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A Multicenter, Randomized, Controlled, Three-Arm, Phase III Study to Evaluate the
Safety and Efficacy of Two Dosing Schedules of Pembrolizumab (MK-3475) Compared to Ipilimumab in Patients with Advanced Melanoma

1. To evaluate progression-free-survival (PFS) in patients with advanced MEL receiving either Pembrolizumab or IPI.2. To evaluate overall survival (OS) in patients with advanced MEL receiving either Pembrolizumab or IPI.

Surgical excision versus combined therapy with Curettage and Imiquimod for Nodular Basal Cell Carcinoma: an open, non-inferiority, randomized controlled trial

Primary objective: To compare long-term efficacy of curettage prior to IMQ 5% cream (Aldara®) therapy versus standard surgical excision in primary nBCC.Secondary objective: To assess compliance, pain, cosmetic outcomes, patient satisfaction, patient…

A Phase III randomized, open-label study comparing GSK2118436 to DTIC in previously untreated subjects with BRAF mutation positive advanced (Stage III) or metastatic (Stage IV) melanoma (BRF113683)

Primary: superiority of GSK2118436 over DTIC with respect to progression-free survival for subjects with BRAF mutation positive metastatic melanoma.Secondary: overall survival, best overall response, duration of response, non-melanoma skin lesions,…

A Randomized Phase 3 Study of Tasisulam Administered as an Intravenous Infusion on Day 1 of a 28-Day Cycle vs. Paclitaxel as Second-Line Treatment in Patients with Metastatic Melanoma

The primary objective of this study is to compare the overall survival (OS) of patients whohave received one prior regimen of dacarbazine or temozolomide-based chemotherapy for metastaticmelanoma when treated with either tasisulam or paclitaxel.The…

A Randomized, Open-Label Phase 3 Trial of BMS-936558 (Nivolumab) versus Investigator's Choice in Advanced (Unresectable or Metastatic) Melanoma Patients Progressing Post Anti-CTLA-4 Therapy.

Primary Objective* To compare the objective response rate and overall survival of BMS-936558 to investigator*s choice in subjects with advanced melanoma.Secondary Objectives* To compare the progression-free survival (PFS) of BMS-936558 to…

BRIM 3: A Randomized, Open-label, Controlled, Multicenter, Phase III Study in Previously Untreated Patients With Unresectable Stage IIIC or Stage IV Melanoma with V600E BRAF Mutation Receiving Vemurafenib (RO5185426) or Dacarbazine.

Primary objective:To evaluate efficacy of RO5185426 as a monotherapy compared to dacarbazine in terms of progression-free survival (PFS) and overall survival (OS) in previously untreated patients with advanced melanoma harbouring the BRAF V600E…

A Randomized Double-Blind Phase III Study of Ipilimumab Administered at 3 mg/kg vs
at 10 mg/kg in Subjects with Previously Treated or Untreated Unresectable or Metastatic
Melanoma

To compare the overall survival of ipilimumab monotherapy at doses of 3 mg/kg versus 10 mg/kg in subjects with previously treated or untreated unresectable Stage III or Stage IV melanoma

A Multi-Center, Randomized, Double-Blind, Two-Arm, Phase III Study in Patients with Untreated Stage III (Unresectable) or IV Melanoma Receiving Dacarbazine Plus 10 mg/kg of Ipilimumab (MDX-010) vs. Dacarbazine With Placebo

To compare OS in patients with previously untreated Stage IIIc, N3 (unresectable) or Stage IV melanoma receiving dacarbazine plus 10mg/kg ipilimumab (MDX-010) vs. dacarbazine with placebo.

A Phase 3 Clinical Trial to evaluate the safety and efficacy of treatment with 2 mg intralesional Allovectin-7® compared to Dacarbazine (DTIC) or Temozolomide (TMZ) in subjects with recurrent metastatic melanoma

The objective of the trial is to compare the efficacy and safety of treatment with Allovectin 7® versus treatment with DTIC or TMZ in subjects with recurrent metastatic melanoma. The results of the trial will be used to support registration of…

The TEAM trial (Tasigna efficacy in advanced melanoma): A randomized, phase III, open label, multi-center, two-arm study to compare the efficacy of Tasigna® versus dacarbazine (DTIC) in the treatment of patients with metastatic and/or inoperable melanoma harboring a c-Kit mutation

Primary objective:* To compare the clinical efficacy of nilotinib to DTIC, based on progression free survival (PFS), in the treatment of c-Kit mutated melanoma in patients who have not received prior therapy with TKIs.Key secondary objectives:* To…

Ultraviolet related DNA-damage in skin of patients with atopic dermatitis and atopic status in relation to the use of Myfortic®

The primary aim is to study the effect of treatment of severe AD patients with Myfortic on DNA-repair after irradiation with UVB.A secondary aim is to study the effect of treatment of severe AD patients on atopic status, measured as total IgE and…

A Randomized Phase 3 Comparison of IMO-2125 with Ipilimumab versus Ipilimumab Alone in Subjects with Anti-PD-1 Refractory Melanoma

PrimaryCompare the efficacy (measured by objective response rate [ORR] and overall survival [OS]) of intratumoral IMO-2125 in combination with ipilimumab versus ipilimumab alone.SecondaryAssess other measures of clinical benefit, safety,…

A Phase 3, Randomized, Open-label Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined with Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence (PIVOT-12)

The primary objective is to compare the efficacy, as measured by recurrence-free survival (RFS) by blinded independent central review (BICR), of bempegaldesleukin plus nivolumab versus nivolumab in patients with completely resected Stage IIIA (lymph…

A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy with Nivolumab
versus Ipilimumab after Complete Resection of Stage IIIb/c or Stage IV Melanoma in Subjects who are at High Risk for Recurrence.

The purpose of this study is to find out if treatment with Nivolumab monotherapy will improve recurrence-free survival (RFS) when compared to Ipilimumab monotherapy in subjects with high risk for recurrence, completely resected Stage III and Stage…

Multicenter phase 3 trial comparing NeoADjuvant Ipilimumab + Nivolumab versus standard Adjuvant nivolumab in macroscopic stage III melanoma - NADINA

This study has been transitioned to CTIS with ID 2024-513519-28-00 check the CTIS register for the current data. Primary objective • To compare the event-free survival (EFS) of neoadjuvant ipilimumab + nivolumab (followed by adjuvant nivolumab or…

An open-label, randomized, Phase 3 clinical trial of IO102-IO103 in
combination with pembrolizumab versus pembrolizumab alone in patients
with previously untreated, unresectable, or metastatic (advanced)
melanoma

This study has been transitioned to CTIS with ID 2024-511996-13-00 check the CTIS register for the current data. The primary objective is to investigate the efficacy of IO102-IO103 in combination with pembrolizumab (compared with pembrolizumab alone…

Randomized phase III study comparing a non-myeloablative lymphocyte depleting regimen of chemotherapy followed by infusion of tumor infiltrating lymphocytes and interleukin-2 to standard ipilimumab treatment in metastatic melanoma

In this randomized controlled phase III study we will evaluate whether TIL infusion preceded by non-myeloablative chemotherapy and followed by high dose bolus interleukin-2 can result in an improved progression free survival when randomly compared…

Phase IIIb/IV, Randomized, Double Blinded, Study of Nivolumab 3 mg/kg in Combination with Ipilimumab 1 mg/kg vs Nivolumab 1 mg/kg in Combination with Ipilimumab 3 mg/kg in Subjects with Previously Untreated, Unresectable or Metastatic Melanoma

Primary Objective:The primary objective is to compare the incidence of drug-related Grade 3 - 5 AEs of N3I1 to N1I3 in subjects with previously untreated, unresectable or metastatic melanoma.Secondary Objective:• To evaluate the ORR, as determined…

The NEMO trial (NRAS melanoma and MEK inhibitor): A randomized Phase III, open label, multicenter, two-arm study comparing the efficacy of MEK162 versus dacarbazine in patients with advanced unresectable or metastatic NRAS mutation-positive melanoma

To determine whether treatment with MEK162 prolongs PFS as compared to dacarbazine in patients with previously untreated, advanced unresectable, or metastatic NRAS mutation-positive melanoma who are previously untreated or who have progressed on or…

A Phase III, randomized, double-blinded study comparing the combination of the BRAF inhibitor, dabrafenib and the MEK inhibitor, trametinib to dabrafenib and placebo as first-line therapy in subjects with unresectable (Stage IIIc) or metastatic (Stage IV) BRAF V600E/K mutation-positive cutaneous melanoma (MEK115306)

Primary: superiority of dabrafenib and trametinib combination therapy over dabrafenib and trametinib-placebo (dabrafenib monotherapy) with respect to progression-free survival (PFS) for subjects with advanced/metastatic BRAF V600E/K mutation-…