PRODIGE 90 - (FFCD 2204) Neoadjuvant Dostarlimab with Short Course Radiotherapy in a Watch-and-wait Strategy for Microsatellite Unstable or Mismatch Repair-deficient Locally Advanced Rectal Cancer Patients

PHASE3RecruitingINTERVENTIONAL
Enrollment

68

Participants

Timeline

Start Date

February 6, 2025

Primary Completion Date

September 30, 2030

Study Completion Date

September 30, 2030

Conditions
Rectal Adenocarcinoma with Mismatch-repair Deficient (dMMR)/ Microsatellite Instability-high (MSI-H)
Interventions
RADIATION

radiotherapy

short course of radiotherapy (5 grays × 5 days)

DRUG

Dostarlimab

dostarlimab 500 mg intravenous infusion every 3 weeks for 6 months (nine cycles)

BIOLOGICAL

Biological study on circulating tumor DNA (optional for the patient)

"* Tissue collection (3 time points: baseline, w12 and 25) for:~* Exome (on tumor and normal tissue),~* 3'RNAseq,~* Hiplex Immunofluorescence~* In addition, 48 patients will be tested for Spatial transcriptomics assuming that 24 patients may have non-complete response and/or local recurrence and/or metastatic recurrence and will be paired with 24 patients with complete response and free of any disease at 2 years.~* Blood collection (5 time points: baseline, w3, 6, 12 and 24) for:~* ctDNA~* Cytokine dosage~* Proteomic analyses~* Stool collection (3 time points: baseline, w3 and 24) for:~Microbiota analyses"

Trial Locations (1)

21000

RECRUITING

CHU Dijon Bourgogne, Dijon

All Listed Sponsors
lead

Centre Hospitalier Universitaire Dijon

OTHER