Melanoma (Skin)Phase 2NCT04200040
A Clinical Study to Evaluate the Safety and Efficacy of OrienX010 in Unresectable Malignant Melanoma Patients
A Phase 2 study testing OrienX010 injection and Dacarbazine (DTIC) in people with Melanoma (Skin), run by OrienGene Biotechnology Ltd. at 1 site in China.
Trial summary
This study is being performed to evaluate the safety and efficacy of Dacarbazine and OrienX010 therapy in Untreated Patients With Unresectable Stage IIIb/IIIc or Stage IV(Mla/Mlb) Melanoma. The study will be conducted in about 6 centres in China and total 165 patients will be enrolled. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Melanoma (Skin)
- What is being tested?
- OrienX010 injection and Dacarbazine (DTIC)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteChina
- Study dates
- 27 Aug 2017to 27 Dec 2022
- Phase
- Phase 2
- 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 70 years
- 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 and ≤ 70 years of age.
- Patients with histologically proven unresectable stage IIIb /IIIc or IV (M1a/M1b) malignant melanoma following AJCC edition 8 published 2016 guidance. If patient in stage IV (M1b), pulmonary lesion as following:
- number of pulmonary lesion must be ≤ 5; any single lesion must less than 20 mm in longest diameter; total cumulative diameter of all lesions must be ≤ 50 mm;
- Patients with at least one measurable lesion with size ≥ 10 mm and < 100mm.
- Patient with at least one injectable lesion (long diameter ≥ 10 mm and < 100mm
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- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Patients with life expectancy > 5 months as judged by investigator.
- Patients with adequate bone marrow, liver and renal function within 28 days prior to study entry, as defined by the following:
- White Blood Cell count ≥3.0 × 109/L
- Absolute neutrophil count (ANC) ≥ 1.5 × 109/L
- Platelet count≥ 100 × 109/L
- Hemoglobin > 10.0 g/dl.
- Albumin ≥ 3 g/dl.
- liver function: Total bilirubin ≤ 1.5 x upper normal limit (UNL) , Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x upper normal limit (UNL).
- renal function: serum creatinine < 1.5 x UNL or 24 hour creatinine clearance rate≥ 50 mL/min（calculated by Cockcroft and Gault）
- International normalized ratio (INR) < 1.5 and Activated partial thromboplastin time (APTT) or Partial thromboplastin time (PTT) ≤ 1.5 × ULN
- Subjects who have received any anti-cancer therapy, including radiotherapy, cytotoxic, hormonal, biological (including humanized antibodies) and targeted agents within 28 days, or five half-lives of the drug (whichever is longer) prior to randomization and not recovered from acute toxicities as a result of prior anti-cancer therapy to less than or equal to Grade 1, according to Common Terminology Criteria for Adverse Events (CTCAE, version 4.03).
- Women of childbearing potential （early menopause, Post-menopause < 2 years and non- sterilization）, Man and man with female partner of childbearing potential should be use effective contraception during the study period , e.g. sterilization, progestogen oral contraceptives, injectable progestogen, implants of levonorgestrel, oestrogenic vaginal ring, percutaneous contraceptive patches or intrauterine device (IUD) or intrauterine system (IUS), abstinence or or double barrier method (condom or occlusive cap plus spermicidal agent).
Who cannot join
- Patients that have previously been treated with dacarbazine.
- Previous treatment with any investigational product or T-VEC or other similar ' oncolytic' viruses therapy.
- Sizes of tumor does not meet the requirement of injection or unacceptable for intratumoral injection.
- Patients who have treatment with anti-HSV antiviral therapy (such as acyclovir, ganciclovir, foscarnet, etc.) within 4 weeks prior to the first IP administration.
- No history of malignancy within the past 5 years except for the following: adequately treated of stage I or II basal cell/squamous cell skin cancer, superficial bladder cancer or any other cancer from which the patient has been completed curative therapy.
- Patients with known or suspected allergies and/or hypersensitivity to any component of OrienX10 or Dacarbazine.
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- HSV - 1 antibody IgG and IgM are negative
- Positive test for hepatitis B virus surface antigen (HBVsAg) and HBV DNA copies >1x103copies /mL.
- Positive test for hepatitis C and Human Immunodeficiency Virus (HIV) Patients with clinically evident Hepatitis C virus (HCV) and Human Immunodeficiency Virus (HIV) infection.
- Patient with uncontrolled systemic illness including, but not limited to, serious infection, uncontrolled, diabetes, unstable angina, cerebrovascular accidents or transient ischaemic attack, myocardial infarction, congestive heart failure, clinically significant arrhythmias not controlled by medication, liver, kidney or metabolic disease.
- Patient with autoimmune diseases.
- Patient has psychological or psychiatric disorder or alcohol dependence or Drug addiction which would increase risk or limit compliance with study requirements or influence the study result.
- Use of any investigational drugs, biologics, or devices within 30 days prior to screening visit or planned use during the course of study.
- Pregnant or breastfeeding women or women desiring to become pregnant within the timeframe of the study or women/men of reproductive potential not using an effective contraception.
- Any condition, judged by investigator, that shows subjects are not suitable for participation
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: A Phase II Clinical Study to Evaluate the Safety and Efficacy of OrienX010 in Previously Untreated With Dacarbazine Patients in Unresectable Stage IIIb/IIIc or Stage IV(Mla/Mlb) Malignant Melanoma
This study is being performed to evaluate the safety and efficacy of Dacarbazine and OrienX010 therapy in Untreated Patients With Unresectable Stage IIIb/IIIc or Stage IV(Mla/Mlb) Melanoma.
The study will be conducted in about 6 centres in China and total 165 patients will be enrolled. All eligible Patients will be randomized between Dacarbazine and OrienX010 in a 1:2 ratio, so 1/3 (55) patients will receive the Dacarbazine and 2/3 (110) patients will receive the OrienX010.
Read more
During the treatment phase, the patient will receive OrienX010 administration once biweekly or Dacarbazine once every 3 week until to the end of treatment (EOT). The duration of safety follow-up for adverse events (AEs) and serious adverse events (SAEs) will be to 90 days after the end of treatment. The details please refer to study schema.
For patients who have completed 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.
After the end of study, if patient want to continue receiving the OrienX010 treatment and judged by investigator, sponsor will provide OrienX010 and Dacarbazine for free until disease progression/death or OrienX010 on marketing launch.
- Conditions
- Melanoma (Skin)
- Being tested
- OrienX010 injection, Dacarbazine (DTIC)
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrienX010 injectionBiological
Also called Recombinant Human GM-CSF Herpes Simplex Virus Injection
OrienX010 to be used in this study have been developed and manufactured by OrienGene Biotechnology Ltd.
Dacarbazine to be used in this study was manufactured by Sinopharm A-Think Pharmaceutical Co., Ltd.
Dacarbazine (DTIC)Drug
Dacarbazine to be used in this study was manufactured by Sinopharm A-Think Pharmaceutical Co., Ltd.
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | OrienX010 will be administered once every two weeks by intratumoral injection. The treatment dose , depends on the patient's tumour size, The maximum dose of OrienX010 in at each treatment , the expected accumulated dose in 10 mL. The investigator should be confirmed the injectable tumor size and adequate dose within 24 hours prior to treatment.
OrienX010 treatment will be continuous and extend from first dose of study medication until to complete response, clinical related progression disease (PDr), untolerated toxicities, lost to follow up, death or meet end of treatment criteria. Receives: Biological: OrienX010 injection |
| Control group | Active comparator | Dacarbazine will be administered once every three weeks by intravenous 1000mg/square meter. Dacarbazine treatment will be continuous and extend from first dose of study medication until to progression disease (PD), untolerated toxicities, lost to follow up, death or meet end of treatment criteria. Receives: Drug: Dacarbazine (DTIC) |
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: Every 12 weeks until subjects disease progressive, an average of 24 weeks
Secondary outcomes (6)
DCR
Disease Control Rate (DCR), defined as the proportion of subjects with complete response, partial response, or stable disease for more than 3 months, according to RECIST v.1.1 criteria
Measured: through study completion, an average of 1 year
ORR
Objective Response Rate (ORR), defined as complete or partial tumor response, according to RECIST v.1.1 criteria
Measured: through study completion, an average of 1 year
OS
Overall survival defined as the time from randomization to death from any cause
Measured: Approximately 3 years
DRR
Durable response rate (DRR) defined as objective response lasting continuously ≥ 6 months
Measured: through study completion, an average of 1 year
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 6 weeks up to 24 weeks, and then every 12 weeks up to the date of end of treatment,an average of 24 weeks
Incidence of treatment-related SAE and AE
Number of participants with treatment-related serious adverse events (SAE) and adverse events that assessed by CTCAE v4.03
Measured: From date of enrolling to 90 days after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study start27 Aug 2017
- Primary completion27 Dec 2022 (estimated)
- Study completion27 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma (Skin)Studies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OrienGene Biotechnology Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jun Guo, MD, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04200040
- Sponsor's protocol ID
- OrienX010-II-21
- Status last verified
- Feb 2020
- First submitted
- 10 Dec 2019
- Last updated
- 27 Feb 2020
- 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 27 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study to Evaluate the Safety and Efficacy of OrienX010 in Previously Untreated With Dacarbazine Patients in Unresectable Stage IIIb/IIIc or Stage IV(Mla/Mlb) Malignant Melanoma
- ClinicalTrials.gov ID
- NCT04200040
- Acronym / sponsor ID
- OrienX010-II-21
- Conditions
- Melanoma (Skin)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- OrienGene Biotechnology Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Aug 2017 (actual)
- Primary completion
- 27 Dec 2022 (estimated)
- Study completion
- 27 Dec 2022 (estimated)
- First posted
- 16 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 being performed to evaluate the safety and efficacy of Dacarbazine and OrienX010 therapy in Untreated Patients With Unresectable Stage IIIb/IIIc or Stage IV(Mla/Mlb) Melanoma.
The study will be conducted in about 6 centres in China and total 165 patients will be enrolled. All eligible Patients will be randomized between Dacarbazine and OrienX010 in a 1:2 ratio, so 1/3 (55) patients will receive the Dacarbazine and 2/3 (110) patients will receive the OrienX010.
During the treatment phase, the patient will receive OrienX010 administration once biweekly or Dacarbazine once every 3 week until to the end of treatment (EOT). The duration of safety follow-up for adverse events (AEs) and serious adverse events (SAEs) will be to 90 days after the end of treatment. The details please refer to study schema.
For patients who have completed 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.
After the end of study, if patient want to continue receiving the OrienX010 treatment and judged by investigator, sponsor will provide OrienX010 and Dacarbazine for free until disease progression/death or OrienX010 on marketing launch.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Biological: OrienX010 injectionOrienX010 will be administered once every two weeks by intratumoral injection. The treatment dose , depends on the patient's tumour size, The maximum dose of OrienX010 in at each treatment , the expected accumulated dose in 10 mL. The investigator should be confirmed the injectable tumor size and adequate dose within 24 hours prior to treatment. OrienX010 treatment will be continuous and extend from first dose of study medication until to complete response, clinical related progression disease (PDr), untolerated toxicities, lost to follow up, death or meet end of treatment criteria. |
| Control group | Active comparator | Drug: Dacarbazine (DTIC)Dacarbazine will be administered once every three weeks by intravenous 1000mg/square meter. Dacarbazine treatment will be continuous and extend from first dose of study medication until to progression disease (PD), untolerated toxicities, lost to follow up, death or meet end of treatment criteria. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 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 and ≤ 70 years of age.
- Patients with histologically proven unresectable stage IIIb /IIIc or IV (M1a/M1b) malignant melanoma following AJCC edition 8 published 2016 guidance. If patient in stage IV (M1b), pulmonary lesion as following:
- number of pulmonary lesion must be ≤ 5; any single lesion must less than 20 mm in longest diameter; total cumulative diameter of all lesions must be ≤ 50 mm;
- Patients with at least one measurable lesion with size ≥ 10 mm and < 100mm.
Key exclusion criteria (15 listed)
- Patients that have previously been treated with dacarbazine.
- Previous treatment with any investigational product or T-VEC or other similar ' oncolytic' viruses therapy.
- Sizes of tumor does not meet the requirement of injection or unacceptable for intratumoral injection.
- Patients who have treatment with anti-HSV antiviral therapy (such as acyclovir, ganciclovir, foscarnet, etc.) within 4 weeks prior to the first IP administration.
- No history of malignancy within the past 5 years except for the following: adequately treated of stage I or II basal cell/squamous cell skin cancer, superficial bladder cancer or any other cancer from which the patient has been completed curative therapy.
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 injectionAlso: Recombinant Human GM-CSF Herpes Simplex Virus InjectionOrienX010 to be used in this study have been developed and manufactured by OrienGene Biotechnology Ltd. Dacarbazine to be used in this study was manufactured by Sinopharm A-Think Pharmaceutical Co., Ltd. | Biological | treatment group |
| Dacarbazine (DTIC)Dacarbazine to be used in this study was manufactured by Sinopharm A-Think Pharmaceutical Co., Ltd. | Drug | Control group |
Primary outcome
PFS
Time frame: Every 12 weeks until subjects disease progressive, an average of 24 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)
6 secondary outcomes
DCR
Time frame: through study completion, an average of 1 year
ORR
Time frame: through study completion, an average of 1 year
OS
Time frame: Approximately 3 years
DRR
Time frame: through study completion, an average of 1 year
Quality of life assessment
Time frame: every 6 weeks up to 24 weeks, and then every 12 weeks up to the date of end of treatment,an average of 24 weeks
Incidence of treatment-related SAE and AE
Time frame: From date of enrolling to 90 days after end of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2020.
- 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.
Jun Guo, MD principal investigator
Peking University Cancer Hospital & Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OrienX010 injection and Dacarbazine (DTIC) in people with Melanoma (Skin), run by OrienGene Biotechnology Ltd. 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 15 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 27 Feb 2020. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Zinan Xiao, Bachelor (+86 15101193329, znxiao@oriengene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: Every 12 weeks until subjects disease progressive, an average of 24 weeks). 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 27 Feb 2020.