The multicenter, randomized Phase II RADIANCE trial will evaluate the efficacy of durvalumab, a PD-L1 immune checkpoint inhibitor, in combination with primary mitomycin C (MMC)/5-fluorouracil (5-FU)-based radiochemotherapy (RCT) in patients with locally advanced anal squamous cell carcinoma (ASCC).
Aim of the study
The study examines patients suffering from a malignant tumor of the anus/anus (anal carcinoma). We are conducting this study to test whether the addition of the immunotherapeutic agent durvalumab to standard radiochemotherapy can achieve a further improvement in clinical tumor response and long-term tumor control in this patient group.
Who can take part?
Patients with stage II/III anal carcinoma
Procedure
This study is a randomized study, which means that the participants are randomly assigned to one of the two treatment groups. 50% of the study participants receive the standard therapy, which consists of radiotherapy and the combined administration of chemotherapeutic agents, while the other 50% of the study participants receive the experimental therapy. In addition to the standard treatment consisting of radiotherapy and chemotherapy, they also receive the immunotherapeutic agent Durvalumab, which is administered over a maximum of 12 cycles.
Compensation
None
Original study name
Radiochemotherapy +/- durvalumab for locally advanced anal carcinoma
BASEC number
2020-01084
Financial support from
Goethe University Frankfurt