Phase II Nivolumab Trial for Metastatic Colorectal and Gastric MSI/dMMR Cancers
Summary
A Phase II single-center clinical trial (NCT07542262) is registered under NIH ClinicalTrials.gov to evaluate low-dose nivolumab (40 mg) immunotherapy in patients with MSI/dMMR locally advanced colorectal and gastric cancers. The trial plans to enroll patients into subgroups receiving nivolumab alone or combined with FOLFOX chemotherapy as preoperative therapy, with primary endpoints measuring complete tumor pathomorphosis rates (pCR/TRG1) and secondary endpoints assessing safety, disease-free survival, and R0 resection rates.
What changed
A new Phase II clinical trial registration (NCT07542262) has been published on ClinicalTrials.gov, describing a single-center study evaluating low-dose nivolumab (40 mg) as preoperative immunotherapy for MSI/dMMR locally advanced colorectal and gastric cancers. The trial enrols patients into three subgroups testing nivolumab monotherapy or nivolumab combined with FOLFOX chemotherapy, with primary endpoint of complete therapeutic tumor pathomorphosis (pCR/TRG1).
For clinical investigators and oncology trial sponsors, this registration provides study design and eligibility parameters that may inform comparator-arm selection in competing or complementary dMMR/MSI immunotherapy programs. Sponsors running similar trials should review enrollment criteria and endpoint definitions for consistency with emerging standard-of-care pathways in this biomarker-defined population.
Archived snapshot
Apr 22, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Phase II Open-lable Single-center Clinical Study of the Efficacy and Safety of Low-dose Immunotherapy in the Treatment of Patients With Metastatic and Locally Advanced Colorectal and Gastric Cancers With Microsatellite Unstable Phenotype (MSI)/Deficiency of Mismatch Repair System (dMMR)
Phase 2 NCT07542262 Kind: PHASE2 Apr 21, 2026
Abstract
It is planned to study the effectiveness of low-dose immunotherapy (IT) nivolumab 40 mg for either 2 courses of therapy or 6 courses as preoperative therapy in patients with dMMR/MSI locally advanced CRC. Parallel recruitment into subgroups of patients by randomization is assumed.
For dMMR/MSI locally advanced gastric cancer, it is planned to study the effectiveness of low-dose immunotherapy nivolumab 40 mg with or without the addition of chemotherapy (CT) in the FOLFOX regimen as preoperative therapy.
Subgroup A includes 6 cycles of IV CT FOLFOX + IV administration of nivolumab 40 mg once every 14 days, subgroup B - 2 cycles of intravenous administration of nivolumab at a dose of 40 mg once every 14 days, and subgroup C - 6 cycles of intravenous administration of nivolumab at a dose of 40 mg once a day 14 days. Thus, it is planned to gradually include patients in the treatment subgroups.
The frequency of complete therapeutic tumor pathomorphoses (pCR, TRG1) will be evaluated as the primary endpoint. Secondary goals are to study the safety of drug doses, to assess the frequency of pronounced therapeutic tumor pathomorphoses (MPR, TRG 1-2), to assess disease-free survival (PFS), the frequency of R0 resections, overall survival(S), and the frequency of objective response.
To study the use of low-dose immunotherapy in combination with chemotherapy in patients with metastatic dMMR/MSI CRC and gastric cancer in the first line of therapy, it is planned to use a combination o...
Conditions: Colorectal Cancer, Gastric Cancer
Interventions: Low-dose nivolumab, Low-dose nivolumab with/without chemotherapy, Low-dose nivolumab combined with chemotherapy
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