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Expanded Access Program With Nivolumab to Treat Melanoma (Checkmate 168)

Primary Purpose

Stage III (Unresectable) or Stage IV Advanced Melanoma

Status
No longer available
Phase
Locations
International
Study Type
Expanded Access
Intervention
Nivolumab
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Stage III (Unresectable) or Stage IV Advanced Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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

Inclusion Criteria:

  • ECOG Performance Status of 0-1
  • Histologically confirmed malignant melanoma
  • Progressed on or after treatment with an anti-CTLA4

Exclusion Criteria:

  • Active brain metastases
  • Life Expectancy <6 weeks
  • Subjects who received prior therapy targeting T-cell costimulation or checkpoint pathways except for Anti CTLA-4 therapy
  • Subjects with autoimmune disease

Sites / Locations

  • Local Institution
  • Southern Cancer Center Pc
  • Local Institution
  • Local Institution
  • Lynn Cancer Institute At Boca Raton Regional Hospital
  • Cancer Specialists Of North Florida
  • Mount Sinai Comprehensive Cancer Center
  • Florida Hospital
  • Winship Cancer Institute
  • Summit Cancer Care
  • Oncology Specialists, S.C.
  • Oncology Hematology Associates Of Sw In
  • Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
  • Nebraska Cancer Specialists
  • Comprehensive Cancer Centers Of Nevada
  • North Shore Hematology/Oncology Associates, P.C.
  • Icahn School Of Medicine At Mount Sinai
  • Mid Ohio Oncology/Hematology, Inc,Dba
  • Lehigh Valley Health Network
  • St. Luke'S Hospital
  • The Jones Clinic, Pc
  • Tennessee Oncology, PLLC
  • Waukesha Memorial Hospital
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 16, 2014
Last Updated
September 28, 2016
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT02142218
Brief Title
Expanded Access Program With Nivolumab to Treat Melanoma
Acronym
Checkmate 168
Official Title
Expanded Access Program With Nivolumab for Subjects With Histologically Confirmed Stage III (Unresectable) or Stage IV Melanoma Progressing Post Prior Systemic Treatment Containing an Anti CTLA-4 Monoclonal Antibody (Checkmate 168: CHECKpoint Pathway for nivoluMAb Clinical Trial Evaluation 168)
Study Type
Expanded Access

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
No longer available
Study Start Date
June 2014 (undefined)
Primary Completion Date
May 2018 (Anticipated)
Study Completion Date
May 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

5. Study Description

Brief Summary
The purpose of this program is to provide treatment with nivolumab to subjects with Stage III or Stage IV advanced melanoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage III (Unresectable) or Stage IV Advanced Melanoma

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Nivolumab

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: ECOG Performance Status of 0-1 Histologically confirmed malignant melanoma Progressed on or after treatment with an anti-CTLA4 Exclusion Criteria: Active brain metastases Life Expectancy <6 weeks Subjects who received prior therapy targeting T-cell costimulation or checkpoint pathways except for Anti CTLA-4 therapy Subjects with autoimmune disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Facility Name
Southern Cancer Center Pc
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Local Institution
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Local Institution
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20057
Country
United States
Facility Name
Lynn Cancer Institute At Boca Raton Regional Hospital
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Cancer Specialists Of North Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Mount Sinai Comprehensive Cancer Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Florida Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Summit Cancer Care
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31404
Country
United States
Facility Name
Oncology Specialists, S.C.
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
Oncology Hematology Associates Of Sw In
City
Newburgh
State/Province
Indiana
ZIP/Postal Code
47630
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
City
Lutherville
State/Province
Maryland
ZIP/Postal Code
21093
Country
United States
Facility Name
Nebraska Cancer Specialists
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
Comprehensive Cancer Centers Of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
North Shore Hematology/Oncology Associates, P.C.
City
East Setauket
State/Province
New York
ZIP/Postal Code
11733
Country
United States
Facility Name
Icahn School Of Medicine At Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Mid Ohio Oncology/Hematology, Inc,Dba
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43219
Country
United States
Facility Name
Lehigh Valley Health Network
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
St. Luke'S Hospital
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
The Jones Clinic, Pc
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Waukesha Memorial Hospital
City
Waukesha
State/Province
Wisconsin
ZIP/Postal Code
53188
Country
United States
Facility Name
Local Institution
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
1280
Country
Argentina
Facility Name
Local Institution
City
Ciudad Autonoma De Buenos Aire
State/Province
Buenos Aires
ZIP/Postal Code
1181
Country
Argentina
Facility Name
Local Institution
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000DSK
Country
Argentina
Facility Name
Local Institution
City
San Miguel De Tucuman
State/Province
Tucuman
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Local Institution
City
San Miguel De Tucuman
State/Province
Tucuman
ZIP/Postal Code
CPT4000IAK
Country
Argentina
Facility Name
Local Institution
City
Buenos Aires
ZIP/Postal Code
1019
Country
Argentina
Facility Name
Local Institution
City
Buenos Aires
ZIP/Postal Code
1431
Country
Argentina
Facility Name
Local Institution
City
Caba
ZIP/Postal Code
1426
Country
Argentina
Facility Name
Local Institution
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
Local Institution
City
Salvador
State/Province
Bahia
ZIP/Postal Code
41950
Country
Brazil
Facility Name
Local Institution
City
Fortaleza
State/Province
Ceara
ZIP/Postal Code
60130
Country
Brazil
Facility Name
Local Institution
City
Brasilia
State/Province
Distrito Federal
ZIP/Postal Code
70200
Country
Brazil
Facility Name
Local Institution
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30150
Country
Brazil
Facility Name
Local Institution
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30380
Country
Brazil
Facility Name
Local Institution
City
Jd. Petropolis-Londrina
State/Province
Parana
ZIP/Postal Code
86015
Country
Brazil
Facility Name
Local Institution
City
Ijui
State/Province
Rio Grande do Sul
ZIP/Postal Code
98700
Country
Brazil
Facility Name
Local Institution
City
Passo Fundo
State/Province
Rio Grande do Sul
ZIP/Postal Code
99010
Country
Brazil
Facility Name
Local Institution
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90840
Country
Brazil
Facility Name
Local Institution
City
Florianopolis
State/Province
Santa Catarina
ZIP/Postal Code
88015
Country
Brazil
Facility Name
Local Institution
City
Itajai
State/Province
Santa Catarina
ZIP/Postal Code
88301
Country
Brazil
Facility Name
Local Institution
City
Barretos
State/Province
Sao Paulo
ZIP/Postal Code
14780
Country
Brazil
Facility Name
Local Institution
City
Jau
State/Province
Sao Paulo
ZIP/Postal Code
17210
Country
Brazil
Facility Name
Local Institution
City
Ribeirao Preto
State/Province
Sao Paulo
ZIP/Postal Code
14025
Country
Brazil
Facility Name
Local Institution
City
Santo Andre
State/Province
Sao Paulo
ZIP/Postal Code
09060
Country
Brazil
Facility Name
Local Institution
City
Sao Jose do Rio Preto
State/Province
Sao Paulo
ZIP/Postal Code
15090
Country
Brazil
Facility Name
Local Institution
City
Sao Paulo
ZIP/Postal Code
01308
Country
Brazil
Facility Name
Local Institution
City
Sao Paulo
ZIP/Postal Code
01323
Country
Brazil
Facility Name
Local Institution
City
Sao Paulo
ZIP/Postal Code
01509
Country
Brazil
Facility Name
Local Institution
City
Sao Paulo
ZIP/Postal Code
03102
Country
Brazil
Facility Name
Local Institution
City
Sao Paulo
ZIP/Postal Code
04538
Country
Brazil
Facility Name
Local Institution
City
Sao Paulo
ZIP/Postal Code
05651
Country
Brazil
Facility Name
Local Institution
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Local Institution
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Local Institution
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 5L3
Country
Canada
Facility Name
Local Institution
City
North Vancouver
State/Province
British Columbia
ZIP/Postal Code
V7L 2L7
Country
Canada
Facility Name
Local Institution
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
Local Institution
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
Local Institution
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 8X3
Country
Canada
Facility Name
Local Institution
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
Facility Name
Local Institution
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
Local Institution
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Local Institution
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Local Institution
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Local Institution
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Local Institution
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Local Institution
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Local Institution
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 4H4
Country
Canada
Facility Name
Local Institution
City
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
Local Institution
City
Bogota
ZIP/Postal Code
110221
Country
Colombia
Facility Name
Local Institution
City
Bogota
Country
Colombia
Facility Name
Local Institution
City
Cali
Country
Colombia
Facility Name
Local Institution
City
Medellin
ZIP/Postal Code
MEDELLIN
Country
Colombia
Facility Name
Local Institution
City
Medellin
Country
Colombia
Facility Name
Local Institution
City
Lima
ZIP/Postal Code
027
Country
Peru
Facility Name
Local Institution
City
Lima
ZIP/Postal Code
34
Country
Peru
Facility Name
Local Institution
City
Lima
Country
Peru

12. IPD Sharing Statement

Links:
URL
http://www.bms.com/studyconnect/Pages/home.aspx
Description
BMS clinical trial educational resource

Learn more about this trial

Expanded Access Program With Nivolumab to Treat Melanoma

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