The Safety and Tolerability of PD-L1 Monoclonal Antibody Plus Lenalidomide in The Treatment of Colorectal Cancer

Colorectal Neoplasms Clinical Trial

Official title: The Safety, Tolerability and Preliminary Efficacy of PD-L1 Monoclonal Antibody Combined With Lenalidomide in Third-line Post-Treatment of Patients With Microsatellite Stable Advanced Colorectal Cancer: A Phase I Clinical Study

Status Not yet recruiting

Clinical Trial Summary

This study proposed by increasing dosage and expand the "3 + 3" queue, main component is divided into two phases, phase 1 for dose escalation, according to preliminary data recommended doses starting dose of climbing, the purpose is to evaluate the safety of combination therapy, tolerance, and explore the maximum tolerated dose (MTD) and right dose recommended development stage;Phase 2 was the expansion phase. Patients were included in the expansion study according to the appropriate dose recommended in phase 1, to further evaluate the safety and tolerability of combination therapy, recommend appropriate dose for phase II clinical trial, and preliminarily explore the efficacy of combination therapy.

Clinical Trial Description

1. Phase 1 was the dose increasing phase, which was divided into three queues (A, B and C). Each team was included in the group of three people.Cohort B: pd-l1 monoclonal antibody 900mg q3w+ lenalidomide 25mg/d, administration for 21 days/discontinuation for 7 days;Cohort C: pd-l1 monoclonal antibody 20mg/kg q3w+ lenalidomide 25mg/d, administration for 21 days/discontinuation for 7 days.If none of the 3 patients in cohort A in phase 1 showed dose limited toxicity (DLT) within 21 days of their first use, they were enrolled in cohort B, and so on.If 1 of the first 3 subjects in a dose group developed DLT during the DLT observation period after the first combination administration, an additional 3 subjects were added to the dose group.If none of the additional 3 subjects developed DLT, the next incremental dose group was entered.If DLT appears in 1 or more of the additional 3 subjects, the investigator shall decide whether to adjust the regimen, or increase the regimen, or terminate the climb.If DLT appears in 2 or more subjects in the initial 3 subjects of a dose group during the observation period of the first combined DLT, the investigator shall decide whether to adjust the dosing regimen, or increase the dosing regimen, or terminate the climbing.

2. In phase 2, 24 patients will be further included under the initially determined dose level and the appropriate administration regimen. Disease control rate (DCR) will be calculated according to the data obtained in phase 1, and the group with the highest DCR dose will be selected for the expansion study. ;

Related Conditions & MeSH terms

• Colorectal Neoplasms

• NCT number: NCT04326296
• Study type: Interventional
• Source: Henan Cancer Hospital
• Contact: Ning Li, PhD
• Phone: 13526501903
• Email: lining97@126.com
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: May 30, 2020
• Completion date: March 2023