Actively Recruiting
Neo-adjuvant Pembrolizumab and Radiotherapy in Localised MSS Rectal Cancer
Led by University Hospital, Geneva · Updated on 2021-09-30
25
Participants Needed
1
Research Sites
404 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Neo-adjuvant Pembrolizumab and Radiotherapy in Localised MSS Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 18 years or older with confirmed rectal adenocarcinoma
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Patients with previously untreated localized T3-T4 N0 or T any or N1-2, M0 rectal adenocarcinoma
- Tumor must be microsatellite stable (MSS)
- Recommendation by a multi-disciplinary tumor board for neo-adjuvant short course radiotherapy and surgery
- Provision of archival or newly obtained tumor tissue sample, preferably formalin-fixed paraffin embedded (FFPE) blocks
- Adequate organ function as defined and specimens collected within 10 days before study treatment start
You will not qualify if you...
- Presence of microsatellite instable tumor (MSI-High)
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2 agents, or other stimulatory/co-inhibitory T-cell receptor agents
- Prior systemic anti-cancer therapy or investigational agents for the same disease before pembrolizumab
- Prior radiotherapy for the same disease; recovery required if prior radiotherapy for another disease
- Receipt of live vaccines within 30 days before first study drug dose
- Participation in another investigational study or use of investigational device within 4 weeks before first study drug dose
- Diagnosis of immunodeficiency or use of systemic steroid therapy over 10 mg prednisone daily within 7 days before first drug dose
- Known progressing additional malignancy requiring active treatment within past 3 years (except certain skin or in situ cancers)
- Known active CNS metastases or carcinomatous meningitis without stable status
- Severe hypersensitivity (Grade 3 or higher) to pembrolizumab or its excipients
- Active autoimmune disease requiring systemic treatment in past 2 years
- History of pneumonitis requiring steroids or current pneumonitis
- Active infection requiring systemic therapy
- Known history of HIV, active Hepatitis B or C infection
- Known history of active tuberculosis
- Conditions or therapies that may interfere with study results or participation
- Psychiatric or substance abuse disorders interfering with trial cooperation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hôpitaux Universitaires de Genève
Geneva, Switzerland, 1205
Actively Recruiting
Research Team
T
Thibaud Kössler, MD PhD
CONTACT
S
Sandra Bettinelli Riccardi, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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