NCT03737721: UNSCARRed

The UNSCARRed Study: UNresctable Squamous Cell Carcinoma Treated With Avelumab and Radical Radiotherapy

Terminated Phase 2 Last updated 27 June 2025

What this trial tests

Phase 2 trial testing Avelumab and Radical radiotherapy in Squamous Cell Carcinoma of the Skin in 8 participants. Terminated before completion.

Timeline

12 April 2019

Primary endpoint
15 July 2024

15 July 2024

Quick facts

Lead sponsor	AHS Cancer Control Alberta
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	8
Start date	12 April 2019
Primary completion	15 July 2024
Estimated completion	15 July 2024
Sites	2 locations across Canada

Drugs / interventions tested

• Avelumab and Radical radiotherapy

Conditions studied

• Squamous Cell Carcinoma of the Skin — all drugs for Squamous Cell Carcinoma of the Skin →

Sponsor

AHS Cancer Control Alberta — full company profile →

Who can join

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

Sponsor's own description

The purpose of this study is to find out what effects the combination of radiation therapy and Avelumab have on you and your cancer. The effectiveness of this treatment as well as what side effects occur will both be studied.

Squamous cell carcinoma of the skin is the most commonly diagnosed cancer. Risk factors for the development of squamous cell cancer include ultraviolet (sun) exposure, as well as increasing age. In the majority of instances, a minor surgical procedure is curative. Less commonly, squamous cell carcinoma cannot be removed surgically, due to the location and/or extent of the cancer, or due to patient-specific factors which would make surgery unsafe (for instance, the presence of unrelated medical illnesses such as heart disease or stroke).

When squamous cell carcinoma cannot be removed surgically, radiation therapy may serve as an effective alternative treatment. Squamous cell carcinomas are typically very sensitive to radiation, and in some instances radiation therapy may also cure a person of their cancer.

While some people may be cured by radiation therapy, not all people are. This study is investigating the combination of radiation therapy and immune therapy. When given together, more patients may be cured of their cancer.

Immune therapy is effective for the treatment of squamous cell carcinoma. In clinical trials, more than half of patients benefit from immune therapy. Immune therapy is not chemotherapy. Instead, immune therapy involves the infusion of antibodies which target a person's own immune system. Immune therapy "re-activates" a person's own immune system against their cancer.

The treatment offered within this clinical trial includes daily radiation treatments as well as immunotherapy treatments administered once every two weeks. The immunotherapy in use is a drug called Avelumab, which is an antibody that helps your body's immune system fight cancer.

Health Canada, the regulatory body that oversees the use of natural health products, drugs and devices in Canada, has not approved the sale or use of this product to treat this kind of cancer, although they have allowed its use in this study

Publications & conference data

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

1. 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
2. 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
3. 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
4. Identifying Candidates for Immunotherapy among Patients with Non-Melanoma Skin Cancer: A Review of the Potential Predictors of Response.
   Zelin E, Maronese CA, Dri A, Toffoli L, et al · · 2022 · cited 24× · PMID 35743435 · DOI 10.3390/jcm11123364
5. Immune Checkpoint Blockade in Advanced Cutaneous Squamous Cell Carcinoma: What Do We Currently Know in 2020?
   Wessely A, Steeb T, Leiter U, Garbe C, et al · · 2020 · cited 23× · PMID 33291277 · DOI 10.3390/ijms21239300
6. 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
7. The Role of Radiation Therapy in the Treatment of Non-Melanoma Skin Cancer.
   Yosefof E, Kurman N, Yaniv D. · · 2023 · cited 14× · PMID 37173875 · DOI 10.3390/cancers15092408
8. Overcoming Resistance to Immunotherapy in Advanced Cutaneous Squamous Cell Carcinoma.
   García-Sancha N, Corchado-Cobos R, Bellido-Hernández L, Román-Curto C, et al · · 2021 · cited 14× · PMID 34680282 · DOI 10.3390/cancers13205134