NCT06428487

Neoadjuvant Prolgolimab Monotherapy in Locally Advanced MMR-deficient Colorectal Cancer

Phase II,Open-label, Non-randomized Study of Neoadjuvant Prolgolimab Monotherapy in Patients With Locally Advanced Colorectal Cancer With Microsatellite Instability (MSI)/Mismatch Repair (dMMR) Deficiency

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Blokhin's Russian Cancer Research Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this phase II study patients with stage II-III MSI/dMMR colorectal adenocarcinoma with no signs of distant metastases will be treated with immunotherapy (prolgolimab). The duration of treatment is 6 months (12 cycles)

Detailed description

In this open-label phase II non-randomized study the investigators will enroll 30 patients with stage II-III MSI/dMMR colorectal cancer to receive anti-PD1 inhibitor prolgolimab. Patients will be treated with 12 cycles (6 months) of prolgolimab 1 mg/kg every 2 weeks until surgery.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Prolgolimab	Prolgolimab infusions 1 mg/kg

Timeline

• Start date: 2022-03-31
• Primary completion: 2024-12-31
• Completion: 2025-06-30
• First posted: 2024-05-24
• Last updated: 2024-05-24

Locations

1 site across 1 country: Russia