Advanced Cutaneous MelanomaIMAGENCT01511913

A Multi-National, Prospective, Observational Study in Patients With Unresectable or Metastatic Melanoma

An observational study of Advanced Cutaneous Melanoma, run by Bristol-Myers Squibb at 186 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to examine the safety of Ipilimumab and patterns of use in the treatment of unresectable or metastatic melanoma in the post-approval setting Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced Cutaneous Melanoma
How many people: 1,411 participants
Where: 186 sitesin 15 countries
Study dates: 3 Jun 2012to 12 Dec 2019
Phase: Observational
Are there results?: None posted in the registry

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

Study population: Eligible patients will be selected from approximately 200 medical practice sites (e.g. community-based, office-based, hospital-based, academic setting) in several European Union countries, Central America, North America, and South America, as well as Australia and Israel.

Who may be able to join

Diagnosis of unresectable or metastatic melanoma
Age of 18 years or older at time of entry into the study
Patients who have initiated treatment for unresectable or metastatic melanoma at medical practice (e.g. community-based, office-based, hospital-based, academic setting)within 21 days before informed consent for this study OR in the case where treatment has not yet been initiated, documentation that the treatment strategy was determined before informed consent for this study, and treatment must be initiated within 28 days after informed consent
Ipilimumab-treated patients must be receiving treatment for the indication(s) approved in their country of residence or where they are receiving treatment

Who cannot join

Current or pending participation in a clinical trial examining therapy for the treatment of any cancer (including unresectable or metastatic melanoma)
Current use of therapy to treat a primary cancer other than melanoma

Trial locations and contacts

186 sites in 15 countries.

Country

City, postcode or hospital

186 sites in 15 countries

Germany32 sites

Local Institution
Augsburg, 86156
Local Institution
Bochum, 44791
Local Institution
Buxtehude, 21614
Local Institution
Chemnitz, 09117
Local Institution
Darmstadt, 64297
Local Institution
Dessau-Roblau, 06847
Local Institution
Dortmund, 44137
Local Institution
Dresden, 01307
Local Institution
Düsseldorf, 40225
Local Institution
Frankfurt, 60590
Local Institution
Gera, 07548
Local Institution
Halle, 06120
Local Institution
Hamburg, 20099
Local Institution
Hamburg, 20246
Local Institution
Hamburg, 20253
Local Institution
Hanover, 30625
Local Institution
Jena, 07743
Local Institution
Koblenz, 56068
Local Institution
Lüdenscheid, 58515
Local Institution
Magdeburg, 39120
Local Institution
Mainz, 55131
Local Institution
Mannheim, 68167
Local Institution
Marburg, 35043
Local Institution
Münster, 48149
Local Institution
Plauen, 08529
Local Institution
Quedlinburg, 06484
Local Institution
Recklinghausen, 45657
Local Institution
Rostock, 18055
Local Institution
Schwäbisch Hall, 74523
Local Institution
Stuttgart, 70374
Local Institution
Tübingen, 72076
Local Institution
Würzburg, 97080

Other trials in Germany

United Kingdom25 sites

Local Institution
Belfast, Ireland, BT9 7AB
Local Institution
Birmingham, B15 2TH
Local Institution
Bristol, BS2 8ED
Local Institution
Cardiff, South Glamorgan, CF14 2TL
Local Institution
Chelmsford, Essex, Essex, CM1 7ET
Local Institution
Exeter, EX2 5DW
Local Institution
Hull, HU16 5JQ
Local Institution
Leeds, LS9 7TF
Local Institution
Lincoln, LN2 5QY
Local Institution
London, England, NW3 2QG
Local Institution
London, SE1 9RT
Local Institution
London, SW3 6JJ
Local Institution
London
Local Institution
Metropolitan Borough of Wirral, CH63 4JY
Local Institution
Oxfordshire, OX3 7LE
Local Institution
Plymouth, PL6 8DH
Local Institution
Poole, BH15 2JB
Local Institution
Preston, PR2 9HT
Local Institution
Rhyl, Denbigshire, LL18 5UJ
Local Institution
Southend, Essex, SS0 0RY
Local Institution
Staffordshire, ST46QG
Local Institution
Taunton, Somerset, TA1 5DA
Local Institution
Truro, Cornwall, TR1 3LJ
Local Institution
Wolverhampton, WS13 6NH
Local Institution
Yeovil, Somerset, BA21 4AT

Other trials in United Kingdom

United States24 sites

Local Institution
Canton, Ohio, 44178
Local Institution
Chicago, Illinois, 60612
Mid Ohio Onc/Hem, Inc
Columbus, Ohio, 43206
Local Institution
Columbus, Ohio, 43219
Local Institution
Denver, Colorado, 80218
Local Institution
Detroit, Michigan, 48201
Local Institution
Encinitas, California, 92024
Local Institution
Everett, Washington, 98201
Local Institution
Gilbert, Arizona, 85234
Local Institution
Hattiesburg, Mississippi, 39401
Local Institution
Hot Springs, Arkansas, 71913
Local Institution
Knoxville, Tennessee, 37920
Local Institution
La Jolla, California, 92093
Local Institution
Lakeland, Florida, 33085
Local Institution
Lincoln, Nebraska, 18015
Local Institution
Long Beach, California, 90813
Local Institution
Los Angeles, California, 90025
Local Institution
Miami Beach, Florida, 33140
Local Institution
Middletown, Ohio, 45042
Local Institution
Morristown, New Jersey, 07960
Local Institution
Niles, Illinois, 60714
Local Institution
Orange Park, Florida, 32073
Local Institution
Portland, Oregon, 97213
Local Institution
Washington D.C., District of Columbia, 20010

Other trials in United States

France19 sites

Local Institution
Bayonne, 64100
Local Institution
Besançon, 25000
Local Institution
Boulogne, 92104
Local Institution
Boulogne-sur-Mer, 62200
Local Institution
Brest, 29609
Local Institution
Clermont Ferrand Cédex 1, 63003
Local Institution
Dijon, 21079
Local Institution
Grenoble Cédex, 38043
Local Institution
Lille, 59037
Local Institution
Limoges, 87042
Local Institution
Montauban, 82000
Local Institution
Mougins, 06250
Local Institution
Nouvelle Caledonie, 98849
Local Institution
Paris, 75475
Local Institution
Pierre-Bénite, 69495
Local Institution
Quimper, 29107
Local Institution
Soissons, 02209
Local Institution
Strasbourg, 67065
Local Institution
Vandœuvre-lès-Nancy, 54500

Other trials in France

Spain18 sites

Local Institution
Barcelona, 08036
Local Institution
Donostia / San Sebastian, 20014
Local Institution
Las Palmas de Gran Canaria, 35016
Local Institution
Madrid, 28007
Local Institution
Madrid, 28033
Local Institution
Madrid, 28034
Local Institution
Madrid, 28041
Local Institution
Palma, 07198
Local Institution
Palma de Mallorca, 07198
Local Institution
Pamplona, 31008
Local Institution
Santa Cruz de Tenerife, 35320
Local Institution
Santa Cruz de Tenerife, 38010
Local Institution
Santander, 39008
Local Institution
Santiago de Compostela; A Coruña, 15706
Local Institution
Seville, 41013
Local Institution
Terrassa, 08027
Local Institution
Valladolid, 47012
Local Institution
Zaragoza, 50009

Other trials in Spain

Australia16 sites

Local Institution
Adelaide, South Australia, 05000
Local Institution
Bedford Park, South Australia, 05042
Local Institution
Cairns, Queensland, 4870
Local Institution
Canberra, Australian Capital Territory, 02605
Local Institution
Corrimal, New South Wales, 02518
Local Institution
Douglas, Queensland, 04810
Local Institution
Frankston, Victoria, 03199
Local Institution
Greenslopes, Queensland, 4120
Local Institution
Kurralta Park, South Australia, 5037
Local Institution
Lismore, New South Wales, 02480
Local Institution
Malvern, Victoria, 03144
Local Institution
Port Macquarie, New South Wales, 02444
Local Institution
Tamworth, New South Wales, 02340
Local Institution
Tweeds Head, New South Wales, 02485
Local Institution
Wagga Wagga, New South Wales, 2650
Local Institution
Waratah, New South Wales, 02298

Other trials in Australia

Greece10 sites

Local Institutio
Alexandroupoli, 68100
Local Institution
Athens, 11528
Local Institution
Athens, 15233
Local Institution
Cholargós, Athens, 15562
Local institution
Goudi, Athens, 11527
Local Institution
Heraklion, Crete, 71100
Local Institution
Mezourlo, 41334
Local Institution
Neas Efkarpia, Thessaloniki, 56429
Local Institution
Neo Faliro, Athens, 18547
Local Institution
Neo Faliro, 18547

Other trials in Greece

Belgium7 sites

Local Institution
Brasschaat, 2930
Local Institution
Brussels, 1200
Local Institution
Edegem, 2650
Local Institution
Haint Saint Paul, 7100
Local Institution
Hasselt, 3500
Local Institution
Kortrijk, 8500
Local Institution
Leuven, 3000

Other trials in Belgium

Canada7 sites

Local Institution
London, Ontario, N6C 6B5
Local Institution
Mississauga, Ontario, L5M 2N1
Local Institution
Moncton, New Brunswick, E1C 6Z8
Local Institution
Québec, Quebec, G1V 4G2
Local Institution
Québec, G1R 2J6
Local Institution
Saskatoon, Saskatchewan, S7N 4H4
Local Institution
Windsor, Ontario, N8W 2X3

Other trials in Canada

Argentina6 sites

Local Institution
CABA, 1426
Local Institution
CABA, C1417DNT
Local Institution
CABA, C1426ANZ
Local Institution
Córdoba, X5006HBF
Local Institution
Rosario- Santa Fe, S2000KZE
Local Institution
San Miguel de Tucumán, T4000GTB

Other trials in Argentina

Austria6 sites

Local Institution
Feldkirch, 6800
Local Institution
Graz, A-8036
Local Institution
Linz, A-4020
Local Institution
Salzburg, A-5020
Local Institution
Sankt Pölten, A-3100
Local Institution
Vienna, A-1090

Other trials in Austria

Ireland5 sites

Local Institution
Cork
Local Institution
Dublin
Local Institution
Galway
Local Institution
Tullamore
Local Institution
Wilton, CORK, T12 DC4A

Other trials in Ireland

Poland4 sites

Local Institution
Bydgoszcz, 85-796
Local Institution
Lodz, 93-510
Local Institution
Warsaw, 02-781
Local Institution
Wroclaw, 51-124

Other trials in Poland

Switzerland4 sites

Local Institution
Baden, CH-5404
Local Institution
Lugano, CH-6900
Local Institution
Zurich, 8091
Local Institution
Zurich, CH-8091

Other trials in Switzerland

Israel3 sites

Local Institution
Haifa, 31096
Local Institution
Tel Aviv, 64239
Local Institution
Tel HaShomer, 52621

Other trials in Israel

About this study

The purpose of this study is to examine the safety of Ipilimumab and patterns of use in the treatment of unresectable or metastatic melanoma in the post-approval setting

Read the detailed description

Time Perspective: this study does have a retrospective component involving a subset of patients

Conditions: Advanced Cutaneous Melanoma
Keywords: Unresectable or metastatic cutaneous melanoma
Medical subject headings: Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01511913
Study group	Role	What they receive
Ipilimumab treatment cohort of 1106 prospective participants		Not described
Non-Ipilimumab treatment cohort of 305 prospective participants		Not described
Retrospective cohort of 177 participants		Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence and severity of adverse reactions in patients treated with Ipilimumab in the post-approval setting
Measured: Every 12 months up to 5 years
Incidence rate with person-year-exposure and frequency estimate of adverse events/serious adverse events
Measured: Every 12 months up to 5 years
Frequency at which immunosuppressive therapy was administered to patients to manage treatment-related adverse events associated with Ipilimumab
Measured: Every 12 months up to 5 years
Patterns of disease monitoring as observed in a real-world setting
To evaluate patterns of care, descriptive statistics will describe treatment, dosing, regimen, indication, treatment rationales, management of treatment-related adverse events, reasons for treatment termination
Measured: Every 12 months up to 5 years

Secondary outcomes (3)

Quality of life (QoL), impact on work productivity, and overall satisfaction among patients receiving any therapy for unresectable or metastatic melanoma
Measured: Every 12 months up to 5 years
Resource utilization associated with advanced melanoma treatment
Descriptive statistics will be reported for healthcare utilization (inpatient, outpatient, emergency department and other ancillary services) and imputed costs
Measured: Every 12 months up to 5 years
Overall survival (OS) in patients receiving Ipilimumab or other therapies for unresectable or metastatic melanoma
Measured: Every 12 months up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Jun 201212 Dec 2019

First posted19 Jan 2012 (estimated)
Study start3 Jun 2012
Primary completion30 Mar 2018
Study completion12 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Advanced Cutaneous MelanomaStudies of the same condition, open and under way.
More trials run by Bristol-Myers SquibbThe 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 1,411 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01511913
Sponsor's protocol ID: CA184-143
Other IDs: ENCEPP/SDPP/2723
Acronym: IMAGE
Status last verified: Dec 2021
First submitted: 15 Nov 2011
Last updated: 28 Dec 2021
Results posted: No
Data monitoring committee: No

Publications

Dalle S, Mortier L, Corrie P, Lotem M, Board R, Arance AM, Meiss F, Terheyden P, Gutzmer R, Buysse B, Oh K, Brokaw J, Le TK, Mathias SD, Scotto J, Lord-Bessen J, Moshyk A, Kotapati S, Middleton MR. Long-term real-world experience with ipilimumab and non-ipilimumab therapies in advanced melanoma: the IMAGE study. BMC Cancer. 2021 May 29;21(1):642. doi: 10.1186/s12885-021-08032-y.
PubMed 34051732
Middleton MR, Dalle S, Claveau J, Mut P, Hallmeyer S, Plantin P, Highley M, Kotapati S, Le TK, Brokaw J, Abernethy AP. Real-world treatment practice in patients with advanced melanoma in the era before ipilimumab: results from the IMAGE study. Cancer Med. 2016 Jul;5(7):1436-43. doi: 10.1002/cam4.717. Epub 2016 Apr 26.
PubMed 27118102

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
Melanoma
RecruitingPhase 3
A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head)
Melanoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 2
Phase II Trial of Combination Anti-PD-1 and Aldesleukin for Metastatic Melanoma and Renal Cell Carcinoma
Metastatic Melanoma, Advanced Locoregional Melanoma

All Advanced Cutaneous Melanoma trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-National, Prospective, Observational Study in Patients With Unresectable or Metastatic Melanoma
ClinicalTrials.gov ID: NCT01511913
Acronym / sponsor ID: IMAGE / CA184-143
Conditions: Advanced Cutaneous Melanoma
Keywords: Unresectable or metastatic cutaneous melanoma
Study type: Observational
Recruitment status: Completed
Enrolment: 1,411 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: 3 Jun 2012 (actual)
Primary completion: 30 Mar 2018 (actual)
Study completion: 12 Dec 2019 (actual)
First posted: 19 Jan 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to examine the safety of Ipilimumab and patterns of use in the treatment of unresectable or metastatic melanoma in the post-approval setting

Detailed description

Time Perspective: this study does have a retrospective component involving a subset of patients

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 3

Arm	Type	Receives
Ipilimumab treatment cohort of 1106 prospective participants	–	–
Non-Ipilimumab treatment cohort of 305 prospective participants	–	–
Retrospective cohort of 177 participants	–	–

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Eligible patients will be selected from approximately 200 medical practice sites (e.g. community-based, office-based, hospital-based, academic setting) in several European Union countries, Central America, North America, and South America, as well as Australia and Israel.

Key inclusion criteria (4 listed)

Diagnosis of unresectable or metastatic melanoma
Age of 18 years or older at time of entry into the study
Patients who have initiated treatment for unresectable or metastatic melanoma at medical practice (e.g. community-based, office-based, hospital-based, academic setting)within 21 days before informed consent for this study OR in the case where treatment has not yet been initiated, documentation that the treatment strategy was determined before informed consent for this study, and treatment must be initiated within 28 days after informed consent
Ipilimumab-treated patients must be receiving treatment for the indication(s) approved in their country of residence or where they are receiving treatment

Key exclusion criteria (2 listed)

Current or pending participation in a clinical trial examining therapy for the treatment of any cancer (including unresectable or metastatic melanoma)
Current use of therapy to treat a primary cancer other than melanoma

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Incidence and severity of adverse reactions in patients treated with Ipilimumab in the post-approval setting
Time frame: Every 12 months up to 5 years
Incidence rate with person-year-exposure and frequency estimate of adverse events/serious adverse events
Time frame: Every 12 months up to 5 years
Frequency at which immunosuppressive therapy was administered to patients to manage treatment-related adverse events associated with Ipilimumab
Time frame: Every 12 months up to 5 years
Patterns of disease monitoring as observed in a real-world setting
Time frame: Every 12 months up to 5 years
To evaluate patterns of care, descriptive statistics will describe treatment, dosing, regimen, indication, treatment rationales, management of treatment-related adverse events, reasons for treatment termination

3 secondary outcomes

Quality of life (QoL), impact on work productivity, and overall satisfaction among patients receiving any therapy for unresectable or metastatic melanoma
Time frame: Every 12 months up to 5 years
Resource utilization associated with advanced melanoma treatment
Time frame: Every 12 months up to 5 years
Overall survival (OS) in patients receiving Ipilimumab or other therapies for unresectable or metastatic melanoma
Time frame: Every 12 months up to 5 years

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2021.
Results publication: PubMed 34051732Dalle S, Mortier L, Corrie P, Lotem M, Board R, Arance AM, Meiss F, Terheyden P, Gutzmer R, Buysse B, Oh K, Brokaw J, Le TK, Mathias SD, Scotto J, Lord-Bessen J, Moshyk A, Kotapati S, Middleton MR. Long-term real-world experience with ipilimumab and non-ipilimumab therapies in advanced melanoma: the IMAGE study. BMC Cancer. 2021 May 29;21(1):642. doi: 10.1186/s12885-021-08032-y.
Results publication: PubMed 27118102Middleton MR, Dalle S, Claveau J, Mut P, Hallmeyer S, Plantin P, Highley M, Kotapati S, Le TK, Brokaw J, Abernethy AP. Real-world treatment practice in patients with advanced melanoma in the era before ipilimumab: results from the IMAGE study. Cancer Med. 2016 Jul;5(7):1436-43. doi: 10.1002/cam4.717. Epub 2016 Apr 26.
Investigator Inquiry formLink provided by the sponsor.
FDA Safety Alerts and RecallsLink provided by the sponsor.
BMS clinical trial educational resourceLink provided by the sponsor.

Related trials for Advanced Cutaneous Melanoma

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
Melanoma
RecruitingPhase 3
A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head)
Melanoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 2
Phase II Trial of Combination Anti-PD-1 and Aldesleukin for Metastatic Melanoma and Renal Cell Carcinoma
Metastatic Melanoma, Advanced Locoregional Melanoma

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.

Bristol-Myers Squibb study director

Bristol-Myers Squibb

186 sites in 15 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Advanced Cutaneous Melanoma, run by Bristol-Myers Squibb at 186 sites in 15 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 2 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 28 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 186 sites in Germany, United Kingdom, United States, France, Spain and 10 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Incidence and severity of adverse reactions in patients treated with Ipilimumab in the post-approval setting (time frame: Every 12 months up to 5 years). The study lists 4 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 NCT01511913, 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 28 Dec 2021.