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Monoclonal Antibodies

Avelumab and Radical radiotherapy for Squamous Cell Carcinoma (UNSCARRed Trial)

Phase 2

Waitlist Available

Led By John Walker, Walker

Research Sponsored by AHS Cancer Control Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up delegated study personnel will assess the patients for adverse events at baseline through to study completion per protocol (baseline, cycles 1-5 (each cycle is 14 days), and in follow up at 30 days, 90 days and every 12 weeks up to 2 years).

Awards & highlights

UNSCARRed Trial Summary

This trial is studying the effectiveness of radiation therapy combined with immunotherapy using the drug Avelumab to treat squamous cell carcinoma.

Eligible Conditions

Skin Squamous Cell Carcinoma

UNSCARRed Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ delegated study personnel will assess the patients for adverse events at baseline through to study completion per protocol (baseline, cycles 1-5 (each cycle is 14 days), and in follow up at 30 days, 90 days and every 12 weeks up to 2 years).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~delegated study personnel will assess the patients for adverse events at baseline through to study completion per protocol (baseline, cycles 1-5 (each cycle is 14 days), and in follow up at 30 days, 90 days and every 12 weeks up to 2 years).

This trial's timeline: 3 weeks for screening, Varies for treatment, and delegated study personnel will assess the patients for adverse events at baseline through to study completion per protocol (baseline, cycles 1-5 (each cycle is 14 days), and in follow up at 30 days, 90 days and every 12 weeks up to 2 years). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective response rate (assessing change in tumour response before treatment vs after)

Secondary outcome measures

Clinical and pathological response rate

Progression-free survival

Safety analysis: CTCAE v.4.03

Other outcome measures

Characterization of tumoral MHC-I/II expression/ Analysis of MHC immunopeptidomes

Patient-reported quality of life: Brief Older People's Quality of Life questionnaire (OPQOL-brief)

Quantification/characterization of tumor-infiltrating lymphocytes/PBMCs

+1 more

UNSCARRed Trial Design

1Treatment groups

Experimental Treatment

Group I: Avelumab and Radical radiotherapyExperimental Treatment1 Intervention

Single-arm combining Avelumab with radical radiotherapy.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

EMD SeronoIndustry Sponsor

143 Previous Clinical Trials

27,181 Total Patients Enrolled

Alberta Cancer FoundationOTHER

17 Previous Clinical Trials

5,613 Total Patients Enrolled

AHS Cancer Control AlbertaLead Sponsor

182 Previous Clinical Trials

36,192 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential risks could be associated with combining Avelumab and Radical radiotherapy?

"Although there is limited clinical evidence indicating its efficacy, avelumab and radical radiotherapy were awarded a score of 2 as prior research has demonstrated their safety."

Answered by AI

Is this research endeavor actively searching for participants?

"Affirmative. Clinicaltrials.gov confirms that this clinical research, initially posted on April 12th 2019, is presently searching for suitable candidates. Approximately 20 patients need to be recruited from 2 distinct medical centres."

Answered by AI

What is the upper-limit of participants in this clinical investigation?

"Affirmative. Clinicaltrials.gov provides information that this medical trial is presently enrolling patients, having been first posted on April 12th 2019 and last updated on January 11th 2021. The study requires 20 people to participate at two different locations."

Answered by AI

Are there any documented precedents of Avelumab and Radical radiotherapy being employed in medical trials?

"Presently, 112 exploratory studies are underway to assess the efficacy of Avelumab and Radical radiotherapy. 10 of these trials have reached Phase 3 status while there exist 3655 sites around the world running tests on this therapy. Most notably, Barcelona and South dakota are currently conducting a large number of such examinations."

Answered by AI

Is this clinical experiment a groundbreaking new endeavor?

"Already in 2014, experiments regarding the efficacy of Avelumab and Radical radiotherapy commenced. Initially sponsored by EMD Serono Research & Development Institute, Inc., a Phase 1 clinical trial was conducted on 204 patients which lead to its subsequent approval for use in phase 2 trials. Presently, 112 studies are being conducted worldwide across 1024 cities within 52 different nations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2019. "The UNSCARRed Study: UNresctable Squamous Cell Carcinoma Treated With Avelumab and Radical Radiotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03737721.

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