NCT02914470

Carboplatin-cyclophosphamide Combined With Atezolizumab

A Phase 1b to Assess the Safety and Tolerability of Carboplatin-cyclophosphamide Combined With Atezolizumab, an Antibody That Targets Programmed Death Ligand 1 (PD-L1), in Patients With Advanced Breast Cancer and Gynaecologic Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: The Netherlands Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single centre, 3+3, dose finding, open label, phase 1b clinical study of carboplatin and cyclophosphamide, in combination with atezolizumab.

Detailed description

The starting dose is carboplatin AUC 5mg/ml\*min, cyclophosphamide 600mg/m2 and atezolizumab 840 mg, all administered intravenously. One cycle is 28 days. On day 1 carboplatin, cyclophosphamide and atezolizumab will be administered. On day 15 atezolizumab only will be administered. Patients will be treated until loss of clinical benefit, unacceptable toxicities, or withdrawal of consent. It is expected that 6-12 patients will be enrolled, depending on safety issues observed.

Conditions

• Breast Cancer
• Cervix Cancer
• Ovarian Cancer
• Endometrial Cancer

Interventions

Type	Name	Description
DRUG	carbplatin, cyclophophamide, atezolizumab

Timeline

• Start date: 2017-01-01
• Primary completion: 2017-08-01
• Completion: 2021-10-01
• First posted: 2016-09-26
• Last updated: 2021-10-19

Locations

1 site across 1 country: Netherlands