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

NCT05928962 | Unknown Phase 1

• 1 other identifier: AKR-S010
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Malignant Melanomas

Keywords

Recombinant Human Adenovirus Type 5 Injection; oncolytic virus; Combined immunotherapy

Outcome Measures

Primary Outcomes (1)

• Assessing the effectiveness of treatment through Objective Response Rate（ORR）

  The proportion of CR and PR in all patients.

  2 years

Secondary Outcomes (4)

• Assessing the effectiveness of treatment through Duration of Response（DOR）

  2 years

• Assessing the effectiveness of treatment through Progression Free Survival（PFS）

  2 years

• Assessing the effectiveness of treatment through Disease Control Rate（DCR）

  2 years

• Assessing the effectiveness of treatment through Overall Survival（OS）

  2 years

Other Outcomes (2)

• Assessing the effectiveness of treatment through Quality of Life（QoL）

  2 years

• Assessing security through Safety

  2 years

Study Arms (1)

PD-1 With Recombinant Human Adenovirus Type 5 Injection

EXPERIMENTAL

1. Recombinant Human Type 5 Adenovirus Injection: Drug specification: 5.0 x 1011vp/0.5ml/stem. Dosage: Dilute with equal volume of saline before injection. For injection of lesions with a longest diameter ≥10mm and ≤40mm, 2 injections of recombinant human type 5 adenovirus injection per tumour, 1ml in total; for injection of lesions with a longest diameter ≥40mm and ≤80mm, 4 injections of recombinant human type 5 adenovirus injection per tumour, 2ml in total. 2. PD1 monoclonal antibody (Tremelimumab): Dosage: 3mg/kg.

Drug: Recombinant Human Adenovirus Type 5 Injection

Interventions

Recombinant Human Adenovirus Type 5 Injection DRUG

1. Recombinant Human Type 5 Adenovirus Injection: This is expected to be administered prior to immunotherapy, i.e. scheduled for injection at C1D1 (C2D1, C3D1, C4D1). 1 treatment period every 2 weeks (3 day window) for a total of 4 cycles. 2. PD1 monoclonal antibody (Tremelimumab): Administered intravenously within 48h of recombinant human adenovirus type 5 injection, scheduled at C1D2 (C2D2, C3D2, C4D2). 1 treatment period every 2 weeks (3 day window) for a total of 4 cycles.

Also known as: Tremelimumab

PD-1 With Recombinant Human Adenovirus Type 5 Injection

Eligibility Criteria

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

You may qualify if:

• years of age ≤ age ≤ 75 years of age, regardless of gender
• have a pathological histological diagnosis of malignant melanoma
• current physical condition and anticipated treatment plan judged by the investigator to be suitable for the treatment regimen of this trial;
• a patient with malignant melanoma who has failed previous immunotherapy
• at least one injectable lesion which must meet the RECIST 1.1 and iRECIST measurable target lesion requirements
• the longest diameter of the injectable lesion must be ≥ 10 mm and ≤ 80 mm;
• an Eastern Cooperative Oncology Group (ECOG) physical status score of 0-2;
• 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;
• Platelet count ≥ 80 x 109/L;
• Haemoglobin ≥ 70 g/L;
• INR ≤ 1.5 and APTT ≤ 1.5 x ULN;
• Total bilirubin ≤ 1.5 x ULN;
• ALT and AST ≤ 5 x ULN;

You may not qualify if:

• the injectable lesion has received other local treatment, such as ablation, intervention, or Hepatome, within the previous 6 months;
• previous treatment with lysoviruses or similar drugs (e.g. T-VEC)
• local lesions that do not meet the volume requirements for intratumoral injection or for which intratumoral injection is inappropriate
• have received antiviral therapy, such as acyclovir, ganciclovir, vancomycin, adenosine, etc., within 4 weeks prior to the first dose of the trial treatment
• known hypersensitivity to the study drug or its active ingredient, excipients or to anti-PD-1 monoclonal antibodies and their components
• positive for hepatitis B surface antigen (HBsAg) and clinically judged to have active hepatitis B;
• other active viral infections;
• 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;
• the presence of an autoimmune disease
• 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
• the patient has been treated with any other experimental drug or participated in another interventional clinical trial within 14 days prior to treatment in this study
• women who are pregnant or breastfeeding or who are planning to become pregnant or breastfeeding during the study period; men or women who do not wish to use effective contraception
• evidence of central nervous system metastases at baseline
• other circumstances which, in the judgment of the investigator, make the patient unsuitable for participation in the clinical trial.

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

Study Sites (1)

Fujian Cancer Hospital, Department of Internal Medicine, Ward 19

Fuzhou, Fujian, China

Location

MeSH Terms

Conditions

Melanoma

Interventions

tremelimumab

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 Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: PD-1 With Recombinant Human Adenovirus Type 5 Injection

Study Record Dates

• First Submitted: June 25, 2023
• First Posted: July 3, 2023
• Study Start: October 27, 2022
• Primary Completion: August 1, 2023
• Study Completion: October 31, 2024
• Last Updated: July 10, 2023

Record last verified: 2023-06

Locations

CN (1)