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MelanomaPhase 3NCT05868707

OH2 Injection in Melanoma

A Phase 3 study testing OH2 in people with Melanoma, run by Binhui Biopharmaceutical Co., Ltd. at 30 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

To evaluate the efficacy of OH2 injection in patients with unresectable or metastatic melanoma who have failed at least second-line standard therapy, using investigator-selected salvage chemotherapy or best supportive care (BSC) as controls. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma
What is being tested?
OH2
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
340 participants
Where
30 sitesChina
Study dates
8 Mar 2023to Mar 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

  • Over 18 years old, male or female;
  • Stage III or stage IV melanoma that has been definitively diagnosed by pathology and/or cytology and has failed at least second-line standard therapy (including chemotherapy, immunotherapy, and targeted therapy for those with genetic mutations) (progression to unresectable or metastatic melanoma within 6 months after the end of adjuvant therapy or during adjuvant therapy, This adjuvant therapy can be considered as advanced first-line therapy) for patients with unresectable or metastatic melanoma;
  • The overall percentage of subjects with mucosal melanoma will not exceed 22%;
  • Eastern Oncology Consortium (ECOG) physical condition score ECOG 0 ~ 1;
  • The expected survival time is more than 3 months;
  • At least 4 weeks after completion of previous antitumor therapy (including chemotherapeutic/radiotherapy, targeted therapy, immunotherapy) (at least 2 weeks after completion of previous bone radiotherapy, at least 6 weeks after withdrawal of chemotherapy using nitrosourea and mitomycin), and have recovered from adverse reactions of previous treatment (≤ grade 1 or baseline, except hair loss), and 4 weeks after surgery for major surgery;
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  • At least one measurable target lesion was present according to RECIST 1.1 criteria. There are lesions suitable for intratumoral injection. Measurable tumor lesions were defined as longest diameter ≥10 mm and scanning thickness less than 5.0 mm. For lymph node lesions, short diameter ≥15 mm.
  • Asymptomatic central nervous system metastases, or treated asymptomatic brain metastases, must be examined by computed tomography (CT) or magnetic resonance imaging (MRI) for no disease progression, stable for at least 3 months, and without steroid medication for at least 4 weeks;
  • No severe dysfunction of major organs; Laboratory tests meet the following criteria:
  • WBC≥3.0×109 / L, ANC≥2.0×109 / L (no correction by granulocyte colony stimulating factor [G-CSF] or granulocyte macrophage colony stimulating factor [GM-CSF] within 14 days prior to screening), PLT≥100×109 /L (do not receive platelet infusion or thrombopoietin [TPO], thrombopoietin (TPO) receptor agonist or interleukin-11 [IL-11] within 14 days before screening), Hb≥90 g/L (do not receive blood transfusion or erythropoietin [EPO] correction within 14 days before screening);
  • Blood BUN and blood creatinine within the range of 1.5 times the upper limit of normal value;
  • TBIL≤ 1.5 times the upper limit of normal (total bilirubin <2×ULN in subjects with Gilbert syndrome, or total bilirubin <3×ULN in subjects with indirect bilirubin indicating extrahepatic cause of total bilirubin elevation);
  • ALT and AST≤ 2.5 times the upper limit of normal value; Patients with liver metastases do not exceed 5 times the upper limit of normal;
  • Normal coagulation function (PT, APPT within 1.5 times the upper limit of normal);
  • Female subjects of childbearing age must have tested serum-negative for pregnancy before receiving the first trial drug;
  • Female subjects of reproductive age and male subjects with partners of women of reproductive age received effective forms of contraception during and for 3 months after treatment;
  • For subjects with genital herpes, need 3 months after the end of herpes;
  • Voluntary signing of informed consent, expected compliance is good.

Who cannot join

  • Severe medical conditions, including uncontrolled diabetes with medication, severe infections requiring systematic treatment, and active digestive tract ulcers;
  • Clinically important cardiovascular and cerebrovascular diseases exist, including:
  • Severe or uncontrolled heart disease requiring treatment, congestive heart failure rated III or IV by the New York Cardiology Association, unstable angina that cannot be controlled by medication, myocardial infarction in the last 6 months, ECG QTc interval: Severe arrhythmias requiring medication (other than atrial fibrillation or paroxysmal supraventricular tachycardia) ≥450 milliseconds in men and 470 milliseconds in women;
  • Patients with heart stents in place within 6 months;
  • Inadequately controlled hypertension, systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg;
  • History of primary uveal melanoma or other malignancies within 5 years prior to treatment (except early resection of cervical carcinoma in situ and skin cancer in situ);
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  • A large amount of pleural fluid or ascites with clinical symptoms or symptomatic management;
  • Bone metastases (stable metastases controlled by treatment can be ruled out) or the presence of active, clinical BMS;
  • Have an active autoimmune disease that has required systemic treatment within the past 2 years (e.g. with disease-regulating drugs, corticosteroids, or immunosuppressive drugs). Replacement therapy (such as thyroxine, insulin, or physiologic corticosteroid replacement for renal or pituitary insufficiency) does not count as systemic therapy;
  • A history of immunodeficiency (HIV antibody positive), or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
  • Patients with active hepatitis B or hepatitis C: HbsAg or HBCAB-positive patients with HBV DNA copy number positive (limit of quantitative detection is 500IU/ml); HBV DNA (negative for HBV-DNA/below the hospital standard for quantitative testing) must be tested in the screening of such patients; Patients who tested positive for HCV antibodies were enrolled in this study only if HCV RNA test results were negative;
  • There is an active TB infection or other infectious disease that requires systematic treatment;
  • The subject has a known history of psychotropic substance abuse, alcoholism, or drug use;
  • Other investigational agents or antiviral therapies have been or are being used within 4 weeks prior to treatment, except for hepatitis B patients on ongoing treatment who may be treated with Entecavir, Tenofovir dipifuroxide fumarate, or adefovir dipivoxil;
  • Use of investigational drug within 4 weeks prior to initial dosing;
  • Had received live attenuated vaccine within 4 weeks prior to initial administration;
  • Pregnant or lactating women;
  • The investigator believed that the patient was not eligible to participate in the study for any reason.

Trial locations and contacts

30 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Wentao Xu contact

15111009972

xuwentao@binhui-bio.com

30 sites in 1 country

China30 sites, 30 recruiting

  • Peking University Cancer Hospital

    Beijing, Beijing Municipality, 100010

    Recruiting

  • Jilin Cancer Hospital

    Changchun, Jilin, 130000

    Recruiting

  • The first hospital of Jilin University

    Changchun, Jilin, 130000

    Not yet recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 410000

    Recruiting

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610000

    Recruiting

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality, 400000

    Not yet recruiting

  • The First Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning, 116000

    Not yet recruiting

  • Fujian Cancer Hosptial

    Fuzhou, Fujian, 350000

    Recruiting

  • Dermatology Hospital of Southern Medical University

    Guangzhou, Guangdong, 510000

    Not yet recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510000

    Not yet recruiting

  • Hainan Cancer Hospital

    Haikou, Hainan, 570100

    Not yet recruiting

  • Cancer Hospital Of The University Of Chinese Academy Of Sciences Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310000

    Recruiting

  • Sir Run Run Shaw Hospital

    Hangzhou, Zhejiang, 310000

    Not yet recruiting

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150000

    Not yet recruiting

  • The Affiliated Cancer Hospital of Shandong First Medical University

    Jinan, Shandong, 250000

    Not yet recruiting

  • Yunnan Cancer Hospital

    Kunming, Yunnan, 650000

    Not yet recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330000

    Not yet recruiting

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, 210000

    Recruiting

  • Guangxi Medical University Cancer Hospital

    Nanning, Guangxi, 530000

    Not yet recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200000

    Recruiting

  • Liaoning Cancer Hospital ＆ Institute

    Shenyang, Liaoning, 116000

    Not yet recruiting

  • The Fourth Hospital of Hebei Medical University and Hebei Tumor Hospital

    Shijiazhuang, Hebei, 050000

    Not yet recruiting

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi, 030000

    Not yet recruiting

  • Tianjin Medical University Cancer Institute ＆ Hospital

    Tianjin, Tianjin Municipality, 300000

    Not yet recruiting

  • The Affiliated Cancer Hospital, Xinjiang Medical University

    Ürümqi, Xinjiang, 830000

    Not yet recruiting

  • Weifang People's Hospital

    Weifang, Shandong, 261000

    Recruiting

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430000

    Not yet recruiting

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei, 430000

    Not yet recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710000

    Not yet recruiting

  • The Third People's Hospital of Zhengzhou

    Zhengzhou, Henan, 450000

    Recruiting

Other trials in China

About this study

Official title: To Evaluate a Phase III Study of OH2 Versus Investigator-selected Salvage Chemotherapy or Best Supportive Care in Melanoma Patients Who Had Failed Standard Therapy

To evaluate the efficacy of OH2 injection in patients with unresectable or metastatic melanoma who have failed at least second-line standard therapy, using investigator-selected salvage chemotherapy or best supportive care (BSC) as controls.

Conditions
Melanoma
Being tested
OH2, Salvage chemotherapy or best supportive care
Keywords
Oncolytic virus
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OH2Drug

    Oncolytic Type 2 Herpes Simplex Virus

  • Salvage chemotherapy or best supportive careDrug

    single or combined, including but not limited to dacarbazine, temozolomide, taxoid, or platinum

Study groups in NCT05868707
Study groupRoleWhat they receive
OH2ExperimentalOH2: 10^7 CCID50/mL intratumoral injection, once every 2 weeks;
Receives: Drug: OH2
Salvage chemotherapy or best supportive careActive comparatorSalvage chemotherapy (single or combined, including but not limited to dacarbazine, temozolomide, taxoid, or platinum) or best supportive care selected by the investigator
Receives: Drug: Salvage chemotherapy or best supportive care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival (OS)

    Overall survival is defined as the interval from first dose to death from any cause.

    Measured: From date of randomization until the date of death from any cause，assessed up to 3 years

Secondary outcomes (5)

  1. Objective response rate (ORR)

    Determination of the ORR is calculated based on the proportion of patients achieving CR or PR using the RECIST v1.1 and iRECIST as assessed by investigators.

    Measured: Tumor assessments were performed every 8 weeks in first year and every 12 weeks thereafter until confirmed PD, start of new anticancer treatment, death, withdrawal of informed consent, loss of follow-up, or the end of the study, assessed up to 3 years

  2. Disease control rate (DCR)

    DCR is defined as the percentage of participants with a best overall response of CR, PR, or SD.

    Measured: Tumor assessments were performed every 8 weeks in first year and every 12 weeks thereafter until confirmed PD, start of new anticancer treatment, death, withdrawal of informed consent, loss of follow-up, or the end of the study, assessed up to 3 years

  3. Progression-free survival (PFS)

    Progression-free survival is defined as the time from first dose to the earlier event of confirmed PD or death from any cause.

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years

  4. Durable Response Rate (DRR)

    DRR is defined as the percentage of participants with a best overall response of CR or PR using the RECIST/iRECIST assessment with a duration of response of at least 6 months.

    Measured: Tumor assessments were performed every 8 weeks in first year and every 12 weeks thereafter until confirmed PD, start of new anticancer treatment, death, withdrawal of informed consent, loss of follow-up, or the end of the study，assessed up to 3 years

  5. Duration of Response (DOR)

    DOR is defined as the time from the first recording of remission (CR or PR) to the first recording of disease progression or death (whichever comes first)

    Measured: Tumor assessments were performed every 8 weeks in first year and every 12 weeks thereafter until confirmed PD, start of new anticancer treatment, death, withdrawal of informed consent, loss of follow-up, or the end of the study，assessed up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2023
  2. Study start8 Mar 2023
  3. Primary completionMar 2026 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
340 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05868707
Sponsor's protocol ID
BH-OH2-020
Status last verified
Jul 2025
First submitted
3 May 2023
Last updated
25 Jul 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wang X, Tian H, Chi Z, Si L, Sheng X, Hu H, Gu X, Li S, Li C, Lian B, Zhou L, Mao L, Tang B, Yan X, Wei X, Li J, Liu B, Guo J, Kong Y, Cui C. Oncolytic virus OH2 extends survival in patients with PD-1 pretreated melanoma: phase Ia/Ib trial results and biomarker insights. J Immunother Cancer. 2025 Feb 6;13(2):e010662. doi: 10.1136/jitc-2024-010662.

    PubMed 39915002

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing OH2 in people with Melanoma, run by Binhui Biopharmaceutical Co., Ltd. at 30 sites 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 18 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: looking for participants now, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Wentao Xu (15111009972, xuwentao@binhui-bio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (OS) (time frame: From date of randomization until the date of death from any cause，assessed up to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05868707, which also lists 1 linked publication.

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 25 Jul 2025; AzTrials last refreshed its copy on 31 Oct 2026.

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