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)
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Prolgolimab infusions 1 mg/kg
N.N. Blokhin NMRCO
Moscow, Russia
Pathological complete response (pCR)
Absence of malignant cells on the specimen of colon/rectal resection in patients who were previously treated with neoadjuvant immunotherapy
Time frame: up to 8 months
Durable complete clinical response rate (DRR)
a continuous response \[complete or partial objective response\] beginning within 6 months of treatment and lasting ≥6 months
Time frame: up to 12 months
Progression-free survival (PFS)
Time from initiation of treatment to the occurrence of disease progression or death.
Time frame: 12 months
Overall survival (OS)
Time from initiation of treatment to death.
Time frame: 12 months
Objective response rate (ORR)
percentage of patients who achieve a response, which can either be complete response (complete disappearance of lesions) or partial response (reduction in the sum of maximal tumor diameters by at least 30% or more)
Time frame: up to 8 months
R0 resection rate
Rate of R0 resection indicates a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed
Time frame: up to 8 months
Major pathologic response (MPR)
Rate of pathologic response TRG 1-2
Time frame: up to 8 months
Incidence of Treatment-Related Adverse Events as assessed by investigator
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Incidence of Adverse Events assessed according to CTCAE version 5
Time frame: up to 6 months