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.
Single center, prospective phase II trial.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
nivolumab 3mg/kg (every 2 weeks)
Severance Hospital, Yonsei University Health System
Seoul, South Korea
RECRUITINGProgression free rate (PFR) at 6 months
proportion of patients who did not progress and were alive at 24 weeks (RECIST version 1.1)
Time frame: at 6 months
Overall Response Rate (ORR) by RECIST version 1.1
Time frame: 8 weeks
Progression-free survival (PFS) by RECIST version 1.1
Time frame: 8 weeks
Overall survival (OS)
Time frame: 8 weeks
Time to progression (TPP)
Time frame: 8 weeks
Drug toxicity and safety analysis by CTCAE Version 5
Time frame: 8 weeks
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