Patients with clinical stage II-III dMMR/MSI colorectal adenocarcinoma will be treated with low-dose immunotherapy: nivolumab 100 mg or pembrolizumab 100 mg. The duration of treatment is 6 months.
Patients with clinical high risk stage II (T3 with extramural extension ≥ 5mm or T4), stage III dMMR/MSI CRC will be treated with low-dose immunotherapy: nivolumab 100 mg every 2 weeks or pembrolizumab 100 mg every 4 weeks, then will be underwent surgery after 6 months of immunotherapy. Pts who refuse surgery and/or in case of complete clinical response (cCR) will continue therapy up to 1 year.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Nivolumab 100 mg infusion
Pembrolizumab 100 mg infusion
N.N. Blokhin NMRCO
Moscow, Russia
Complete response (pathological complete response - pCR + durable clinical complete response - cCR)
pCR: absence of malignant cells on the specimen of colon/rectal resection in patients who were previously treated with neoadjuvant immunotherapy cCR: absence of detectable tumor via endoscopy and MRI up to 6 months
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
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
Incidence of Adverse Events assessed according to CTCAE version 5
Time frame: up to 6 months
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