MelanomaPhase 2NCT02156804

A Single-Arm, Open-Label, Multicenter Clinical Trial With Nivolumab (BMS-936558) for Subjects With Histologically Confirmed Stage III (Unresectable) or Stage IV Melanoma Progressing Post Prior Treatment Containing an Anti-CTLA4 Monoclonal Antibody (CheckMate 172)

A Phase 2 study testing Nivolumab (BMS-936558) in people with Melanoma, run by Bristol-Myers Squibb at 170 sites in 20 countries.

Completed

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

Official record

Search all trials

Trial summary

The purpose of this study is to determine the rate and frequency of high-grade (CTCAE v4.0 Grade 3 or higher), treatment-related, select adverse events in subjects with histologically confirmed stage III (unresectable) or stage IV melanoma and progression post prior treatment containing an anti-Cytotoxic T Lymphocyte… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Melanoma
What is being tested?: Nivolumab (BMS-936558)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,009 participants
Where: 170 sitesin 20 countries
Study dates: 7 Oct 2014to 18 Jan 2019
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects with histologically confirmed malignant melanoma
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS):
PS 0 to 1
PS 2
Previously treated unresectable stage III or stage IV melanoma as per the American Joint Committee on Cancer 2010 Guidelines regardless of BRAF mutation status
Subjects must have experienced evaluable Response Evaluation Criteria In Solid Tumors (RECIST 1.1)-defined disease progression

Show all 12Show fewer

Prior treatment with chemotherapy, interferon (adjuvant setting), Interleukin (IL-2), BRAF/MEK inhibitors for subjects with known BRAF mutations, Mitogen-activated or extracellular signal- regulated protein kinase (MEK) inhibitors for Neuroblastoma Ras Viral (v-ras) oncogene homolog (NRAS) mutations, and cKIT inhibitor subjects with known cKIT mutations are allowed
Patients with CNS metastases are eligible:
if CNS metastases are treated, patients are asymptomatic or neurologically returned to baseline
if they have previously untreated CNS metastases and are asymptomatic
if they have leptomeningeal metastases, are treated and asymptomatic or neurologically returned to baseline with life expectancy > 3 months
Patients with a known history of Grades 3-4 immune-related adverse reactions during/after anti-CTLA-4 therapy if all toxicities have resolved at least to Grade 1

Who cannot join

Subjects with untreated, active Central Nervous System (CNS) metastases are excluded

Trial locations and contacts

170 sites in 20 countries.

Country

City, postcode or hospital

170 sites in 20 countries

Germany41 sites

Local Institution
Augsburg, 86156
Local Institution
Bochum, 44791
Local Institution
Buxtehude, 21614
Local Institution
Chemnitz, 09117
Local Institution
Cologne, 50937
Local Institution
Dessau, 06847
Local Institution
Dresden, 01307
Local Institution
Erfurt, 99089
Local Institution
Erlangen, 91054
Local Institution
Essen, 45 122
Local Institution
Frankfurt am Main, 60590
Local Institution
Freiburg im Breisgau, 79104
Local Institution
Gera, 07548
Local Institution
Giessen, 35385
Local Institution
Göttingen, 37075
Local Institution
Hamburg, 20253
Local Institution
Hanover, 30625
Local Institution
Heidelberg, 69120
Local Institution
Heilbronn, 74078
Local Institution
Jena, 07740
Local Institution
Kassel, 34125
Local Institution
Kiel, 24105
Local Institution
Leipzig, 04103
Local Institution
Lübeck, Schleswig-Holstein, 23538
Local Institution
Ludwigshafen, 67063
Local Institution
Magdeburg, 39120
Local Institution
Mainz, 55131
Local Institution
Marburg, 35043
Local Institution
Minden, 32429
Local Institution
München, 80337
Local Institution
München, 81675
Local Institution
Münster, 48149
Local Institution
Münster, 48157
Local Institution
Nuremberg, 90419
Local Institution
Quedlinburg, 06484
Local Institution
Recklinghausen, 45657
Local Institution
Regensburg, 93053
Local Institution
Schwerin, 19049
Local Institution
Traunstein, 83278
Local Institution
Tübingen, 72076
Local Institution
Wurzbug, 97080

Other trials in Germany

Spain21 sites

Local Institution
Albacete, 02006
Local Institution
Barcelona, 08035
Local Institution
Barcelona, 08036
Local Institution
Barcelona, 08908
Local Institution
Bilbao, 48013
Local Institution
Donostia / San Sebastian, 20014
Local Institution
Granada, 18014
Local Institution
Las Palmas de Gran Canaria, 35016
Local Institution
Madrid, 28007
Local Institution
Madrid, 28041
Local Institution
Madrid, 28046
Hospital De Madrid, Norte Sanchinarro
Madrid, 28050
Local Institution
Málaga, 29010
Local Institution
Oviedo, 33011
Local Institution
Palma de Mallorca, 07010
Local Institution
Salamanca, 37007
Hospital Clinico Univ. de Santiago-CHUS
Santiago de Compostela, 15706
Local Institution
Seville, 41071
Local Institution
Toledo, 45071
Local Institution
Valencia, 46009
Local Institution
Valencia, 46026

Other trials in Spain

United Kingdom16 sites

Local Institution
Birmingham, B15 2TH
Local Institution
Bristol, AVON, BS2 8ED
Local Institution
Cambridge, CB2 0QQ
Local Institution
Cottingham, HU16 5JQ
Local Institution
Essex
Local Institution
Glasgow, G12 0YN
Local Institution
London, SE1 9RT
Local Institution
Manchester, M20 4BX
Local Institution
Metropolitan Borough of Wirral, CH63 4JY
Local Institution
Newcastle upon Tyne, NE7 7DN
Local Institution
Northwood, Middlesex, HA6 2RN
Local Institution
Oxford, OX3 7LE
Local Institution
Southampton, SO16 6YD
Local Institution
Surrey, SM2 5PT
Local Institution
Swansea, SA2 8QA
Local Institution
Truro, TR1 3LJ

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Italy15 sites

Local Institution
Bari, 70124
Local Institution
Bergamo, 24127
Local Institution
Genova, 16132
Local Institution
Meldola (FC), 47014
Local Institution
Milan, 20132
Local Institution
Milan, 20133
Local Institution
Milan, 20141
Local Institution
Naples, 80131
Local Institution
Padova, 35128
Local Institution
Palermo, 90127
Local Institution
Roma, 00144
Local Institution
Roma, 00167
Local Institution
Siena, 53100
Local Institution
Terni, 05100
Local Institution
Torino, 10137

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Netherlands14 sites

Local Institution
Amsterdam, North Holland, 1081 HZ
Local Institution
Amsterdam, 1066 CX
Local Institution
Breda, 4918 EV
Local Institution
Enschede, 7513 ER
Local Institution
Groningen, 9713 GZ
Local Institution
Leeuwarden, 8934 AD
Local Institution
Leiden, 2300 RC
Local Institution
Maastrict, 6229 HX
Local Institution
Nijmegen, 6525 GA
Local Institution
Rotterdam, 3075 EA
Local Institution
Sittard-Geleen, 6162 BG
Local Institution
Utrecht, 3584 CX
Local Institution
Veldhoven, 5504 DB
Local Institution
Zwolle, 8025-AB

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Belgium9 sites

Institut Jules Bordet
Brussels, 1000
Universitair Ziekenhuis Brussel
Brussels, 1090
Cliniques Universitaires Saint-Luc
Brussels, 1200
Local Institution
Edegem, 2650
Local Institution
Ghent, 9000
Local Institution
Hasselt, 3500
Az Groeninge
Kortrijk, 8500
Local Institution
Leuven, 3000
Chu De Liege
Liège, 4000

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Ireland7 sites

Local Institution
Dublin, 4
Local Institution
Dublin, 7
Local Institution
Dublin, 8
Local Institution
Dublin, 9
Local Institution
Galway
Local Institution
Waterford, 9026
Local Institution
Wilton, CORK

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Austria6 sites

Local Institution
Graz, 8036
Local Institution
Innsbruck, 6020
Local Institution
Salzburg, 5020
Local Institution
Sankt Pölten, 3100
Local Institution
Vienna, 1030
Local Institution
Wein, 1090

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Hungary6 sites

Local Institution
Budapest, 1122
Local Institution
Budapest, H-7085
Local Institution
Debrecen, 4032
Local Institution
Pécs, H-7632
Local Institution
Szeged, H-6720
Local Institution
Szombathely, 9700

Other trials in Hungary

Greece5 sites

Local Institution
Athens, 11527
Local Institution
Athens, 18547
Local Institution
Heraklion, Crete, 71201
Local Institution
Thessaloniki, 54007
Local Institution
Thessaloniki, 57010

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Switzerland5 sites

Local Institution
Aarau, 5001
Local Institution
Basel, 4031
Local Institution
Bellinzona, 6501
Local Institution
Chur, 7000
Local Institution
Zurich, 8091

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Czechia4 sites

Local Institution
Brno, 656 53
Local Institution
Hradec Králové, 500 05
Local Institution
Prague, 100 34
Local Institution
Prague, 120 28

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Finland4 sites

Local Institution
Helsinki, 00290
Local Institution
Jyväskylä, 40620
Local Institution
Oulu, 90220
Local Institution
Tampere, 33520

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Poland4 sites

Local Institution
Bydgoszcz, 85-796
Local Institution
Gdansk, 80-952
Local Institution
Lodz, 93-513
Local Institution
Warsaw, 02781

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Norway3 sites

Local Institution
Ålesund, 6017
Local Institution
Bergen, 5021
Local Institution
Oslo, 0310

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Russia3 sites

Local Institution
Moscow, 115478
Local Institution
Saint Petersburg, 197022
Local Institution
Saint Petersburg, 197758

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Portugal2 sites

Local Institution
Lisbon, 1099-023
Local Institution
Porto, 4200-072

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Romania2 sites

Local Institution
Bucharest, 022328
Local Institution
Romania, 400015

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Sweden2 sites

Local Institution
Lund, 221 85
Local Institution
Uppsala, 751 85

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Luxembourg1 site

Local Institution
Luxembourg, 1210

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About this study

Official title: A Single-Arm, Open-Label, Multicenter Clinical Trial With Nivolumab (BMS-936558) for Subjects With Histologically Confirmed Stage III (Unresectable) or Stage IV Melanoma Progressing Post Prior Treatment Containing an Anti-CTLA4 Monoclonal Antibody

Conditions: Melanoma
Being tested: Nivolumab (BMS-936558)
Medical subject headings: Melanoma

What participants receive

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

Nivolumab (BMS-936558)Drug

Study groups in NCT02156804
Study group	Role	What they receive
Nivolumab (BMS-936558)	Experimental	Nivolumab (BMS-936558) Intravenous solution every 2 weeks Receives: Drug: Nivolumab (BMS-936558)

What is being measured

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

the Incidence of Highgrade (CTCAE v4.0 Grade 3 or Higher), Treatment Related,Select Adverse Events.
The number of participants who reported high-grade (CTCAE v4.0 Grade 3 or higher), treatment-related, select AEs (pulmonary,gastrointestinal, skin, renal, hepatic, endocrine) were summarized using the all treated analysis set by system organ class and Medical Dictionary for Regulatory (MedDRA) preferred term.
Measured: Up to 2 years

Secondary outcomes (4)

The Incidence of All High-grade (Grades 3 and Higher), Select Adverse Events
The number of Participants who reported high-grade (CTCAE v4.0 Grade 3 or higher), select AEs were summarized using the all treated analysis set by system organ class and MedDRA preferred term.
Measured: Up to 2 years
Median Time to Onset (Grades 3-4) of Select Adverse Events
Select AEs were summarized according to their incidence as well as their time to onset.
Measured: Up to 2 years.
Median Time to Resolution (Grades 3-4) of Select Adverse Events
Select AEs were summarized according to their incidence as well as their time to resolution
Measured: Up to 2 years
Overall Survival
The time from first dosing date to the date of death.
Measured: Up to 4 years

Timeline

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

7 Oct 201418 Jan 2019

First posted5 Jun 2014 (estimated)
Study start7 Oct 2014
Primary completion18 Jan 2019
Study completion18 Jan 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 (2)Papers the sponsor has linked to this study.
Other trials for 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: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 1,009 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02156804
Sponsor's protocol ID: CA209-172
Other IDs: 2014-001286-28, 2014
Status last verified: Sep 2020
First submitted: 29 May 2014
Last updated: 11 Sep 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Schadendorf D, Ascierto PA, Haanen J, Espinosa E, Demidov L, Garbe C, Guida M, Lorigan P, Chiarion-Sileni V, Gogas H, Maio M, Fierro MT, Hoeller C, Terheyden P, Gutzmer R, Guren TK, Bafaloukos D, Rutkowski P, Plummer R, Waterston A, Kaatz M, Mandala M, Marquez-Rodas I, Munoz-Couselo E, Dummer R, Grigoryeva E, Young TC, Nathan P. Safety and efficacy of nivolumab in challenging subgroups with advanced melanoma who progressed on or after ipilimumab treatment: A single-arm, open-label, phase II study (CheckMate 172). Eur J Cancer. 2019 Nov;121:144-153. doi: 10.1016/j.ejca.2019.08.014. Epub 2019 Sep 30.
PubMed 31581055
Nathan P, Ascierto PA, Haanen J, Espinosa E, Demidov L, Garbe C, Guida M, Lorigan P, Chiarion-Sileni V, Gogas H, Maio M, Fierro MT, Hoeller C, Terheyden P, Gutzmer R, Guren TK, Bafaloukos D, Rutkowski P, Plummer R, Waterston A, Kaatz M, Mandala M, Marquez-Rodas I, Munoz-Couselo E, Dummer R, Grigoryeva E, Young TC, Schadendorf D. Safety and efficacy of nivolumab in patients with rare melanoma subtypes who progressed on or after ipilimumab treatment: a single-arm, open-label, phase II study (CheckMate 172). Eur J Cancer. 2019 Sep;119:168-178. doi: 10.1016/j.ejca.2019.07.010. Epub 2019 Aug 21.
PubMed 31445199

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

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IL-17 Blockade to Decrease irAEs (REPLAY)
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A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
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All Melanoma trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Arm, Open-Label, Multicenter Clinical Trial With Nivolumab (BMS-936558) for Subjects With Histologically Confirmed Stage III (Unresectable) or Stage IV Melanoma Progressing Post Prior Treatment Containing an Anti-CTLA4 Monoclonal Antibody
ClinicalTrials.gov ID: NCT02156804
Acronym / sponsor ID: CA209-172
Conditions: Melanoma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,009 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: 7 Oct 2014 (actual)
Primary completion: 18 Jan 2019 (actual)
Study completion: 18 Jan 2019 (actual)
First posted: 5 Jun 2014 (estimated)
Results: Posted 20 Feb 2020

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Nivolumab (BMS-936558)	Experimental	Drug: Nivolumab (BMS-936558)Nivolumab (BMS-936558) Intravenous solution every 2 weeks

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Subjects with histologically confirmed malignant melanoma
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS):
Previously treated unresectable stage III or stage IV melanoma as per the American Joint Committee on Cancer 2010 Guidelines regardless of BRAF mutation status
Subjects must have experienced evaluable Response Evaluation Criteria In Solid Tumors (RECIST 1.1)-defined disease progression
Prior treatment with chemotherapy, interferon (adjuvant setting), Interleukin (IL-2), BRAF/MEK inhibitors for subjects with known BRAF mutations, Mitogen-activated or extracellular signal- regulated protein kinase (MEK) inhibitors for Neuroblastoma Ras Viral (v-ras) oncogene homolog (NRAS) mutations, and cKIT inhibitor subjects with known cKIT mutations are allowed

Key exclusion criteria (1 listed)

Subjects with untreated, active Central Nervous System (CNS) metastases are excluded

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
Nivolumab (BMS-936558)	Drug	Nivolumab (BMS-936558)

Primary outcome

the Incidence of Highgrade (CTCAE v4.0 Grade 3 or Higher), Treatment Related,Select Adverse Events.
Time frame: Up to 2 years
The number of participants who reported high-grade (CTCAE v4.0 Grade 3 or higher), treatment-related, select AEs (pulmonary,gastrointestinal, skin, renal, hepatic, endocrine) were summarized using the all treated analysis set by system organ class and Medical Dictionary for Regulatory (MedDRA) preferred term.

4 secondary outcomes

The Incidence of All High-grade (Grades 3 and Higher), Select Adverse Events
Time frame: Up to 2 years
Median Time to Onset (Grades 3-4) of Select Adverse Events
Time frame: Up to 2 years.
Median Time to Resolution (Grades 3-4) of Select Adverse Events
Time frame: Up to 2 years
Overall Survival
Time frame: Up to 4 years

Results and safety

Results posted to the registry on 20 Feb 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Nivolumab 3mg/kg	1,009	1,008

Primary outcome: the Incidence of Highgrade (CTCAE v4.0 Grade 3 or Higher), Treatment Related,Select Adverse Events.

Time frame: Up to 2 years. Number. Unit: Number of Participants

Measure	Nivolumab 3mg/kg n = 1008
Gastrointestinal Adverse events (Grade 3-4)	16
Gastrointestinal adverse events (Grade 5)	0
Hepatic adverse events (Grade 3-4)	30
Hepatic adverse events (Grade 5)	0
Pulmonary adverse events(Grade 3-4)	6
Pulmonary adverse events(Grade 5)	0
Renal adverse events (Grade 3-4)	4
Renal adverse events (Grade 5)	0

Population analysed: All treated participants

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Between first dose and 30 days after last dose ( up to 2 years). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NIVOLUMAB 3 MG/KG IV	593 of 1,008 (58.8%)	857 of 1,008 (85%)	527 of 1,008

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31581055Schadendorf D, Ascierto PA, Haanen J, Espinosa E, Demidov L, Garbe C, Guida M, Lorigan P, Chiarion-Sileni V, Gogas H, Maio M, Fierro MT, Hoeller C, Terheyden P, Gutzmer R, Guren TK, Bafaloukos D, Rutkowski P, Plummer R, Waterston A, Kaatz M, Mandala M, Marquez-Rodas I, Munoz-Couselo E, Dummer R, Grigoryeva E, Young TC, Nathan P. Safety and efficacy of nivolumab in challenging subgroups with advanced melanoma who progressed on or after ipilimumab treatment: A single-arm, open-label, phase II study (CheckMate 172). Eur J Cancer. 2019 Nov;121:144-153. doi: 10.1016/j.ejca.2019.08.014. Epub 2019 Sep 30.
Derived from this study: PubMed 31445199Nathan P, Ascierto PA, Haanen J, Espinosa E, Demidov L, Garbe C, Guida M, Lorigan P, Chiarion-Sileni V, Gogas H, Maio M, Fierro MT, Hoeller C, Terheyden P, Gutzmer R, Guren TK, Bafaloukos D, Rutkowski P, Plummer R, Waterston A, Kaatz M, Mandala M, Marquez-Rodas I, Munoz-Couselo E, Dummer R, Grigoryeva E, Young TC, Schadendorf D. Safety and efficacy of nivolumab in patients with rare melanoma subtypes who progressed on or after ipilimumab treatment: a single-arm, open-label, phase II study (CheckMate 172). Eur J Cancer. 2019 Sep;119:168-178. doi: 10.1016/j.ejca.2019.07.010. Epub 2019 Aug 21.
BMS Clinical Trial InformationLink provided by the sponsor.
BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
FDA Safety Alerts and RecallsLink provided by the sponsor.

Related trials for 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
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
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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.

Bristol-Myers Squibb study director

Bristol-Myers Squibb

170 sites in 20 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nivolumab (BMS-936558) in people with Melanoma, run by Bristol-Myers Squibb at 170 sites in 20 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 12 inclusion and 1 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 11 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 170 sites in Germany, Spain, United Kingdom, Italy, Netherlands and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Feb 2020). 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?

the Incidence of Highgrade (CTCAE v4.0 Grade 3 or Higher), Treatment Related,Select Adverse Events. (time frame: Up to 2 years). 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 NCT02156804, 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 11 Sep 2020.