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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.

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

Other trials in United Kingdom

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

Other trials in Italy

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

Other trials in Netherlands

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

Other trials in Belgium

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

Other trials in Ireland

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

Other trials in Austria

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

Other trials in Greece

Switzerland5 sites

  • Local Institution

    Aarau, 5001

  • Local Institution

    Basel, 4031

  • Local Institution

    Bellinzona, 6501

  • Local Institution

    Chur, 7000

  • Local Institution

    Zurich, 8091

Other trials in Switzerland

Czechia4 sites

  • Local Institution

    Brno, 656 53

  • Local Institution

    Hradec Králové, 500 05

  • Local Institution

    Prague, 100 34

  • Local Institution

    Prague, 120 28

Other trials in Czechia

Finland4 sites

  • Local Institution

    Helsinki, 00290

  • Local Institution

    Jyväskylä, 40620

  • Local Institution

    Oulu, 90220

  • Local Institution

    Tampere, 33520

Other trials in Finland

Poland4 sites

  • Local Institution

    Bydgoszcz, 85-796

  • Local Institution

    Gdansk, 80-952

  • Local Institution

    Lodz, 93-513

  • Local Institution

    Warsaw, 02781

Other trials in Poland

Norway3 sites

  • Local Institution

    Ålesund, 6017

  • Local Institution

    Bergen, 5021

  • Local Institution

    Oslo, 0310

Other trials in Norway

Russia3 sites

  • Local Institution

    Moscow, 115478

  • Local Institution

    Saint Petersburg, 197022

  • Local Institution

    Saint Petersburg, 197758

Other trials in Russia

Portugal2 sites

  • Local Institution

    Lisbon, 1099-023

  • Local Institution

    Porto, 4200-072

Other trials in Portugal

Romania2 sites

  • Local Institution

    Bucharest, 022328

  • Local Institution

    Romania, 400015

Other trials in Romania

Sweden2 sites

  • Local Institution

    Lund, 221 85

  • Local Institution

    Uppsala, 751 85

Other trials in Sweden

Luxembourg1 site

  • Local Institution

    Luxembourg, 1210

Other trials in Luxembourg

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

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 Antigen (CTLA-4) monoclonal antibody, treated with Nivolumab (BMS-936558) at a dose of 3 mg/kg every two weeks.

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 groupRoleWhat they receive
Nivolumab (BMS-936558)ExperimentalNivolumab (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.

  1. 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)

  1. 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

  2. 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.

  3. 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

  4. 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.

  1. First posted5 Jun 2014 (estimated)
  2. Study start7 Oct 2014
  3. Primary completion18 Jan 2019
  4. Study completion18 Jan 2019

Resources

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
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

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.

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