A phase 1/2 clinical trial of a HSV-1 oncolytic virus with IL-12 expression for malignant melanoma

JRCT ID: jRCT2033190086

Registered date:27/08/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: malignant melanoma
• Date of first enrollment: 16/01/2020
• Target sample size: 24
• Study type: Interventional
• Intervention(s): Test drug (T-hIL12) will be administered into the tumor of skin or lymph node metastases in subjects with advanced stage of malignant melanoma. The assigned dose will be repeatedly inoculated into the metastases 2 or 4 times, with an interval of 14 (14 -28) days.

Outcome(s)

Primary Outcome

(Phase 1 part)
Safety
(Phase 2 part)
Response rate (RECIST 1.1)

Secondary Outcome

(Phase 1 part)
1) Response rate (RECIST 1.1 and Response evaluation criteria for oncolytic virus therapy)
2) Overall survival
3) Progression-free survial (RECIST 1.1 and Response evaluation criteria for oncolytic virus therapy)
4) Tumor reduction effects on cutaneous and/or subcutaneous lesions, or lymph nodes inoculated with T-hIL12
(Phase 2 part)
1) Response rate (Response evaluation criteria for oncolytic virus therapy)
2) Safety
3) Overall survival
4) Progression-free survial (RECIST 1.1 and Response evaluation criteria for oncolytic virus therapy)
5) Tumor reduction effects on cutaneous and/or subcutaneous lesions, or lymph nodes inoculated with T-hIL12

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(Phase 1)
1) Histologically confirmed malignant melanoma with stage 3 or 4.
2) Patients who have at least one metastatic skin lesion with 10 mm or larger (the longest diameter), and/or at least one metastatic lymph node with 15 mm or larger (the shortest axis).
3) Patients who were administered with anti-PD-1 antibody and/or molecular targeted drugs.
4) The size and distribution of all the metastatic lesions are recognized with clinical findings including imaging studies (CT, MRI).
5) Age >=20 years
6) More than 30 days have passed from the previous treatment.
7) Eastern Cooperative Oncology Group (ECOG) performance Status (PS) of 0-2.
8) Patients without severe disorders (severe myelosuppression, liver dysfunction, chronic renal dysfunction).

(Phase 2)
1) Histologically confirmed malignant melanoma with stage 3 or 4.
2) Patients who have at least one metastatic skin lesion with 10 mm or larger (the longest diameter), and/ or at least one metastatic lymph node with 15 mm or larger (the shortest axis).
3) Patients who have not been administered with anti-PD-1 antibody or molecular targeted drugs.
4) The size and distribution of all the metastatic lesions are recognized with clinical findings including imaging studies (CT, MRI).
5) Age >=20 years.
6)More than 30 days have passed from the previous treatment.
7) Eastern Cooperative Oncology Group (ECOG) performance Status (PS) of 0-1.
8) Patients without severe disorders (severe myelosuppression, liver dysfunction, chronic renal dysfunction).

Exclude criteria

(Phase 1 and 2)
1) Patients who have brain and/or spinal cord metastases.
2)Estimated survival period < 6 months.
3) Patients who are prgnant or nursing.
4) Patients who cannot prevent pregnancy until 6 months after the trial.
5) Patients who have severe pleural or pericardial effusion or ascites that requires immediate medical attention.
6) Patients who have active infection.
7) Patients who have other malignancies.
8) Patients who are HIV seropositive or had been HIV seropositve before .
9) Patients who have active herpes infection.
10) Patients who have allergy to anti-HSV drugs.
11) Patients who take >10mg of prednisolone or immunosuppressants.
12) Patients who were administered with other clinical trial drugs within 30 days of T-hIL12 administration.
13) Patients who had oncolytic virus therapy before.
14) Patients who are in conditions considered inadequate for the subject to be enrolled in this study.

Related Information

• Primary Sponsor: Okuyama Ryuhei
• Source(s) of Monetary Support: AMED