Clinical trials: Melanoma BRAF V600E/K Mutated
Metastatic Melanoma
Radiotherapy & Combi in Metastatic Melanoma
The purpose of this study is to investigate the side effects and safety, and effectiveness of combining dabrafenib and trametinib with radiotherapy.
- Trial name
- CombiRT (NCT02392871)
- Testing
- Palliative radiotherapy, Dabrafenib and trametinib (combination)
- Where
- 3 sites in Australia
- Volunteers
- 10 people
- Sponsor
- Melanoma and Skin Cancer Trials Limited
Malignant Melanoma
Biopsy- and Biology-driven Optimization of Targeted Therapy in Subjects With Advanced Melanoma
This is an open-label, multi-center, clinical phase II study to explore the correlation of the genetic make-up of the treated tumor before start of therapy and to correlate clinical response at 8 weeks as well as metabolic…
- Trial name
- BOTTOM (NCT02410863)
- Testing
- Dabrafenib, Trametinib
- Where
- 6 sites in Germany
- Volunteers
- 10 people
- Sponsor
- Prof. Dr. med. Dirk Schadendorf
Melanoma
A Clinical Trial of Three Study Medicines (Encorafenib, Binimetinib, and Pembrolizumab) in Patients With Advanced or Metastatic Melanoma
The purpose of this study is to learn about the effects of three study medicines (encorafenib, binimetinib, and pembrolizumab) given together for the treatment of melanoma that: is advanced or metastatic (spread to other parts of…
- Trial name
- NCT04657991
- Testing
- Encorafenib, Binimetinib, Pembrolizumab
- Where
- 151 sites in United States, Argentina and 25 more
- Volunteers
- 257 people
- Sponsor
- Pfizer
Melanoma
Access Study of Trametinib for Subjects With Advanced Unresectable (Stage IIIc) or Distant Metastatic (Stage IV) BRAF V600E/K Mutation Positive Cutaneous Melanoma
This is a single arm open label, multicenter, non randomized, access study of trametinib for subjects with histologically confirmed cutaneous melanoma with a BRAF V600E/K positive mutation that is either advanced unresectable…
- Trial name
- NCT02416232
- Testing
- Trametinib, Dabrafenib
- Where
- 46 sites in France
- 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
Adjuvant Encorafenib and Binimetinib in High-risk Stage II Melanoma With a BRAF Mutation.
The purpose of the Columbus-AD study is to evaluate the efficacy and safety of 12 months of encorafenib in combination with binimetinib in adjuvant setting of BRAF V600E/K mutant stage IIB/C melanoma versus the current standard…
- Trial name
- COLUMBUS-AD (NCT05270044)
- Testing
- Encorafenib and Binimetinib
- Where
- 155 sites in Argentina, Australia and 21 more
- Volunteers
- 815 people
- Sponsor
- Pierre Fabre Medicament
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
Solid Tumours
Study of Dabrafenib +/- Trametinib in Combination With Ipilimumab for V600E/K Mutation Positive Metastatic or Unresectable Melanoma
This is an open-label, multi-center, dose-finding Phase 1 study that will enroll subjects at least 18 years old with unresectable or metastatic melanoma and BRAF V600 mutations.
- Trial name
- NCT01767454
- Testing
- Dabrafenib, Trametinib, Ipilimumab
- Where
- 7 sites in United States
- Volunteers
- 38 people
- Sponsor
- GlaxoSmithKline
Melanoma BRAF V600E/K Mutated
Surgical or Radiotherapeutic Intervention Concerning Large Singular Stable to Progressive Metastases in Patients With BRAFV600-mutated Melanoma Receiving Treatment With Encorafenib + Binimetinib
This is an open-label, prospective, single arm study conducted in Germany to investigate local treatment (i.e. surgery or radiotherapy or electrochemotherapy) of metastases showing no response to encorafenib (E) + binimetinib (B)…
- Trial name
- SuRage-EB (NCT07092410)
- Testing
- Encorafenib & Binimetinib Treatment
- Sponsor
- SRH Wald-Klinikum Gera GmbH
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 BRAF V600E/K Mutated, Melanoma and Brain Metastases
Encorafenib and biNimetinib Followed by CEmiplimab and FiAnLimab in Patients With BRAF Mutant melanOma and Symptomatic Brain Metastases
Brain metastases in patients with advanced and metastatic melanoma are a frequent complication and a significant cause of morbidity and mortality in this patient population.
- Trial name
- ENCEFALO (NCT06887088)
- Testing
- Encorafenib + Binimetinib, cemiplimab+fianlimab
- Where
- 18 sites in Spain
- Volunteers
- 33 people
- Sponsor
- Grupo Español Multidisciplinar de Melanoma
Melanoma
A Study Comparing 3 Study Medicines (Encorafenib, Binimetinib, Pembrolizumab) to 2 Study Medicines (Ipilimumab and Nivolumab) in Patients With Advanced Melanoma
The purpose of this study is to learn about the effects of 3 study medicines (encorafenib, binimetinib, pembrolizumab) compared to 2 study medicines (ipilimumab and nivolumab) given for the treatment of melanoma.
- Trial name
- PORTSIDE (NCT05926960)
- Testing
- encorafenib, binimetinib, pembrolizumab
- Where
- 24 sites in Germany, Italy and 3 more
- Volunteers
- 38 people
- Sponsor
- Pfizer
Melanoma BRAF V600E/K Mutated, CDNKN2A Loss Defined
Phase I-II Study With Tumor Molecular Pharmacodynamic (MPD) Evaluation and Pharmacokinetics of PD-0332991 in Patients Suffering Metastatic Melanoma
An open label multicentre, phase I-II study with tumour molecular pharmacodynamics (MPD) evaluation and pharmacokinetics of PD-0332991 added to vemurafenib in patients suffering metastatic melanoma with BR.
- Trial name
- OPTIMUM (NCT02202200)
- Testing
- PD- 0332991
- Where
- France
- Volunteers
- 40 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Melanoma
HL-085+Vemurafenib to Treat Advanced Melanoma Patients With BRAF V600E/K Mutation
The main purpose of this study is to Evaluate the Efficacy and Safety of the combination of HL-085 and Vemurafenib in Advanced Melanoma Patients with BRAF V600E/K Mutation. This study includes IIa and IIb phase.
- Trial name
- NCT05263453
- Testing
- HL-085, Vemurafenib
- Where
- China
- Volunteers
- 104 people
- Sponsor
- Shanghai Kechow Pharma, Inc.
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
Melanoma Metastatic, Melanoma of Skin
Different Doses of BI-1607 in Combination With Pembrolizumab and Ipilimumab, in Participants With Unresectable or Metastatic Melanoma
Why the research is needed: Researchers are looking for a better way to treat melanoma that has spread or cannot be removed surgically.
- Conditions
- Melanoma Metastatic, Melanoma of Skin, Melanoma BRAF V600E/K Mutated, Melanoma Recurrent
- Trial name
- NCT06784648
- Testing
- pembrolizumab (KEYTRUDA®), BI-1607, Ipilimumab (YervoyTM, 50 mg/10 mL solution)
- Where
- 4 sites in Germany, Spain and 1 more
- Volunteers
- 35 people
- Sponsor
- BioInvent International AB