Status:
UNKNOWN
Nivolumab for Recurrent/Metastatic Carcinosarcoma
Lead Sponsor:
Yonsei University
Conditions:
Recurrent/Metastatic Carcinosarcoma
Eligibility:
All Genders
19+ years
Phase:
PHASE2
Brief 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 ra...
Detailed Description
Single center, prospective phase II trial.
Eligibility Criteria
Inclusion
- Histologically confirmed recurrent/metastatic carcinosarcoma
- ECOG performance status of 0 to 1
- ≥ 19 years of age
- At least 1 prior chemotherapy
- Patients who have at least 1 measurable disease per the RECIST Guideline Ver. 1.1 as confirmed by imaging within 28 days before randomization
- Subjects who meet the following criteria:
- Absolute neutrophil count (ANC) ≥ 1500 /µ
- Platelet count ≥ 75,000/ µL
- Serum creatinine \< 1.5 x upper limit of normal (ULN)
- AST (SGOT) and ALT (SGPT) \< 3 x upper limit of normal (ULN) (If there is Liver Metastasis \< 5 x upper limit of normal (ULN))
- Total bilirubin \< 1.5 x upper limit of normal (ULN)
Exclusion
- More than 4 prior cytotoxic agents
- Prior treatment with systemic PD-L1-directed therapy
- Patient who has had chemotherapy, radiotherapy, or biological therapy within 2 weeks prior to entering the study, or who has not recovered from the adverse events due to previous agents administered more than 2 weeks prior to study day
- Subjects with symptomatic central nervous system (CNS) metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms
- Patients with multiple primary cancers (with the exception of completely resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, or superficial bladder cancer, or any other cancer that has not recurred for at least 3 years)
- History of active non-infectious pneumonitis requiring treatment with steroids, or history or current signs of chronic interstitial lung disease
- Known active infection
Key Trial Info
Start Date :
November 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT05224999
Start Date
November 13 2019
End Date
December 1 2023
Last Update
February 4 2022
Active Locations (1)
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1
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 03722