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

8 februari 2021 uppdaterad av: Novartis Pharmaceuticals

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

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

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

704

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Argentina
      • Ciudad Autonoma de Buenos Aires, Argentina, C1121ABE
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      • San Miguel de Tucuman, Argentina, T4000IAK
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      • Santa Fe, Argentina, 3000
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    • Buenos Aires
      • Capital Federal, Buenos Aires, Argentina, C1426ANZ
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    • Río Negro
      • Viedma, Río Negro, Argentina, R8500ACE
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    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000KZE
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  • Australien
    • New South Wales
      • North Sydney, New South Wales, Australien, 2060
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      • Westmead, New South Wales, Australien, 2145
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    • Queensland
      • Greenslopes, Queensland, Australien, 4120
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      • Herston, Queensland, Australien, 4029
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      • South Brisbane, Queensland, Australien, 4101
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    • South Australia
      • Woodville, South Australia, Australien, 5011
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    • Victoria
      • Box Hill, Victoria, Australien, 3128
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      • Melbourne, Victoria, Australien, 3004
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    • Western Australia
      • Nedlands, Western Australia, Australien, 6009
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  • Belgien
      • Brasschaat, Belgien, 2930
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      • Brussel, Belgien, 1090
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      • Brussels, Belgien, 1200
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      • Gent, Belgien, 9000
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      • Kortrijk, Belgien, 8500
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      • Leuven, Belgien, 3000
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      • Namur, Belgien, 5000
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      • Wilrijk, Belgien, 2610
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  • Brasilien
      • Sao Paulo - SP, Brasilien, 01323-900
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    • Rio Grande Do Sul
      • Ijui, Rio Grande Do Sul, Brasilien, 98700-000
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    • Santa Catarina
      • Itajai, Santa Catarina, Brasilien, 88301-215
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      • Arhus C, Danmark, 8000
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      • Herlev, Danmark, 2730
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      • Odense, Danmark, 5000 C
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      • Helsinki, Finland, 00029
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      • Bordeaux, Frankrike, 33075
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      • Roma, Lazio, Italien, 00167
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      • Genova, Liguria, Italien, 16132
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      • Bergamo, Lombardia, Italien, 24128
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      • Milano, Lombardia, Italien, 20141
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    • Toscana
      • Pisa, Toscana, Italien, 56126
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    • Veneto
      • Padova, Veneto, Italien, 35128
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      • Quebec, Kanada, G1R 2J6
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    • Alberta
      • Calgary, Alberta, Kanada, T2N 4N2
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    • British Columbia
      • Kelowna, British Columbia, Kanada, V1Y 5L3
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      • Vancouver, British Columbia, Kanada, V5Z 4E6
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    • Manitoba
      • Winnipeg, Manitoba, Kanada, R3E 0V9
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    • Nova Scotia
      • Halifax, Nova Scotia, Kanada, B3H 2Y9
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    • Ontario
      • Kingston, Ontario, Kanada, K7L 5P9
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      • Oshawa, Ontario, Kanada, L1G 2B9
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      • Ottawa, Ontario, Kanada, K1H 8L6
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      • Toronto, Ontario, Kanada, M5G 2M9
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      • Toronto, Ontario, Kanada, M4N 3M5
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    • Quebec
      • Montreal, Quebec, Kanada, H2L 4M1
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  • Korea, Republiken av
      • Goyang-si, Gyeonggi-Do, Korea, Republiken av, 410-769
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      • Seoul, Korea, Republiken av, 03080
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      • Seoul, Korea, Republiken av, 135-710
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  • Nederländerna
      • Amsterdam, Nederländerna, 1066 CX
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      • Amsterdam, Nederländerna, 1081 HV
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      • Groningen, Nederländerna, 9713 GZ
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      • Leeuwarden, Nederländerna, 8934 AD
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      • Leiden, Nederländerna, 2333 ZA
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      • Rotterdam, Nederländerna, 3015 GD
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  • Norge
      • Kristiansand, Norge, 4604
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      • Lorenskog, Norge, 1478
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      • Oslo, Norge, 0310
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  • Nya Zeeland
      • Christchurch, Nya Zeeland, 8011
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      • Newtown, Wellington, Nya Zeeland, 6002
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  • Polen
      • Gdansk, Polen, 80-215
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      • Konin, Polen, 62-500
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      • Poznan, Polen, 60-693
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      • Warszawa, Polen, 02-781
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  • Ryska Federationen
      • Chelyabinsk, Ryska Federationen, 454087
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      • Magnitogorsk, Ryska Federationen, 455001
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      • Moscow, Ryska Federationen, 115478
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      • Moscow, Ryska Federationen, 143423
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      • Nizhniy Novgorod, Ryska Federationen, 603081
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      • Ryazan, Ryska Federationen, 390011
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      • St. Petersburg, Ryska Federationen, 197758
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  • Schweiz
      • Basel, Schweiz, 4031
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      • Lausanne, Schweiz, 1011
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      • Zurich, Schweiz, 8091
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  • Spanien
      • Barcelona, Spanien, 08036
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      • Hospitalet de Llobregat, Barcelona, Spanien, 08907
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      • Las Palmas De Gran Canaria, Spanien, 35016
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      • Madrid, Spanien, 28007
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      • Madrid, Spanien, 28050
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      • Palma de Mallorca, Spanien, 07010
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      • Pamplona, Spanien, 31008
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      • Valencia, Spanien, 46014
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      • Valencia, Spanien, 46009
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  • Storbritannien
      • Cambridge, Storbritannien, CB2 0QQ
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      • Glasgow, Storbritannien, G12 0YN
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      • London, Storbritannien, NW3 2QG
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      • London, Storbritannien, SE1 7EH
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      • Manchester, Storbritannien, M20 4BX
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      • Southampton, Storbritannien, SO16 6YD
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      • Swansea, Storbritannien, SA2 8QA
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  • Sverige
      • Linkoping, Sverige, SE-581 85
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      • Umea, Sverige, SE-901 85
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  • Taiwan
      • Tainan, Taiwan, 704
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      • Taipei, Taiwan, 100
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      • Taoyuan, Taiwan, 333
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  • Tjeckien
      • Olomouc, Tjeckien, 775 20
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      • Ostrava, Tjeckien, 708 52
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      • Praha 10, Tjeckien, 100 34
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      • Praha 2, Tjeckien, 128 08
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      • Zlin, Tjeckien, 76275
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  • Tyskland
    • Baden-Wuerttemberg
      • Heidelberg, Baden-Wuerttemberg, Tyskland, 69120
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      • Heilbronn, Baden-Wuerttemberg, Tyskland, 74078
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      • Mannheim, Baden-Wuerttemberg, Tyskland, 68167
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      • Tuebingen, Baden-Wuerttemberg, Tyskland, 72076
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    • Bayern
      • Erlangen, Bayern, Tyskland, 91054
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      • Muenchen, Bayern, Tyskland, 80337
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      • Muenchen, Bayern, Tyskland, 80804
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      • Muenchen, Bayern, Tyskland, 80802
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      • Nuernberg, Bayern, Tyskland, 90419
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    • Niedersachsen
      • Buxtehude, Niedersachsen, Tyskland, 21614
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    • Nordrhein-Westfalen
      • Bonn, Nordrhein-Westfalen, Tyskland, 53127
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      • Essen, Nordrhein-Westfalen, Tyskland, 45122
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      • Koeln, Nordrhein-Westfalen, Tyskland, 50937
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    • Rheinland-Pfalz
      • Ludwigshafen, Rheinland-Pfalz, Tyskland, 67063
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    • Sachsen
      • Dresden, Sachsen, Tyskland, 01307
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      • Leipzig, Sachsen, Tyskland, 04103
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    • Sachsen-Anhalt
      • Magdeburg, Sachsen-Anhalt, Tyskland, 39120
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    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Tyskland, 24105
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    • Thueringen
      • Erfurt, Thueringen, Tyskland, 99089
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      • Gera, Thueringen, Tyskland, 07548
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  • Ukraina
      • Dnipropetrovsk, Ukraina, 49102
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      • Donetsk, Ukraina, 83092
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Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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)

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Dabrafenib plus Trametinib
BRAF inhibitor plus MEK inhibitor
Läkemedel: Dabrafenib
Dabrafenib 150 mg twice daily orally
Andra namn:
  • GSK2118436
Läkemedel: Trametinib
Trametinib 2 mg once daily orally
Andra namn:
  • GSK1120212
Aktiv komparator: Vemurafenib
BRAF inhibitor
Läkemedel: Vemurafenib
Vemurafenib 960 mg twice daily orally
Andra namn:
  • Monoterapi

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Overall Survival (OS)
Tidsram: From the date of randomization until date of death due to any cause (up to approximately 6 years)
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.
From the date of randomization until date of death due to any cause (up to approximately 6 years)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Progression-Free Survival (PFS), as Assessed by the Investigator
Tidsram: From randomization until the earliest date of disease progression (PD) or death due to any cause (up to approximately 6 years)
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.
From randomization until the earliest date of disease progression (PD) or death due to any cause (up to approximately 6 years)
Overall Response Rate (ORR) During Randomized Phase, as Assessed by the Investigator
Tidsram: From randomization until the first documented complete response or partial response (up to approximately 6 years)
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.
From randomization until the first documented complete response or partial response (up to approximately 6 years)
Duration of Response (DOR), as Assessed by the Investigator
Tidsram: From the time of the first documented response (CR or PR) until disease progression (up to approximately 6 years)
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.
From the time of the first documented response (CR or PR) until disease progression (up to approximately 6 years)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Novartis Pharmaceuticals

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

4 juni 2012

Primärt slutförande (Faktisk)

17 april 2014

Avslutad studie (Faktisk)

25 april 2019

Studieregistreringsdatum

Först inskickad

10 maj 2012

Först inskickad som uppfyllde QC-kriterierna

10 maj 2012

Första postat (Uppskatta)

14 maj 2012

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

24 februari 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

8 februari 2021

Senast verifierad

1 februari 2021

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 116513
  • CDRB436B2302 (Annan identifierare: Novartis)
  • 2011-006088-23 (EudraCT-nummer)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

Ja

IPD-planbeskrivning

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.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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