Recombinant Human Adenovirus Type 5 Injection Combined With PD-1 Monoclonal Antibody and Nab-paclitaxel in the Treatment of Patients With Liver Metastases From Malignant Melanoma

NCT05664139 | Unknown Phase 2

• 1 other identifier: FJCH-HR-001
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is the first to explore the efficacy and safety of recombinant human adenovirus type 5 injection combined with PD-1 monoclonal antibody and nab-paclitaxel in the treatment of patients with liver metastases of melanoma, in order to provide a new method for the clinical treatment of melanoma. The model also provides reference and basis for other tumor treatments.

Conditions

Malignant Melanoma; Liver Metastases

Keywords

recombinant human adenovirus type 5; Camrelizumab; Nab-paclitaxel; Malignant Melanoma; Liver Metastases

Outcome Measures

Primary Outcomes (1)

• Objective tumor response rate (ORR)

  From the first administration of the study drug to disease progression, unacceptable toxicity, withdrawal of informed consent or termination of the study (up to 1 year), including the proportion of CR and PR among all patients.

  1 year

Secondary Outcomes (5)

• Disease control rate (DCR)

  1 year

• Progression-free survival (PFS)

  1 year

• One-year Overall Survival

  1 year

• Quality of life (QoL)

  1 year

• Adverse event collection

  1 year

Other Outcomes (3)

• Pathological changes of injection lesions

  1 year

• MRI-based changes in injected lesions

  1 year

• Changes of CD4+ cells count, CD8+ cells count, Th1 cells count, Th2 cells count, Treg cells count in peripheral blood

  1 year

Study Arms (1)

Experimental Arm

EXPERIMENTAL

* Recombinant Human Adenovirus Type 5 Injection: 1ml or 2ml, d1, q3w, 4 cycles; * Camrelizumab: 200mg, d2, q3w; * Nab-paclitaxel: 260mg/m2, d1, q3w, 4-6 cycles;

Drug: Recombinant Human Adenovirus Type 5 Injection,Camrelizumab,Nab-paclitaxel

Interventions

Recombinant Human Adenovirus Type 5 Injection,Camrelizumab,Nab-paclitaxel DRUG

Recombinant Human Adenovirus Type 5 Injection:①the longest diameter of the lesion≥10mm and≤40mm, inject 1ml into the tumor each time;②the longest diameter of the lesion≥40mm and≤80mm, inject 2ml into the tumor each time. planned injections at D1. Every 3 weeks is a period, a total of 4 cycles; if there are visceral and superficial lesions at the same time, the injection lesions will be selected by the investigator based on possible benefits. Camrelizumab:200mg/time.Intravenous within 48 hours after injection of recombinant human adenovirus type 5 injection. Every 3 weeks is a period, and the treatment is continued until the subject has disease progression or unacceptable toxicity or death. Nab-paclitaxel:260mg/m2, D1, every 3 weeks as a period, a total of 4-6 cycles (determined by the investigator), or continue treatment until the subject has disease progression or Intolerable toxicity or death.

Experimental Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old, and ≤ 75 years old, gender is not limited;
• Patients with liver metastasis of malignant melanoma diagnosed by histopathology;
• There must be an injectable lesion in the liver, and the lesion must meet the requirements of RECIST 1.1 measurable target lesion;
• The liver lesion needs to be judged by the surgeon to have a poor prognosis in biological behavior; or the surgeon judges that it can be resected, but the patient refuses the operation, and the liver metastases must meet the following requirements:
• The number of metastatic lesions should not exceed 5, and the sum of the longest diameters of the total metastatic lesions must be ≤100mm;
• The longest diameter of a single lesion ≤ 100 mm;
• The longest diameter of the injection lesion must be ≥10mm and ≤80mm;
• ECOG physical condition score 0-1 points;
• Expected survival time \> 3 months;
• Laboratory examinations meet the following standards:
• White blood cell count ≥3.0×109/L, absolute value of neutrophils ≥3.0×109/L, platelet count ≥100×109/L, hemoglobin ≥90g/L;
• International normalized ratio (INR) ≤ 1.5, and activated partial thromboplastin time (APTT) ≤ 1.5 × upper limit of normal (ULN) or partial prothrombin time (PTT) ≤ 1.5 × ULN;
• Total bilirubin ≤ 1.5×ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN;
• Serum creatinine ≤1.5×ULN or creatinine clearance ≥50ml/min at 24 hours.
• The interval between the date of the first treatment in this study and the date of the last anti-tumor treatment in the past is ≥14 days, and the adverse reactions of the previous anti-tumor treatment have recovered to baseline or below grade 1 \[evaluation criteria for common adverse events (CTCAE version 5.0)\] (hair loss and grade 2 anemia);

You may not qualify if:

• Bone metastasis, lymph node metastasis, brain metastasis and other metastatic malignant melanoma;
• njectable lesions have previously received other local treatments such as ablation, intervention, and Haifu Knife;
• Patients who have previously received oncolytic virus drugs (such as T-VEC) or other similar drugs;
• Patients who have previously received PD-1/PD-L1/PD-L2 therapy;
• Local lesions cannot meet the volume requirements for intratumoral injection or are not suitable for intratumoral injection;
• Accompanied by malignant pleural effusion and ascites;
• Patients who are positive for hepatitis C virus (HCV) antibody or human immunodeficiency virus (HIV) antibody;
• People who are known to be allergic to the study drug or its active ingredients, or have a history of allergy to similar biological agents;
• Received antiviral drug treatment within 4 weeks before enrollment, such as acyclovir, ganciclovir, valaciclovir, vidarabine, etc.;
• Received any other experimental drugs or participated in other interventional clinical trials within 4 weeks before enrollment;
• Pregnant or lactating women, men or women who are unwilling to take effective contraceptive measures;
• Vulnerable groups: including the mentally ill, critically ill subjects, minors, cognitively impaired, etc.;
• Child-Pugh C Evidence of liver function or hepatocyte decompensation, including refractory ascites, bleeding from esophageal or gastric varices, and hepatic encephalopathy;
• There is a history of immunodeficiency or autoimmune disease, or receiving long-term systemic steroid therapy or any form of immunosuppressive therapy within 7 days before enrollment;
• Patients with a history of active tuberculosis (TB), active hepatitis, patients who have been evaluated for oral nucleoside (acid) analogues, known human immunodeficiency virus (HIV) positive patients, other serious infections that require treatment, and those who are taking anti-inflammatory drugs Viral drugs or large doses of adrenal corticosteroids;

Sponsors & Collaborators

• Fujian Cancer Hospital: lead
• Jiangsu Hengrui Pharmaceutical Co., Ltd.: collaborator
• SunWay Biotech Co., LTD.: collaborator

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Yu Chen, PhD

  Fujian Cancer Hospital

  STUDY DIRECTOR

Central Study Contacts

Yu Chen, PhD

CONTACT

13859089836; 13859089836@139.com

Study Design

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

Study Record Dates

• First Submitted: December 8, 2022
• First Posted: December 23, 2022
• Study Start: February 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: February 8, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share