BridgeMD
New treatment option for Melanoma of Skin
Official title Perioperative Toripalimab and Endostatin for Stage II Melanoma: A Phase II Trial
ClinicalTrials.gov ID: NCT06965231
What this study is testing
What is Toripalimab combined with Endostar?
Toripalimab combined with Endostar is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for melanoma of skin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase II clinical trial to evaluate the efficacy and safety of perioperative toripalimab (anti-PD-1) combined with recombinant human endostatin (Endostar) as postoperative adjuvant therapy in patients with clinical stage II cutaneous or acral malignant melanoma. The study aims to answer: 1.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 2 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years, regardless of gender;
- ECOG performance status: 0-1;
- Patients with histologically or cytologically confirmed cutaneous or acral malignant melanoma, excluding mucosal and uveal melanoma;
- Patients with BRAF, CKIT, and NRAS gene test results;
- Treatment-naïve patients who have not received prior anti-tumor therapy;
You likely can't join if
- History of allergic reactions to biological products;
- Patients with prior or concurrent malignancies within 5 years (except cured basal cell carcinoma of skin or carcinoma in situ of cervix);
- Any active autoimmune disease or history of autoimmune disorders (including but not limited to: autoimmune hepatitis, interstitial pneumonia...
- Requirement for immunosuppressive therapy using systemic or absorbable topical corticosteroids (equivalent to prednisone \>10mg/day) within 2 weeks...
- 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...
- Patients with severe and/or uncontrolled comorbidities including:
See the full eligibility criteria
- Age ≥ 18 years, regardless of gender;
- ECOG performance status: 0-1;
- Patients with histologically or cytologically confirmed cutaneous or acral malignant melanoma, excluding mucosal and uveal melanoma;
- Patients with BRAF, CKIT, and NRAS gene test results;
- Treatment-naïve patients who have not received prior anti-tumor therapy;
- Clinical stage II (AJCC 8th edition, 2017);
- Laboratory tests must meet the following criteria:
- 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;
- 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;
- Coagulation: Activated partial thromboplastin time (APTT), international normalized ratio (INR), and prothrombin time (PT) ≤1.5×ULN;
- Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) ≥50%;
- 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...
- Patients must voluntarily participate in the study, sign the informed consent form, and demonstrate good compliance.
- History of allergic reactions to biological products;
- Patients with prior or concurrent malignancies within 5 years (except cured basal cell carcinoma of skin or carcinoma in situ of cervix);
- 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...
- Requirement for immunosuppressive therapy using systemic or absorbable topical corticosteroids (equivalent to prednisone \>10mg/day) within 2 weeks prior to first dose;
- 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...
- Patients with severe and/or uncontrolled comorbidities including:
- Poorly controlled hypertension (SBP ≥150 mmHg or DBP ≥90 mmHg);
- Unstable angina, myocardial infarction, ≥grade 2 congestive heart failure, or arrhythmias requiring treatment (including QTc ≥480ms) within 6 months prior to first dose;
- Active or uncontrolled severe infections (≥grade 2 per CTCAE);
- 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...
- HIV-positive status;
- Poorly controlled diabetes (fasting glucose ≥grade 2 per CTCAE);
- Urinalysis showing proteinuria ≥++ with 24-hour urinary protein \>1.0 g;
- Administration of live vaccines within 4 weeks prior to treatment or anticipated need during study;
- Other conditions deemed by investigators to potentially lead to premature study termination, including: severe comorbidities (including psychiatric disorders) requiring concomitant therapy, significant laboratory...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.