Immunotherapy followed by Epidermal Growth Factor Receptor (EGFR) in Locally advanced or metastatic squamous cell cancer of the skin: tackling ineffectiveness of drugs

Phase 1

• Conditions: Patient with Locally Advanced Or Metastatic Squamous Cell Cancer Of The Skin; MedDRA version: 21.1Level: PTClassification code 10041834Term: Squamous cell carcinoma of skinSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2017-003765-10-IT
• Lead Sponsor: FONDAZIONE IRCCS ISTITUTO NAZIONALE DEI TUMORI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-17
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

1.Have histological diagnosis of squamous cell carcinoma of the skin not amenable to surgical treatment and to radiation with curative purposes or with clinical contraindication to surgery and radiation. Hereafter the possible clinical situations matching these criteria. A multidisciplinary evaluation with surgeon, radiation oncologist and medical oncologist is required to be performed:
¿ skin SCC that has recurred in the same location after two or more surgical procedures and curative resection is deemed unlikely; the tumor is not amenable to radiation as it has been already performed or it is not considered effective
anticipated substantial morbidity and/or deformity from surgery (e.g., removal of all or part of a facial structure, such as nose, ear, eyelid, eye; or requirement for limb amputation); radiation therapy is similarly not indicated due to anticipated morbidity and/or deformity
¿ anticipated difficulty in obtaining a curative resection or a curative radiation due to the location of the tumor, the size of disease
¿ anticipated difficulty in reconstructing the area that will be surgically removed
¿ significant comorbidities that preclude the feasibility of a radical surgery
¿ contraindication to radiotherapy:
a) previous radiation therapy administered to the area of disease
b) site of previous burns
c) areas of vascular insufficiency
d) skin areas which lead to compromised healing or increased risk of late skin necrosis (e.g.: skin of the back overlying the spine; skin overlying the shin and malleoli of the lower leg)
e) patients with ataxia telangiectasia or with xeroderma pigmentosus
f) other contraindications according to physician’s judgement (to be reported in clinical chart)
OR
Have metastatic disease
2.Have measurable disease based on RECIST 1.1.
3.Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on Day 1. Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the Sponsor.
4.Have a performance status of 0 or 1 on the ECOG Performance Scale.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 33
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1.Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
2.Previous treatment with anti-EGFR agent
3.Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (prednisone equivalent dose > 10 mg per day) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
4.Has a known history of active TB (Bacillus Tuberculosis)
5.Has previously received an organ transplant
6.Has previously received bone marrow transplantation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified