NCT06680739

Single cEll pRofiling PErsistaNce To ImmuNothErapy

Single Cell Characterization of Persistent Cells Upon Treatment With Durvalumab (MEDI4736) With or Without Tremelimumab in MSS and MSI Colorectal and Endometrial Tumors: the SERPENTINE Clinical Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Vall d'Hebron Institute of Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The SERPENTINE trial (ESR 21-21165) is a phase II clinical study aiming to evaluate the efficacy of durvalumab and tremelimumab, alone or in combination, in patients with colorectal or endometrial cancer. The trial targets patients with microsatellite instability-high (MSI-H) tumors and those with microsatellite stable (MSS) tumors. Colorectal and endometrial cancers present significant challenges due to their heterogeneity and variable responses to treatment. Immunotherapy, particularly checkpoint inhibitors like durvalumab and tremelimumab, has shown promise in some patients, but predicting response remains elusive. The SERPENTINE trial aims to address this gap by investigating the effectiveness of these immunotherapies in a carefully selected patient population.

Detailed description

The trial is a single-center, open-label study with two cohorts: one for patients with MSI-H tumors and another for those with MSS tumors. Patients will be randomized to receive either durvalumab alone or in combination with tremelimumab. Tumor assessments will be conducted every 8 weeks using RECIST v1.1 criteria. Statistical analysis will employ descriptive statistics, and safety and efficacy data will be analyzed based on intention-to-treat principles.

Conditions

• Colorectal Cancer
• Endometrial Cancer

Interventions

Type	Name	Description
DRUG	Durvalumab	Durvalumab 1500 mg IV every 4 weeks
DRUG	Tremelimumab	Tremelimumab 300 mg IV as a single dose

Timeline

• Start date: 2022-03-01
• Primary completion: 2025-09-01
• Completion: 2025-12-01
• First posted: 2024-11-08
• Last updated: 2024-11-08

Locations

1 site across 1 country: Spain