Camrelizumab Plus Anlotinib in Patients With Recurrent Sporadic MMRd Endometrial Cancer

Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study ID
NCT05550558
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Nov 1, 2022
Status verified
Apr 2022
Primary completion
Nov 30, 2025
Completion
Nov 30, 2027

Study Design

Enrollment
43 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Anlotinib + Camrelizumab
    Anlotinib 12 mg QD p.o for 2 weeks and then stop for 1 week plus Camrelizumab 200 mg (fixed dose) IV every 3 weeks (+/- 3 days) until progression or adverse effects prohibit therapy

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: 24 months ]

Central Contacts

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