Recurrent/Metastatic Carcinosarcoma
Conditions
Keywords
carcinosarcoma, nivolumab
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 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.
Interventions
DRUGnivolumab
nivolumab 3mg/kg (every 2 weeks)
Sponsors
Yonsei University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histologically confirmed recurrent/metastatic carcinosarcoma 2. ECOG performance status of 0 to 1 3. ≥ 19 years of age 4. At least 1 prior chemotherapy 5. Patients who have at least 1 measurable disease per the RECIST Guideline Ver. 1.1 as confirmed by imaging within 28 days before randomization 6. 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 criteria
1. More than 4 prior cytotoxic agents 2. Prior treatment with systemic PD-L1-directed therapy 3. 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 4. 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 5. 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) 6. History of active non-infectious pneumonitis requiring treatment with steroids, or history or current signs of chronic interstitial lung disease 7. Known active infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression free rate (PFR) at 6 months | at 6 months | proportion of patients who did not progress and were alive at 24 weeks (RECIST version 1.1) |
Secondary
| Measure | Time frame |
|---|---|
| Overall Response Rate (ORR) by RECIST version 1.1 | 8 weeks |
| Progression-free survival (PFS) by RECIST version 1.1 | 8 weeks |
| Overall survival (OS) | 8 weeks |
| Time to progression (TPP) | 8 weeks |
| Drug toxicity and safety analysis by CTCAE Version 5 | 8 weeks |
Countries
South Korea
Contacts
Primary ContactHyo Song Kim
Outcome results
None listed