Clinical trials: Stage IIIC Melanoma
Malignant Melanoma
A Study of Vemurafenib (RO5185426) in Comparison With Dacarbazine in Previously Untreated Patients With Metastatic Melanoma (BRIM 3)
This randomized, open-label study evaluated the efficacy, safety and tolerability of vemurafenib (RO5185426) as compared to dacarbazine in previously untreated patients with metastatic melanoma.
- Trial name
- NCT01006980
- Testing
- Vemurafenib, Dacarbazine
- Where
- 111 sites in United States, Australia and 10 more
- Volunteers
- 675 people
- Sponsor
- Hoffmann-La Roche
Completely Resectable Stage IIIB, IIIC, or IVM1a Melanoma
Efficacy and Safety of Talimogene Laherparepvec Neoadjuvant Treatment Plus Surgery Versus Surgery Alone for Melanoma
This is a phase 2, multicenter, randomized, open-label study to estimate the efficacy of talimogene laherparepvec as a neoadjuvant treatment followed by surgery compared to surgery alone in subjects with completely resectable…
- Trial name
- NCT02211131
- Testing
- Talimogene Laherparepvec, Immediate surgical resection of melanoma lesion(s)
- Where
- 46 sites in United States, Australia and 7 more
- Volunteers
- 150 people
- Sponsor
- Amgen
Malignant Melanoma
BRIM-P: A Study of Vemurafenib in Pediatric Patients With Stage IIIC or Stage IV Melanoma Harboring BRAFV600 Mutations
This open-label, multicenter. single arm Phase I dose-escalation study with efficacy tail extension will evaluate the maximum tolerated dose/recommended dose, the safety and efficacy of vemurafenib (RO5185426) in pediatric…
- Trial name
- NCT01519323
- Testing
- vemurafenib
- Where
- 26 sites in United States, Australia and 8 more
- Volunteers
- 6 people
- Sponsor
- Hoffmann-La Roche
Melanoma
A Study of Talimogene Laherparepvec in Stage IIIc and Stage IV Malignant Melanoma
The primary objective of the study was to assess the clinical efficacy of talimogene laherparepvec in terms of tumor response rates.
- Trial name
- NCT00289016
- Testing
- Talimogene Laherparepvec
- Where
- 8 sites in United States, United Kingdom
- Volunteers
- 50 people
- Sponsor
- BioVex Limited
Melanoma
An Extended Use Study of Safety and Efficacy of Talimogene Laherparepvec in Melanoma
The purpose of this study is to learn about the safety and the risks of using talimogene laherparepvec in patients who already received treatment with talimogene laherparepvec in study 005/05 (NCT00769704), and to see if extended…
- Trial name
- NCT01368276
- Testing
- Talimogene Laherparepvec, Granulocyte Macrophage Colony-Stimulating Factor (GM-CSF)
- Where
- 10 sites in United States, United Kingdom
- Volunteers
- 31 people
- Sponsor
- BioVex Limited
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
CAVATAK in Patients With Stage IIIc or IV Malignant Melanoma to Extend Dosing to 48 Weeks (VLA-008 CALM Ext)
This is an extended use study for patients who have received 10 doses of CAVATAK™ in the VLA 007 trial. There may be patients who have benefitted from the study drug and who might benefit from further treatment.
- Trial name
- CALMext (NCT01636882)
- Testing
- CVA21
- Where
- 4 sites in United States
- Volunteers
- 16 people
- Sponsor
- Viralytics
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
Malignant Melanoma
Study Of Zelboraf (Vemurafenib) in Patients With Locally-Advanced, Unresectable, Stage IIIc Or Metastatic Melanoma and Activating Exon 15 BRAF Mutations Other Than V600E
This is an open-label, multicenter, single-agent, phase II study of continuous oral Zelboraf (vemurafenib) in participants with locally-advanced, unresectable, stage IIIc or metastatic melanoma and activating exon 15 BRAF…
- Trial name
- NCT01586195
- Testing
- Vemurafenib
- Where
- 15 sites in United States
- Volunteers
- 31 people
- Sponsor
- Genentech, Inc.
Stage IIIC Melanoma, Stage IV Melanoma
Study of Denileukin Diftitox in Participants With Stage IIIC and Stage IV Melanoma
The purpose of this study is to determine whether participants with Stage IIIC and Stage IV Melanoma experience benefit when treated with Denileukin diftitox in two different dosing schedules.
- Trial name
- NCT01127451
- Testing
- Denileukin diftitox
- Where
- 10 sites in United States
- Volunteers
- 75 people
- Sponsor
- Eisai Inc.
Malignant Melanoma
A Study of Intratumoral CAVATAK™ in Patients With Stage IIIc and Stage IV Malignant Melanoma (VLA-007 CALM )
The purpose of this study is to assess the clinical efficacy of Intratumoral (IT) CVA21 in terms of immune-related Progression-Free Survival (irPFS) at 6 months as monitored via immune-related Response Criteria [irRECIST 1.1]…
- Trial name
- CALM (NCT01227551)
- Testing
- Coxsackievirus A21 (CVA21)
- Where
- 10 sites in United States
- Volunteers
- 57 people
- Sponsor
- Viralytics
Cutaneous Melanoma, Relapsed/Refractory, Locally Advanced Unresectable Melanoma (Stage IIIB, IIIC, or IIID)
Study of the Effectiveness and Safety of Acasunlimab Alone and With Pembrolizumab to Treat Advanced Melanoma of the Skin That Has Returned After Treatment With an Approved Checkpoint Inhibitor Therapy (ABBIL1TY MELANOMA-07)
The goal of this clinical trial is to learn about the effectiveness and safety of the bispecific antibody acasunlimab (also known as DuoBody®-PD-L1x4-1BB) when given either alone or together with the cancer drug pembrolizumab in…
- Conditions
- Cutaneous Melanoma, Relapsed/Refractory, Locally Advanced Unresectable Melanoma (Stage IIIB, IIIC, or IIID), Metastatic Cutaneous Melanoma (Stage IV)
- Trial name
- NCT06984328
- Testing
- Acasunlimab, Pembrolizumab
- Where
- 2 sites in United States, Puerto Rico
- Volunteers
- 1 people
- Sponsor
- Genmab
Melanoma
Efficacy and Safety Study of Talimogene Laherparepvec Compared to Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) in Melanoma
The objective of this study is to evaluate the efficacy and safety of treatment with talimogene laherparepvec compared to subcutaneously administered GM-CSF in patients with unresectable Stage IIIb, IIIc and Stage IV melanoma.
- Trial name
- NCT00769704
- Testing
- Talimogene laherparepvec, GM-CSF
- Where
- 83 sites in United States, Canada and 2 more
- Volunteers
- 437 people
- Sponsor
- BioVex Limited
Melanoma
An Extension Protocol for the Extended Use of Talimogene Laherparepvec for Eligible Patients Who Participated in Study 002/03 (NCT00289016)
The primary objective of this extension study was to further assess the safety and tolerability of talimogene laherparepvec. Secondary objectives were to assess objective tumor response rate and survival.
- Trial name
- NCT02574260
- Testing
- Talimogene Laherparepvec
- Volunteers
- 3 people
- Sponsor
- BioVex Limited
Melanoma
Dacarbazine and Ipilimumab vs. Dacarbazine With Placebo in Untreated Unresectable Stage III or IV Melanoma
The purpose of this clinical research study is to examine the safety and effectiveness (how well the drug works) of two different treatments for patients with melanoma.
- Trial name
- NCT00324155
- Testing
- Ipilimumab, Dacarbazine
- Where
- 127 sites in United States, Argentina and 23 more
- Volunteers
- 681 people
- Sponsor
- Bristol-Myers Squibb
Cutaneous Melanoma
PV-10 vs Chemotherapy or Oncolytic Viral Therapy for Treatment of Locally Advanced Cutaneous Melanoma
This is an international multicenter, open-label, randomized controlled trial (RCT) of single-agent intralesional PV-10 versus systemic chemotherapy or intralesional oncolytic viral therapy to assess treatment of locally advanced…
- Trial name
- NCT02288897
- Testing
- PV-10 (10% rose bengal disodium), Dacarbazine, temozolomide or talimogene laherparepvec
- Where
- 23 sites in United States, France and 3 more
- Volunteers
- 20 people
- Sponsor
- Provectus Biopharmaceuticals, Inc.
Cancer
Fentanyl Sublingual Spray in Treating Patients With Breakthrough Cancer Pain
This is a phase III, randomized, double-blind, placebo-controlled, multicenter study of the clinical response to fentanyl sublingual spray as a treatment for breakthrough cancer pain.
- Trial name
- NCT00538850
- Testing
- Fentanyl sublingual spray
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- INSYS Therapeutics Inc