Clinical trials: Stage IIIB Skin Melanoma
Melanoma Stage III, Melanoma Stage IV
A Study of Combination with TBI-1401(HF10) and Ipilimumab in Japanese Patients with Unresectable or Metastatic Melanoma
The purpose of this study is to determine if TBI-1401(HF10) in combination with ipilimumab is effective in Japanese patients with stages IIIB, IIIC, or IV unresectable or metastatic melanoma.
- Trial name
- NCT03153085
- Testing
- TBI-1401(HF10), Ipilimumab
- Where
- 12 sites in Japan
- Volunteers
- 28 people
- Sponsor
- Takara Bio Inc.
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
Malignant Melanoma
A Study of Combination Treatment With HF10 and Ipilimumab in Patients With Unresectable or Metastatic Melanoma
The purpose of this study is to determine if HF10 in combination with ipilimumab is effective in patients with stages IIIB, IIIC, or IV unresectable or metastatic melanoma.
- Trial name
- NCT02272855
- Testing
- HF10 plus Ipilimumab
- Where
- 8 sites in United States
- Volunteers
- 46 people
- Sponsor
- Takara Bio Inc.
Malignant Melanoma
Study of Dabrafenib+Trametinib in the Adjuvant Treatment of Stage III BRAF V600+ Melanoma After Complete Resection to Evaluate the Impact on Pyrexia Related Outcomes
The main purpose of this study was to evaluate the impact on pyrexia-related outcomes of an adapted pyrexia adverse event (AE)-management algorithm, as well as safety, efficacy and health-related outcomes.
- Trial name
- COMBI-APlus (NCT03551626)
- Testing
- Dabrafenib, Trametinib
- Where
- 100 sites in Argentina, Australia and 21 more
- Volunteers
- 552 people
- Sponsor
- Novartis Pharmaceuticals
Non-Small Cell Lung Cancer (NSCLC), Microsatellite Instability-High (MSI-H)
Study of RP1 Monotherapy and RP1 in Combination With Nivolumab (IGNYTE)
The Phase 2 study is a multicenter, open-label study of RP1 to further investigate safety and to estimate the efficacy of RP1 at the RP2D in combination with nivolumab in patients with Stage IIIb-IV unresectable melanoma…
- Conditions
- Non-Small Cell Lung Cancer (NSCLC), Microsatellite Instability-High (MSI-H), Non-melanoma Skin Cancer (NMSC), Cutaneous Melanoma
- Trial name
- IGNYTE (NCT03767348)
- Testing
- RP1, nivolumab
- Where
- 51 sites in United States, France and 3 more
- Volunteers
- 340 people
- Sponsor
- Replimune, Inc.
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.
Melanoma
Single-arm Trial to Evaluate the Biodistribution and Shedding of Talimogene Laherparepvec
The primary objective was to estimate the proportion of participants with detectable talimogene laherparepvec deoxyribonucleic acid (DNA) in the blood and urine at any time after administration of talimogene laherparepvec within…
- Trial name
- NCT02014441
- Testing
- Talimogene laherparepvec
- Where
- 14 sites in United States, Canada
- Volunteers
- 61 people
- Sponsor
- Amgen
Malignant Melanoma
Neoadjuvant L19IL2/L19TNF- Pivotal Study
Phase III, open-label, randomized, controlled multi-center study of the efficacy of L19IL2/L19TNF neoadjuvant intratumoral treatment in Stage III B/C melanoma patients.
- Trial name
- Pivotal (NCT02938299)
- Testing
- L19IL2 + L19TNF, Surgery
- Where
- 22 sites in France, Germany and 2 more
- Volunteers
- 214 people
- Sponsor
- Philogen S.p.A.
Melanoma
Pembrolizumab With Talimogene Laherparepvec or Placebo in Unresected Melanoma
The primary objectives of the Phase 1b part of the study are to evaluate the safety, as assessed by incidence of dose limiting toxicity (DLT), of talimogene laherparepvec in combination with pembrolizumab in adults with…
- Trial name
- MASTERKEY-265 (NCT02263508)
- Testing
- Talimogene Laherparepvec, Pembrolizumab
- Where
- 161 sites in United States, Australia and 19 more
- Volunteers
- 713 people
- Sponsor
- Amgen
Melanoma
Efficacy Study of Nivolumab Compared to Ipilimumab in Prevention of Recurrence of Melanoma After Complete Resection of Stage IIIb/c or Stage IV Melanoma
The purpose of this study is to determine whether nivolumab is better than ipilimumab to prevent recurrence of melanoma.
- Trial name
- CheckMate 238 (NCT02388906)
- Testing
- Ipilimumab, Nivolumab
- Where
- 136 sites in United States, Argentina and 23 more
- Volunteers
- 906 people
- Sponsor
- Bristol-Myers Squibb
Melanoma
A Trial of Intratumoural Tigilanol Tiglate in Adult Participants With Stage IIIB to IV M1c Melanoma
A phase IIb, multicentre, open label study to evaluate the effectiveness, safety, and tolerability of intratumoural tigilanol tiglate in adult participants with Stage IIIB to IV M1c melanoma
- Trial name
- NCT05234437
- Testing
- tigilanol tiglate
- Where
- 3 sites in Australia
- Volunteers
- 1 people
- Sponsor
- QBiotics Group Limited
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
Stage IIIB Skin Melanoma, Stage IIIC Skin Melanoma
A Study of Transgenic Lymphocyte Immunization (TLI) Against Telomerase in Subjects With Stage III Melanoma
The purpose of this study is to assess the safety, efficacy, and immunological response to the study product, TLI, as an adjuvant therapy in subjects with Stage III Melanoma. Normal cells in the body have an established lifespan.
- Trial name
- NCT00925314
- Testing
- CB-10-01 (Transgenic Lymphocyte Immunization)
- Where
- 5 sites in United States
- Volunteers
- 20 people
- Sponsor
- Cosmo Bioscience
Unresected Stage IIIB to IVM1c Melanoma
Expanded Access Study of Talimogene Laherparepvec for Treatment of Subjects With Unresected Stage IIIB-IVM1c Melanoma
The study is a phase 3b, multicenter, open-label, single-arm study designed to provide expanded access of Talimogene Laherparepvec for the treatment of subjects with unresected stage IIIB to IVM1c melanoma.
- Trial name
- NCT02297529
- Testing
- Talimogene Laherparepvec
- Where
- 3 sites in Switzerland
- Sponsor
- Amgen
Unresected Stage IIIb to IVM1c Melanoma
Single-arm Trial to Evaluate the Role of the Immune Response to Talimogene Laherparepvec in Unresected Melanoma
The study is a phase 2, multi centered, single arm study designed to evaluate the correlation between cluster of differentiation 8-positive (CD8+) cell density and objective response rate in adults with unresected stage IIIB to…
- Trial name
- TVEC-325 (NCT02366195)
- Testing
- Talimogene Laherparepvec
- Where
- 42 sites in United States, Austria and 11 more
- Volunteers
- 112 people
- Sponsor
- Amgen
Melanoma (Skin)
A Clinical Study to Evaluate the Safety and Efficacy of OrienX010 in Unresectable Malignant Melanoma Patients
This study is being performed to evaluate the safety and efficacy of Dacarbazine and OrienX010 therapy in Untreated Patients With Unresectable Stage IIIb/IIIc or Stage IV(Mla/Mlb) Melanoma.
- Trial name
- NCT04200040
- Testing
- OrienX010 injection, Dacarbazine (DTIC)
- Where
- China
- Volunteers
- 165 people
- Sponsor
- OrienGene Biotechnology Ltd.
Melanoma Stage IIIB, Melanoma Stage IIIC
Efficacy of Daromun Neoadjuvant Intratumoral Treatment in Clinical Stage IIIB/C/D Melanoma Patients
The trial aims to evaluate the efficacy of Daromun neoadjuvant treatment followed by surgery and adjuvant therapy to improve in a statistically significant manner the recurrence-free survival (RFS) of Stage IIIB/C/D melanoma…
- Conditions
- Melanoma Stage IIIB, Melanoma Stage IIIC, Melanoma Stage IIID
- Trial name
- NeoDREAM (NCT03567889)
- Testing
- Daromun, Surgery, Adjuvant therapy
- Where
- 37 sites in United States, Spain and 1 more
- Volunteers
- 186 people
- Sponsor
- Philogen S.p.A.
Melanoma
Talimogene Laherparepvec With Pembrolizumab in Melanoma Following Progression on Prior Anti-PD-1 Based Therapy (MASTERKEY-115) (Mk-3475-A07/KEYNOTE-A07).
This is a phase 2, open-label, single-arm, multicenter clinical trial designed to evaluate the efficacy and safety of talimogene laherparepvec in combination with pembrolizumab following disease progression on prior…
- Trial name
- NCT04068181
- Testing
- Talimogene laherparepvec, Pembrolizumab
- Where
- 46 sites in United States, Australia and 9 more
- Volunteers
- 72 people
- Sponsor
- Amgen
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 Stage IV, Melanoma Stage III
Study of Adjuvant Immunotherapy With EVX-02 and Anti-PD-1
This is a Phase 1/2, open label, multi-centre study to assess the safety, tolerability, PD, and efficacy of adjuvant immunotherapy EVX-02 vaccine and anti-PD-1 (Nivolumab) in patients who have had a complete resection of a Stage…
- Trial name
- NCT04455503
- Testing
- EVX-02A, EVX-02B, EVX-02A OR EVX-02B
- Where
- 6 sites in Australia
- Volunteers
- 15 people
- Sponsor
- Evaxion Biotech A/S