Nivolumab for Recurrent/Metastatic Carcinosarcoma

Sponsor
Yonsei University
Study ID
NCT05224999
Phase
PHASE2
Status
Unknown

Conditions

  • Recurrent/Metastatic Carcinosarcoma

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • nivolumab — DRUG
    nivolumab 3mg/kg (every 2 weeks)

Study Details

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.

Key Dates

Start date
Nov 13, 2019
Status verified
Feb 2022
Primary completion
Jan 31, 2023
Completion
Dec 31, 2023

Study Design

Enrollment
28 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: nivolumab

Primary Outcome Measure

Progression free rate (PFR) at 6 months [ Time Frame: at 6 months ]

Central Contacts