NCT05224999

Nivolumab for Recurrent/Metastatic Carcinosarcoma

A Phase II Trial of Nivolumab for Recurrent/Metastatic Carcinosarcoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

Carcinosarcoma is a malignant neoplasm that is composed of both epithelial and mesenchymal elements and aggressive tumor that are staged as high-grade cancer in NCCN guideline. They are regarded as rare aggressive malignancies with a high potential to develop distant metastases and are associated with an overall poor survival. The aggressive nature of this malignancy coupled with a high relapse rate defines a poor clinical course for most patients. First line treatment of patients with advanced uterine carcinosarcoma with paclitaxel plus carboplatin achieved an objective response rate of 54% of patients. For this orphan tumor, carcinosarcoma, as these drugs would hypothetically act only on tissues with overexpression of PD-L1, they theoretically provide a more precise therapeutic effect on tumor cells with considerably less side effects. Therefore, the investigators suggest phase II trial of nivolumab for metastatic/recurred carcinosarcoma who have progressed after prior chemotherapy.

Detailed description

Single center, prospective phase II trial.

Conditions

• Recurrent/Metastatic Carcinosarcoma

Interventions

Type	Name	Description
DRUG	nivolumab	nivolumab 3mg/kg (every 2 weeks)

Timeline

• Start date: 2019-11-13
• Primary completion: 2023-01-01
• Completion: 2023-12-01
• First posted: 2022-02-04
• Last updated: 2022-02-04

Locations

1 site across 1 country: South Korea