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Intratumoral Administration of L19IL2/L19TNF

NCT02076633 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2015-05-27

No results posted yet for this study

Summary

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.

Conditions

  • Malignant Melanoma, Skin

Interventions

DRUG

L19IL2+L19TNF

Patients will be treated with intratumoral injections of 10 MioIU L19IL2 and 312μg L19TNF once weekly for up to 4 weeks.

Sponsors & Collaborators

  • Philogen S.p.A.

    lead INDUSTRY

Principal Investigators

  • Mario Santinami, Dr · Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02076633 on ClinicalTrials.gov