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Dabrafenib Plus Trametinib vs Vemurafenib Alone in Unresectable or Metastatic BRAF V600E/K Cutaneous Melanoma (COMBI-v)

Primary Purpose

Melanoma

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Dabrafenib

Vemurafenib

Trametinib

About this trial

This is an interventional treatment trial for Melanoma focused on measuring BRAF inhibitor, Metastatic Melanoma, Cancer, MEK inhibitor

Eligibility Criteria

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

Key Inclusion Criteria:

>= 18 years of age
Stage IIIc or Stage IV BRAF V600E/K cutaneous melanoma
Measurable disease according to RECIST 1.1
Women of childbearing potential with negative serum pregnancy test prior to randomisation
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Adequate baseline organ function

Key Exclusion Criteria:

Any prior use of a BRAF or MEK inhibitor
Prior systemic anti-cancer treatment in the advanced or metastatic setting; prior systemic treatment in the adjuvant setting is allowed
History of another malignancy (except subjects who have been disease free for 3 years or with a history of completely resected non-melanoma skin cancer)
Known HIV, HBV, HCV infection (except chronic or cleared HBV and HCV infection which will be allowed)
Brain metastases (except if all known lesions were previously treated with surgery or stereotactic radiosurgery and lesions, if still present, are confirmed stable for >= 12 weeks prior to randomisation or if no longer present are confirmed no evidence of disease for >= 12 weeks, and are asymptomatic with no corticosteroid requirements for >= 4 weeks prior to randomisation, and no enzyme inducing anticonvulsants for >= 4 weeks prior to randomisation
History or evidence of cardiovascular risk (LVEF < LLN; QTcB >= 480 msec; blood pressure or systolic >=140 mmHg or diastolic >= 90 mmHg which cannot be controlled by anti-hypertensive therapy)
History or current evidence/risk of retinal vein occlusion (RVO) or central serous retinopathy (CSR)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dabrafenib plus Trametinib

Vemurafenib

Arm Description

BRAF inhibitor plus MEK inhibitor

BRAF inhibitor

Outcomes

Primary Outcome Measures

Overall Survival (OS)

Overall Survival (OS) was defined as the interval of time between the date of randomization and the date of death due to any cause. For patients who did not die, OS was censored at the date of last contact.

Secondary Outcome Measures

Progression-Free Survival (PFS), as Assessed by the Investigator

Progression-free survival (PFS) was defined as the interval of time between the date of randomization and the first documented occurrence of disease progression or death due to any cause. PFS for investigator-assessed response was summarized per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1, which is a set of published rules defining when cancer patients improve (respond), stay the same (stabilize), or worsen (progress) during treatment. Disease progression was defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 millimeters (mm) or the appearance of at least 1 new lesion, or the worsening of non-target lesions significant enough to require study treatment discontinuation.

Overall Response Rate (ORR) During Randomized Phase, as Assessed by the Investigator

Overall response was defined as the percentage of confirmed responders (complete response [CR] + partial response [PR] per RECIST, Version 1.1) as summarized by Investigator assessment. CR was defined as the disappearance of all evidence of target lesions. PR was defined as at least a 30% reduction from Baseline in the sum of the longest diameter (LD) of all target lesions. Data were reported as those participants with measureable disease at Baseline.

Duration of Response (DOR), as Assessed by the Investigator

Duration of Response (DOR) was defined as the time from the first documented evidence of a CR (disappearance of all evidence of target lesions) or a PR (at least a 30% reduction from Baseline in the sum of the longest diameter of all target lesions) until disease progression or death due to any cause. PD was defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of at least1 new lesion, or the worsening of non-target lesions significant enough to require study treatment discontinuation. Data were summarized per RECIST, Version 1.1.

Full Information

NCT ID

NCT01597908

First Posted

May 10, 2012

Last Updated

February 8, 2021

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01597908

Brief Title

Dabrafenib Plus Trametinib vs Vemurafenib Alone in Unresectable or Metastatic BRAF V600E/K Cutaneous Melanoma

Acronym

COMBI-v

Official Title

A Phase III, Randomised, Open-label Study Comparing the Combination of the BRAF Inhibitor, Dabrafenib and the MEK Inhibitor, Trametinib to the BRAF Inhibitor Vemurafenib in Subjects With Unresectable (Stage IIIc) or Metastatic (Stage IV) BRAF V600E/K Mutation Positive Cutaneous Melanoma

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

June 4, 2012 (Actual)

Primary Completion Date

April 17, 2014 (Actual)

Study Completion Date

April 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This was a two-arm, open-label, randomized, Phase III study comparing dabrafenib (GSK2118436) and trametinib (GSK1120212) combination therapy with vemurafenib.

Detailed Description

Screening/Subject eligibility: Subjects with histologically confirmed cutaneous melanoma that was either unresectable or metastatic (Stages IIIC or IV), were screened for eligibility. Eligible subjects were BRAF V600E or V600K mutation positive. Subjects who had prior systemic anti-cancer treatment in the advanced or metastatic setting were not eligible although prior systemic treatment in the adjuvant setting was allowed. Randomization: A total of 704 subjects were randomized in a ratio of 1:1 to receive combination therapy (352 subjects) or vemurafenib treatment (352 subjects). Subjects were stratified by LDH level (> the ULN versus =< ULN) and BRAF mutation (V600E versus V600K). Study treatment: Dabrafenib and trametinib were administered orally at their recommended doses of 150 mg b.i.d. and 2.0 mg once daily, respectively. Subjects randomized in the combination therapy arm received both the agents. Subjects randomized in the vemurafenib arm received vemurafenib at the recommended dose of 960 mg orally b.i.d. Subjects in both the arms continued treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent. The protocol was amended on 07-Aug-2014 which allowed subjects who were still receiving vemurafenib to cross over to the dabrafenib and trametinib combination arm, including those subjects who were still receiving vemurafenib monotherapy treatment after disease progression. A washout period of a minimum of 7 days was considered prior to initiating dabrafenib in combination with trametinib. Subjects who experienced disease progression on the vemurafenib monotherapy arm, discontinued vemurafenib monotherapy, and subsequently received another anticancer therapy were ineligible for cross over to the dabrafenib and trametinib combination arm. Follow-up/Study closure: After study treatment discontinuation, subjects were followed for survival and disease progression as applicable. This study completed once all the subjects had at least the 5-years of follow-up.

6. Conditions and Keywords

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

Melanoma

Keywords

BRAF inhibitor, Metastatic Melanoma, Cancer, MEK inhibitor

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

704 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dabrafenib plus Trametinib

Arm Type

Experimental

Arm Description

BRAF inhibitor plus MEK inhibitor

Arm Title

Vemurafenib

Arm Type

Active Comparator

Arm Description

BRAF inhibitor

Intervention Type

Drug

Intervention Name(s)

Dabrafenib

Other Intervention Name(s)

GSK2118436

Intervention Description

Dabrafenib 150 mg twice daily orally

Intervention Type

Drug

Intervention Name(s)

Vemurafenib

Other Intervention Name(s)

Monotherapy

Intervention Description

Vemurafenib 960 mg twice daily orally

Intervention Type

Drug

Intervention Name(s)

Trametinib

Other Intervention Name(s)

GSK1120212

Intervention Description

Trametinib 2 mg once daily orally

Primary Outcome Measure Information:

Title

Overall Survival (OS)

Description

Time Frame

From the date of randomization until date of death due to any cause (up to approximately 6 years)

Secondary Outcome Measure Information:

Title

Progression-Free Survival (PFS), as Assessed by the Investigator

Description

Time Frame

From randomization until the earliest date of disease progression (PD) or death due to any cause (up to approximately 6 years)

Title

Overall Response Rate (ORR) During Randomized Phase, as Assessed by the Investigator

Description

Time Frame

From randomization until the first documented complete response or partial response (up to approximately 6 years)

Title

Duration of Response (DOR), as Assessed by the Investigator

Description

Time Frame

From the time of the first documented response (CR or PR) until disease progression (up to approximately 6 years)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: >= 18 years of age Stage IIIc or Stage IV BRAF V600E/K cutaneous melanoma Measurable disease according to RECIST 1.1 Women of childbearing potential with negative serum pregnancy test prior to randomisation Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 Adequate baseline organ function Key Exclusion Criteria: Any prior use of a BRAF or MEK inhibitor Prior systemic anti-cancer treatment in the advanced or metastatic setting; prior systemic treatment in the adjuvant setting is allowed History of another malignancy (except subjects who have been disease free for 3 years or with a history of completely resected non-melanoma skin cancer) Known HIV, HBV, HCV infection (except chronic or cleared HBV and HCV infection which will be allowed) Brain metastases (except if all known lesions were previously treated with surgery or stereotactic radiosurgery and lesions, if still present, are confirmed stable for >= 12 weeks prior to randomisation or if no longer present are confirmed no evidence of disease for >= 12 weeks, and are asymptomatic with no corticosteroid requirements for >= 4 weeks prior to randomisation, and no enzyme inducing anticonvulsants for >= 4 weeks prior to randomisation History or evidence of cardiovascular risk (LVEF < LLN; QTcB >= 480 msec; blood pressure or systolic >=140 mmHg or diastolic >= 90 mmHg which cannot be controlled by anti-hypertensive therapy) History or current evidence/risk of retinal vein occlusion (RVO) or central serous retinopathy (CSR)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35243

Country

United States

Facility Name

Novartis Investigative Site

City

Gilbert

State/Province

Arizona

ZIP/Postal Code

85234

Country

United States

Facility Name

Novartis Investigative Site

City

Beverly Hills

State/Province

California

ZIP/Postal Code

90211

Country

United States

Facility Name

Novartis Investigative Site

City

San Francisco

State/Province

California

ZIP/Postal Code

94115

Country

United States

Facility Name

Novartis Investigative Site

City

Vallejo

State/Province

California

ZIP/Postal Code

94589

Country

United States

Facility Name

Novartis Investigative Site

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80010

Country

United States

Facility Name

Novartis Investigative Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32204

Country

United States

Facility Name

Novartis Investigative Site

City

Miami Beach

State/Province

Florida

ZIP/Postal Code

33140

Country

United States

Facility Name

Novartis Investigative Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32804

Country

United States

Facility Name

Novartis Investigative Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

Novartis Investigative Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30341

Country

United States

Facility Name

Novartis Investigative Site

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

Facility Name

Novartis Investigative Site

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Facility Name

Novartis Investigative Site

City

Fridley

State/Province

Minnesota

ZIP/Postal Code

55432

Country

United States

Facility Name

Novartis Investigative Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Novartis Investigative Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89148

Country

United States

Facility Name

Novartis Investigative Site

City

Hackensack

State/Province

New Jersey

ZIP/Postal Code

07601

Country

United States

Facility Name

Novartis Investigative Site

City

New Brunswick

State/Province

New Jersey

ZIP/Postal Code

08901

Country

United States

Facility Name

Novartis Investigative Site

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

Novartis Investigative Site

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599-7600

Country

United States

Facility Name

Novartis Investigative Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28204

Country

United States

Facility Name

Novartis Investigative Site

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

Novartis Investigative Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45219

Country

United States

Facility Name

Novartis Investigative Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Facility Name

Novartis Investigative Site

City

Bend

State/Province

Oregon

ZIP/Postal Code

97701

Country

United States

Facility Name

Novartis Investigative Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97213

Country

United States

Facility Name

Novartis Investigative Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

Novartis Investigative Site

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

Novartis Investigative Site

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29605

Country

United States

Facility Name

Novartis Investigative Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

Facility Name

Novartis Investigative Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Facility Name

Novartis Investigative Site

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84106

Country

United States

Facility Name

Novartis Investigative Site

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84112-5550

Country

United States

Facility Name

Novartis Investigative Site

City

Burlington

State/Province

Vermont

ZIP/Postal Code

05403

Country

United States

Facility Name

Novartis Investigative Site

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22903

Country

United States

Facility Name

Novartis Investigative Site

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

Facility Name

Novartis Investigative Site

City

Capital Federal

State/Province

Buenos Aires

ZIP/Postal Code

C1426ANZ

Country

Argentina

Facility Name

Novartis Investigative Site

City

Viedma

State/Province

Río Negro

ZIP/Postal Code

R8500ACE

Country

Argentina

Facility Name

Novartis Investigative Site

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

S2000KZE

Country

Argentina

Facility Name

Novartis Investigative Site

City

Ciudad Autonoma de Buenos Aires

ZIP/Postal Code

C1121ABE

Country

Argentina

Facility Name

Novartis Investigative Site

City

San Miguel de Tucuman

ZIP/Postal Code

T4000IAK

Country

Argentina

Facility Name

Novartis Investigative Site

City

Santa Fe

ZIP/Postal Code

3000

Country

Argentina

Facility Name

Novartis Investigative Site

City

North Sydney

State/Province

New South Wales

ZIP/Postal Code

2060

Country

Australia

Facility Name

Novartis Investigative Site

City

Westmead

State/Province

New South Wales

ZIP/Postal Code

2145

Country

Australia

Facility Name

Novartis Investigative Site

City

Greenslopes

State/Province

Queensland

ZIP/Postal Code

4120

Country

Australia

Facility Name

Novartis Investigative Site

City

Herston

State/Province

Queensland

ZIP/Postal Code

4029

Country

Australia

Facility Name

Novartis Investigative Site

City

South Brisbane

State/Province

Queensland

ZIP/Postal Code

4101

Country

Australia

Facility Name

Novartis Investigative Site

City

Woodville

State/Province

South Australia

ZIP/Postal Code

5011

Country

Australia

Facility Name

Novartis Investigative Site

City

Box Hill

State/Province

Victoria

ZIP/Postal Code

3128

Country

Australia

Facility Name

Novartis Investigative Site

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3004

Country

Australia

Facility Name

Novartis Investigative Site

City

Nedlands

State/Province

Western Australia

ZIP/Postal Code

6009

Country

Australia

Facility Name

Novartis Investigative Site

City

Graz

ZIP/Postal Code

A-8036

Country

Austria

Facility Name

Novartis Investigative Site

City

Innsbruck

ZIP/Postal Code

6020

Country

Austria

Facility Name

Novartis Investigative Site

City

Salzburg

ZIP/Postal Code

A-5020

Country

Austria

Facility Name

Novartis Investigative Site

City

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

Novartis Investigative Site

City

Wien

ZIP/Postal Code

A-1030

Country

Austria

Facility Name

Novartis Investigative Site

City

Brasschaat

ZIP/Postal Code

2930

Country

Belgium

Facility Name

Novartis Investigative Site

City

Brussels

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Novartis Investigative Site

City

Brussel

ZIP/Postal Code

1090

Country

Belgium

Facility Name

Novartis Investigative Site

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Kortrijk

ZIP/Postal Code

8500

Country

Belgium

Facility Name

Novartis Investigative Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Namur

ZIP/Postal Code

5000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Wilrijk

ZIP/Postal Code

2610

Country

Belgium

Facility Name

Novartis Investigative Site

City

Ijui

State/Province

Rio Grande Do Sul

ZIP/Postal Code

98700-000

Country

Brazil

Facility Name

Novartis Investigative Site

City

Itajai

State/Province

Santa Catarina

ZIP/Postal Code

88301-215

Country

Brazil

Facility Name

Novartis Investigative Site

City

Sao Paulo - SP

ZIP/Postal Code

01323-900

Country

Brazil

Facility Name

Novartis Investigative Site

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4N2

Country

Canada

Facility Name

Novartis Investigative Site

City

Kelowna

State/Province

British Columbia

ZIP/Postal Code

V1Y 5L3

Country

Canada

Facility Name

Novartis Investigative Site

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 4E6

Country

Canada

Facility Name

Novartis Investigative Site

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3E 0V9

Country

Canada

Facility Name

Novartis Investigative Site

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 2Y9

Country

Canada

Facility Name

Novartis Investigative Site

City

Kingston

State/Province

Ontario

ZIP/Postal Code

K7L 5P9

Country

Canada

Facility Name

Novartis Investigative Site

City

Oshawa

State/Province

Ontario

ZIP/Postal Code

L1G 2B9

Country

Canada

Facility Name

Novartis Investigative Site

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 8L6

Country

Canada

Facility Name

Novartis Investigative Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4N 3M5

Country

Canada

Facility Name

Novartis Investigative Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

Facility Name

Novartis Investigative Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2L 4M1

Country

Canada

Facility Name

Novartis Investigative Site

City

Quebec

ZIP/Postal Code

G1R 2J6

Country

Canada

Facility Name

Novartis Investigative Site

City

Olomouc

ZIP/Postal Code

775 20

Country

Czechia

Facility Name

Novartis Investigative Site

City

Ostrava

ZIP/Postal Code

708 52

Country

Czechia

Facility Name

Novartis Investigative Site

City

Praha 10

ZIP/Postal Code

100 34

Country

Czechia

Facility Name

Novartis Investigative Site

City

Praha 2

ZIP/Postal Code

128 08

Country

Czechia

Facility Name

Novartis Investigative Site

City

Zlin

ZIP/Postal Code

76275

Country

Czechia

Facility Name

Novartis Investigative Site

City

Arhus C

ZIP/Postal Code

8000

Country

Denmark

Facility Name

Novartis Investigative Site

City

Herlev

ZIP/Postal Code

2730

Country

Denmark

Facility Name

Novartis Investigative Site

City

Odense

ZIP/Postal Code

5000 C

Country

Denmark

Facility Name

Novartis Investigative Site

City

Helsinki

ZIP/Postal Code

00029

Country

Finland

Facility Name

Novartis Investigative Site

City

Jyvaskyla

ZIP/Postal Code

40620

Country

Finland

Facility Name

Novartis Investigative Site

City

Tampere

ZIP/Postal Code

33520

Country

Finland

Facility Name

Novartis Investigative Site

City

Turku

ZIP/Postal Code

20520

Country

Finland

Facility Name

Novartis Investigative Site

City

Bordeaux

ZIP/Postal Code

33075

Country

France

Facility Name

Novartis Investigative Site

City

Grenoble

ZIP/Postal Code

38043

Country

France

Facility Name

Novartis Investigative Site

City

Lille

ZIP/Postal Code

59037

Country

France

Facility Name

Novartis Investigative Site

City

Marseille cedex 5

ZIP/Postal Code

13385

Country

France

Facility Name

Novartis Investigative Site

City

Montpellier cedex 5

ZIP/Postal Code

34295

Country

France

Facility Name

Novartis Investigative Site

City

Nantes

ZIP/Postal Code

44093

Country

France

Facility Name

Novartis Investigative Site

City

Nice

ZIP/Postal Code

06202

Country

France

Facility Name

Novartis Investigative Site

City

Paris Cedex 10

ZIP/Postal Code

75475

Country

France

Facility Name

Novartis Investigative Site

City

Reims Cedex

ZIP/Postal Code

51092

Country

France

Facility Name

Novartis Investigative Site

City

Rennes Cedex

ZIP/Postal Code

35042

Country

France

Facility Name

Novartis Investigative Site

City

Villejuif cedex

ZIP/Postal Code

94805

Country

France

Facility Name

Novartis Investigative Site

City

Heidelberg

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

Novartis Investigative Site

City

Heilbronn

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

74078

Country

Germany

Facility Name

Novartis Investigative Site

City

Mannheim

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

68167

Country

Germany

Facility Name

Novartis Investigative Site

City

Tuebingen

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

72076

Country

Germany

Facility Name

Novartis Investigative Site

City

Erlangen

State/Province

Bayern

ZIP/Postal Code

91054

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenchen

State/Province

Bayern

ZIP/Postal Code

80337

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenchen

State/Province

Bayern

ZIP/Postal Code

80802

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenchen

State/Province

Bayern

ZIP/Postal Code

80804

Country

Germany

Facility Name

Novartis Investigative Site

City

Nuernberg

State/Province

Bayern

ZIP/Postal Code

90419

Country

Germany

Facility Name

Novartis Investigative Site

City

Regensburg

State/Province

Bayern

ZIP/Postal Code

93053

Country

Germany

Facility Name

Novartis Investigative Site

City

Wuerzburg

State/Province

Bayern

ZIP/Postal Code

97080

Country

Germany

Facility Name

Novartis Investigative Site

City

Buxtehude

State/Province

Niedersachsen

ZIP/Postal Code

21614

Country

Germany

Facility Name

Novartis Investigative Site

City

Hannover

State/Province

Niedersachsen

ZIP/Postal Code

30625

Country

Germany

Facility Name

Novartis Investigative Site

City

Bonn

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

53127

Country

Germany

Facility Name

Novartis Investigative Site

City

Essen

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

45122

Country

Germany

Facility Name

Novartis Investigative Site

City

Koeln

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

50937

Country

Germany

Facility Name

Novartis Investigative Site

City

Ludwigshafen

State/Province

Rheinland-Pfalz

ZIP/Postal Code

67063

Country

Germany

Facility Name

Novartis Investigative Site

City

Mainz

State/Province

Rheinland-Pfalz

ZIP/Postal Code

55131

Country

Germany

Facility Name

Novartis Investigative Site

City

Magdeburg

State/Province

Sachsen-Anhalt

ZIP/Postal Code

39120

Country

Germany

Facility Name

Novartis Investigative Site

City

Dresden

State/Province

Sachsen

ZIP/Postal Code

01307

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

State/Province

Sachsen

ZIP/Postal Code

04103

Country

Germany

Facility Name

Novartis Investigative Site

City

Kiel

State/Province

Schleswig-Holstein

ZIP/Postal Code

24105

Country

Germany

Facility Name

Novartis Investigative Site

City

Luebeck

State/Province

Schleswig-Holstein

ZIP/Postal Code

23538

Country

Germany

Facility Name

Novartis Investigative Site

City

Erfurt

State/Province

Thueringen

ZIP/Postal Code

99089

Country

Germany

Facility Name

Novartis Investigative Site

City

Gera

State/Province

Thueringen

ZIP/Postal Code

07548

Country

Germany

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1062

Country

Hungary

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

H-1122

Country

Hungary

Facility Name

Novartis Investigative Site

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Novartis Investigative Site

City

Gyor

ZIP/Postal Code

H-9024

Country

Hungary

Facility Name

Novartis Investigative Site

City

Kaposvar

ZIP/Postal Code

7400

Country

Hungary

Facility Name

Novartis Investigative Site

City

Miskolc

ZIP/Postal Code

3526

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szeged

ZIP/Postal Code

6720

Country

Hungary

Facility Name

Novartis Investigative Site

City

Co.Cork

Country

Ireland

Facility Name

Novartis Investigative Site

City

Dublin

ZIP/Postal Code

Country

Ireland

Facility Name

Novartis Investigative Site

City

Dublin

ZIP/Postal Code

Country

Ireland

Facility Name

Novartis Investigative Site

City

Dublin

ZIP/Postal Code

Country

Ireland

Facility Name

Novartis Investigative Site

City

Galway

Country

Ireland

Facility Name

Novartis Investigative Site

City

Jerusalem

Country

Israel

Facility Name

Novartis Investigative Site

City

Ramat Gan

ZIP/Postal Code

52621

Country

Israel

Facility Name

Novartis Investigative Site

City

Napoli

State/Province

Campania

ZIP/Postal Code

80131

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

Lazio

ZIP/Postal Code

00167

Country

Italy

Facility Name

Novartis Investigative Site

City

Genova

State/Province

Liguria

ZIP/Postal Code

16132

Country

Italy

Facility Name

Novartis Investigative Site

City

Bergamo

State/Province

Lombardia

ZIP/Postal Code

24128

Country

Italy

Facility Name

Novartis Investigative Site

City

Milano

State/Province

Lombardia

ZIP/Postal Code

20133

Country

Italy

Facility Name

Novartis Investigative Site

City

Milano

State/Province

Lombardia

ZIP/Postal Code

20141

Country

Italy

Facility Name

Novartis Investigative Site

City

Pisa

State/Province

Toscana

ZIP/Postal Code

56126

Country

Italy

Facility Name

Novartis Investigative Site

City

Padova

State/Province

Veneto

ZIP/Postal Code

35128

Country

Italy

Facility Name

Novartis Investigative Site

City

Goyang-si, Gyeonggi-Do

ZIP/Postal Code

410-769

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

135-710

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Amsterdam

ZIP/Postal Code

1066 CX

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Amsterdam

ZIP/Postal Code

1081 HV

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Groningen

ZIP/Postal Code

9713 GZ

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Leeuwarden

ZIP/Postal Code

8934 AD

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Leiden

ZIP/Postal Code

2333 ZA

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Rotterdam

ZIP/Postal Code

3015 GD

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Christchurch

ZIP/Postal Code

8011

Country

New Zealand

Facility Name

Novartis Investigative Site

City

Newtown, Wellington

ZIP/Postal Code

6002

Country

New Zealand

Facility Name

Novartis Investigative Site

City

Kristiansand

ZIP/Postal Code

4604

Country

Norway

Facility Name

Novartis Investigative Site

City

Lorenskog

ZIP/Postal Code

1478

Country

Norway

Facility Name

Novartis Investigative Site

City

Oslo

ZIP/Postal Code

0310

Country

Norway

Facility Name

Novartis Investigative Site

City

Gdansk

ZIP/Postal Code

80-215

Country

Poland

Facility Name

Novartis Investigative Site

City

Konin

ZIP/Postal Code

62-500

Country

Poland

Facility Name

Novartis Investigative Site

City

Poznan

ZIP/Postal Code

60-693

Country

Poland

Facility Name

Novartis Investigative Site

City

Warszawa

ZIP/Postal Code

02-781

Country

Poland

Facility Name

Novartis Investigative Site

City

Chelyabinsk

ZIP/Postal Code

454087

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Magnitogorsk

ZIP/Postal Code

455001

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

115478

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

143423

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Nizhniy Novgorod

ZIP/Postal Code

603081

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Ryazan

ZIP/Postal Code

390011

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St. Petersburg

ZIP/Postal Code

197758

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Novartis Investigative Site

City

Hospitalet de Llobregat, Barcelona

ZIP/Postal Code

08907

Country

Spain

Facility Name

Novartis Investigative Site

City

Las Palmas De Gran Canaria

ZIP/Postal Code

35016

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28007

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28050

Country

Spain

Facility Name

Novartis Investigative Site

City

Palma de Mallorca

ZIP/Postal Code

07010

Country

Spain

Facility Name

Novartis Investigative Site

City

Pamplona

ZIP/Postal Code

31008

Country

Spain

Facility Name

Novartis Investigative Site

City

Valencia

ZIP/Postal Code

46009

Country

Spain

Facility Name

Novartis Investigative Site

City

Valencia

ZIP/Postal Code

46014

Country

Spain

Facility Name

Novartis Investigative Site

City

Linkoping

ZIP/Postal Code

SE-581 85

Country

Sweden

Facility Name

Novartis Investigative Site

City

Umea

ZIP/Postal Code

SE-901 85

Country

Sweden

Facility Name

Novartis Investigative Site

City

Basel

ZIP/Postal Code

4031

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Lausanne

ZIP/Postal Code

1011

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Zurich

ZIP/Postal Code

8091

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Tainan

ZIP/Postal Code

704

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taipei

ZIP/Postal Code

100

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taoyuan

ZIP/Postal Code

333

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Dnipropetrovsk

ZIP/Postal Code

49102

Country

Ukraine

Facility Name

Novartis Investigative Site

City

Donetsk

ZIP/Postal Code

83092

Country

Ukraine

Facility Name

Novartis Investigative Site

City

Kharkiv

ZIP/Postal Code

61070

Country

Ukraine

Facility Name

Novartis Investigative Site

City

Kyiv

ZIP/Postal Code

03022

Country

Ukraine

Facility Name

Novartis Investigative Site

City

Lviv

ZIP/Postal Code

79031

Country

Ukraine

Facility Name

Novartis Investigative Site

City

Sumy

ZIP/Postal Code

40005

Country

Ukraine

Facility Name

Novartis Investigative Site

City

Uzhgorod

ZIP/Postal Code

88017

Country

Ukraine

Facility Name

Novartis Investigative Site

City

Cambridge

ZIP/Postal Code

CB2 0QQ

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Glasgow

ZIP/Postal Code

G12 0YN

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

NW3 2QG

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

SE1 7EH

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Manchester

ZIP/Postal Code

M20 4BX

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Southampton

ZIP/Postal Code

SO16 6YD

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Swansea

ZIP/Postal Code

SA2 8QA

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.

Citations:

PubMed Identifier

34225229

Citation

Schadendorf D, Robert C, Dummer R, Flaherty KT, Tawbi HA, Menzies AM, Banerjee H, Lau M, Long GV. Pyrexia in patients treated with dabrafenib plus trametinib across clinical trials in BRAF-mutant cancers. Eur J Cancer. 2021 Aug;153:234-241. doi: 10.1016/j.ejca.2021.05.005. Epub 2021 Jul 2.

Results Reference

derived

PubMed Identifier

31166680

Citation

Robert C, Grob JJ, Stroyakovskiy D, Karaszewska B, Hauschild A, Levchenko E, Chiarion Sileni V, Schachter J, Garbe C, Bondarenko I, Gogas H, Mandala M, Haanen JBAG, Lebbe C, Mackiewicz A, Rutkowski P, Nathan PD, Ribas A, Davies MA, Flaherty KT, Burgess P, Tan M, Gasal E, Voi M, Schadendorf D, Long GV. Five-Year Outcomes with Dabrafenib plus Trametinib in Metastatic Melanoma. N Engl J Med. 2019 Aug 15;381(7):626-636. doi: 10.1056/NEJMoa1904059. Epub 2019 Jun 4.

Results Reference

derived

PubMed Identifier

27864013

Citation

Long GV, Grob JJ, Nathan P, Ribas A, Robert C, Schadendorf D, Lane SR, Mak C, Legenne P, Flaherty KT, Davies MA. Factors predictive of response, disease progression, and overall survival after dabrafenib and trametinib combination treatment: a pooled analysis of individual patient data from randomised trials. Lancet Oncol. 2016 Dec;17(12):1743-1754. doi: 10.1016/S1470-2045(16)30578-2. Epub 2016 Nov 16.

Results Reference

derived

PubMed Identifier

26433819

Citation

Grob JJ, Amonkar MM, Karaszewska B, Schachter J, Dummer R, Mackiewicz A, Stroyakovskiy D, Drucis K, Grange F, Chiarion-Sileni V, Rutkowski P, Lichinitser M, Levchenko E, Wolter P, Hauschild A, Long GV, Nathan P, Ribas A, Flaherty K, Sun P, Legos JJ, McDowell DO, Mookerjee B, Schadendorf D, Robert C. Comparison of dabrafenib and trametinib combination therapy with vemurafenib monotherapy on health-related quality of life in patients with unresectable or metastatic cutaneous BRAF Val600-mutation-positive melanoma (COMBI-v): results of a phase 3, open-label, randomised trial. Lancet Oncol. 2015 Oct;16(13):1389-98. doi: 10.1016/S1470-2045(15)00087-X.

Results Reference

derived

PubMed Identifier

25399551

Citation

Robert C, Karaszewska B, Schachter J, Rutkowski P, Mackiewicz A, Stroiakovski D, Lichinitser M, Dummer R, Grange F, Mortier L, Chiarion-Sileni V, Drucis K, Krajsova I, Hauschild A, Lorigan P, Wolter P, Long GV, Flaherty K, Nathan P, Ribas A, Martin AM, Sun P, Crist W, Legos J, Rubin SD, Little SM, Schadendorf D. Improved overall survival in melanoma with combined dabrafenib and trametinib. N Engl J Med. 2015 Jan 1;372(1):30-9. doi: 10.1056/NEJMoa1412690. Epub 2014 Nov 16.

Results Reference

derived

Learn more about this trial

Dabrafenib Plus Trametinib vs Vemurafenib Alone in Unresectable or Metastatic BRAF V600E/K Cutaneous Melanoma

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Dabrafenib Plus Trametinib vs Vemurafenib Alone in Unresectable or Metastatic BRAF V600E/K Cutaneous Melanoma (COMBI-v)

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