Nivolumab for Recurrent/Metastatic Carcinosarcoma

NCT ID: NCT05224999

Last Updated: 2022-02-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-13
• Study Completion Date: 2023-12-31

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.

Conditions

Recurrent/Metastatic Carcinosarcoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

nivolumab

Group Type: EXPERIMENTAL

nivolumab

Intervention Type: DRUG

nivolumab 3mg/kg (every 2 weeks)

Interventions

nivolumab

nivolumab 3mg/kg (every 2 weeks)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Hyo Song Kim

Role: CONTACT

hyosong77@yuhs.ac

82-2-2228-8124

Facility Contacts

Hyo Song Kim

Role: primary

hyosong77@yuhs.ac

82-2-2228-8124

Other Identifiers

4-2019-1104

Identifier Type: -

Identifier Source: org_study_id