NCT03944941 is a Phase 2 clinical trial of Avelumab in Skin Squamous Cell Carcinoma, sponsored by Alliance for Clinical Trials in Oncology.

Who is sponsoring NCT03944941?

NCT03944941 is sponsored by Alliance for Clinical Trials in Oncology.

What drugs are being tested in NCT03944941?

Interventions in NCT03944941: Avelumab, Cetuximab.

What condition does NCT03944941 study?

NCT03944941 studies Skin Squamous Cell Carcinoma, Metastatic Skin Cancer.

Is NCT03944941 still recruiting?

NCT03944941 is currently active, enrolled. Last updated 5 February 2026.

Last reviewed 2026-02-05 · How we verify

NCT03944941

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

Avelumab With or Without Cetuximab in Treating Patients With Advanced Skin Squamous Cell Cancer

Active, enrolled Phase 2 Last updated 5 February 2026

What this trial tests

Phase 2 trial testing Avelumab in Skin Squamous Cell Carcinoma in 60 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

17 June 2019

Primary endpoint
26 February 2025

1 December 2028

Quick facts

Lead sponsor	Alliance for Clinical Trials in Oncology
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	17 June 2019
Primary completion	26 February 2025
Estimated completion	1 December 2028
Sites	428 locations across United States

Drugs / interventions tested

Avelumab (avelumab) — full drug profile →
Cetuximab (cetuximab) — full drug profile →

Conditions studied

Skin Squamous Cell Carcinoma — all drugs for Skin Squamous Cell Carcinoma →
Metastatic Skin Cancer — all drugs for Metastatic Skin Cancer →

Sponsor

Alliance for Clinical Trials in Oncology

Who can join

18 and older, any sex, with Skin Squamous Cell Carcinoma or Metastatic Skin Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase II trial studies how well avelumab with or without cetuximab work in treating patients with skin squamous cell cancer that has spread to other places in the body. Immunotherapy with monoclonal antibodies, such as avelumab and cetuximab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Publications & conference data

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

Cutaneous Squamous Cell Carcinoma: From Biology to Therapy.
Corchado-Cobos R, García-Sancha N, González-Sarmiento R, Pérez-Losada J, et al · · 2020 · cited 137× · PMID 32331425 · DOI 10.3390/ijms21082956
Metastatic disease in head & neck oncology.
Pisani P, Airoldi M, Allais A, Aluffi Valletti P, et al · · 2020 · cited 128× · PMID 32469009 · DOI 10.14639/0392-100x-suppl.1-40-2020
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
Cetuximab is efficient and safe in patients with advanced cutaneous squamous cell carcinoma: a retrospective, multicentre study.
Montaudié H, Viotti J, Combemale P, Dutriaux C, et al · · 2020 · cited 45× · PMID 32064041 · DOI 10.18632/oncotarget.27434
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
Neoadjuvant Therapy for Non-melanoma Skin Cancer: Updated Therapeutic Approaches for Basal, Squamous, and Merkel Cell Carcinoma.
Zelin E, Zalaudek I, Agozzino M, Dianzani C, et al · · 2021 · cited 30× · PMID 33725197 · DOI 10.1007/s11864-021-00826-3
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

Verify or expand the search:

Other trials of Avelumab

Trials testing the same drug.

NCT06939036 — Study of 225Ac-SS0110 in Subjects With ES-SCLC or MCC (SANTANA-225 ) · Phase 1, PHASE2 · terminated
NCT05687721 — Copanlisib and Avelumab as a Maintenance Therapy for Advanced Bladder Cancer · Phase 1, PHASE2 · withdrawn
NCT06518564 — Avelumab and M1774 in ARID1A-mutated Endometrial Cancer · Phase 2 · recruiting
NCT06424717 — Study of Avelumab and Tuvusertib in Participants With Advanced Urothelial Cancer That Has Progressed on Prior Anti-PD-(L · Phase 2 · withdrawn
NCT06302426 — Trial of INI-4001 in Patients With Advanced Solid Tumours · Phase 1 · recruiting

Other recruiting trials for Skin Squamous Cell Carcinoma

Currently open trials in the same condition.

NCT07144384 — Intratumoral Injection of Standard Universal Donor Expanded Natural Killer Cells and TGF-beta Imprinted Natural Killer C · EARLY_PHASE1 · recruiting
NCT06223659 — EMLA Topical Cream for Treatment of Pain in Patients Receiving Intra-Dermal Technetium 99 Injections for Lymphoscintigra · Phase 2 · recruiting
NCT05269381 — Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab for Treatment of Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
NCT02978625 — Talimogene Laherparepvec and Nivolumab in Treating Patients With Refractory Lymphomas or Advanced or Refractory Non-mela · Phase 2 · active not recruiting

Other Alliance for Clinical Trials in Oncology trials

Trials by the same sponsor.

NCT07293247 — A Study of Targeted Post-Surgery Radiation Therapy for Non-Small Cell Lung Cancer With Remaining Lymph Node Cancer After · Phase 2 · not yet recruiting
NCT07283939 — Studying the PAGODA Algorithm for Chemotherapy Dose Changes to Prevent Unplanned Treatment Delays · NA · recruiting
NCT07059884 — Distance-Based Exercise to Preserve Function and Prevent Disability · NA · recruiting
NCT07321652 — Testing the Addition of Anti-Cancer Drug Sonrotoclax, to the Standard Treatment Zanubrutinib, for Previously Untreated C · Phase 3 · not yet recruiting
NCT07091617 — Testing an Enhanced Digital Delivery Model for Inherited Cancer Genetic Testing in Young Adults With Cancer · NA · 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 NCT03944941 (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 Alliance for Clinical Trials in Oncology
Last refreshed: 5 February 2026

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/NCT03944941.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing