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Dacarbazine and Ipilimumab vs. Dacarbazine With Placebo in Untreated Unresectable Stage III or IV Melanoma

Primary Purpose

Melanoma

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Ipilimumab

Placebo

Dacarbazine

About this trial

This is an interventional treatment trial for Melanoma focused on measuring Stage IIIc N3 (unresectable), Stage IV melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Informed Consent Measurable Disease Eastern Cooperative Oncology Group (ECOG) 0 or 1 Lab / imaging requirements Neg for Human Immunodeficiency Virus (HIV), Hepatitis B (HepB), C Men and Women > 18 years (16 were allowable) Prior therapy restriction (adjuvant only) Exclusion: Pregnant / nursing Inadequate contraception Brain metastasis Primary ocular or mucosal melanoma

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A: Ipilimumab and Dacarbazine

Arm B: Placebo and Dacarbazine

Arm Description

In Maintenance phase: Ipilimumab will be continued. Dacarbazine was given up to Week 22 and is not given in the Maintenance phase

Outcomes

Primary Outcome Measures

Overall Survival (OS)

OS was defined as the time from the date of randomization until the date of death. Analysis of OS was to be done once 416 deaths had occurred (primary endpoint). However, analysis occurred at 414 deaths (February 7, 2011), due to operational timing of the study. Median number of months of OS and associated confidence interval calculated using the method of Brookmeyer and Crowley.

Secondary Outcome Measures

Survival Rate at 1 Year, 18 Months, 2 Years, and 3 Years

The survival rate (percentage of participants alive) was defined as the probability that a participant is alive at 1 year (or 18 months, 2 years, or 3 years) following randomization and was estimated via the Kaplan-Meier method.

Disease Control Rate (DCR)

DCR=number whose best overall response (BOR) was partial response (PR), complete response (CR) or stable disease (SD), divided by all randomized participants (unevaluable participants included). Independent review committee assessment. BOR=date of first dose to last tumor assessment prior to subsequent cancer therapy (including tumor resection, excluding palliative local radiotherapy). Modified World Health Organization criteria: CR=disappearance of all lesions; no evidence of progressive disease (PD); PR=50% or more decrease in the sum of products of the longest diameter and greatest perpendicular diameter of all index lesions compared with baseline; SD=neither sufficient decrease to qualify for PR nor sufficient increase to qualify for PD; PD=at least 25% increase in sum of products of all index lesions and/or appearance of any new lesions; nonindex lesions: appearance of any new lesions and/or unequivocal progression of nonindex lesions.

Median Number of Months of Progression-free Survival (PFS)

PFS=time between randomization and date of progression or death, whichever occurs first. Participants who died without reported prior progression were considered to have progressed on date of death. For those alive and not progressed, PFS was censored on date of last evaluable tumor assessment (TA). Those who have not died and have no recorded postbaseline TA were censored at randomization. Those who died without any recorded postbaseline TA were considered to have progressed on date of death. Evaluation was conducted by both investigator and an independent review committee (IRC), who assessed radiologic imaging studies, photographs of skin lesions, and clinical data. Progressive disease defined using modified criteria of the World Health Organization: demonstration of at least a 25% increase in the sum of products of all index lesions or the appearance of any new lesions. For nonindex lesions: appearance of any new lesions or unequivocal progression of nonindex lesions.

Progression-free Survival (PFS) Rate Truncated at Week 12

PFS rate=probability patient was progression-free at Day 78, calculated as total patients receiving treatment and with an overall response of stable disease (SD), partial response (PR), or complete response (CR) at Week 12, divided by total patients. For those alive and not progressed at or before Week 12, PFS censored on date of last evaluable tumor assessment (TA) at or before Week 12. Those with an assessment of PD prior to Week 12 and subsequent assessment of SD, PR, or CR at Week 12 were called progression-free at Week 12. Those with no recorded postbaseline TA dated on or before Day 109, and who had not died on or before Day 109, were censored at randomization. PD=at least 25% increase in sum of products of all index lesions or appearance of any new lesions. Both an investigator and independent review committee (IRC) assessed radiologic imaging studies, photographs of skin lesions, and clinical data. IRC assessment was considered primary over that of the investigators.

Best Overall Response Rate (BORR)

BORR=number with Best Overall Response (BOR) of complete response (CR) or partial response (PR), divided by total number of randomized patients. BOR=date of first dose to the last tumor assessment prior to subsequent cancer therapy (including tumor resection surgery but excluding palliative local radiotherapy for bone lesions). Independent review committee assessment. Modified criteria of the World Health Organization (mWHO): CR=disappearance of all lesions; no evidence of progressive disease; PR=50% or greater decrease in the sum of products of the longest diameter and greatest perpendicular diameter of all index lesions compared with baseline. Immune-related (ir) response criteria (irRC) assess tumor response in patients on immunotherapy: irCR=disappearance of all lesions in 2 consecutive observations at least 4 weeks apart; irPR=50% or greater decrease in total measureable tumor burden compared with peak in 2 observations at least 4 weeks apart.

Duration of Response (DOR): Randomized Participants With Response of Complete Response (CR) or Partial Response (PR)

DOR defined in those with Best Overall Response (BOR)=CR or PR per independent review committee (IRC) as time between date of response of confirmed CR or PR, whichever occurred first, and date of PD or death. If PR assessed before CR, DOR confirmed at earlier time-point showing PR. Modified criteria of the World Health Organization (mWHO): CR=disappearance of all lesions;no evidence of PD; PR=50% or greater decrease in the sum of products of longest and greatest perpendicular diameters (SPD) of all index lesions compared with baseline. PD=an increase of 25% or greater in SPD of index lesions compared with the smallest recorded sum, or appearance of 1 or more new lesions. Immune-related response criteria (irRC): SD=50% decrease in total measurable tumor burden compared with peak cannot be established nor 25% increase compared with nadir, in absence of unequivocal progression of nonindex lesions. Unconfirmed immune-related (ir) CR, irPR, or irPD=irSD.

Time to Response: All Randomized Participants With Response to Treatment

Time to response was defined as the time between the first dose of study therapy and the date when measurement criteria were met for Best Overall Response (BOR) of partial response (PR) or complete response (CR), whichever occurred first, per independent review committee. Note that if an overall response of PR occurred before confirmation of CR, the time to response endpoint was not determined by the time that the BOR of CR was shown but rather by the earlier time point showing PR. Modified criteria of the World Health Organization: CR=disappearance of all lesions; no evidence of progressive disease (PD); PR=50% or more decrease in the sum of products of the longest and greatest perpendicular diameters (SPD) of all index lesions compared with baseline; PD=an increase of 25% or greater in the SPD of index lesions compared with the smallest recorded sum, or the appearance of 1 or more new lesions.

Duration of Stable Disease (SD): Randomized Participants With Stable Disease

Duration of SD was defined in those whose Best Overall Response (BOR) was SD, per independent review committee (IRC) as the time between Week 12 and date of progressive disease (PD) or death , whichever occurs first. For those who underwent tumor resection following Week 12 but prior to PD, duration of SD was censored on date of last evaluable tumor assessment (TA) prior to resection. For those with BOR of SD at Week 12, date of PD was used in analysis of duration of SD. For those with BOR=SD who have not subsequently progressed and who remain alive, duration of SD censored on date of last evaluable TA. Modified criteria of the World Health Organization (mWHO): SD=insufficient decrease to qualify for partial response or sufficient increase to qualify for PD; PD=an increase of 25% or more in sum of products of longest diameter and greatest perpendicular diameter of index lesions compared with smallest recorded sum, or appearance of 1 or more new lesions.

Percentage of Participants With Brain Metastasis-Free Survival at Time of Data Cutoff

Brain metastasis-free survival was defined as the time from randomization to the date of progression with a new lesion located in the brain. New brain lesions prior to Week 12 constituted a progression event (unlike main progression-free survival analysis). A participant who dies without documentation of a brain lesion was considered to have progressed with brain metastasis on the date of death. Participants who are free of brain metastasis were censored on the date of their last tumor assessment. An independent review committee evaluated images of participants with clinical symptoms to determine the number of those free of brain metastasis. The brain metastasis-free status was reported as a percent of participants (n/N), where n= participants with metastasis-free brains at data cutoff for the Primary Endpoint and N= randomized participants. A 2-sided Clopper and Pearson confidence interval was performed.

Number of Participants With Adverse Events (AEs), Drug-related AEs, AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Drug-related SAEs, Drug-related Hypersensitivity, Immune-related AEs/SAEs, and Inflammatory AEs/SAEs

AE=any new undesirable symptom, sign, clinically significant laboratory abnormality, or medical condition occurring after starting study treatment, even if the event was not considered to be drug-related. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Randomization=Day 1; start of treatment (first dose)=Week 1. Summarization time frame is from first dose to 70 days after last dose of study at time of 414 deaths.

Number of Participants With Grade 2-3 and Grade 3-4 Immune-related Adverse Events (irAEs) With Resolution Resolved

irAEs included the categories: gastrointestinal (GI), diarrhea, liver, endocrine, and skin. Grade 2=moderate adverse events (AEs); minimal, local, or noninvasive intervention indicated. Grade 3=severe AEs, medically significant but not immediately life-threatening. Grade 4=life-threatening consequences; urgent intervention indicated. Resolution is defined as improvement to Grade 1 or less or to the Grade at baseline (prior to treatment).

Time to Resolution of Grade 2-3, Grade 3-4 Immune-related Adverse Events (irAEs)

irAEs included the categories: gastrointestinal (GI), diarrhea, liver, endocrine, and skin. Grade 2=Moderate adverse events (AEs); minimal, local or noninvasive intervention indicated. Grade 3=severe AEs, medically significant but not immediately life-threatening. Grade 4=life-threatening consequences; urgent intervention indicated. Time to resolution is defined as improvement to Grade 1 or less or to the Grade at baseline (prior to treatment).

Full Information

NCT ID

NCT00324155

First Posted

May 8, 2006

Last Updated

October 24, 2014

Sponsor

Bristol-Myers Squibb

Collaborators

Medarex

1. Study Identification

Unique Protocol Identification Number

NCT00324155

Brief Title

Dacarbazine and Ipilimumab vs. Dacarbazine With Placebo in Untreated Unresectable Stage III or IV Melanoma

Official Title

A Multi-center, Randomized, Double-Blind, Two-Arm, Phase III Study in Patients With Untreated Stage III (Unresectable) or IV Melanoma Receiving Dacarbazine Plus 10 mg/kg Ipilimumab (MDX-010) vs. Dacarbazine With Placebo

Study Type

Interventional

2. Study Status

Record Verification Date

October 2014

Overall Recruitment Status

Completed

Study Start Date

August 2006 (undefined)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

Collaborators

Medarex

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this clinical research study is to examine the safety and effectiveness (how well the drug works) of two different treatments for patients with melanoma. One treatment is an investigational compound (a drug that is not currently approved by the United States Food and Drug Administration [FDA]), know as Ipilimumab (also known as MDX-010 or BMS-734016) together with an approved chemotherapy drug called Dacarbazine

Detailed Description

For the extension phase: Allocation: single arm study; Masking: open label; Intervention Model: Single Group

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Melanoma

Keywords

Stage IIIc N3 (unresectable), Stage IV melanoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

681 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A: Ipilimumab and Dacarbazine

Arm Type

Experimental

Arm Description

In Maintenance phase: Ipilimumab will be continued. Dacarbazine was given up to Week 22 and is not given in the Maintenance phase

Arm Title

Arm B: Placebo and Dacarbazine

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Ipilimumab

Other Intervention Name(s)

MDX-010, BMS-734016

Intervention Description

Intravenous solution; intravenous; 10mg/kg; one dose every 3 weeks for 10 weeks then one dose every 12 weeks starting at Week 24, until disease progression, unacceptable toxicity or withdrawal of consent In Maintenance phase: Only Ipilimumab: 10mg/kg, every 12 weeks will be continued until disease progression

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Intravenous solution; intravenous; 0 mg; one dose every 3 weeks for 10 weeks then one dose every 12 weeks starting at Week 24; until disease progression, unacceptable toxicity or withdrawal of consent

Intervention Type

Drug

Intervention Name(s)

Dacarbazine

Intervention Description

Intravenous solution; intravenous; 850 mg/m^2; one dose every 3 weeks for 22 weeks, until disease progression, unacceptable toxicity or withdrawal of consent

Primary Outcome Measure Information:

Title

Overall Survival (OS)

Description

Time Frame

Date of randomization to 37 months through 5-year follow-up and up to approximately 76 months

Secondary Outcome Measure Information:

Title

Survival Rate at 1 Year, 18 Months, 2 Years, and 3 Years

Description

Time Frame

Date of randomization to 3 years following randomization

Title

Disease Control Rate (DCR)

Description

Time Frame

First dose to last tumor assessment prior to subsequent therapy at data cutoff for Primary Endpoint (approximately 5 years)

Title

Median Number of Months of Progression-free Survival (PFS)

Description

Time Frame

Randomization to date of progression or death to approximately 5 years

Title

Progression-free Survival (PFS) Rate Truncated at Week 12

Description

Time Frame

Day 78

Title

Best Overall Response Rate (BORR)

Description

Time Frame

First dose to last tumor assessment at data cutoff for primary endpoint (approximately 5 years)

Title

Duration of Response (DOR): Randomized Participants With Response of Complete Response (CR) or Partial Response (PR)

Description

Time Frame

Day of CR or PR to day of PD or death up to data cutoff for primary endpoint (approximately 5 years)

Title

Time to Response: All Randomized Participants With Response to Treatment

Description

Time Frame

First dose to date of BOR up to data cutoff for primary endpoint (approximately 5 years)

Title

Duration of Stable Disease (SD): Randomized Participants With Stable Disease

Description

Time Frame

Week 12 to date of disease progression or death up to data cutoff for primary endpoint (approximately 5 years)

Title

Percentage of Participants With Brain Metastasis-Free Survival at Time of Data Cutoff

Description

Time Frame

Date of randomization up to data cutoff for primary endpoint (approximately 5 years)

Title

Description

Time Frame

Week 1 (First Dose) to 70 days after last dose of study up to data cutoff for primary endpoint (approximately 5 years)

Title

Number of Participants With Grade 2-3 and Grade 3-4 Immune-related Adverse Events (irAEs) With Resolution Resolved

Description

Time Frame

Week 1 (first dose) to 70 days after last dose up to data cutoff for primary endpoint (approximately 5 years)

Title

Time to Resolution of Grade 2-3, Grade 3-4 Immune-related Adverse Events (irAEs)

Description

Time Frame

Week 1 (first dose) to 70 days after last dose up to database lock for primary endpoint (approximately 5 years)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Pacific Cancer Medical Center

City

Anaheim

State/Province

California

ZIP/Postal Code

92801

Country

United States

Facility Name

Wilshire Oncology Medical Group Inc

City

La Verne

State/Province

California

ZIP/Postal Code

91750

Country

United States

Facility Name

The Angeles Clinic And Research Institute

City

Los Angeles

State/Province

California

ZIP/Postal Code

90025

Country

United States

Facility Name

Comprehensive Cancer Center

City

Palm Springs

State/Province

California

ZIP/Postal Code

92262

Country

United States

Facility Name

Sharp Clinical Oncology Research

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

Saint Francis Hospital And Medical Center

City

Hartford

State/Province

Connecticut

ZIP/Postal Code

06105

Country

United States

Facility Name

Hematology Oncology, P.C.

City

Stamford

State/Province

Connecticut

ZIP/Postal Code

06902-3628

Country

United States

Facility Name

Cancer Specialists Of North Florida Beaches

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32256

Country

United States

Facility Name

Orlando Health, Inc. M.D. Anderson Cancer Center Orlando

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Hematology Oncology Associates Of The Treasure Coast

City

Port Saint Lucie

State/Province

Florida

ZIP/Postal Code

34952

Country

United States

Facility Name

University Of Chicago

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

Facility Name

Mid-Illinois Hematology/Oncology Associates, Ltd.

City

Normal

State/Province

Illinois

ZIP/Postal Code

61761

Country

United States

Facility Name

Oncology Specialists, Sc

City

Park Ridge

State/Province

Illinois

ZIP/Postal Code

60068

Country

United States

Facility Name

Central Indiana Cancer Centers

City

Fishers

State/Province

Indiana

ZIP/Postal Code

46037

Country

United States

Facility Name

Indiana University Cancer Center

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

Hutchinson Clinic, Pa

City

Hutchinson

State/Province

Kansas

ZIP/Postal Code

67502

Country

United States

Facility Name

Kentucky Cancer Clinic

City

Hazard

State/Province

Kentucky

ZIP/Postal Code

41701

Country

United States

Facility Name

Greater Baltimore Medical Center

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21204

Country

United States

Facility Name

Sinai Hospital Of Baltimore

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21215

Country

United States

Facility Name

Dana Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

Ellis Fischel Cancer Center

City

Columbia

State/Province

Missouri

ZIP/Postal Code

65203

Country

United States

Facility Name

St Joseph Oncology Inc

City

Saint Joseph

State/Province

Missouri

ZIP/Postal Code

64507

Country

United States

Facility Name

University Of New Mexico Cancer Center

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87106

Country

United States

Facility Name

Memorial Sloan Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

Blumenthal Cancer Center

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28204

Country

United States

Facility Name

Providence Portland Medical Center

City

Portland

State/Province

Oregon

ZIP/Postal Code

97213

Country

United States

Facility Name

St. Luke'S Hospital & Health Network

City

Bethlehem

State/Province

Pennsylvania

ZIP/Postal Code

18015

Country

United States

Facility Name

Lowcountry Hematology & Oncology, Pa

City

Mount Pleasant

State/Province

South Carolina

ZIP/Postal Code

29464

Country

United States

Facility Name

Thompson Cancer Survival Center

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37916

Country

United States

Facility Name

Vanderbilt-Ingram Cancer Ctr

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

Facility Name

Joe Arrington Cancer Research And Treatment Center

City

Lubbock

State/Province

Texas

ZIP/Postal Code

79410

Country

United States

Facility Name

Virginia Cancer Institute

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23226

Country

United States

Facility Name

Local Institution

City

Buenos Aires

ZIP/Postal Code

1185

Country

Argentina

Facility Name

Local Institution

City

Buenos Aires

ZIP/Postal Code

C1408INH

Country

Argentina

Facility Name

Local Institution

City

Buenos Aires

ZIP/Postal Code

C1426ANZ

Country

Argentina

Facility Name

Local Institution

City

Cordoba

ZIP/Postal Code

X5000AAI

Country

Argentina

Facility Name

Local Institution

City

Santa Fe

ZIP/Postal Code

S3000FFU

Country

Argentina

Facility Name

Local Institution

City

Coffs Harbour

State/Province

New South Wales

ZIP/Postal Code

2450

Country

Australia

Facility Name

Local Institution

City

Newcastle

State/Province

New South Wales

ZIP/Postal Code

2300

Country

Australia

Facility Name

Local Institution

City

Port Macquarie

State/Province

New South Wales

ZIP/Postal Code

2444

Country

Australia

Facility Name

Local Institution

City

South Brisbane

State/Province

Queensland

ZIP/Postal Code

4101

Country

Australia

Facility Name

Local Institution

City

Box Hill

State/Province

Victoria

ZIP/Postal Code

3128

Country

Australia

Facility Name

Local Institution

City

Vienna

ZIP/Postal Code

1090

Country

Austria

Facility Name

Local Institution

City

Brasschaat

ZIP/Postal Code

2930

Country

Belgium

Facility Name

Local Institution

City

Brussels

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Local Institution

City

Edegem

ZIP/Postal Code

B-2650

Country

Belgium

Facility Name

Local Institution

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Local Institution

City

Fortaleza

State/Province

Ceara

ZIP/Postal Code

60430-230

Country

Brazil

Facility Name

Local Institution

City

Porto Alegre, Rs

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90610-000

Country

Brazil

Facility Name

Local Institution

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90050-170

Country

Brazil

Facility Name

Local Institution

City

Sao Paulo

ZIP/Postal Code

01508-010

Country

Brazil

Facility Name

Local Institution

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 1Z2

Country

Canada

Facility Name

Local Institution

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H1T 2W4

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

Santiago

Country

Chile

Facility Name

Local Institution

City

Olomouc

ZIP/Postal Code

775 20

Country

Czech Republic

Facility Name

Local Institution

City

Praha

ZIP/Postal Code

128 08

Country

Czech Republic

Facility Name

Local Institution

City

Nantes

State/Province

Cedex 1

ZIP/Postal Code

44093

Country

France

Facility Name

Local Institution

City

Saint Etienne

State/Province

Cedex 2

ZIP/Postal Code

42055

Country

France

Facility Name

Local Institution

City

Brest

State/Province

Cedex

ZIP/Postal Code

29200

Country

France

Facility Name

Local Institution

City

Bordeaux

ZIP/Postal Code

33075

Country

France

Facility Name

Local Institution

City

Marseille

ZIP/Postal Code

13009

Country

France

Facility Name

Local Institution

City

Paris

ZIP/Postal Code

75010

Country

France

Facility Name

Local Institution

City

Pierre Benite

ZIP/Postal Code

69495

Country

France

Facility Name

Local Institution

City

Villejuif

ZIP/Postal Code

94805

Country

France

Facility Name

Local Institution

City

Berlin

ZIP/Postal Code

12200

Country

Germany

Facility Name

Local Institution

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

Local Institution

City

Jena

ZIP/Postal Code

07740

Country

Germany

Facility Name

Local Institution

City

Kiel

ZIP/Postal Code

24105

Country

Germany

Facility Name

Local Institution

City

Mannheim

ZIP/Postal Code

68167

Country

Germany

Facility Name

Local Institution

City

Muenchen

ZIP/Postal Code

81675

Country

Germany

Facility Name

Local Institution

City

Tubingen

ZIP/Postal Code

72076

Country

Germany

Facility Name

Local Institution

City

Kaposyar

ZIP/Postal Code

7400

Country

Hungary

Facility Name

Local Institution

City

Dublin

State/Province

Dublin 4

Country

Ireland

Facility Name

Local Institution

City

Cork

Country

Ireland

Facility Name

Local Institution

City

Galway

Country

Ireland

Facility Name

Local Institution

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Facility Name

Local Institution

City

Tel Aviv

ZIP/Postal Code

64239

Country

Israel

Facility Name

Local Institution

City

Genova

ZIP/Postal Code

16128

Country

Italy

Facility Name

Local Institution

City

Milano

ZIP/Postal Code

20141

Country

Italy

Facility Name

Local Institution

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Local Institution

City

Padova

ZIP/Postal Code

35128

Country

Italy

Facility Name

Local Institution

City

Ragusa

ZIP/Postal Code

97100

Country

Italy

Facility Name

Local Institution

City

Rome

ZIP/Postal Code

00144

Country

Italy

Facility Name

Local Institution

City

Siena

ZIP/Postal Code

53100

Country

Italy

Facility Name

Local Institution

City

Eindhoven

ZIP/Postal Code

5623 EJ

Country

Netherlands

Facility Name

Local Institution

City

Hv Amsterdam

ZIP/Postal Code

1081

Country

Netherlands

Facility Name

Local Institution

City

Wurzburg

ZIP/Postal Code

97080

Country

Netherlands

Facility Name

Local Institution

City

Montebello

State/Province

Oslo

ZIP/Postal Code

0310

Country

Norway

Facility Name

Local Institution

City

Gdansk

ZIP/Postal Code

80-219

Country

Poland

Facility Name

Local Institution

City

Lodz

ZIP/Postal Code

93-509

Country

Poland

Facility Name

Local Institution

City

Lublin

ZIP/Postal Code

20-090

Country

Poland

Facility Name

Local Institution

City

Poznan

ZIP/Postal Code

61-866

Country

Poland

Facility Name

Local Institution

City

Wroclaw

ZIP/Postal Code

51-124

Country

Poland

Facility Name

Local Institution

City

Lisboa

ZIP/Postal Code

1099-023

Country

Portugal

Facility Name

Local Institution

City

Pyatigorsk

State/Province

Stavropol

ZIP/Postal Code

357502

Country

Russian Federation

Facility Name

Local Institution

City

Moscow

ZIP/Postal Code

105229

Country

Russian Federation

Facility Name

Local Institution

City

Moscow

ZIP/Postal Code

115478

Country

Russian Federation

Facility Name

Local Institution

City

Murmansk

ZIP/Postal Code

183047

Country

Russian Federation

Facility Name

Local Institution

City

Ryazan

ZIP/Postal Code

390011

Country

Russian Federation

Facility Name

Local Institution

City

Samara

ZIP/Postal Code

443066

Country

Russian Federation

Facility Name

Local Institution

City

St Petersburg

ZIP/Postal Code

198255

Country

Russian Federation

Facility Name

Local Institution

City

St.-Petersburg

ZIP/Postal Code

191104

Country

Russian Federation

Facility Name

Local Institution

City

Stavropol

ZIP/Postal Code

355047

Country

Russian Federation

Facility Name

Local Institution

City

Port Elizabeth

State/Province

Eastern Cape

ZIP/Postal Code

6000

Country

South Africa

Facility Name

Local Institution

City

Groenkloof

State/Province

Gauteng

ZIP/Postal Code

0181

Country

South Africa

Facility Name

Local Institution

City

Pretoria

State/Province

Gauteng

ZIP/Postal Code

0041

Country

South Africa

Facility Name

Local Institution

City

Saxonworld

State/Province

Gauteng

ZIP/Postal Code

2196

Country

South Africa

Facility Name

Local Institution

City

Cape Town

State/Province

Western Cape

ZIP/Postal Code

7570

Country

South Africa

Facility Name

Local Institution

City

Johannesburg

ZIP/Postal Code

2199

Country

South Africa

Facility Name

Local Institution

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Local Institution

City

Canarias

ZIP/Postal Code

38320

Country

Spain

Facility Name

Local Institution

City

Valencia

ZIP/Postal Code

46014

Country

Spain

Facility Name

Local Institution

City

Zaragoza

ZIP/Postal Code

50009

Country

Spain

Facility Name

Local Institution

City

Basel

ZIP/Postal Code

CH-4031

Country

Switzerland

Facility Name

Local Institution

City

Geneva

ZIP/Postal Code

1211

Country

Switzerland

Facility Name

Local Institution

City

Cherkassy

ZIP/Postal Code

18009

Country

Ukraine

Facility Name

Local Institution

City

Dnepropetrovsk

ZIP/Postal Code

49044

Country

Ukraine

Facility Name

Local Institution

City

Lviv

ZIP/Postal Code

79031

Country

Ukraine

Facility Name

Local Institution

City

Uzhgorod

ZIP/Postal Code

88000

Country

Ukraine

Facility Name

Local Institution

City

Bristol

State/Province

Avon

ZIP/Postal Code

BS2 8ED

Country

United Kingdom

Facility Name

Local Institution

City

Poole

State/Province

Dorset

ZIP/Postal Code

BH15 2JB

Country

United Kingdom

Facility Name

Local Institution

City

Chelmsford

State/Province

Essex

ZIP/Postal Code

CM1 7ET

Country

United Kingdom

Facility Name

Local Institution

City

London

State/Province

Greater London

ZIP/Postal Code

SW3 6JJ

Country

United Kingdom

Facility Name

Local Institution

City

Wirral

State/Province

Merseyside

ZIP/Postal Code

CH63 3JY

Country

United Kingdom

Facility Name

Local Institution

City

Guildford

State/Province

Surrey

ZIP/Postal Code

GU2 7XX

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

25713437

Citation

Maio M, Grob JJ, Aamdal S, Bondarenko I, Robert C, Thomas L, Garbe C, Chiarion-Sileni V, Testori A, Chen TT, Tschaika M, Wolchok JD. Five-year survival rates for treatment-naive patients with advanced melanoma who received ipilimumab plus dacarbazine in a phase III trial. J Clin Oncol. 2015 Apr 1;33(10):1191-6. doi: 10.1200/JCO.2014.56.6018. Epub 2015 Feb 23.

Results Reference

derived

PubMed Identifier

25667295

Citation

Schadendorf D, Hodi FS, Robert C, Weber JS, Margolin K, Hamid O, Patt D, Chen TT, Berman DM, Wolchok JD. Pooled Analysis of Long-Term Survival Data From Phase II and Phase III Trials of Ipilimumab in Unresectable or Metastatic Melanoma. J Clin Oncol. 2015 Jun 10;33(17):1889-94. doi: 10.1200/JCO.2014.56.2736. Epub 2015 Feb 9.

Results Reference

derived

PubMed Identifier

21639810

Citation

Robert C, Thomas L, Bondarenko I, O'Day S, Weber J, Garbe C, Lebbe C, Baurain JF, Testori A, Grob JJ, Davidson N, Richards J, Maio M, Hauschild A, Miller WH Jr, Gascon P, Lotem M, Harmankaya K, Ibrahim R, Francis S, Chen TT, Humphrey R, Hoos A, Wolchok JD. Ipilimumab plus dacarbazine for previously untreated metastatic melanoma. N Engl J Med. 2011 Jun 30;364(26):2517-26. doi: 10.1056/NEJMoa1104621. Epub 2011 Jun 5.

Results Reference

derived

Links:

URL

http://www.bms.com/studyconnect/Pages/home.aspx

Description

BMS clinical trial educational resource

Learn more about this trial

Dacarbazine and Ipilimumab vs. Dacarbazine With Placebo in Untreated Unresectable Stage III or IV Melanoma

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Dacarbazine and Ipilimumab vs. Dacarbazine With Placebo in Untreated Unresectable Stage III or IV Melanoma

Melanoma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial