Trial Title:
OH2 Injection in Melanoma
NCT ID:
NCT05868707
Condition:
Melanoma
Conditions: Official terms:
Melanoma
Conditions: Keywords:
Oncolytic virus
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
OH2
Description:
Oncolytic Type 2 Herpes Simplex Virus
Arm group label:
OH2
Intervention type:
Drug
Intervention name:
Salvage chemotherapy or best supportive care
Description:
single or combined, including but not limited to dacarbazine, temozolomide, taxoid, or
platinum
Arm group label:
Salvage chemotherapy or best supportive care
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Over 18 years old, male or female;
2. 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;
3. The overall percentage of subjects with mucosal melanoma will not exceed 22%;
4. Eastern Oncology Consortium (ECOG) physical condition score ECOG 0 ~ 1;
5. The expected survival time is more than 3 months;
6. 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;
7. 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.
8. 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;
9. No severe dysfunction of major organs; Laboratory tests meet the following criteria:
1. 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);
2. Blood BUN and blood creatinine within the range of 1.5 times the upper limit of
normal value;
3. 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);
4. 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;
5. Normal coagulation function (PT, APPT within 1.5 times the upper limit of
normal);
10. Female subjects of childbearing age must have tested serum-negative for pregnancy
before receiving the first trial drug;
11. 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;
12. For subjects with genital herpes, need 3 months after the end of herpes;
13. Voluntary signing of informed consent, expected compliance is good.
Exclusion Criteria:
1. Severe medical conditions, including uncontrolled diabetes with medication, severe
infections requiring systematic treatment, and active digestive tract ulcers;
2. 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;
3. 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);
4. A large amount of pleural fluid or ascites with clinical symptoms or symptomatic
management;
5. Bone metastases (stable metastases controlled by treatment can be ruled out) or the
presence of active, clinical BMS;
6. 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;
7. A history of immunodeficiency (HIV antibody positive), or other acquired or
congenital immunodeficiency diseases, or a history of organ transplantation;
8. 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;
9. There is an active TB infection or other infectious disease that requires systematic
treatment;
10. The subject has a known history of psychotropic substance abuse, alcoholism, or drug
use;
11. 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;
12. Use of investigational drug within 4 weeks prior to initial dosing;
13. Had received live attenuated vaccine within 4 weeks prior to initial administration;
14. Pregnant or lactating women;
15. The investigator believed that the patient was not eligible to participate in the
study for any reason.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking University Cancer Hospital
Address:
City:
Beijing
Zip:
100010
Country:
China
Status:
Recruiting
Facility:
Name:
Chongqing University Cancer Hospital
Address:
City:
Chongqing
Zip:
400000
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Fujian Cancer Hosptial
Address:
City:
Fuzhou
Zip:
350000
Country:
China
Status:
Recruiting
Facility:
Name:
Dermatology Hospital of Southern Medical University
Address:
City:
Guangzhou
Zip:
510000
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510000
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Guangxi Medical University Cancer Hospital
Address:
City:
Nanning
Zip:
530000
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Hainan Cancer Hospital
Address:
City:
Haikou
Zip:
570100
Country:
China
Status:
Not yet recruiting
Facility:
Name:
The Fourth Hospital of Hebei Medical University and Hebei Tumor Hospital
Address:
City:
Shijiazhuang
Zip:
050000
Country:
China
Status:
Not yet recruiting
Facility:
Name:
The First Affiliated Hospital of Harbin Medical University
Address:
City:
Harbin
Zip:
150000
Country:
China
Status:
Not yet recruiting
Facility:
Name:
The Third People's Hospital of Zhengzhou
Address:
City:
Zhengzhou
Zip:
450000
Country:
China
Status:
Recruiting
Facility:
Name:
Hubei Cancer Hospital
Address:
City:
Wuhan
Zip:
430000
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Address:
City:
Wuhan
Zip:
430000
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Zip:
410000
Country:
China
Status:
Recruiting
Facility:
Name:
Nanjing Drum Tower Hospital
Address:
City:
Nanjing
Zip:
210000
Country:
China
Status:
Recruiting
Facility:
Name:
The First Affiliated Hospital of Nanchang University
Address:
City:
Nanchang
Zip:
330000
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Jilin Cancer Hospital
Address:
City:
Changchun
Zip:
130000
Country:
China
Status:
Recruiting
Facility:
Name:
The first hospital of Jilin University
Address:
City:
Changchun
Zip:
130000
Country:
China
Status:
Not yet recruiting
Facility:
Name:
The First Affiliated Hospital of Dalian Medical University
Address:
City:
Dalian
Zip:
116000
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Liaoning Cancer Hospital ＆ Institute
Address:
City:
Shenyang
Zip:
116000
Country:
China
Status:
Not yet recruiting
Facility:
Name:
The First Affiliated Hospital of Xi'an Jiaotong University
Address:
City:
Xi'an
Zip:
710000
Country:
China
Status:
Not yet recruiting
Facility:
Name:
The Affiliated Cancer Hospital of Shandong First Medical University
Address:
City:
Jinan
Zip:
250000
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Weifang People's Hospital
Address:
City:
Weifang
Zip:
261000
Country:
China
Status:
Recruiting
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200000
Country:
China
Status:
Recruiting
Facility:
Name:
Shanxi Bethune Hospital
Address:
City:
Taiyuan
Zip:
030000
Country:
China
Status:
Not yet recruiting
Facility:
Name:
West China Hospital of Sichuan University
Address:
City:
Chengdu
Zip:
610000
Country:
China
Status:
Recruiting
Facility:
Name:
Tianjin Medical University Cancer Institute ＆ Hospital
Address:
City:
Tianjin
Zip:
300000
Country:
China
Status:
Not yet recruiting
Facility:
Name:
The Affiliated Cancer Hospital, Xinjiang Medical University
Address:
City:
Urumqi
Zip:
830000
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Yunnan Cancer Hospital
Address:
City:
Kunming
Zip:
650000
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Cancer Hospital Of The University Of Chinese Academy Of Sciences Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Zip:
310000
Country:
China
Status:
Recruiting
Facility:
Name:
Sir Run Run Shaw Hospital
Address:
City:
Hangzhou
Zip:
310000
Country:
China
Status:
Not yet recruiting
Start date:
March 8, 2023
Completion date:
March 2026
Lead sponsor:
Agency:
Binhui Biopharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Binhui Biopharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05868707
