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An Exploratory Single-arm Study: PD-1 With Recombinant Human Adenovirus Type 5 Injection for Malignant Melanomas | Clinical Trials | Clareo Health

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An Exploratory Single-arm Study: PD-1 With Recombinant Human Adenovirus Type 5 Injection for Malignant Melanomas

PD-1 Monoclonal Antibody With Recombinant Human Adenovirus Type 5 Injection for the Treatment of Advanced Malignant Melanoma Patients Who Has Failed Immunotherapy: an Exploratory Single-arm Study

NCT05928962•Fujian Cancer Hospital

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is provide new treatment for patients with advanced melanoma who have failed previous immunotherapy. The main questions it aims to answer are: * Efficacy of PD1 monoclonal antibody combined with recombinant human adenovirus type 5 injection in patients with advanced malignant melanoma. * Safety of PD1 monoclonal antibody combined with recombinant human adenovirus type 5 injection in patients with advanced malignant melanoma.

Detailed Description

The study is divided into 5 phases: screening phase, washout phase, baseline phase, treatment phase and follow-up phase. Patients with advanced malignant melanoma who are eligible for screening and have failed previous anti-PD1 antibody therapy and who meet the inclusion exclusion criteria undergo elution with 1 PD1 monoclonal antibody injection, patients whose tumours progress after PD1 monoclonal antibody injection enter the treatment phase and are followed up every 1 month for at least 2 years in the follow-up phase.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 18 years of age ≤ age ≤ 75 years of age, regardless of gender
•2. have a pathological histological diagnosis of malignant melanoma
•3. current physical condition and anticipated treatment plan judged by the investigator to be suitable for the treatment regimen of this trial;
•4. a patient with malignant melanoma who has failed previous immunotherapy
•5. at least one injectable lesion which must meet the RECIST 1.1 and iRECIST measurable target lesion requirements
•6. the longest diameter of the injectable lesion must be ≥ 10 mm and ≤ 80 mm;
•7. an Eastern Cooperative Oncology Group (ECOG) physical status score of 0-2;
•8. laboratory tests must meet the following criteria:
•* A white blood cell count of ≥ 1.0 x 109/L;
•* Absolute neutrophil count ≥ 1.0 x 109/L;
+9 more criteria

Exclusion Criteria

•1. the injectable lesion has received other local treatment, such as ablation, intervention, or Hepatome, within the previous 6 months;
•2. previous treatment with lysoviruses or similar drugs (e.g. T-VEC)
•3. local lesions that do not meet the volume requirements for intratumoral injection or for which intratumoral injection is inappropriate
•4. have received antiviral therapy, such as acyclovir, ganciclovir, vancomycin, adenosine, etc., within 4 weeks prior to the first dose of the trial treatment
•5. known hypersensitivity to the study drug or its active ingredient, excipients or to anti-PD-1 monoclonal antibodies and their components
•6. positive for hepatitis B surface antigen (HBsAg) and clinically judged to have active hepatitis B;
•7. other active viral infections;
•8. patients with any unstable systemic disease, including but not limited to: severe infection, uncontrolled diabetes mellitus, unstable angina pectoris, cerebrovascular accident or transient cerebral ischaemia, myocardial infarction, congestive heart failure, severe arrhythmia requiring pharmacological treatment, liver, renal or metabolic disease;
•9. the presence of an autoimmune disease
•10. the patient has a concomitant disease (e.g. mental illness, etc.) or condition (e.g. alcohol or drug abuse, etc.) that would increase the patient's risk of receiving the trial drug or would affect the patient's ability to comply with the requirements of the trial, or would have the potential to confound the results of the study
+4 more criteria

Locations (1)

Fujian Cancer Hospital, Department of Internal Medicine, Ward 19

Fuzhou, Fujian, China

Key Dates

Start Date

October 27, 2022

Primary Completion Date

August 1, 2023

Completion Date

October 31, 2024

Last Updated

July 10, 2023

Enrollment

ESTIMATED participants

Conditions

Malignant Melanomas

Interventions

Recombinant Human Adenovirus Type 5 Injection

DRUG