Nivolumab for Recurrent/Metastatic Carcinosarcoma

NCT05224999 | Unknown Phase 2 DMC

• 1 other identifier: 4-2019-1104
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent/Metastatic Carcinosarcoma

Keywords

carcinosarcoma; nivolumab

Outcome Measures

Primary Outcomes (1)

• Progression free rate (PFR) at 6 months

  proportion of patients who did not progress and were alive at 24 weeks (RECIST version 1.1)

  at 6 months

Secondary Outcomes (5)

• 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

Study Arms (1)

nivolumab

EXPERIMENTAL

Drug: nivolumab

Interventions

nivolumab DRUG

nivolumab 3mg/kg (every 2 weeks)

nivolumab

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

RECRUITING

MeSH Terms

Conditions

Carcinosarcoma

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Neoplasms; Sarcoma; Neoplasms, Connective and Soft Tissue

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Hyo Song Kim

CONTACT

82-2-2228-8124; hyosong77@yuhs.ac

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: February 4, 2022
• Study Start: November 13, 2019
• Primary Completion: January 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 4, 2022

Record last verified: 2022-02

Locations

KR (1)