Malignant MelanomasPhase 1NCT05928962
An Exploratory Single-arm Study: PD-1 With Recombinant Human Adenovirus Type 5 Injection for Malignant Melanomas
A Phase 1 study testing Recombinant Human Adenovirus Type 5 Injection in people with Malignant Melanomas, run by Fujian Cancer Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Malignant Melanomas
- What is being tested?
- Recombinant Human Adenovirus Type 5 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 27 Oct 2022to 31 Oct 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 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;
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- 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;
- Blood creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 ml/min.
- 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;
- voluntarily signed informed consent with good expected compliance;
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Fujian Cancer Hospital, Department of Internal Medicine, Ward 19
Fuzhou, Fujian
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Malignant Melanomas
- Being tested
- Recombinant Human Adenovirus Type 5 Injection
- Keywords
- Recombinant Human Adenovirus Type 5 Injection, oncolytic virus, Combined immunotherapy
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Human Adenovirus Type 5 InjectionDrug
Also called Tremelimumab
- 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.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Recombinant Human Adenovirus Type 5 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing the effectiveness of treatment through Objective Response Rate（ORR）
The proportion of CR and PR in all patients.
Measured: 2 years
Secondary outcomes (4)
Assessing the effectiveness of treatment through Duration of Response（DOR）
This refers to the time from the first assessment of the tumour as CR or PR to the first assessment of PD or death from any cause (whichever event occurs first).
Measured: 2 years
Assessing the effectiveness of treatment through Progression Free Survival（PFS）
Time from the date of first treatment to the first event of disease progression or death from any cause, whichever occurs first, with the endpoint event determined by the investigator in accordance with RECIST v1.1.
Measured: 2 years
Assessing the effectiveness of treatment through Disease Control Rate（DCR）
Proportion of CR, PR and SD in all patients.
Measured: 2 years
Assessing the effectiveness of treatment through Overall Survival（OS）
Time between the date of randomisation to the date of death from any cause or the end of the last follow-up visit.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start27 Oct 2022
- Primary completion1 Aug 2023 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant MelanomasStudies of the same condition, open and under way.
- More trials run by Fujian Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- PD-1 With Recombinant Human Adenovirus Type 5 Injection
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05928962
- Sponsor's protocol ID
- AKR-S010
- Status last verified
- Jun 2023
- First submitted
- 25 Jun 2023
- Last updated
- 10 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05928962
- Acronym / sponsor ID
- AKR-S010
- Conditions
- Malignant Melanomas
- Keywords
- Recombinant Human Adenovirus Type 5 Injection, oncolytic virus, Combined immunotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 27 Oct 2022 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- PD-1 With Recombinant Human Adenovirus Type 5 Injection
| Arm | Type | Receives |
|---|---|---|
| PD-1 With Recombinant Human Adenovirus Type 5 Injection | Experimental | Drug: Recombinant Human Adenovirus Type 5 Injection1. 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 18 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant Human Adenovirus Type 5 InjectionAlso: Tremelimumab1. 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. | Drug | PD-1 With Recombinant Human Adenovirus Type 5 Injection |
Primary outcome
Assessing the effectiveness of treatment through Objective Response Rate（ORR）
Time frame: 2 years
The proportion of CR and PR in all patients.
4 secondary outcomes
Assessing the effectiveness of treatment through Duration of Response（DOR）
Time frame: 2 years
Assessing the effectiveness of treatment through Progression Free Survival（PFS）
Time frame: 2 years
Assessing the effectiveness of treatment through Disease Control Rate（DCR）
Time frame: 2 years
Assessing the effectiveness of treatment through Overall Survival（OS）
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
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Melanoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Recombinant Human Adenovirus Type 5 Injection in people with Malignant Melanomas, run by Fujian Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing the effectiveness of treatment through Objective Response Rate（ORR） (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2023.