Nivolumab for Recurrent/Metastatic Carcinosarcoma

Sponsor

Yonsei University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05224999

Collaborator

(none)

Enrollment

Location

Arm

48.6

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Recurrent/Metastatic Carcinosarcoma	Drug: nivolumab	Phase 2

Detailed Description

Single center, prospective phase II trial.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

28 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase II Trial of Nivolumab for Recurrent/Metastatic Carcinosarcoma

Actual Study Start Date :

Nov 13, 2019

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: nivolumab	Drug: nivolumab nivolumab 3mg/kg (every 2 weeks)

Arm

Intervention/Treatment

Experimental: nivolumab

Drug: nivolumab

nivolumab 3mg/kg (every 2 weeks)

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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