Phase 2, Open-label, study of the safety and efficacy of TM5614 in combination with Nivolumab in patients with unresectable malignant melanoma

JRCT ID: jRCT2021210029

Registered date:20/08/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Advanced malignant melanoma
• Date of first enrollment: 10/09/2021
• Target sample size: 40
• Study type: Interventional
• Intervention(s): TM5614 (120mg-180mg, once a day orally for 8 weeks)

Outcome(s)

• Primary Outcome: Response rate at 8 weeks after the start of treatment (RECIST score)

Secondary Outcome

Response rate (RECIST evaluation) 8 weeks after the end of the investigational drug treatment period
Recurrence-free survival, overall survival, incidence of adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.Age 18 years or older.
2.Patients who have obtained written consent from the patient (or a surrogate) to participate in this clinical trial
3.Histologically confirmed incurable, unresectable advanced, malignant melanoma
4.Nivolumab non-treated patients(Including other PD-1 checkpoint inhibitors)
BRAF wild-type patients with no prior chemotherapy
BRAF-mutated patients treated with BRAF / MEK inhibitors who have difficulty continuing BRAF / MEK in hibitor combination therapy due to side effects, or patients with advanced results (PD)
5.Nivolumab-treated patients(Including other PD-1 checkpoint inhibitors)
Among patients who had difficulty in continuing nivolumab + ipilimumab combination therapy due to side effects, patients with advanced results (hereinafter referred to as PD) (including patients who continue to receive nivolumab alone).
Patients who had been treated with nivolumab alone and had PD at the stage of enrollment in this stud
6.ECOG performance status 0-1.
7.Life expectancy >=90 days
8.Patients with oral prednisolone of 10 mg / day or less

Exclude criteria

1. Patients with or with a high degree of hypersensitivity reaction to other antibody preparations.
2. Patients whose side effects from prior treatment or the effects of surgical therapy remain and are judged by the investigator or investigator to affect the safety assessment of the investigational drug.
3. Patients with a history of complications of autoimmune disease or chronic or recurrent autoimmune disease. However, patients with hypothyroidism that can be treated with hormone replacement therapy or skin diseases that do not require systemic therapy (white spots, psoriasis, alopecia, etc.) can be registered.
4. Patients with double cancer (completely resected basal cell carcinoma, carcinoma in situ, intramucosal cancer or superficial bladder cancer, or patients with other cancers that have not recurred for more than 5 years prior to consent are enrolled to enable).
5. Patients with central nervous system metastasis. However, patients who are asymptomatic and do not require treatment can be registered.
6. Patients with or with a history of interstitial lung disease, pulmonary fibrosis or radiation pneumonitis diagnosed by diagnostic imaging. However, for radiation pneumonitis, stabilization due to fibrosis has been confirmed, and patients who are not concerned about relapse can be registered.
7. Patients with diverticulitis or symptomatological gastrointestinal ulcer disease.
8. Patients with pericardial fluid, pleural effusion or ascites that require continuous treatment.
9. Patients whose tumor-related pain cannot be stably controlled.
10. Patients with a history of transient ischemic attack or cerebrovascular attack within 180 days prior to enrollment in this study
11. Patients with a history of thrombosis or thromboembolism (pulmonary artery embolism or deep vein thrombosis). However, patients who have passed 90 days or more and are not concerned about relapse can be registered.
12. Patients participating in other clinical trials within 30 days prior to enrollment
13. Patients with a history of hypersensitivity to nivolumab
14. Patients with the following cardiovascular diseases:
Patients with a history of myocardial infarction 6 months before registration. Patients with symptomatic arrhythmia requiring treatment.
15. Patients with active malignancies other than the target.
16. Patients who received radiation therapy within 28 days prior to enrollment in this study. However, irradiation for the purpose of mitigation and irradiation 15 days before registration is permitted.
17. Patients who received radiopharmaceuticals (excluding the use of radiopharmaceuticals for testing and diagnosis) within 56 days prior to enrollment in this study.
18. Patients who are positive for HIV antibody test, HBs antigen test, or HCV antibody test. Patients who are negative for HBsAg test but positive for either HBs antibody test or HBc antibody test and whose HBV-DNA quantification is higher than the detection sensitivity
19. Patients with bleeding tendency.
20. Patients who are pregnant, lactating or may be pregnant
21. Other patients who are not eligible for this clinical trial by the investigator (sharing).

Related Information

• Primary Sponsor: Fujimura Taku
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development(AMED)