Back to resultsNivolumab for Recurrent/Metastatic Carcinosarcoma
Primary Purpose
Recurrent/Metastatic Carcinosarcoma
Status
Recruiting
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
nivolumab
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent/Metastatic Carcinosarcoma focused on measuring carcinosarcoma, nivolumab
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Severance Hospital, Yonsei University Health SystemRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
nivolumab
Arm Description
Outcomes
Primary Outcome Measures
Progression free rate (PFR) at 6 months
proportion of patients who did not progress and were alive at 24 weeks (RECIST version 1.1)
Secondary Outcome Measures
Overall Response Rate (ORR) by RECIST version 1.1
Progression-free survival (PFS) by RECIST version 1.1
Overall survival (OS)
Time to progression (TPP)
Drug toxicity and safety analysis by CTCAE Version 5
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05224999
Brief Title
Nivolumab for Recurrent/Metastatic Carcinosarcoma
Official Title
A Phase II Trial of Nivolumab for Recurrent/Metastatic Carcinosarcoma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 13, 2019 (Actual)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent/Metastatic Carcinosarcoma
Keywords
carcinosarcoma, nivolumab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
nivolumab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
nivolumab
Intervention Description
nivolumab 3mg/kg (every 2 weeks)
Primary Outcome Measure Information:
Title
Progression free rate (PFR) at 6 months
Description
proportion of patients who did not progress and were alive at 24 weeks (RECIST version 1.1)
Time Frame
at 6 months
Secondary Outcome Measure Information:
Title
Overall Response Rate (ORR) by RECIST version 1.1
Time Frame
8 weeks
Title
Progression-free survival (PFS) by RECIST version 1.1
Time Frame
8 weeks
Title
Overall survival (OS)
Time Frame
8 weeks
Title
Time to progression (TPP)
Time Frame
8 weeks
Title
Drug toxicity and safety analysis by CTCAE Version 5
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyo Song Kim
Phone
82-2-2228-8124
Email
hyosong77@yuhs.ac
Facility Information:
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyo Song Kim
Phone
82-2-2228-8124
Email
hyosong77@yuhs.ac
12. IPD Sharing Statement
Learn more about this trial
Nivolumab for Recurrent/Metastatic Carcinosarcoma
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