Combining Chidamide and Toripalimab for Advanced Melanoma Treatment

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

This study is testing a new combination of two drugs, Chidamide and Toripalimab, to see if it can help people with advanced melanoma who have run out of other treatment options.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 43 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Peking University Cancer Hospital & Institute (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, Toripalimab
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT05478473 on ClinicalTrials.gov

What this trial studies

This clinical study evaluates the safety and efficacy of Chidamide in combination with Toripalimab for patients with advanced melanoma. It is a single-arm study that focuses on individuals who have inoperable stage III-IV melanoma and have either failed previous treatments or have no standard treatment options available. Participants must meet specific eligibility criteria, including having measurable lesions and stable organ function. The study aims to provide insights into a potential new treatment approach for this challenging condition.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with histologically confirmed inoperable stage III-IV melanoma who have not responded to previous treatments.

Not a fit: Patients with operable melanoma or those who have already received PD-(L)1/CTLA-4 treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment combination could offer a new therapeutic option for patients with advanced melanoma.

How similar studies have performed: While this specific combination has not been widely tested, similar approaches using immunotherapy and targeted therapies have shown promise in treating melanoma.

Eligibility 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 total duration of drug treatment should be ≥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.
* Previous anti-tumor therapy (chemotherapy, radiotherapy, targeting, traditional Chinese medicine, other immunotherapy) requires eluting for 28 days.
* The adverse effects of previous antitumor therapy were resolved to grade 0-1 before the screening period (as determined by NCI CTCAE 5.0; Except for toxicity, such as hair loss, which the investigator determined did not pose a safety risk to the subject)

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 \[active bacterial, viral, fungal, mycobacterial, parasitic infections or other infections (excluding fungal infections of the nail bed) within 4 weeks before the screening period, or any major infection event requiring intravenous antibiotic therapy, or targeted antiviral therapy, or hospitalization; Active hepatitis is defined as HBsAg positive with HBV DNA≥500 IU/ml or HCV antibody positive with HCV copy number \> the upper limit of normal\], 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, Hypertriglyceridemia ≥ grade 2, 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.

Where this trial is running

Beijing, Beijing

• Beijing Cancer Hospital — Beijing, Beijing, China (Recruiting)

Study contacts

• Study coordinator: Jun Guo, Doctor

Conditions Melanoma