Clinical Study of Chidamide Combined With Toripalimab in the Treatment of Advanced Melanoma

• Status: Not yet recruiting
• Trial end date: 2024-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The study was a single-arm study designed to evaluate the efficacy and safety of Chidamide combined with Toripalimab.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Cancer Hospital

Criteria

Inclusion Criteria:

• aged ≥ 18 years, male or female

• histologically and/or cytologically confirmed melanoma, clinically diagnosed as inoperable stage III-IV

• previous treatment for advanced tumors (including chemotherapy, targeted, anti-vascular drugs, etc.) failure or no standard treatment, and no PD- (L) 1/CTLA-4 drug treatment; if neoadjuvant/adjuvant therapy has received PD- (L) 1/CTLA-4 drug treatment, the treatment time needs ≥ 6 months

• if there is brain metastasis, local treatment must have been received before participating in this study and clinical stability ≥ 3 months

• ECOG score 0-1

• at least one measurable lesion (according to RECISTv1.1 evaluation criteria)

• absolute neutrophil count ≥ 1.5 × 109/L, platelets ≥ 100 × 109/L, hemoglobin ≥ 90 g/L

• other organ function needs to meet: ① cardiac function needs to meet: left ventricular ejection fraction ≥ 50%, no organic arrhythmia; ② liver function needs to meet: ALT and AST ≤ 2.5 times the upper limit of normal (such as with liver metastasis, ALT and AST ≤ 5 times the upper limit of normal), total bilirubin ≤ 1.5 times the upper limit of normal;③ renal function needs to meet: creatinine ≤ 1.5 times the upper limit of normal; ④ coagulation function: international normalized ratio (International Normalized Ratio,INR) ≤ 1.5 times upper limit of normal; prothrombin time (PT), activated partial thromboplastin time (APTT) ≤ 1.5 times upper limit of normal (unless the subject was receiving anticoagulant therapy and PT and APTT were within the expected range of anticoagulant therapy at screening); ⑤ Thyroid function: thyrotropin (TSH) or free thyroxine (FT4) or free triiodothyronine (FT3) were within ± 10% of normal values.

• Expected survival time ≥ 3 months

• Voluntarily participate in this clinical trial and sign a written informed consent.

Exclusion Criteria:

• no measurable lesions, such as pleural or pericardial exudates, ascites, etc.

• choroidal melanoma

• previous treatment with HDAC inhibitors (including cedaramide, romidepsin, vorinostat, bellistat, panobinostat, etc.)

• history of interstitial lung disease or pneumonia requiring oral or intravenous steroids

• previous vaccination or planned vaccination with live vaccines (seasonal influenza vaccine without live vaccines is allowed), major surgery within 30 days before the first study treatment

• active infection [active bacterial, viral, fungal, mycobacterial, parasitic infections or other infections (excluding fungal infections of the nail bed) within 4 weeks before the screening period, or any major infection event requiring intravenous antibiotic therapy, or targeted antiviral therapy, or hospitalization], or persistent fever within 14 days before screening

• history of immunodeficiency, including positive HIV testing, or other acquired, congenital immunodeficiency diseases, or history of organ transplantation

• uncontrolled cardiovascular disease; history of clinically significant QT prolongation, or screening period > 470 ms for females and > 450 ms for males

• positive baseline pregnancy test in female subjects who are pregnant or lactating or fertile females; or subjects of childbearing age who are unwilling to take effective contraceptive measures for at least 180 days during study participation and after the last dose of study drug

• According to the investigator 's judgment, there are concomitant diseases that seriously jeopardize the subject' s safety or affect the subject 's completion of the study (e.g., severe hypertension ≥ 180/110 mmHg, uncontrolled diabetes, thyroid disease, etc.)

• History of definite neurological or psychiatric disorders, including epilepsy or dementia

• Any condition that, in the opinion of the investigator, would make participation in this study inappropriate.