RecruitingPhase 2NCT04109755

Neo-adjuvant Pembrolizumab and Radiotherapy in Localised MSS Rectal Cancer

A Phase II Study to Evaluate Safety and Efficacy of Neo-adjuvant Pembrolizumab and Radiotherapy in Localised MSS Rectal Cancer


Sponsor

University Hospital, Geneva

Enrollment

25 participants

Start Date

Jun 2, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

This project investigates the clinical and biological impact of combining immunotherapy (pembrolizumab) with short course radiotherapy (5Gy, five times) in the neo-adjuvant treatment of localised microsatellite stable (MSS) rectal cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding the immunotherapy drug pembrolizumab (Keytruda) to short-course radiation therapy before surgery can improve outcomes for people with rectal cancer that has specific biological features (called microsatellite stable, or MSS). This type of cancer does not usually respond well to immunotherapy on its own. **You may be eligible if...** - You are 18 years old or older - You have been diagnosed with rectal cancer (adenocarcinoma) that has not been treated yet - Your tumour is a locally advanced stage (T3-T4 or with lymph node involvement) but has not spread to distant organs - Your tumour has been confirmed to be microsatellite stable (MSS) - A specialist team has recommended short-course radiation and surgery as your treatment **You may NOT be eligible if...** - Your tumour has high microsatellite instability (MSI-High) - You have previously received any immunotherapy drugs (such as anti-PD-1 or anti-CTLA-4) - You have received prior systemic cancer treatment for rectal cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPembrolizumab

5x5 Gy radiotherapy in 1 week, 4 cycles of Pembrolizumab (200 mg every three week), surgery


Locations(1)

Hôpitaux Universitaires de Genève

Geneva, Switzerland

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NCT04109755


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