MelanomaPhase 1NCT04206358
Study to Evaluate OrienX010 in Combination With JS001 in the Treatment of Stage IV (M1c) Liver Metastasis From Melanoma
A Phase 1 study testing OrienX010 combination with JS001 in people with Melanoma, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
This study is an open-label, Phase Ib clinical study to evaluate Evaluate the Recombinant Human GM-CSF Herpes Simplex Virus Injection (OrienX010) in Combination with Recombinant Human Anti-PD1 Monoclonal Antibody Injection (JS001) in the Treatment of Stage IV (M1c) Liver Metastasis from Melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- OrienX010 combination with JS001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 13 May 2019to 31 Dec 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Obtain the current IRB approved informed consent with written from potential patients before the any screening activities or procedures.
- Male or female, ≥ 18 years of age.
- Patients with definite diagnosis of IV (M1c) Liver metastasis from melanoma based on histology and/or cytology.Patients who lack existing therapies or fail or relapse with existing therapies.
- Patients with at least one injectable lesion on the liver (long diameter ≥ 10 mm and < 100 mm).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Expected Survival> 4 months;
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- The patients has good function in each organ, and the following conditions are required at screening according to the laboratory reference range:
- White blood cell count ≥ 3.0 × 109/L; Absolute neutrophil value ≥ 1.5 × 109/L; Platelet count ≥ 100 × 109/L; Hemoglobin ≥ 90 g/L; Serum albumin ≥ 2.5 g/dL; Liver function tests: Total bilirubin ≤ 1.5 × upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 × ULN; Renal function tests: Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min at 24 hours (Cockcroft and Gault formula); International normalized ratio (INR) ≤ 1.5, and activated partial thromboplastin time (APTT) or partial prothrombin time (PTT) ≤ 1.5 × ULN;
- Child-Pugh Grade A;
- Patients receiving treatment for the first time in this study from the date of the last previous anti-tumor treatment date interval more than 28 days, and Patients have recovered from adverse events as a result of prior anti-tumor therapy to less than or equal to Grade 1, according to Common Terminology Criteria for Adverse Events (CTCAE, version 5.0) (Except alopecia).
- Female patients with childbearing potential (including premature menopause, menopausal < 2 years and non-surgical sterilization), male patients, and partners of male patients must agree to use effective contraception during the study: Surgical sterilization, oral contraceptives, intrauterine devices, sexual abstinence or barrier contraceptive combination spermicides; All patients must continue contraception for 6 months after the last treatment
Who cannot join
- Patients previously treated with T-VEC or similar.
- Patients previously treated with anti-PD-1, anti-PD-L1, anti-PD-L2.
- Patients with negative anti-herpes simplex virus type I (HSV-1) antibodies IgG and IgM.
- The patient's lesion does not meet the requirement of the intratumoral injection volume or is not suitable for intratumoral injection.
- Received anti-herpes simplex virus therapy (such as aciclovir, ganciclovir, valaciclovir, and arabinoside) within 4 weeks prior to the first dose of study treatment.
- Received another anti-tumor monoclonal antibody (mAb) within 4 weeks prior to the first dose of study treatment or hasn't recover (≤ Grade 1) from adverse events due to prior therapy (occurring earlier than 4 weeks;
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- Patients with a history of other (including unknown primary) malignancies within 5 years prior to the first dose of trial treatment. Note: Except for fully treated stage 1 or 2 basal/squamous cell carcinoma of the skin, superficial bladder cancer, or in situ cancer that is treated with potentially curative therapy.
- Patients with known hypersensitivity to the study drug, its active ingredient, excipients.
- Patient with HBsAg positive and HBV DNA copies > 1×10^3copies/mL.
- Patients with positive hepatitis C virus (HCV) antibodies or human immunodeficiency virus (HIV) antibodies.
- Patients with any unstable systemic disease, including but not limited to: Serious infection, uncontrolled diabetes mellitus, unstable angina, cerebrovascular accident or transient cerebral ischemia, myocardial infarction, congestive heart failure, and serious arrhythmia liver, kidney, or metabolic disease requiring medical treatment.
- patients with active CNS metastases. patients may participate in the study if their CNS is adequately treated and their neurological symptoms recover to levels less than or equal to CTCAE1 for at least 2 weeks before enrollment, with the exception of residual signs or symptoms associated with CNS therapy . In addition, patients must be those who do not use corticosteroids or who take stable doses of ≤ 10 mg prednisone/day (or equivalent dose) or who decrease to ≤ 10 mg prednisone/day.
- Patients with meningeal carcinomatosis.
- Patients with autoimmune disease.
- The disease (e.g., mental illness, etc.) or condition (e.g., alcoholism or drug abuse, etc.) of the patient may increase the patient's risk of receiving trial medication or affect the patient's compliance with the study requirements, or may confuse the study results.
- Within 30 days of screening, the patient had received any other study product or had participated in another intervention clinical trial.
- Pregnant or lactating women, or women who are prepared to become pregnant or lactating during the study; Men or women who are unwilling to use effective contraception.
- Other situations that the investigators think are not suitable for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Jun Guo, MD, 010-88121122, guoj307@126.com
About this study
Official title: An Open Phase Ib Clinical Study to Evaluate OrienX010 in Combination With JS001 in the Treatment of Stage IV (M1c) Liver Metastasis From Melanoma
This study is an open-label, Phase Ib clinical study to evaluate Evaluate the Recombinant Human GM-CSF Herpes Simplex Virus Injection (OrienX010) in Combination with Recombinant Human Anti-PD1 Monoclonal Antibody Injection (JS001) in the Treatment of Stage IV (M1c) Liver Metastasis from Melanoma.
This study is planned to enroll approximately 30 patients with Stage IV (M1c) Liver Metastasis from Melanoma who meet protocol requirements. This study is a single-arm clinical trial.
Read more
All participator will be given OrienX010 in combination with JS001. JS001 injection: 3 mg/kg, IV infusion: Once every 2 weeks ; OrienX010: Maximum injection volume 8 × 10^8 pfu, intratumoral injection: Once every 2 weeks. Treatment will be continuous and extend from first dose of study medication until to complete response, clinical related progression disease (PDr), intolerable AE, or withdrew informed consent or meet other criteria of discontinuation.
For patients who have stopped the study treatment and no disease progression, follow-up visits will take place every 3 months after the end of treatment visit until the occurrence of disease progression. If disease progression occurred, the investigator will collect the anticancer treatment information and survival of individuals until 80% death event.
- Conditions
- Melanoma
- Being tested
- OrienX010 combination with JS001
- Keywords
- melanoma, Liver Metastasis
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrienX010 combination with JS001Biological
Also called Recombinant Human GM-CSF Herpes Simplex Virus Injection combination with Recombinant Human Anti-PD-1 Monoclonal Antibody Injection
OrienX010 Produced by Oriengene Biotechnology Co., Ltd. Strength: 1.0 mL/vial. Label claim: Titer 8.0 × 10^7Pfu/mL, NMT 1 × 10 particles11VP/mL.
JS001 Produced by Junshi Biosciences Co., Ltd. Strength: 240 mg/6 mL/vial; Sterile water injection dosage form; Expiry date: 24 months; Date of manufacture: Based on the date of manufacture indicated in the product package.
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | The Recombinant Human GM-CSF Herpes Simplex Virus Injection (OrienX010) in Combination with Recombinant Human Anti-PD1 Monoclonal Antibody Injection (JS001), Once every 2 weeks Receives: Biological: OrienX010 combination with JS001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression-free survival (PFS), defined as the first documentation of objective disease progression, according to Response Evaluation Criteria in Solid Tumors (RECIST v.1.1)
Measured: From date of enrolling until subjects disease progressive, an average of 16 weeks
ORR
Objective Response Rate (ORR), defined as complete or partial tumor response, according to RECIST v.1.1 criteria
Measured: From date of enrolling until the date of all patients disease progression , an average of 20 months.
Secondary outcomes (3)
OS
Overall survival defined as the time from randomization to death from any cause
Measured: Approximately 3 years
Quality of life assessment
Use EORTC QLQ-C30 to assess quality of life. The EORTC(European Organization for Research and Treatment of Cancer) QLQ-C30 (Quality of Life Questionnaire C30), is a cancer-specific quality of life instrument applicable to a broad range of cancer patients.
QLQ-C30 contain 15 domain, The standard score for each domain from 0-100. higher scores mean a worse outcome.
Measured: every 8 weeks, up to the date of 28 days after stopping treatment, an average of 24 weeks
Incidence of SAE and AE
Number of AE (adverse events) and SAE (serious adverse events) occurrences， Number of participants with treatment-related SAE and AE that assessed by CTCAE v5.0
Measured: From date of enrolling to 90 days after stopping treatment, an average of 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start13 May 2019
- Primary completion27 Feb 2021 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe 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
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Guo, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04206358
- Sponsor's protocol ID
- OrienX010-II-11
- Status last verified
- Dec 2019
- First submitted
- 18 Dec 2019
- Last updated
- 20 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Phase Ib Clinical Study to Evaluate OrienX010 in Combination With JS001 in the Treatment of Stage IV (M1c) Liver Metastasis From Melanoma
- ClinicalTrials.gov ID
- NCT04206358
- Acronym / sponsor ID
- OrienX010-II-11
- Conditions
- Melanoma
- Keywords
- melanoma, Liver Metastasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 13 May 2019 (actual)
- Primary completion
- 27 Feb 2021 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 20 Dec 2019 (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.
This study is an open-label, Phase Ib clinical study to evaluate Evaluate the Recombinant Human GM-CSF Herpes Simplex Virus Injection (OrienX010) in Combination with Recombinant Human Anti-PD1 Monoclonal Antibody Injection (JS001) in the Treatment of Stage IV (M1c) Liver Metastasis from Melanoma.
This study is planned to enroll approximately 30 patients with Stage IV (M1c) Liver Metastasis from Melanoma who meet protocol requirements. This study is a single-arm clinical trial.
All participator will be given OrienX010 in combination with JS001. JS001 injection: 3 mg/kg, IV infusion: Once every 2 weeks ; OrienX010: Maximum injection volume 8 × 10^8 pfu, intratumoral injection: Once every 2 weeks. Treatment will be continuous and extend from first dose of study medication until to complete response, clinical related progression disease (PDr), intolerable AE, or withdrew informed consent or meet other criteria of discontinuation.
For patients who have stopped the study treatment and no disease progression, follow-up visits will take place every 3 months after the end of treatment visit until the occurrence of disease progression. If disease progression occurred, the investigator will collect the anticancer treatment information and survival of individuals until 80% death event.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Biological: OrienX010 combination with JS001The Recombinant Human GM-CSF Herpes Simplex Virus Injection (OrienX010) in Combination with Recombinant Human Anti-PD1 Monoclonal Antibody Injection (JS001), Once every 2 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Obtain the current IRB approved informed consent with written from potential patients before the any screening activities or procedures.
- Male or female, ≥ 18 years of age.
- Patients with definite diagnosis of IV (M1c) Liver metastasis from melanoma based on histology and/or cytology.Patients who lack existing therapies or fail or relapse with existing therapies.
- Patients with at least one injectable lesion on the liver (long diameter ≥ 10 mm and < 100 mm).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Key exclusion criteria (18 listed)
- Patients previously treated with T-VEC or similar.
- Patients previously treated with anti-PD-1, anti-PD-L1, anti-PD-L2.
- Patients with negative anti-herpes simplex virus type I (HSV-1) antibodies IgG and IgM.
- The patient's lesion does not meet the requirement of the intratumoral injection volume or is not suitable for intratumoral injection.
- Received anti-herpes simplex virus therapy (such as aciclovir, ganciclovir, valaciclovir, and arabinoside) within 4 weeks prior to the first dose of study treatment.
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 |
|---|---|---|
| OrienX010 combination with JS001Also: Recombinant Human GM-CSF Herpes Simplex Virus Injection combination with Recombinant Human Anti-PD-1 Monoclonal Antibody InjectionOrienX010 Produced by Oriengene Biotechnology Co., Ltd. Strength: 1.0 mL/vial. Label claim: Titer 8.0 × 10^7Pfu/mL, NMT 1 × 10 particles11VP/mL. JS001 Produced by Junshi Biosciences Co., Ltd. Strength: 240 mg/6 mL/vial; Sterile water injection dosage form; Expiry date: 24 months; Date of manufacture: Based on the date of manufacture indicated in the product package. | Biological | treatment group |
Primary outcome
PFS
Time frame: From date of enrolling until subjects disease progressive, an average of 16 weeks
Progression-free survival (PFS), defined as the first documentation of objective disease progression, according to Response Evaluation Criteria in Solid Tumors (RECIST v.1.1)
ORR
Time frame: From date of enrolling until the date of all patients disease progression , an average of 20 months.
Objective Response Rate (ORR), defined as complete or partial tumor response, according to RECIST v.1.1 criteria
3 secondary outcomes
OS
Time frame: Approximately 3 years
Quality of life assessment
Time frame: every 8 weeks, up to the date of 28 days after stopping treatment, an average of 24 weeks
Incidence of SAE and AE
Time frame: From date of enrolling to 90 days after stopping treatment, an average of 20 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2019.
- Individual participant dataSharing planned: No
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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.
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 OrienX010 combination with JS001 in people with Melanoma, run by Peking University Cancer Hospital & Institute 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 11 inclusion and 18 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 20 Dec 2019. 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?
Contact Chuanliang Cui, MD (010-88121122, 1008ccl@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: From date of enrolling until subjects disease progressive, an average of 16 weeks). The study lists 2 primary outcomes in all. 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 20 Dec 2019.