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)

Melanoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02156804
• Other study ID #: CA209-172
• Secondary ID: 2014-001286-28
• Status: Completed
• Phase: Phase 2
• Start date: October 7, 2014
• Est. completion date: January 18, 2019

Study information

• Verified date: September 2020
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1009
• Est. completion date: January 18, 2019
• Est. primary completion date: January 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• 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

• 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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Melanoma

Intervention

Drug:
• Nivolumab (BMS-936558)

Locations

Country	Name	City	State
Austria	Local Institution	Graz
Austria	Local Institution	Innsbruck
Austria	Local Institution	Salzburg
Austria	Local Institution	St. Polten
Austria	Local Institution	Wein
Austria	Local Institution	Wien
Belgium	Universitair Ziekenhuis Brussel	Brussels
Belgium	Cliniques Universitaires Saint-Luc	Bruxelles
Belgium	Institut Jules Bordet	Bruxelles
Belgium	Local Institution	Edegem
Belgium	Local Institution	Gent
Belgium	Local Institution	Hasselt
Belgium	Az Groeninge	Kortrijk
Belgium	Local Institution	Leuven
Belgium	Chu De Liege	Liege
Czechia	Local Institution	Brno
Czechia	Local Institution	Hradec Kralove
Czechia	Local Institution	Praha 10
Czechia	Local Institution	Praha 2
Finland	Local Institution	Helsinki
Finland	Local Institution	Jyvaskyla
Finland	Local Institution	Oulu
Finland	Local Institution	Tampere
Germany	Local Institution	Augsburg
Germany	Local Institution	Bochum
Germany	Local Institution	Buxtehude
Germany	Local Institution	Chemnitz
Germany	Local Institution	Dessau
Germany	Local Institution	Dresden
Germany	Local Institution	Erfurt
Germany	Local Institution	Erlangen
Germany	Local Institution	Essen
Germany	Local Institution	Frankfurt Am Main
Germany	Local Institution	Freiburg
Germany	Local Institution	Gera
Germany	Local Institution	Giessen
Germany	Local Institution	Goettingen
Germany	Local Institution	Hamburg
Germany	Local Institution	Hannover
Germany	Local Institution	Heidelberg
Germany	Local Institution	Heilbronn
Germany	Local Institution	Jena
Germany	Local Institution	Kassel
Germany	Local Institution	Kiel
Germany	Local Institution	Koln
Germany	Local Institution	Leipzig
Germany	Local Institution	Ludwigshafen
Germany	Local Institution	Luebeck	Schleswig-holstein
Germany	Local Institution	Magdeburg
Germany	Local Institution	Mainz
Germany	Local Institution	Marburg
Germany	Local Institution	Minden
Germany	Local Institution	Muenster
Germany	Local Institution	Munchen
Germany	Local Institution	Munchen
Germany	Local Institution	Munster
Germany	Local Institution	Nuernberg
Germany	Local Institution	Quedlinburg
Germany	Local Institution	Recklinghausen
Germany	Local Institution	Regensburg
Germany	Local Institution	Schwerin
Germany	Local Institution	Traunstein
Germany	Local Institution	Tubingen
Germany	Local Institution	Wurzbug
Greece	Local Institution	Athens
Greece	Local Institution	Athens
Greece	Local Institution	Heraklion	Creta
Greece	Local Institution	Thessaloniki
Greece	Local Institution	Thessaloniki
Hungary	Local Institution	Budapest
Hungary	Local Institution	Budapest
Hungary	Local Institution	Debrecen
Hungary	Local Institution	Pecs
Hungary	Local Institution	Szeged
Hungary	Local Institution	Szombathely
Ireland	Local Institution	Dublin
Ireland	Local Institution	Dublin
Ireland	Local Institution	Dublin
Ireland	Local Institution	Dublin
Ireland	Local Institution	Galway
Ireland	Local Institution	Waterford
Ireland	Local Institution	Wilton	Cork
Italy	Local Institution	Bari
Italy	Local Institution	Bergamo
Italy	Local Institution	Genova
Italy	Local Institution	Meldola (FC)
Italy	Local Institution	Milano
Italy	Local Institution	Milano
Italy	Local Institution	Milano
Italy	Local Institution	Napoli
Italy	Local Institution	Padova
Italy	Local Institution	Palermo
Italy	Local Institution	Roma
Italy	Local Institution	Roma
Italy	Local Institution	Siena
Italy	Local Institution	Terni
Italy	Local Institution	Torino
Luxembourg	Local Institution	Luxembourg
Netherlands	Local Institution	Amsterdam	Noord-holland
Netherlands	Local Institution	Amsterdam
Netherlands	Local Institution	Breda
Netherlands	Local Institution	Enschede
Netherlands	Local Institution	Groningen
Netherlands	Local Institution	Leeuwarden
Netherlands	Local Institution	Leiden
Netherlands	Local Institution	Maastrict
Netherlands	Local Institution	Nijmegen
Netherlands	Local Institution	Rotterdam
Netherlands	Local Institution	Sittard-Geleen
Netherlands	Local Institution	Utrecht
Netherlands	Local Institution	Veldhoven
Netherlands	Local Institution	Zwolle
Norway	Local Institution	Alesund
Norway	Local Institution	Bergen
Norway	Local Institution	Oslo
Poland	Local Institution	Bydgoszcz
Poland	Local Institution	Gdansk
Poland	Local Institution	Lodz
Poland	Local Institution	Warszawa
Portugal	Local Institution	Lisboa
Portugal	Local Institution	Porto
Romania	Local Institution	Bucharest
Romania	Local Institution	Romania
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	St. Petersburg
Russian Federation	Local Institution	St. Petersburg
Spain	Local Institution	Albacete
Spain	Local Institution	Barcelona
Spain	Local Institution	Barcelona
Spain	Local Institution	Barcelona
Spain	Local Institution	Bilbao
Spain	Local Institution	Granada
Spain	Local Institution	Las Palmas de Gran Canaria
Spain	Hospital De Madrid, Norte Sanchinarro	Madrid
Spain	Local Institution	Madrid
Spain	Local Institution	Madrid
Spain	Local Institution	Madrid
Spain	Local Institution	Malaga
Spain	Local Institution	Oviedo
Spain	Local Institution	Palma de Mallorca
Spain	Local Institution	Salamanca
Spain	Local Institution	San Sebastian
Spain	Hospital Clinico Univ. de Santiago-CHUS	Santiago de Compostela
Spain	Local Institution	Sevilla
Spain	Local Institution	Toledo
Spain	Local Institution	Valencia
Spain	Local Institution	Valencia
Sweden	Local Institution	Lund
Sweden	Local Institution	Uppsala
Switzerland	Local Institution	Aarau
Switzerland	Local Institution	Basel
Switzerland	Local Institution	Bellinzona
Switzerland	Local Institution	Chur
Switzerland	Local Institution	Zurich
United Kingdom	Local Institution	Birmingham
United Kingdom	Local Institution	Bristol	Avon
United Kingdom	Local Institution	Cambridge
United Kingdom	Local Institution	Cottingham
United Kingdom	Local Institution	Essex
United Kingdom	Local Institution	Glasgow
United Kingdom	Local Institution	London
United Kingdom	Local Institution	Manchester
United Kingdom	Local Institution	Newcastle Upon Tyne
United Kingdom	Local Institution	Northwood	Middlesex
United Kingdom	Local Institution	Oxford
United Kingdom	Local Institution	Southampton
United Kingdom	Local Institution	Surrey
United Kingdom	Local Institution	Swansea
United Kingdom	Local Institution	Truro
United Kingdom	Local Institution	Wirral

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

Austria,  Belgium,  Czechia,  Finland,  Germany,  Greece,  Hungary,  Ireland,  Italy,  Luxembourg,  Netherlands,  Norway,  Poland,  Portugal,  Romania,  Russian Federation,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 2 years
Secondary	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.	Up to 2 years
Secondary	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.	Up to 2 years.
Secondary	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	Up to 2 years
Secondary	Overall Survival	The time from first dosing date to the date of death.	Up to 4 years

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form