EUCTR2017-003582-10-IT
Active, Not Recruiting
Phase 1
PHASE II STUDY OF PREOPERATIVE CHEMORADIOTHERAPY PLUS AVELUMAB IN PATIENTS WITH LOCALLY ADVANCED RECTAL CANCER - AVANA
G.O.N.O. - GRUPPO ONCOLOGICO DEL NORD OVEST0 sites101 target enrollmentJune 17, 2021
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- ocally advanced rectal cancer
- Sponsor
- G.O.N.O. - GRUPPO ONCOLOGICO DEL NORD OVEST
- Enrollment
- 101
- Status
- Active, Not Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Locally advanced, resectable disease defined by the presence of at least one of the following features:
- •cN\+, cT4, high risk cT3 (according to magnetic resonance imaging \[MRI] criteria);
- •distal tumor margin at \< 12 cm from the anal verge;
- •no evidence of metastatic disease by computed tomography (CT) scan of the chest and abdomen and total body FDG\-PET/CT scan;
- •tumor must be amenable to curative resection;
- •no history of invasive rectal malignancy;
- •no other rectal cancers (i.e., sarcoma, lymphoma, carcinoid, squamous cell carcinoma, or cloacogenic carcinoma) or synchronous colon cancer;
- •available tumor samples at baseline (archival biopsy) and after chemoradiotheraphy \+ avelumab.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
Exclusion Criteria
- •Previous therapy with any antibody or drug targeting T cell coregulatory proteins, or immunosuppressive agents;
- •previous pelvic RT;
- •active autoimmune disease;
- •current use of immunosuppressive medication, EXCEPT for the following: a. Intranasal, inhaled, topical steroids, or local steroids injection (e.g. intra\- articular injection); b. Systemic corticosteroids at physiologic doses \= 10 mg/day of prednisone or equivalent, steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication);
- •prior organ transplantation;
- •known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS);
- •hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening;
- •vaccination within 4 weeks of the first dose of avelumab and while on trials is prohibited except for administration of inactivated vaccines.
Outcomes
Primary Outcomes
Not specified
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