Clinical trials: Melanoma BRAF V600E/K Mutated
Melanoma
GSK1120212 vs Chemotherapy in Advanced or Metastatic BRAF V600E/K Mutation-positive Melanoma
This is a two-arm, open-label, randomized Phase III study comparing single agent GSK1120212 to chemotherapy (either dacarbazine or paclitaxel) in subjects with Stage IIIc or Stage IV malignant cutaneous melanoma.
- Trial name
- NCT01245062
- Testing
- GSK1120212, Chemotherapy
- Where
- 112 sites in United States, Argentina and 17 more
- Volunteers
- 322 people
- Sponsor
- GlaxoSmithKline
Melanoma
A Study Comparing Trametinib and Dabrafenib Combination Therapy to Dabrafenib Monotherapy in Subjects With BRAF-mutant Melanoma
This was a two-arm, double-blinded, randomized, Phase III study comparing dabrafenib and trametinib combination therapy to dabrafenib administered with a placebo (dabrafenib monotherapy).
- Trial name
- NCT01584648
- Testing
- Dabrafenib, Trametinib
- Where
- 121 sites in United States, Argentina and 12 more
- Volunteers
- 423 people
- Sponsor
- Novartis Pharmaceuticals
Melanoma
Dabrafenib Plus Trametinib vs Vemurafenib Alone in Unresectable or Metastatic BRAF V600E/K Cutaneous Melanoma
This was a two-arm, open-label, randomized, Phase III study comparing dabrafenib (GSK2118436) and trametinib (GSK1120212) combination therapy with vemurafenib.
- Trial name
- COMBI-v (NCT01597908)
- Testing
- Dabrafenib, Vemurafenib, Trametinib
- Where
- 205 sites in United States, Argentina and 26 more
- Volunteers
- 704 people
- Sponsor
- Novartis Pharmaceuticals
Solid Tumours
Japan PhI/II of GSK2118436 and GSK1120212 Combination in Subjects With BRAF V600E/K Mutation Positive Advanced Solid Tumors (Phase I Part) or Cutaneous Melanoma (Phase II Part)
This is a Japanese Phase I/II, open-label, non-controlled study to evaluate the safety, tolerability, pharmacokinetic profile, and efficacy of the combination of GSK2118436 and GSK1120212 in subjects with BRAF V600E/K mutation…
- Trial name
- NCT01928940
- Testing
- dabrafenib, trametinib
- Where
- 2 sites in Japan
- Volunteers
- 12 people
- Sponsor
- GlaxoSmithKline