F16IL2 Plus Paclitaxel in Metastatic Merkel Cell Carcinoma
Status:
Terminated
Trial end date:
2017-12-15
Target enrollment:
Participant gender:
Summary
There is no standard treatment for Merkel cell carcinoma(MCC), as no randomized trials have
been conducted to establish standard of care. Despite a sizable number of objective responses
induced by combination cyototoxic chemotherapy, a prolongation of patients overall survival
has never been demonstrated.
This open-label, randomized, double-arm, multi-centre, phase II study of F16IL2 in
combination with paclitaxel versus paclitaxel monotherapy, proposes to test the therapeutic
efficacy of F16IL2 plus paclitaxel in patients with metastatic Merkel cell carcinoma, who are
not amenable to surgery.
A total of 90 patients with Merkel cell carcinoma will be enrolled and treated during the
study; 45 patients will receive the combination treatment of F16IL2 and paclitaxel (Arm A),
and 45 patients will receive paclitaxel monotherapy (Arm B).