study drug at a dose of 10.0 mg/kg every Q2W starting on Day 1 of each cycle for up to 15 months. Receives: Drug: INCAGN01876 |
| Phase 1: 400 mg/kg Every 4 Weeks (Q4W) | Experimental | Participants received IV infusion of study drug at a dose of 400 mg/kg every Q2W starting on Day 1 of each cycle for up to 15 months. Receives: Drug: INCAGN01876 |
| Phase 2: 300 mg/kg Q2W | Experimental | Participants received IV infusion of study drug at a dose of 300 mg/kg every Q2W starting on Day 1 of each cycle for up to 15 months. Receives: Drug: INCAGN01876 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Any Treatment-Emergent Adverse Event (TEAE) and as Per the Severity
AE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. A treatment-emergent AE is any AE either reported for first time or worsening of a pre-existing event after the first dose of study drug. Grade 1 AEs is defined as Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 AEs is defined as Moderate; minimal, local, or non-invasive intervention indicated; limiting age-appropriate activities of daily living. Grade 3 AEs is defined as the severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living and Grade 4 AEs as life-threatening consequences; urgent intervention indicated. Data is reported for Grade 3 and higher severity for this outcome measure.
Measured: From screening through 60 days after end of treatment, up to Month 15
Secondary outcomes (8)
Maximum Observed Plasma Concentration (Cmax)
Measured: Day 1 of Cycles 1 and 6 post-dose
Time to Maximum Concentration (Tmax)
Measured: Day 1 of Cycles 1 and 6 post-dose
Minimum Observed Plasma Concentration Over the Dose Interval (Cmin)
Measured: Day 1 of Cycles 2, 3, 4, 6, and 7 post-dose
Area Under the Plasma Time Curve From Time = 0 to the Last Measurable Concentration (AUC0-t)
Measured: Day 1 of Cycles 1 and 6 post-dose
Objective Response Rate (ORR) Per RECIST v1.1 and Modified RECISTv1.1 (mRECIST)
ORR is defined as the percentage of participants having complete response (CR) or partial response (PR), as determined by investigator assessment of radiographic disease assessments. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm.
Measured: Baseline and every 8 weeks for the first 12 months and then every 12 weeks thereafter up to 15 months
Duration of Response (DOR) Per RECIST and mRECIST
DOR is defined as the time from earliest date of disease response (CR or PR) until earliest date of disease progression, as determined by investigator assessment of radiographic disease assessments per RECIST v1.1 and mRECIST, or death due to any cause if occurring sooner than progression. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm.
Measured: Baseline and every 8 weeks for the first 12 months and then every 12 weeks thereafter up to 15 months
Duration of Disease Control Per RECIST and mRECIST
Duration of disease control (CR, PR, and stable disease [SD]), as measured from first report of SD or better until disease progression, as determined by investigator assessment of radiographic disease assessments per RECIST v1.1 and mRECIST, or death due to any cause if occurring sooner than progression. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm. Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Measured: Baseline and every 8 weeks for the first 12 months and then every 12 weeks thereafter up to 15 months
Progression Free Survival (PFS) Per RECIST and mRECIST
PFS is defined as the time from date of first dose of study drug until the earliest date of disease progression, as determined by investigator assessment of objective radiographic disease assessments per RECIST v1.1 and mRECIST, or death due to any cause if occurring sooner than progression. Progression is defined by RECIST and mRECIST as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and an absolute lesion increase of at least 5 mm or the appearance of new lesions.
Measured: Baseline and every 8 weeks for the first 12 months and then every 12 weeks thereafter up to 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2016 (estimated)
- Study start20 Jun 2016
- Primary completion16 Dec 2019
- Study completion16 Dec 2019
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 Advanced MalignanciesStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Biosciences International Sàrl
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Janik, MD, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02697591
- Sponsor's protocol ID
- INCAGN 1876-101
- Status last verified
- Feb 2021
- First submitted
- 22 Feb 2016
- Last updated
- 26 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Hamid O, Cardin DB, Hodi FS, LoRusso P, Merghoub T, Zappasodi R, Maniyar R, Janik JE, van der Velden MVW, Zhou F, Dong Z, Chen X, Harding JJ. First-in-Human Phase I/II Study of INCAGN01876, a Glucocorticoid-Induced Tumor Necrosis Factor Receptor Agonist, in Patients with Advanced or Metastatic Solid Tumors. Clin Cancer Res. 2025 Oct 1;31(19):4089-4100. doi: 10.1158/1078-0432.CCR-24-4141.
PubMed 40711469
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCAGN01876 in Subjects With Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT02697591
- Acronym / sponsor ID
- INCAGN 1876-101
- Conditions
- Advanced Malignancies, Metastatic Cancer
- Keywords
- Solid tumor, adenocarcinoma of the endometrium, melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), glucocorticoid-induced tumor necrosis factor receptor (GITR)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Incyte Biosciences International SàrlIndustry (pharma, biotech, devices)
- Study start
- 20 Jun 2016 (actual)
- Primary completion
- 16 Dec 2019 (actual)
- Study completion
- 16 Dec 2019 (actual)
- First posted
- 3 Mar 2016 (estimated)
- Results
- Posted 26 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was an open-label, non-randomized Phase 1/2 safety study of INCAGN01876 in participants with advanced or metastatic solid tumors that was conducted in 2 parts. Part 1 is dose escalation and safety expansion which determines the optimal dose and maximum number of tolerated doses. Part 2 is dose expansion in which Part 1 recommended dose will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Phase 1: 20.0 Milligram Per Kilograms (mg/kg) Every 2 Weeks (Q2W) | Experimental | Drug: INCAGN01876Participants received IV infusion of study drug at a dose of 20.0 mg/kg every Q2W starting on Day 1 of each cycle for up to 15 months. |
| Phase 1: 0.03 mg/kg Q2W | Experimental | Drug: INCAGN01876Participants received intravenous (IV) infusion of study drug at a dose of 0.03 mg/kg every Q2W starting on Day 1 of each cycle for up to 15 months. |
| Phase 1: 0.1 mg/kg Q2W | Experimental | Drug: INCAGN01876Participants received IV infusion of study drug at a dose of 0.1 mg/kg every Q2W starting on Day 1 of each cycle for up to 15 months. |
| Phase 1: 0.3 mg/kg Q2W | Experimental | Drug: INCAGN01876Participants received IV infusion of study drug at a dose of 0.3 mg/kg every Q2W starting on Day 1 of each cycle for up to 15 months. |
| Phase 1: 1.0 mg/kg Q2W | Experimental | Drug: INCAGN01876Participants received IV infusion of study drug at a dose of 1.0 mg/kg every Q2W starting on Day 1 of each cycle for up to 15 months. |
| Phase 1: 3.0 mg/kg Q2W | Experimental | Drug: INCAGN01876Participants received IV infusion of study drug at a dose of 3.0 mg/kg every Q2W starting on Day 1 of each cycle for up to 15 months. |
| Phase 1: 5.0 mg/kg Q2W | Experimental | Drug: INCAGN01876Participants received IV infusion of study drug at a dose of 5.0 mg/kg every Q2W starting on Day 1 of each cycle for up to 15 months. |
| Phase 1: 10.0 mg/kg Q2W | Experimental | Drug: INCAGN01876Participants received IV infusion of study drug at a dose of 10.0 mg/kg every Q2W starting on Day 1 of each cycle for up to 15 months. |
| Phase 1: 400 mg/kg Every 4 Weeks (Q4W) | Experimental | Drug: INCAGN01876Participants received IV infusion of study drug at a dose of 400 mg/kg every Q2W starting on Day 1 of each cycle for up to 15 months. |
| Phase 2: 300 mg/kg Q2W | Experimental | Drug: INCAGN01876Participants received IV infusion of study drug at a dose of 300 mg/kg every Q2W starting on Day 1 of each cycle for up to 15 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent.
- Part 1: Participants with advanced or metastatic solid tumors.
- Part 2: Participants with advanced or metastatic adenocarcinoma of endometrium, melanoma, non-small cell lung cancer, and renal cell carcinoma.
- Participants who have disease progression after treatment with available therapies that are known to confer clinical benefit, or who are intolerant to treatment, or participants who refuse standard treatment.
- Presence of measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Key exclusion criteria (9 listed)
- Laboratory and medical history parameters not within the protocol-defined range.
- Receipt of anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug.
- Has not recovered to ≤ Grade 1 from toxic effects of prior therapy and/or complications from prior surgical intervention before starting therapy.
- Receipt of a live vaccine within 30 days of planned start of study therapy.
- Active autoimmune disease.
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 |
|---|---|---|
| INCAGN01876Initial cohort dose of INCAGN01876 monotherapy at the protocol-defined starting dose, with subsequent cohort escalations based on protocol-specific criteria. The recommended dose will be taken forward into expansion cohorts. | Drug | Phase 1: 0.03 mg/kg Q2W, Phase 1: 0.1 mg/kg Q2W, Phase 1: 0.3 mg/kg Q2W, Phase 1: 1.0 mg/kg Q2W, Phase 1: 10.0 mg/kg Q2W, Phase 1: 20.0 Milligram Per Kilograms (mg/kg) Every 2 Weeks (Q2W), Phase 1: 3.0 mg/kg Q2W, Phase 1: 400 mg/kg Every 4 Weeks (Q4W), Phase 1: 5.0 mg/kg Q2W, Phase 2: 300 mg/kg Q2W |
Primary outcome
Number of Participants With Any Treatment-Emergent Adverse Event (TEAE) and as Per the Severity
Time frame: From screening through 60 days after end of treatment, up to Month 15
AE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. A treatment-emergent AE is any AE either reported for first time or worsening of a pre-existing event after the first dose of study drug. Grade 1 AEs is defined as Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 AEs is defined as Moderate; minimal, local, or non-invasive intervention indicated; limiting age-appropriate activities of daily living. Grade 3 AEs is defined as the severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living and Grade 4 AEs as life-threatening consequences; urgent intervention indicated. Data is reported for Grade 3 and higher severity for this outcome measure.
8 secondary outcomes
Maximum Observed Plasma Concentration (Cmax)
Time frame: Day 1 of Cycles 1 and 6 post-dose
Time to Maximum Concentration (Tmax)
Time frame: Day 1 of Cycles 1 and 6 post-dose
Minimum Observed Plasma Concentration Over the Dose Interval (Cmin)
Time frame: Day 1 of Cycles 2, 3, 4, 6, and 7 post-dose
Area Under the Plasma Time Curve From Time = 0 to the Last Measurable Concentration (AUC0-t)
Time frame: Day 1 of Cycles 1 and 6 post-dose
Objective Response Rate (ORR) Per RECIST v1.1 and Modified RECISTv1.1 (mRECIST)
Time frame: Baseline and every 8 weeks for the first 12 months and then every 12 weeks thereafter up to 15 months
Duration of Response (DOR) Per RECIST and mRECIST
Time frame: Baseline and every 8 weeks for the first 12 months and then every 12 weeks thereafter up to 15 months
Duration of Disease Control Per RECIST and mRECIST
Time frame: Baseline and every 8 weeks for the first 12 months and then every 12 weeks thereafter up to 15 months
Progression Free Survival (PFS) Per RECIST and mRECIST
Time frame: Baseline and every 8 weeks for the first 12 months and then every 12 weeks thereafter up to 15 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40711469Hamid O, Cardin DB, Hodi FS, LoRusso P, Merghoub T, Zappasodi R, Maniyar R, Janik JE, van der Velden MVW, Zhou F, Dong Z, Chen X, Harding JJ. First-in-Human Phase I/II Study of INCAGN01876, a Glucocorticoid-Induced Tumor Necrosis Factor Receptor Agonist, in Patients with Advanced or Metastatic Solid Tumors. Clin Cancer Res. 2025 Oct 1;31(19):4089-4100. doi: 10.1158/1078-0432.CCR-24-4141.
- 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.
John Janik, MD study director
Incyte Corporation
8 sites 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 INCAGN01876 in people with Advanced Malignancies and Metastatic Cancer, run by Incyte Biosciences International Sàrl at 8 sites 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 6 inclusion and 9 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: finished, as of the sponsor's last update on 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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 26 Feb 2021). 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?
Number of Participants With Any Treatment-Emergent Adverse Event (TEAE) and as Per the Severity (time frame: From screening through 60 days after end of treatment, up to Month 15). 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 NCT02697591, 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 26 Feb 2021.