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A randomized, double-blinded, regimen controlled, phase II, multicenter study to assess the efficacy and safety of two different vismodegib regimens in patients with multiple basal cell carcinomas (BCCs).

The primairy objective of this fase II study, is to compare two treatment regimens of vismodegib in two populations of patients with multiple BCC's (patients with Gorlin syndrome and patients who do not have Gorlin syndrome). Primary to assess…

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 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 phase II, randomized double-blind study of efficacy and safety of two dose levels of LDE225 in patients with locally advanced or metastatic basal cell carcinoma

The purpose of this phase II study is to assess the efficacy and safety of oral treatment with two dose levels of LDE225, as measured by objective response rate (ORR), in patients with locally advanced or metastatic BCC. Additional assessments…

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.

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…

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…

A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF VEMURAFENIB (RO5185426) ADJUVANT THERAPY IN PATIENTS WITH SURGICALLY RESECTED, CUTANEOUS BRAF-MUTANT MELANOMA AT HIGH RISK FOR RECURRENCE

Primary ObjectiveThe primary objective of this study is as follows:* To evaluate the efficacy of vemurafenib adjuvant treatment administered over a 52-week period in patients with completely resected BRAFV600 mutation*positive, cutaneous melanoma,…

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-…

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-…

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…

Conversion of unresponsiveness to immunotherapy by Fecal Microbiota Transplantation in patients with metastatic melanoma and non-melanoma skin cancer: a randomized phase Ib/IIa trial

Primary objective:• To investigate the efficacy, defined as clinical benefit (stable disease (SD), partial response (PR), complete response (CR)) at 12 weeks, confirmed on a second scan after 4 weeks, of an FMT-intervention with responder and non-…

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-…

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 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…