Durvalumab (MEDI4736) Plus Total Neoadjuvant Therapy (TNT) in Locally Advanced Rectal Cancer
Status:
Recruiting
Trial end date:
2025-03-01
Target enrollment:
Participant gender:
Summary
The addition of durvalumab to total neoadjuvant therapy (TNT) in locally advanced rectal
cancer may improve the pathological complete response rate. The induction platinum-based
chemotherapy may increase the neoantigen formation together with the chemoradiotherapy
period. Starting durvalumab during the first chemotherapy session and continuing during the
6-week period of chemoradiotherapy could change and create the needed environment to increase
the efficacy of durvalumab in this setting. Additionally, the 8-12 week rest period from the
end of the chemoradiotherapy and the radical surgery, treatment with durvalumab may continue
improving the response and outcome of patients without jeopardizing the surgery (which needs
this period out of chemotherapy and radiotherapy to avoid postoperative complications, but
not for anti-PDL-1 therapy).
Patients will be included following inclusion/exclusion criteria in a prospective,
non-randomized, open label, single arm phase II study to receive 6 cycles of mFOLFOX6
(oxaliplatin, leucovorin and fluorouracil) followed by long course chemoradiotherapy (50.4 Gy
together with capecitabine) followed by surgery. Patients will receive durvalumab 1500 mg
every 4 weeks during induction chemotherapy, chemoradiotherapy and waiting period until
surgery.
Phase:
Phase 2
Details
Lead Sponsor:
Grupo Espanol Multidisciplinario del Cancer Digestivo
Collaborators:
AstraZeneca Vall d'Hebron Institute of Oncology (VHIO)