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A Phase I/II Dose Escalation Study of the Tumor-targeting Human L19-IL2 Monoclonal Antibody-cytokine Fusion Protein in Combination With Dacarbazine for Patients With Metastatic Melanoma

NCT02076646 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2022-04-14

No results posted yet for this study

Summary

A prospective, open-label, multi-center, Phase I/II study of L19IL2 in combination with Dacarbazine in patients with metastatic melanoma.

Conditions

  • Metastatic Melanoma Stage IV

Interventions

DRUG

L19IL2 - Ph I

During phase I part of the study, increasing dose of L19IL2 from one cohort to the next will be performed in steps of 160,000 IU/kg starting at 480,000 IU/kg (i.e., 0.48; 0.64; 0.80 MioIU/kg until MTD is reached).

DRUG

L19IL2 at RD - Ph II

L19IL2 at RD will be administered to Arm 1 patients during phase II part of the study.

DRUG

DTIC

Dacarbazine: 1 hour intravenous infusion on day 1 of each 21-cycle at a dosage of 1000 mg/m2 (fixed dose).

Sponsors & Collaborators

  • Philogen S.p.A.

    lead INDUSTRY

Principal Investigators

  • Claus Garbe, Prof. M.D. · University Hospital Tuebingen (Germany)

  • Michele Maio, Dr.med. · Azienda Ospedaliera Universitaria Senese, Siena (Italy)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2016-05-17
Completion
2022-06-30

Countries

  • Germany
  • 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 NCT02076646 on ClinicalTrials.gov