A Study of mDCF in Combination or Not With Atezolizumab in Advanced Squamous Cell Anal Carcinoma

Summary

SCARCE is a non-comparative randomized, 2:1 phase II study. The purpose of this study is to assess the progression-free survival rate at 12 months. (evaluation according with RECISTv1.1 criteria). For all patients, CT scan will be planned at baseline, and every 8 weeks until 12 months from randomization (or disease progression), and every 12 weeks thereafter. PET scan will be performed at baseline, at the end of mDCF treatment, and at 12 months after randomization (in absence of disease progression). CT scan and PET scan will be collected for a centralized review.

Timeline

Start

2018-07-03

Primary completion

2023-02-07

Completion

2023-09-20

Outcome

Missed primary endpoint

paper although the primary efficacy endpoint was not met. PMID 38547895 ↗

Publications

• Kim S, Ghiringhelli F, de la Fouchardiere C, Evesque L, Smith D, Badet N, Samalin E, Lopez-Trabada Ataz D, Parzy A, Desrame J, Baba Hamed N, Buecher B, Tougeron D, Bouche O, Dahan L, Chibaudel B, El Hajbi F, Mineur L, Dubreuil O, Ben Abdelghani M, Pecout S, Bibeau F, Herfs M, Garcia ML, Meurisse A, Vernerey D, Taieb J, Borg C. Atezolizumab plus modified docetaxel, cisplatin, and fluorouracil as first-line treatment for advanced anal cancer (SCARCE C17-02 PRODIGE 60): a randomised, non-comparative, phase 2 study. Lancet Oncol. 2024 Apr;25(4):518-528. doi: 10.1016/S1470-2045(24)00081-0.
• Kim S, Buecher B, Andre T, Jary M, Bidard FC, Ghiringhelli F, Francois E, Taieb J, Smith D, de la Fouchardiere C, Desrame J, Samalin E, Parzy A, Baba-Hamed N, Bouche O, Tougeron D, Dahan L, El Hajbi F, Jacquin M, Rebucci-Peixoto M, Spehner L, Vendrely V, Vernerey D, Borg C. Atezolizumab plus modified docetaxel-cisplatin-5-fluorouracil (mDCF) regimen versus mDCF in patients with metastatic or unresectable locally advanced recurrent anal squamous cell carcinoma: a randomized, non-comparative phase II SCARCE GERCOR trial. BMC Cancer. 2020 Apr 25;20(1):352. doi: 10.1186/s12885-020-06841-1.

Drugs

Indications