Phase II study of Durvalumab (MEDI4736) plus Total Neoadjuvant Therapy (TNT) in locally advanced rectal cancer (The DUREC trial)

Grupo Espanol Multidisciplinar En Cancer Digestivo10 sites in 1 country60 target enrollmentNovember 15, 2024

DrugsOXALIPLATIN MEDI4736 FLUOROURACIL 5-FU 5-FLOUROURACIL LEUCOVORIN CALCIUM DURVALUMAB CAPECITABINE 5-FLUOROURACIL 5-FLUORO-1H-PYRIMIDINE-2,4-DIONE CALCIUM FOLINATE

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Not specified
Sponsor: Grupo Espanol Multidisciplinar En Cancer Digestivo
Enrollment: 60
Locations: 10
Primary Endpoint: 1) Pathological complete response (pCR) rate.
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Pathological complete response (pCR) rate.

Registry

euclinicaltrials.eu

Start Date

November 15, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

Grupo Espanol Multidisciplinar En Cancer Digestivo

Responsible Party

Principal Investigator

Coordinator investigator

Scientific

Grupo Espanol Multidisciplinar En Cancer Digestivo

Eligibility Criteria

Inclusion Criteria

•Written informed consent obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
•Adequate normal organ and marrow function
•Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients
•Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
•Age ≥ 18 years at time of study entry.
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
•Body weight >30kg.
•Biopsy-proven, newly diagnosed primary rectal adenocarcinoma, with the lowest part of the tumour less than 12 cm from the anal verge using a rigid rectoscope or flexible endoscope.
•MSS (microsatellite stable) rectal cancer assessed by local practice (immunohistochemistry or PCR).
•Mandatory tumour and blood samples for translational research.

Exclusion Criteria

•Participation in another clinical study with an investigational product during the last 6 months.
•Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab.
•Mean QT interval corrected for heart rate (QTc) ≥470 ms calculated from 3 electrocardiograms (ECGs) using Fridericia’s Correction.
•Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid.
•Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
•Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
•Previous radiotherapy in the pelvic region (e.g. prostate) or previous rectal surgery (e.g.TEM).
•History of allogenic organ transplantation.
•Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]).
•Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.