Perioperative Toripalimab and Endostatin for Stage II Melanoma: A Phase II Trial

Launched by FUDAN UNIVERSITY · May 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with stage II melanoma, a type of skin cancer. The researchers want to see if combining two medications, toripalimab (an immunotherapy drug) and endostatin (which helps control blood vessel growth), can improve the chances of patients remaining cancer-free for at least two years after surgery compared to past treatments. They are also checking to see if this combination is safe and easy for patients to tolerate.

To participate in the trial, you need to be at least 18 years old and have a confirmed diagnosis of stage II melanoma. You should not have received any previous treatments for cancer and must meet certain health criteria. If you join the study, you will first receive two rounds of toripalimab before having surgery to remove the tumor. After the surgery, you will continue treatment with toripalimab and endostatin for several weeks. Throughout the study, your health will be closely monitored for potential side effects and to check if the cancer comes back. This trial is taking place in multiple hospitals across China and aims to find new ways to improve care for patients with melanoma.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥ 18 years, regardless of gender;
• • 2. ECOG performance status: 0-1;
• • 3. Patients with histologically or cytologically confirmed cutaneous or acral malignant melanoma, excluding mucosal and uveal melanoma;
• • 4. Patients with BRAF, CKIT, and NRAS gene test results;
• • 5. Treatment-naïve patients who have not received prior anti-tumor therapy;
• • 6. Clinical stage II (AJCC 8th edition, 2017);
• 7. Laboratory tests must meet the following criteria:
• • 1. Hematology: Hemoglobin (Hb) ≥90 g/L (no transfusion within 14 days); absolute neutrophil count (ANC) ≥1.5×10\^9/L; platelet count (PLT) ≥100×10\^9/L;
• • 2. Biochemistry: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN; total bilirubin (TBIL) ≤1.5×ULN; serum creatinine (Cr) ≤1.5×ULN, and creatinine clearance \>50 μmol/L;
• • 3. Coagulation: Activated partial thromboplastin time (APTT), international normalized ratio (INR), and prothrombin time (PT) ≤1.5×ULN;
• • 4. Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) ≥50%;
• • 8. Female patients must agree to use contraception (e.g., intrauterine device \[IUD\], oral contraceptives, or condoms) during the study and for 6 months after study completion. A negative serum or urine pregnancy test within 7 days before enrollment is required, and patients must be non-lactating. Male patients must agree to use contraception during the study and for 6 months after study completion;
• • 9. Patients must voluntarily participate in the study, sign the informed consent form, and demonstrate good compliance.
• Exclusion Criteria:
• • 1. History of allergic reactions to biological products;
• • 2. Patients with prior or concurrent malignancies within 5 years (except cured basal cell carcinoma of skin or carcinoma in situ of cervix);
• • 3. Any active autoimmune disease or history of autoimmune disorders (including but not limited to: autoimmune hepatitis, interstitial pneumonia, enteritis, vasculitis, nephritis; asthma requiring bronchodilators for medical intervention). Exceptions include: vitiligo, psoriasis, alopecia not requiring systemic therapy, well-controlled type I diabetes, or hypothyroidism with normal thyroid function on replacement therapy;
• • 4. Requirement for immunosuppressive therapy using systemic or absorbable topical corticosteroids (equivalent to prednisone \>10mg/day) within 2 weeks prior to first dose;
• • 5. Any history or evidence of bleeding diathesis regardless of severity; grade ≥3 bleeding events per CTCAE v5.0 within 4 weeks prior to first dose; or presence of unhealed wounds, fractures, active gastrointestinal ulcers, ulcerative colitis, tumors with active bleeding, or other conditions deemed by investigators to potentially cause gastrointestinal hemorrhage or perforation;
• 6. Patients with severe and/or uncontrolled comorbidities including:
• • 1. Poorly controlled hypertension (SBP ≥150 mmHg or DBP ≥90 mmHg);
• • 2. Unstable angina, myocardial infarction, ≥grade 2 congestive heart failure, or arrhythmias requiring treatment (including QTc ≥480ms) within 6 months prior to first dose;
• • 3. Active or uncontrolled severe infections (≥grade 2 per CTCAE);
• • 4. Clinically significant liver disease including viral hepatitis (active HBV infection with HBV DNA \>1×10³ copies/mL or \>500 IU/mL; HCV infection with HCV RNA \>1×10³ copies/mL or \>100 IU/mL), decompensated liver disease, or chronic hepatitis requiring antiviral therapy;
• • 5. HIV-positive status;
• • 6. Poorly controlled diabetes (fasting glucose ≥grade 2 per CTCAE);
• • 7. Urinalysis showing proteinuria ≥++ with 24-hour urinary protein \>1.0 g;
• • 7. Administration of live vaccines within 4 weeks prior to treatment or anticipated need during study;
• • 8. Other conditions deemed by investigators to potentially lead to premature study termination, including: severe comorbidities (including psychiatric disorders) requiring concomitant therapy, significant laboratory abnormalities, or social/family factors that may compromise patient safety or data/sample collection.