NCT03666325 (I-Tackle) is a Phase 2 clinical trial of Pembrolizumab in Skin Neoplasm, sponsored by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano.

Who is sponsoring NCT03666325?

NCT03666325 is sponsored by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano.

What drugs are being tested in NCT03666325?

Interventions in NCT03666325: Pembrolizumab, Cetuximab.

What condition does NCT03666325 study?

NCT03666325 studies Skin Neoplasm.

Is NCT03666325 still recruiting?

NCT03666325 is currently status unknown. Last updated 11 September 2018.

Last reviewed 2018-09-11 · How we verify

NCT03666325: I-Tackle

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Immunotherapy +/- EGFR Inhibitor In Advanced/Metastatic cSCC: Tackling Primary And Secondary Resistance

Status unknown Phase 2 Last updated 11 September 2018

What this trial tests

Phase 2 trial testing Pembrolizumab in Skin Neoplasm in 43 participants. Status unknown.

Timeline

1 October 2018

Primary endpoint
1 October 2020

1 October 2022

Quick facts

Lead sponsor	Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	43
Start date	1 October 2018
Primary completion	1 October 2020
Estimated completion	1 October 2022
Sites	7 locations across Italy

Drugs / interventions tested

Pembrolizumab (pembrolizumab) — full drug profile →
Cetuximab (cetuximab) — full drug profile →

Conditions studied

Skin Neoplasm — all drugs for Skin Neoplasm →

Sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano — full company profile →

Who can join

18 and older, any sex, with Skin Neoplasm. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Cutaneous Squamous Cell Cancer (Cscc, 25%) and basal cell carcinoma (BCC; 75%) are the major subtypes of non-melanoma skin cancer. Most cSCC arise in the head and neck region because it is frequently exposed to sunlight and its ensuing UV radiation-induced DNA damage, which is the major etiologic factor. There is an urgent need to identify new therapeutic targets for patients with locally advanced or metastatic squamous Cell Cancer of the skin. Substantial progress has recently been made in the development of immunotherapy for the treatment of cancer. In particular, the treatment with pembrolizumab alone or in conjunction with an anti epidermal growth factor receptor (EGFR) agent may reverse this condition, so performing radical surgery. Finally, the adjunct of an anti EGFR agent as cetuximab could reverse the primary and secondary resistance to pembrolizumab, with a synergistic effect able to counteract pathway redundancy (i.e. the presence of several concurrent pathways which need to be addressed together) and boosting T cell priming. Hence, there is rationale to combine cetuximab with pembrolizumab in order to increase its effectiveness.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Skin cancer: understanding the journey of transformation from conventional to advanced treatment approaches.
Hasan N, Nadaf A, Imran M, Jiba U, et al · · 2023 · cited 117× · PMID 37803407 · DOI 10.1186/s12943-023-01854-3
Update in the treatment of non-melanoma skin cancers: the use of PD-1 inhibitors in basal cell carcinoma and cutaneous squamous-cell carcinoma.
Ascierto PA, Schadendorf D. · · 2022 · cited 39× · PMID 36455990 · DOI 10.1136/jitc-2022-005082
Cutaneous Squamous Cell Carcinoma: An Updated Review.
Jiang R, Fritz M, Que SKT. · · 2024 · cited 36× · PMID 38791879 · DOI 10.3390/cancers16101800
Immunotherapy for the Treatment of Cutaneous Squamous Cell Carcinoma.
Boutros A, Cecchi F, Tanda ET, Croce E, et al · · 2021 · cited 28× · PMID 34513710 · DOI 10.3389/fonc.2021.733917
Immune Checkpoint Inhibition in Non-Melanoma Skin Cancer: A Review of Current Evidence.
Stonesifer CJ, Djavid AR, Grimes JM, Khaleel AE, et al · · 2021 · cited 25× · PMID 34988009 · DOI 10.3389/fonc.2021.734354
Immunotherapy for Cutaneous Squamous Cell Carcinoma: Results and Perspectives.
Alberti A, Bossi P. · · 2021 · cited 24× · PMID 35070956 · DOI 10.3389/fonc.2021.727027
Clinical application of immunogenic cell death inducers in cancer immunotherapy: turning cold tumors hot.
Han Y, Tian X, Zhai J, Zhang Z. · · 2024 · cited 20× · PMID 38774648 · DOI 10.3389/fcell.2024.1363121
Immune Checkpoint Inhibitors in Advanced Cutaneous Squamous Cell Carcinoma: Real-World Experience from a Canadian Comprehensive Cancer Centre.
Koch Hein EC, Vilbert M, Hirsch I, Fernando Ribeiro M, et al · · 2023 · cited 14× · PMID 37686588 · DOI 10.3390/cancers15174312

Verify or expand the search:

Other trials of Pembrolizumab

Trials testing the same drug.

NCT07572123 — Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem · Phase 2, PHASE3 · not yet recruiting
NCT07275216 — Pembrolizumab in Combination With Chemotherapy for the Treatment of Frail Hodgkin Lymphoma Patients Ineligible for Stand · Phase 2 · not yet recruiting
NCT07302347 — A Study of Pembrolizumab in Japanese Pediatric Participants With Solid Tumors or Lymphomas and Japanese Adult Participan · Phase 1, PHASE2 · recruiting
NCT06724042 — Study of ISM5939 in Patients With Advanced and/or Metastatic Solid Tumors · Phase 1 · not yet recruiting
NCT07383441 — Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer · Phase 3 · not yet recruiting

Other recruiting trials for Skin Neoplasm

Currently open trials in the same condition.

NCT07213154 — Optical Imaging Scans for the Diagnosis of Skin Cancer in Patients With Lesions · NA · recruiting
NCT07062003 — Minibeam Radiation Therapy With Tungsten Slit Collimator for the Treatment of Recurrent or Metastatic Skin or Soft Tissu · NA · recruiting

Other Fondazione IRCCS Istituto Nazionale dei Tumori, Milano trials

Trials by the same sponsor.

NCT06799624 — Prognostic Role of molEcular classiFication in Fertility-sparing treAtment of Endometrial canCEr · not yet recruiting
NCT07253402 — Microbiota-guided Radiotherapy for Head and Neck Cancer · recruiting
NCT06938724 — Omission of Local Therapies in Women Patients With HER2-positive or Triple-negative Breast Cancer · Phase 2 · recruiting
NCT06999824 — Revisiting the Concept of Nerve Sparing Radical Hysterectomy · not yet recruiting
NCT06986486 — Liver Transplantation for Unresectable Perihilar Cholangiocarcinoma · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03666325 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Last refreshed: 11 September 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03666325.

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