Clinical Study of Chidamide Combined With Toripalimab in the Treatment of Advanced Melanoma
Study Details
Study Description
Brief Summary
The study was a single-arm study designed to evaluate the efficacy and safety of Chidamide combined with Toripalimab.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Chidamide combined with Toripalimab
|
Drug: Chidamide combined with Toripalimab
chidamide：oral, 30 mg/time, twice weekly; Toripalimab：intravenous drip, 3 mg/kg, once every 2 weeks
|
Outcome Measures
Primary Outcome Measures
- Objective response rate (ORR) [Up to approximately 24 months]
Objective response rate (ORR)as measure of efficacy by RECIST 1.1
Secondary Outcome Measures
- Progression Free survival （PFS） [Up to approximately 24 months]
Defined as the time from first dosing (C1D1) to date of first observed progression or death from any cause (whichever comes first)
- Overall Survival（OS） [Up to approximately 24 months]
OS as measure of efficacy by RECIST 1.1
- Duration of Response(DoR) [Up to approximately 24 months]
DoR as measure of efficacy by RECIST 1.1
- Disease control rate（DCR） [Up to approximately 24 months]
Defined as the percentage of patients who have achieved a confirmed response of at least CR or PR or a response of SD
- Incidence Rate of each Toxicity (safety and tolerability) [Up to approximately 24 months]
safety and tolerability as measure of efficacy by CTCAE 5.0
Eligibility Criteria
Criteria
Inclusion Criteria:
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aged ≥ 18 years, male or female
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histologically and/or cytologically confirmed melanoma, clinically diagnosed as inoperable stage III-IV
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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
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if there is brain metastasis, local treatment must have been received before participating in this study and clinical stability ≥ 3 months
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ECOG score 0-1
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at least one measurable lesion (according to RECISTv1.1 evaluation criteria)
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absolute neutrophil count ≥ 1.5 × 109/L, platelets ≥ 100 × 109/L, hemoglobin ≥ 90 g/L
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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.
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Expected survival time ≥ 3 months
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Voluntarily participate in this clinical trial and sign a written informed consent.
Exclusion Criteria:
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no measurable lesions, such as pleural or pericardial exudates, ascites, etc.
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choroidal melanoma
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previous treatment with HDAC inhibitors (including cedaramide, romidepsin, vorinostat, bellistat, panobinostat, etc.)
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history of interstitial lung disease or pneumonia requiring oral or intravenous steroids
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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
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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
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history of immunodeficiency, including positive HIV testing, or other acquired, congenital immunodeficiency diseases, or history of organ transplantation
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uncontrolled cardiovascular disease; history of clinically significant QT prolongation, or screening period > 470 ms for females and > 450 ms for males
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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
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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.)
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History of definite neurological or psychiatric disorders, including epilepsy or dementia
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Any condition that, in the opinion of the investigator, would make participation in this study inappropriate.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Peking University Cancer Hospital & Institute
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CSIIT-Q31