Advanced melanoma
Conditions
Interventions
investigational material(s)
Generic name etc : GEN0101
INN of investigational material : -
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material
Sponsors
Osaka University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients meeting all of the criteria from 1) to 10) below are eligible for the trial. 1)A patient who gave written informed consent to trial enrollment of his/her own free will. 2)A patient who is aged 20 to 85 years. 3)A patient who was histologically or cytologically confirmed to have melanoma. 4)A patient with a diagnosis of incurable and unrespectable, Stage3C, 3D or Stage4 advanced melanoma, showing confirmed SD or unconfirmed PD in assessment after >=12-week treatment with anti-PD-1 antibody, e.g., nivolumab or Pembrolizumab, and also in confirmatory assessment within successive 6 weeks. Or the assessment for the treatment over 12 weeks is PD. 5)A patient who has a measurable tumor. 6)A patient who is expected to survive for at least 12 weeks since the planned day of the first trial treatment. 7)A patient whose ECOG performance status is 0 or 1. 8)A patient who has met the following criteria of clinical laboratory tests at screening. (1)White blood cells>=3,000/microL and also neutrophil count>=1,500/microL (2)Platelet>=75,000/microL (3)Hemoglobin>=8.0g/dL (4)AST not higher than the 2.5-fold of the upper limit of the institutional reference (5)ALT not higher than the 2.5-fold of the upper limit of the institutional reference (6)Total bilirubin not higher than the 2-fold of the upper limit of the institutional reference (7)Serum creatinine not higher than the 2-fold of the upper limit of the institutional reference 9)LDH is not higher than the 2-fold of the upper limit of the institutional reference. 10)A female patient of childbearing potential(a premenopausal woman, a woman with medically or drug-induced amenorrhea, and a woman with no history of sterilization), who has agreed to use appropriate contraception, e.g., the barrier method and a total abstinence, during the trial treatment until 3 months passed after completion of the trial treatment. A male patient who has agreed to use appropriate contraception, e.g., the barrier method and a total abstinence, during the above period.
Exclusion criteria
Exclusion criteria: Patients meeting any of the criteria from 1) to 19) below are ineligible for the trial. 1)A patient who has brain metastases. However, patients with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging(note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment. 2)A patient who has showed positive reaction in a prick testing for GEN0101. 3)A patient who has the mutant BRAF gene in a tumor biopsy. 4)A patient who has current pneumonitis or interstitial lung disease. 5)A patient who concurrently has an active infection requiring systemic therapy. 6)A patient who has received other systemic anticancer therapy than anti-PD-1 antibody therapy, e.g., nivolumab or Pembrolizumab, or local IFN-beta therapy within 3 weeks before informed consent(or within 6 weeks before informed consent for a patient received nitrosourea or mitomycin C). 7)A patient who has received another unapproved drug than the anti-PD-L1 antibody within 4 weeks before informed consent. 8)A patient who has intraocular (uveal) melanoma. 9)A patient who has or had another malignant tumor than melanoma. However, this criterion does not apply to a patient who has experienced neither recurrence nor metastasis for at least 5 years at the time of informed consent. 10)A patient who received a systemic corticosteroid or systemic immunosuppressant within 1 week before the first trial treatment. However, this criterion does not apply to a patient who received prophylactic immunosuppressant against contrast media allergy in the case of a long-term (>6-month) treatment at a low dose (equivalent to oral prednisolone =10%-shorter PT(%) compared to the lower limit of the institutional reference or >=1.5-fold longer APTT compared to the upper limit of the institutional reference at screening. 18)A patient who showed positive reaction to any of HBs antigen, HCV antibody, or HIV-1 or HIV-2 antibody at screening. However, even
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety efficacy Phase1b:The index of DLT Phase2:Overall response rate(ORR) | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy Phase1b,2:Antitumor effect(ORR, BOR), individual tumor response, Progression free survival (PFS), Overall survival (OS), induction of antitumor immunity and safety | — |
Countries
Japan
Outcome results
None listed