Efficacy of Daromun Neoadjuvant Intratumoral Treatment in Clinical Stage IIIB/C/D Melanoma Patients

Conditions

• Melanoma Stage IIIB
• Melanoma Stage IIIC
• Melanoma Stage IIID

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Daromun — DRUG
  Patients will receive intratumoral administrations into injectable cutaneous, subcutaneous, and nodal tumors of Daromun once weekly for up to 4 weeks.
• Surgery — PROCEDURE
  Patients will receive surgery.
• Adjuvant therapy — DRUG
  Patients will receive adjuvant therapy at the investigator's discretion following the surgery.

Study Details

The trial aims to evaluate the efficacy of Daromun neoadjuvant treatment followed by surgery and adjuvant therapy to improve in a statistically significant manner the recurrence-free survival (RFS) of Stage IIIB/C/D melanoma patients with respect to the standard of care (surgery and adjuvant therapy).

Key Dates

Start date

Sep 20, 2018

Status verified

Dec 2025

Primary completion

Dec 31, 2027

Completion

Dec 31, 2031

Study Design

Enrollment

186 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Daromun plus Surgery and Adjuvant therapy
  Arm-1 patients will follow these steps: 1. screening period, 2. 4-week open-label treatment period, 3. surgery within a maximum of 4 weeks, 4. adjuvant therapy.
• Active Comparator: Surgery and adjuvant therapy
  Arm-2 patients will follow these steps: 1. Screening period, 2. direct surgery within 4 weeks from randomization, 3. adjuvant therapy.

Primary Outcome Measure

Recurrence Free Survival (RFS) [ Time Frame: From date of randomization until the date of the first recurrence or date of death from any cause, whichever occurs first assessed up to 60 months. ]

Central Contacts

• Sheila Dakhel, PhD
  +41 (0) 43 544 88 02
  [email protected]
• Concetta Aulicino
  +39 0577 17 816
  [email protected]

Locations (19)

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