Phase II Trial of Pimasertib Versus Dacarbazine in N-Ras Mutated Cutaneous Melanoma

Phase 2 Completed 194 enrolled EMD Serono Merck KGaA, Darmstadt, Germany · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

This is a Phase 2, multicenter, randomized, controlled, open-label trial of pimasertib versus dacarbazine aimed to confirm the activity of pimasertib in previously untreated subjects with N-Ras mutated locally advanced or metastatic malignant cutaneous melanoma by comparing the progression-free survival (PFS) of subjects treated with either pimasertib or dacarbazine and by getting a better understanding of the efficacy, safety, pharmacogenomics (PGx) and their relationship with pimasertib exposure.

Timeline

Start: 2012-12-05
Primary completion: 2015-07-04
Completion: 2016-10-24

Outcome

Met primary endpoint

paper PFS was significantly improved with pimasertib versus DTIC (median 13 versus 7 weeks, respectively; PMID 32610581 ↗

registry analysis (other test); Dacarbazine vs Pimasertib; p = 0.0022; Hazard Ratio (HR) 0.59 (95% CI 0.42 to 0.83); Stratified Log Rank Test NCT01693068 ↗

Publications

Lebbe C, Dutriaux C, Lesimple T, Kruit W, Kerger J, Thomas L, Guillot B, Braud F, Garbe C, Grob JJ, Loquai C, Ferraresi V, Robert C, Vasey P, Conry R, Isaacs R, Espinosa E, Schueler A, Massimini G, Dreno B. Pimasertib Versus Dacarbazine in Patients With Unresectable NRAS-Mutated Cutaneous Melanoma: Phase II, Randomized, Controlled Trial with Crossover. Cancers (Basel). 2020 Jun 29;12(7):1727. doi: 10.3390/cancers12071727.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Dacarbazine	Small molecule	1000 mg/m2	Intravenous
Subject	Pimasertib	Small molecule	60 mg	Oral