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Neo-adjuvant Pembrolizumab and Radiotherapy in Localised MSS Rectal Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

NCT04109755•University Hospital, Geneva

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male/female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of rectal adenocarcinoma will be enrolled in this study.
•Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the date of allocation.
•Patients with previously untreated localized T3-T4 N0 or T any or N1-2, M0 rectal adenocarcinoma.
•Tumour must be microsatellite stable (MSS).
•A multi-disciplinary tumour board should recommend neo-adjuvant short course radiotherapy and surgery.
•Have provided archival tumour tissue sample or newly obtained core or excisional biopsy of a tumour lesion not previously irradiated. Formalin-fixed paraffin embedded (FFPE) tissue blocks are preferred.
•Have adequate organ function as defined in the following table. Specimens must be collected within 10 days prior to the start of study treatment.

Exclusion Criteria

•Has a microsatellite instable tumour (MSI-High).
•Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
•Has received for the same disease prior systemic anti-cancer therapy including investigational agents prior to starting pembrolizumab. Note: If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment.
•Has received prior radiotherapy for the same disease. If treated with radiotherapy for another disease, participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
•Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.
•Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment. Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
•Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
•Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
•Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
•Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
+8 more criteria

Locations (1)

Hôpitaux Universitaires de Genève

Geneva, Switzerland

Key Dates

Start Date

June 2, 2020

Primary Completion Date

June 1, 2022

Completion Date

March 1, 2028

Last Updated

September 30, 2021

Enrollment

ESTIMATED participants

Conditions

Rectum CancerRectal Cancer

Interventions

Pembrolizumab

DRUG

Contacts

Thibaud Kössler, MD PhD

CONTACT

+41 (0)22 372 77 68 thibaud.kossler@hcuge.ch

Sandra Bettinelli Riccardi, PhD

CONTACT

+41223722903 Sandra.BettinelliRiccardi@hcuge.ch

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 30, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Neo-adjuvant Pembrolizumab and Radiotherapy in Localised MSS Rectal Cancer

Inclusion Criteria

Exclusion Criteria

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