Who is sponsoring NCT02076633?

NCT02076633 is sponsored by Philogen S.p.A..

What condition does NCT02076633 study?

NCT02076633 studies Malignant Melanoma, Skin.

What is the status of NCT02076633?

NCT02076633 is currently COMPLETED.

Last reviewed 2015-05-25 · How we verify

A Phase II Study of Intratumoral Application of L19IL2/L19TNF in Melanoma Patients in Clinical Stage III or Stage IV M1a With Presence of Injectable Cutaneous and/or Subcutaneous Lesions

NCT02076633 Phase 2 COMPLETED

This Phase II study is an uncontrolled, multicenter, prospective study for patients with malignant melanoma of the skin in clinical stage III or stage IV M1a. Twenty Patients will be treated with a mixture of L19IL2 and L19TNF once weekly for up to 4 weeks. The dose will be distributed among the lesions via multiple intralesional injections. The proportion of patients with complete response at week 12 will be calculated.

Details

Lead sponsor	Philogen S.p.A.
Phase	Phase 2
Status	COMPLETED
Enrolment	21
Start date	2012-12
Completion	2015-05

Conditions

Malignant Melanoma, Skin

Interventions

L19IL2+L19TNF

Primary outcomes

Rate of patients with complete response (CR) of L19IL2 treated Index/Non-Index lesions at week 12. — Week 12

Countries

Italy