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A PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF VEMURAFENIB VERSUS VEMURAFENIB PLUS GDC-0973 IN PREVIOUSLY UNTREATED BRAFV600-MUTATION POSITIVE PATIENTS WITH UNRESECTABLE LOCALLY ADVANCED OR METASTATIC MELANOMA

Efficacy ObjectivesThe primary efficacy objective of study GO28141 is as follows:* To evaluate the efficacy of vemurafenib in combination with GDC-0973, compared with vemurafenib and placebo, in previously untreated BRAFV600 mutation-positive…

Topical sinecatechins ointment in treatment of primary superficial Basal Cell Carcinoma: a double blind, randomized, placebo-controlled trial.

Primary Objective: To determine whether topical sinecatechins 10% (Veregen®) ointment application can lead to a histological clearance (efficacy) of a superficial basal cell carcinoma. Secondary Objective(s): To assess compliance and adverse…

A Phase 3, Randomized, Double-Blind Study of Adjuvant Immunotherapy with Nivolumab versus Placebo after Complete Resection of Stage IIB/C Melanoma (CA209-76K)

This study has been transitioned to CTIS with ID 2022-502354-14-00 check the CTIS register for the current data. Primary Objective:To measure the efficacy provided by nivolumab therapy on its own compared to placebo in participants who have had…

A phase Ib/II randomized double-blind placebo controlled trial evaluating the effect of Nivolumab for patients with in-transit melanoma metastases treated with isolated limb perfusion (NivoILP trial)

This study has been transitioned to CTIS with ID 2023-509265-21-00 check the CTIS register for the current data. To evaluate safety and the effect of isolated limb perfusion together with nivolumab as a way to increase efficacy and give further…

Adjuvant encorafenib & binimetinib vs. placebo in fully resected stage IIB/C BRAF V600E/K mutated melanoma: a randomized triple-blind phase III study in collaboration with the EORTC Melanoma Group

To characterize the safety and tolerability.1. To describe the available RFS data by treatment arm.2. To describe the available DMFS data by treatment arm.3. To describe-reported health-related quality of life (HRQoL) bytreatment arm.

A Phase 1b/3, Multicenter, Trial of Talimogene Laherparepvec in Combination With Pembrolizumab (MK-3475) for Treatment of Unresectable, Stage IIIB to IVM1c Melanoma (MASTERKEY-265)

Primary Objectives:To evaluate the efficacy of talimogene laherparepvec with pembrolizumab versus placebo with pembrolizumab, as assessed by progression free survival (PFS) (response evaluation by blinded independent central review using modified…

A Randomized Controlled Phase II Clinical Trial with Intradermal IMO-2125 (Tilsotolimod) in pT3-4 cN0M0 Melanoma

This study has been transitioned to CTIS with ID 2023-509461-20-00 check the CTIS register for the current data. The primary objective is to investigate if IMO-2125 is capable of a) lowering the number of tumor positive SLN and b) inducing a loco-…

COMBI-AD: A phase III randomized double blind study of dabrafenib (GSK2118436) in COMBInation with trametinib (GSK1120212) versus two placebos in the ADjuvant treatment of high-risk BRAF V600 mutation-positive melanoma after surgical resection (BRF115532)

Primary: efficacy of dabrafenib and trametinib combination therapy compared to placebo with respect to relapse-free survival in patients with completely resected, histologically confirmed, BRAF V600E/K high risk, stage III cutaneous melanoma.…

A randomized, double-blind, placebo-controlled, phase III study comparing the combination of PDR001, dabrafenib and trametinib versus placebo, dabrafenib and trametinib in previously untreated patients with unresectable or metastatic BRAF V600 mutant melanoma

* Safety Run inTo determine the recommended regimen of PDR001 in combination with dabrafenib and trametinib for the randomized part (part 3)* Biomarker cohortTo evaluate changes in the immune microenvironment and biomarker modulations upon treatment…

A PHASE 3 TRIAL OF FIANLIMAB (REGN3767, ANTI-LAG-3) + CEMIPLIMAB VERSUS PEMBROLIZUMAB IN PATIENTS WITH PREVIOUSLY UNTREATED UNRESECTABLE LOCALLY ADVANCED OR METASTATIC MELANOMA

This study has been transitioned to CTIS with ID 2023-505772-30-00 check the CTIS register for the current data. From protocol amendment 3 27JUn2022, Clinical Study Protocol Synopsis, page 1Primary Objective• To demonstrate superiority of fianlimab…

A Phase 3, Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined with Ipilimumab Versus Ipilimumab Monotherapy in Subjects with Previously Untreated Unresectable or Metastatic Melanoma

Primary Objectives - To compare Overall Survival (OS) and Progression free survival (PFS) of nivolumab monotherapy to ipilimumab monotherapy and that of nivolumab combined with ipilimumab to ipilimumab monotherapy in subjects with previously…

A phase III, double-blinded, randomized, placebo-controlled study of atezolizumab plus cobimetinib and vemurafenib versus placebo plus cobimetinib and vemurafenib in previously untreated BRAF V600 mutation-positive patients with unresectable locally advanced or metastatic melanoma

This study will evaluate the efficacy, safety, and pharmacokinetics of atezo + cobi + vem compared with placebo plus cobimetinib plus vemurafenib (placebo+ cobi + vem) in patients with previously untreated, BRAFV600 mutation*positive, metastatic or…

Adjuvant immunotherapy with anti-CTLA-4 monoclonal antibody (ipilimumab) versus placebo after complete resection of high-risk Stage III melanoma: A randomized, double-blind Phase 3 trial of the EORTC Melanoma Group

The purpose of this study is to determine the safety and efficacy of post-surgery treatment with the monoclonal antibody ipilimumab, to see whether treatment improves recurrence-free survival (RFS), overall survival and distant metastases-free…

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of Pembrolizumab (MK-3475) in Combination With Epacadostat or Placebo in Subjects with Unresectable or Metastatic Melanoma (KEYNOTE-252 / ECHO-301).

The objective of this study is to test the safety, tolerability and anti-tumor activity of the combination of the investigational products epacadostat and pembrolizumab, compared to pembrolizumab as mono therapy, in patients with unresectable or…

A randomized, double-blind, placebo-controlled phase III study to evaluate active immunization in adjuvant therapy of patients with stage IIIB and IIIC melanoma with natural dendritic cells pulsed with synthetic peptides

The primary objective is to determine whether adjuvant treatment with natural dendritic cell (nDC) vaccination, after complete radical lymph node dissection or sentinel node procedure in stage IIIB and IIIC melanoma patients, improves recurrence-…