GEN0101 and pembrolizumab combination therapy in patients with advanced melanoma
- Conditions
- advanced melanomaD008545
- Registration Number
- JPRN-jRCT2051190009
- Lead Sponsor
- TANEMURA ATSUSHI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 46
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 or 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 unresectable, Stage 3C, 3D or Stage 4 advanced melanoma, showing confirmed SD or unconfirmed PD in assessment after 12 week treatment with anti PD1 antibody,
e.g., nivolumab or Pembrolizumab, and also in confirmatory assessment within successive 6 weeks.
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 the following functions of the bone marrow, liver, and kidney at screening.
(1) White blood cells 3,000 micro L and also neutrophil count 1,500 micro L
(2) Platelet 75,000 micro L
(3) Hemoglobin 8.0 g per 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
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.
To confirm the stability of the existing brain metastasis, when conducting image inspection of the brain, it should be carried out by MRI as much as possible. However, if MRI is contraindicated, contrast CT is allowed.
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.
5) A patient who concurrently has an active infection requiring systemic therapy
6)A patient who has received other systemic anticancer therapy than anti PD1 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 has been on long term (in 6month) treatment at a low dose (equivalent to oral prednisolone 10 mg per day) or who received prophylactic immunosuppressant against contrast media allergy.
11)A patient who received a live vaccine within 30 days before registration.
12)A patient who was enrolled in another clinical trial and received an investigational drug within 4 months before the first trial treatment or a patient who intends to be enrolled in another clinical trial in parallel with this clinical trial.
13) A patient who has an active TB infection.
14)A female patient who is pregnant (including one with a positive result in the pregnancy test at screening), lactating, or intending to become pregnant during participation in the trial or before 3 months have passed after the completion of the trial. However, this criterion does not apply to a patient who will stop lactating (from the date of informed consent until 30 days passed after the last trial treatment). Of note, female patients should undergo a beta HCG test to demonstrate pregnancy status. A male patient who does not agree to use appropriate contraception, e.g., the barrier method and a total abstinence, during the trial until 3 months passed after the completion of the trial.
15)A patient who has psychiatric disease considered to be a potential concern from the viewpoints of follow up and protocol adherence.
16)A patient who was given autografting or allografting of organ or tissue (receiving an immunosuppressant).
17)A patient who has 10% shorter PT (%) compared to the lower limit of the institutional reference or 1.5
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method