Phase 3
N=704
Dabrafenib Plus Trametinib vs Vemurafenib Alone in Unresectable or Metastatic BRAF V600E/K Cutaneous Melanoma
Melanoma
Bottom Line
View on ClinicalTrials.gov: NCT01597908 ↗Enrolled (actual)
704
Serious AEs
45.0%
Results posted
Dec 2014
Primary outcome: Primary: Overall Survival (OS) — 26.0; 17.8 Months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Dabrafenib (Drug); Vemurafenib (Drug); Trametinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) |
26.0; 17.8 | — |
| SECONDARY Progression-Free Survival (PFS), as Assessed by the Investigator |
12.1; 7.3 | — |
| SECONDARY Overall Response Rate (ORR) During Randomized Phase, as Assessed by the Investigator |
68; 53 | — |
| SECONDARY Duration of Response (DOR), as Assessed by the Investigator |
13.8; 8.5 | — |
Summary
This was a two-arm, open-label, randomized, Phase III study comparing dabrafenib (GSK2118436) and trametinib (GSK1120212) combination therapy with vemurafenib.
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 = 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)
Data sourced from ClinicalTrials.gov (NCT01597908). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.