Uveal MelanomaPhase 1/2NCT02570308
A Study of the Intra-Patient Escalation Dosing Regimen With IMCgp100 in Patients With Advanced Uveal Melanoma
A Phase 1/2 study testing IMCgp100 in people with Uveal Melanoma, run by Immunocore Ltd at 26 sites in 5 countries.
Trial summary
IMCgp100-102 is a Phase I/II study of the weekly intra-patient escalation dose regimen with IMCgp100 as a single agent in participants with metastatic uveal melanoma (mUM). According to this regimen, all participants in the trial received 2 weekly doses of IMCgp100 at a dose level below the identified weekly… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveal Melanoma
- What is being tested?
- IMCgp100
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 26 sitesin 5 countries
- Study dates
- 29 Feb 2016to 17 Oct 2022
- 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
- Male or female participants age ≥ 18 years of age at the time of informed consent.
- Ability to provide and understand written informed consent prior to any study procedures.
- Histologically or cytologically confirmed diagnosis of metastatic uveal melanoma (mUM).
- Surgically sterile participants or participants of child-bearing potential who agree to use highly effective methods of contraception during study dosing and for 6 months after last dose of study drug.
- Human leukocyte antigen (HLA)-A*0201 positive.
- ECOG Performance Status of 0 or 1 at Screening.
- Phase 2 will include participants with previously treated uveal melanoma in the metastatic setting.
Who cannot join
- Presence of symptomatic or untreated central nervous system (CNS) metastases, or CNS metastases that require doses of corticosteroids.
- History of severe hypersensitivity reactions to other biologic drugs or monoclonal antibodies.
- Participants with any out-of-range laboratory values.
- Clinically significant cardiac disease or impaired cardiac function.
- Active infection requiring systemic antibiotic therapy.
- Known history of HIV infection.
Show all 12Show fewer
- Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection per institutional protocol.
- Participants receiving systemic treatment with systemic steroid therapy or any other immunosuppressive medication at any dose level that would interfere with the action of the study drugs in the opinion of the investigator.
- Malignant disease, other than that being treated in this study.
- Any medical condition that would, in the investigator's judgment, prevent participation in the clinical study due to safety concerns, compliance with clinical study procedures or interpretation of study results.
- Presence of NCI CTCAE ≥ grade 2 toxicity (except alopecia, peripheral neuropathy and ototoxicity, which are excluded if ≥ NCI CTCAE grade 3) due to prior cancer therapy.
- Pregnant, likely to become pregnant, or lactating women.
Trial locations and contacts
26 sites in 5 countries.
26 sites in 5 countries
United States17 sites
University of Colorado Denver Anschutz Medical Campus
Aurora, Colorado, 80045
Roswell Park Cancer Institute
Buffalo, New York, 14263
The University of Chicago Medical Center
Chicago, Illinois, 60637
University California, San Diego Moores Cancer Center
La Jolla, California, 92093
The Angeles Clinic and Research Institute - W LA Office
Los Angeles, California, 90025
University of Miami Hospital Clinics/Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Columbia University Medical Center - The New York Presbyterian Hospital
New York, New York, 10032
Memorial Sloan Kettering Hospital
New York, New York, 10065
Dean A. Mcgee Eye Institute
Oklahoma City, Oklahoma, 73104
Thomas Jefferson University Medical Oncology Clinic
Philadelphia, Pennsylvania, 19107
Providence Portland Medical Center
Portland, Oregon, 97213
California Pacific Medical Center
San Francisco, California, 94115
Washington University, School of Medicine
St Louis, Missouri, 63110
H. Lee Moffitt Cancer Center and Research Institute, Inc
Tampa, Florida, 33612-9497
Baylor Scott & White Health
Temple, Texas, 76508
Georgetown University - Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, 20007
Spain4 sites
ICO l'Hospitalet - Hospital Duran i Reynals
L'Hospitalet de Llobregat, Barcelona, 08908
Hospital Universitario La Paz
Madrid, 28046
Hospital Universitario Virgen Macarena
Seville, 41009
Hospital General Universitario de Valencia
Valencia, 46014
Germany2 sites
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
Berlin, 12200
Universitaetsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
United Kingdom2 sites
The Clatterbridge Cancer Centre
Metropolitan Borough of Wirral, Merseyside, CH63 4JY
Mount Vernon Cancer Centre
Northwood, Middlesex, HA6 2RN
About this study
Official title: A Phase I/II Open-label, Multi-center Study of the Safety and Efficacy of IMCgp100 Using the Intra-patient Escalation Dosing Regimen in Patients With Advanced Uveal Melanoma
IMCgp100-102 is a Phase I/II study of the weekly intra-patient escalation dose regimen with IMCgp100 as a single agent in participants with metastatic uveal melanoma (mUM). According to this regimen, all participants in the trial received 2 weekly doses of IMCgp100 at a dose level below the identified weekly recommended Phase II dose (RP2D-QW) and then a dose escalation commenced at the third weekly dose at C1D15. The Phase I testing of the intra-patient escalation dosing regimen is designed to achieve a higher exposure and maximal plasma concentration of IMCgp100 after doses at Cycle 1 Day 15 (C1D15) and thereafter.
Read the detailed description
This is a Phase I/II clinical study of IMCgp100 in participants with advanced uveal melanoma.
This is a Phase I/II study of IMCgp100 administered on a weekly basis with an intra-patient escalation dosing regimen. The intra-patient escalation occurred at the third weekly dose on Cycle 1 Day 15 (C1D15). According to this regimen, all participants in the trial received 2 weekly doses of IMCgp100 at a dose level below the identified weekly recommended Phase II dose (RP2D-QW), and then a dose escalation commenced at the third weekly dose at C1D15 with the goal to achieve a long-term dosing regimen at a dose higher than that identified for the weekly dosing regimen (RP2D-QW). The dose escalation identified the intra-patient escalation regimen (RP2D-IE).
The Phase I portion of the study was a standard 3+3 dose escalation design.The recommended Phase II dose of the intra-patient escalation dose regimen (RP2D-IE) was identified and expansion cohorts in metastatic uveal melanoma was accrued based on prior therapy.
- Conditions
- Uveal Melanoma
- Being tested
- IMCgp100
- Keywords
- Tebentafusp, IMCgp100, gp100, metastatic melanoma, ImmTAC, Immunotherapy, Bispecific T cell receptor fusion protein, Immune mobilizing monoclonal T cell receptor, against cancer, UM, mUM, Kimmtrak
- Medical subject headings
- Uveal Melanoma, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMCgp100Drug
Also called Tebentafusp, Kimmtrak
Bispecific soluble HLA-A2 restricted gp100-specific T-cell receptor fused to anti-CD3
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation | Experimental | Dose escalation cohorts of the intra-patient escalation regimen. Receives: Drug: IMCgp100 |
| Dose expansion | Experimental | Dose expansion cohort with the recommended phase 2 dose of the intra-patient dose escalation regimen. Receives: Drug: IMCgp100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With a Dose Limiting Toxicity (DLT) in Phase 1
Number of participants with a dose limiting toxicity, defined as an adverse event (AE) or abnormal laboratory value assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle of treatment and meets any of the pre-specified criteria.
Measured: Up to 49 months
Objective Response Rate in Phase 2
Objective response rate (ORR) is defined as the percentage of participants with measurable disease with at least 1 visit response of complete response (CR) or partial response (PR) that is confirmed at least 4 weeks later, as defined in RECIST v.1.1 and assessed by an independent central review (ICR). The denominator in the calculation of the ORR is the number of participants in the full analysis set with measurable disease at baseline.
Measured: Up to 38 months
Secondary outcomes (13)
Objective Response Rate in Phase 1
ORR is defined as the percentage of participants with measurable disease with at least 1 visit response of CR or PR that is confirmed at least 4 weeks later, as defined in RECIST v.1.1 and assessed by an investigator. The denominator in the calculation of the ORR is the number of participants in the full analysis set with measurable disease at baseline.
Measured: Up to 49 months
Progression-free Survival
Progression-free survival is defined as the time in months from first dose of study drug until the date of disease progression or death (by any cause in the absence of disease progression) as assessed by RECIST v1.1 by the investigator for Phase 1 and ICR for Phase 2.
Measured: Up to 49 months
Disease Control Rate
Disease control rate (DCR) is defined as the percentage of participants with a best overall response of CR or PR or stable disease (SD) recorded at least 24 weeks (± 1 week) after commencement of study drug and prior to any progressive disease (PD) event, as assessed by RECIST v1.1 by the investigator for Phase 1 and ICR for Phase 2.
Measured: 24 weeks
Duration of Response
Duration of response (DOR) is defined as the time in months from the date of first documented objective response (CR or PR) until the date of documented disease progression or death by any cause in the absence of disease progression as assessed by RECIST v1.1 by the investigator for Phase 1 and ICR for Phase 2.
Measured: Up to 49 months
Time to Response
Time to response (TTR) is defined as the time in months from the date of first dose of study drug until the date of first documented objective response as assessed by RECIST v1.1 by the investigator for Phase 1 and ICR for Phase 2.
Measured: Up to 49 months
Overall Survival
Overall survival (OS) is defined as the time in months from the date of first dose of study drug until death due to any cause in general.
Measured: Up to 49 months
Minor Response Rate
Rate of minor response (or better) is defined as the proportion of participants with a confirmed CR, PR, or minor response (MinR) as assessed by RECIST v1.1 by the investigator for Phase 1 or ICR for Phase 2, where MinR is a reduction from baseline in sum of diameters between 10%-29%. The sum of diameters is defined as per RECIST v1.1 as the sum of longest diameters or short axis of target lesions (mm).
Measured: Up to 49 months
Number of Participants With Treatment Dose Interruptions or Reductions
Tolerability of study treatment was assessed by summarizing the number of participants with dose interruptions or reductions that occurred during the treatment period.
Measured: Up to 49 months
Area Under the Plasma Concentration-Time Curve (AUC) of Tebentafusp
The AUC was determined in in dose escalation cohorts.
Measured: Cycle 1 Day 1 and Cycle 1 Day 15: predose, end of infusion, and 4 and 8 hours postdose
Maximum Plasma Concentration (Cmax) of Tebentafusp
The Cmax is determined in dose escalation cohorts.
Measured: Cycle 1 Day 1 and Cycle 1 Day 15: predose, end of infusion, and 4 and 8 hours postdose
Time to Maximum Plasma Concentration (Tmax) of Tebentafusp
The Tmax of tebentafusp is determined in dose escalation cohorts.
Measured: Cycle 1 Day 1 and Cycle 1 Day 15: predose, end of infusion, and 4 and 8 hours postdose
Apparent Terminal Plasma Half-life (t½) of Tebentafusp
The t½ of tebentafusp is reported in dose escalation cohorts.
Measured: Cycle 1 Day 1 and Cycle 1 Day 15: predose, end of infusion, and 4 and 8 hours postdose
Percentage of Participants With Anti-IMCgp100 Antibody Formation
Overall antidrug antibody (ADA) is presented as number of ADA-positive participants relative to total number of participants with evaluable ADA results in each cohort
Measured: Up to 49 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2015 (estimated)
- Study start29 Feb 2016
- Primary completion20 Mar 2020
- Study completion17 Oct 2022
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 Uveal MelanomaStudies 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
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Immunocore Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02570308
- Sponsor's protocol ID
- IMCgp100-102
- Status last verified
- Feb 2023
- First submitted
- 6 Oct 2015
- Last updated
- 21 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
Publications
Rifaldi F, De Braud F, Del Vecchio M, Di Guardo L. Tebentafusp induces systemic immune activation, but tumor immune remodeling remains incompletely validated: a narrative review in metastatic uveal melanoma. Front Immunol. 2026 Oct 12;17:1934256. doi: 10.3389/fimmu.2026.1934256. eCollection 2026.
PubMed 42935816Carvajal RD, Butler MO, Shoushtari AN, Hassel JC, Ikeguchi A, Hernandez-Aya L, Nathan P, Hamid O, Piulats JM, Rioth M, Johnson DB, Luke JJ, Espinosa E, Leyvraz S, Collins L, Goodall HM, Ranade K, Holland C, Abdullah SE, Sacco JJ, Sato T. Clinical and molecular response to tebentafusp in previously treated patients with metastatic uveal melanoma: a phase 2 trial. Nat Med. 2022 Nov;28(11):2364-2373. doi: 10.1038/s41591-022-02015-7. Epub 2022 Oct 13.
PubMed 36229663
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Open-label, Multi-center Study of the Safety and Efficacy of IMCgp100 Using the Intra-patient Escalation Dosing Regimen in Patients With Advanced Uveal Melanoma
- ClinicalTrials.gov ID
- NCT02570308
- Acronym / sponsor ID
- IMCgp100-102
- Conditions
- Uveal Melanoma
- Keywords
- Tebentafusp, IMCgp100, gp100, metastatic melanoma, ImmTAC, Immunotherapy, Bispecific T cell receptor fusion protein, Immune mobilizing monoclonal T cell receptor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Immunocore LtdIndustry (pharma, biotech, devices)
- Study start
- 29 Feb 2016 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 17 Oct 2022 (actual)
- First posted
- 7 Oct 2015 (estimated)
- Results
- Posted 1 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
IMCgp100-102 is a Phase I/II study of the weekly intra-patient escalation dose regimen with IMCgp100 as a single agent in participants with metastatic uveal melanoma (mUM). According to this regimen, all participants in the trial received 2 weekly doses of IMCgp100 at a dose level below the identified weekly recommended Phase II dose (RP2D-QW) and then a dose escalation commenced at the third weekly dose at C1D15. The Phase I testing of the intra-patient escalation dosing regimen is designed to achieve a higher exposure and maximal plasma concentration of IMCgp100 after doses at Cycle 1 Day 15 (C1D15) and thereafter.
Detailed description
This is a Phase I/II clinical study of IMCgp100 in participants with advanced uveal melanoma.
This is a Phase I/II study of IMCgp100 administered on a weekly basis with an intra-patient escalation dosing regimen. The intra-patient escalation occurred at the third weekly dose on Cycle 1 Day 15 (C1D15). According to this regimen, all participants in the trial received 2 weekly doses of IMCgp100 at a dose level below the identified weekly recommended Phase II dose (RP2D-QW), and then a dose escalation commenced at the third weekly dose at C1D15 with the goal to achieve a long-term dosing regimen at a dose higher than that identified for the weekly dosing regimen (RP2D-QW). The dose escalation identified the intra-patient escalation regimen (RP2D-IE).
The Phase I portion of the study was a standard 3+3 dose escalation design.The recommended Phase II dose of the intra-patient escalation dose regimen (RP2D-IE) was identified and expansion cohorts in metastatic uveal melanoma was accrued based on prior therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose escalation | Experimental | Drug: IMCgp100Dose escalation cohorts of the intra-patient escalation regimen. |
| Dose expansion | Experimental | Drug: IMCgp100Dose expansion cohort with the recommended phase 2 dose of the intra-patient dose escalation regimen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female participants age ≥ 18 years of age at the time of informed consent.
- Ability to provide and understand written informed consent prior to any study procedures.
- Histologically or cytologically confirmed diagnosis of metastatic uveal melanoma (mUM).
- Surgically sterile participants or participants of child-bearing potential who agree to use highly effective methods of contraception during study dosing and for 6 months after last dose of study drug.
- Human leukocyte antigen (HLA)-A*0201 positive.
Key exclusion criteria (12 listed)
- Presence of symptomatic or untreated central nervous system (CNS) metastases, or CNS metastases that require doses of corticosteroids.
- History of severe hypersensitivity reactions to other biologic drugs or monoclonal antibodies.
- Participants with any out-of-range laboratory values.
- Clinically significant cardiac disease or impaired cardiac function.
- Active infection requiring systemic antibiotic therapy.
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 |
|---|---|---|
| IMCgp100Also: Tebentafusp, KimmtrakBispecific soluble HLA-A2 restricted gp100-specific T-cell receptor fused to anti-CD3 | Drug | Dose escalation, Dose expansion |
Primary outcome
Number of Participants With a Dose Limiting Toxicity (DLT) in Phase 1
Time frame: Up to 49 months
Number of participants with a dose limiting toxicity, defined as an adverse event (AE) or abnormal laboratory value assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle of treatment and meets any of the pre-specified criteria.
Objective Response Rate in Phase 2
Time frame: Up to 38 months
Objective response rate (ORR) is defined as the percentage of participants with measurable disease with at least 1 visit response of complete response (CR) or partial response (PR) that is confirmed at least 4 weeks later, as defined in RECIST v.1.1 and assessed by an independent central review (ICR). The denominator in the calculation of the ORR is the number of participants in the full analysis set with measurable disease at baseline.
13 secondary outcomes
Objective Response Rate in Phase 1
Time frame: Up to 49 months
Progression-free Survival
Time frame: Up to 49 months
Disease Control Rate
Time frame: 24 weeks
Duration of Response
Time frame: Up to 49 months
Time to Response
Time frame: Up to 49 months
Overall Survival
Time frame: Up to 49 months
Minor Response Rate
Time frame: Up to 49 months
Number of Participants With Treatment Dose Interruptions or Reductions
Time frame: Up to 49 months
Area Under the Plasma Concentration-Time Curve (AUC) of Tebentafusp
Time frame: Cycle 1 Day 1 and Cycle 1 Day 15: predose, end of infusion, and 4 and 8 hours postdose
Maximum Plasma Concentration (Cmax) of Tebentafusp
Time frame: Cycle 1 Day 1 and Cycle 1 Day 15: predose, end of infusion, and 4 and 8 hours postdose
Time to Maximum Plasma Concentration (Tmax) of Tebentafusp
Time frame: Cycle 1 Day 1 and Cycle 1 Day 15: predose, end of infusion, and 4 and 8 hours postdose
Apparent Terminal Plasma Half-life (t½) of Tebentafusp
Time frame: Cycle 1 Day 1 and Cycle 1 Day 15: predose, end of infusion, and 4 and 8 hours postdose
Percentage of Participants With Anti-IMCgp100 Antibody Formation
Time frame: Up to 49 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42935816Rifaldi F, De Braud F, Del Vecchio M, Di Guardo L. Tebentafusp induces systemic immune activation, but tumor immune remodeling remains incompletely validated: a narrative review in metastatic uveal melanoma. Front Immunol. 2026 Oct 12;17:1934256. doi: 10.3389/fimmu.2026.1934256. eCollection 2026.
- Derived from this study: PubMed 36229663Carvajal RD, Butler MO, Shoushtari AN, Hassel JC, Ikeguchi A, Hernandez-Aya L, Nathan P, Hamid O, Piulats JM, Rioth M, Johnson DB, Luke JJ, Espinosa E, Leyvraz S, Collins L, Goodall HM, Ranade K, Holland C, Abdullah SE, Sacco JJ, Sato T. Clinical and molecular response to tebentafusp in previously treated patients with metastatic uveal melanoma: a phase 2 trial. Nat Med. 2022 Nov;28(11):2364-2373. doi: 10.1038/s41591-022-02015-7. Epub 2022 Oct 13.
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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.
The record lists no contact. Use the official record to reach the sponsor.
26 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IMCgp100 in people with Uveal Melanoma, run by Immunocore Ltd at 26 sites in 5 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 7 inclusion and 12 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 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, Spain, Germany, United Kingdom, Canada. 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 1 Sep 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 a Dose Limiting Toxicity (DLT) in Phase 1 (time frame: Up to 49 months). The study lists 2 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 NCT02570308, 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 21 Mar 2023.