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Trial Title:
An Exploratory Single-arm Study: PD-1 With Recombinant Human Adenovirus Type 5 Injection for Malignant Melanomas
NCT ID:
NCT05928962
Condition:
Malignant Melanomas
Conditions: Official terms:
Adenoviridae Infections
Melanoma
Tremelimumab
Conditions: Keywords:
Recombinant Human Adenovirus Type 5 Injection
oncolytic virus
Combined immunotherapy
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Enrolling by invitation
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
PD-1 With Recombinant Human Adenovirus Type 5 Injection
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Recombinant Human Adenovirus Type 5 Injection
Description:
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.
Arm group label:
PD-1 With Recombinant Human Adenovirus Type 5 Injection
Other name:
Tremelimumab
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.
Criteria for eligibility:
Criteria:
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;
- 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;
- Blood creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 ml/min.
9. have recovered from previous antineoplastic treatment to baseline or below grade 1
(CTCAE version 5.0) (except for alopecia and grade 2 anaemia) after an interval of
≥14 days between the date of first treatment and the date of the last previous
antineoplastic treatment;
10. voluntarily signed informed consent with good expected compliance;
11. female patients of childbearing potential (including early menopause, menopause < 2
years and non-surgical sterilisation), male patients and partners of male patients
must agree to use effective contraception during the study period: surgical
sterilisation, oral contraceptive pills, intrauterine device, abstinence or barrier
contraceptive method combined with spermicide; and contraception must be continued
for 6 months after receiving the last, treatment.
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
11. 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
12. 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
13. evidence of central nervous system metastases at baseline
14. other circumstances which, in the judgment of the investigator, make the patient
unsuitable for participation in the clinical trial.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fujian Cancer Hospital, Department of Internal Medicine, Ward 19
Address:
City:
Fuzhou
Country:
China
Start date:
October 27, 2022
Completion date:
October 31, 2024
Lead sponsor:
Agency:
Fujian Cancer Hospital
Agency class:
Other
Source:
Fujian Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05928962
