drugset / Trial / NCT05550558

Camrelizumab Plus Anlotinib in Patients With Recurrent Sporadic MMRd Endometrial Cancer

NCT05550558 ↗

Phase 2 Not yet recruiting 43 enrolled Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
NaSingle-groupOpen-labelTreatment

Summary

Patients with advanced mismatch repair-deficient (MMRd) or microsatellite instability-high (MSI-H) endometrial cancer (EC) are currently treated as one entity, and immune checkpoint inhibitor (ICI) monotherapy is the treatment of choice. However, different molecular mechanisms drive the development of dMMR/MSI-H tumors, including germline mutations in canonical MMR genes (Lynch syndrome), somatically acquired MMR gene mutations (Lynch-like), and homozygous methylation of the MLH1 gene promoter (sporadic). There is increasing evidence that patients with sporadic MMRd EC have a worse response to ICI monotherapy than those with Lynch/Lynch-like tumors. Antiangiogenic therapy can relieve immunosuppression through blood vessel normalization and the oxygen metabolism pathway, thereby having a synergistic effect with ICIs. Anlotinib is an oral anti-angiogenic tyrosine kinase inhibitor (TKI). Camrelizumab is a fully humanized, high-affinity monoclonal antibody against PD-1. The purpose of this trial is to assess the efficacy and safety and tolerability of anlotinib plus camrelizumab in recurrent EC patients with sporadic MMRd tumors.

Timeline

Start
2022-11-01
Primary completion
2025-11-30
Completion
2027-11-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Camrelizumab Monoclonal antibody 200 mg Intravenous
Subject Catequentinib Small molecule 12 mg Oral

Indications