Envafolimab Combined With Recombinant Human Endostatin and First-line Chemotherapy Treat of Advanced Mucosal Melanoma

Launched by FUDAN UNIVERSITY · Sep 15, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for advanced mucosal melanoma, a type of skin cancer that occurs in the mucous membranes. The researchers want to see how well a combination of three treatments—Envafolimab, recombinant human endostatin, and two chemotherapy drugs (temozolomide and cisplatin)—works together to help patients. They will also look at patients’ blood and tissue samples to find out more about the disease and how it behaves, which might help predict how well the treatment is working.

To participate in this trial, you need to be at least 18 years old and have a confirmed diagnosis of advanced mucosal melanoma. You should not have received any previous treatment for this advanced stage of the disease, and you need to meet specific health criteria. If you qualify and decide to join, you will receive the treatment for up to two years, with regular check-ins to monitor your progress. Throughout the trial, the safety and effectiveness of the treatment will be closely observed. This is an important step in finding better ways to help patients with this challenging condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 18 years old, regardless of gender.
• • Histology and pathology confirmed advanced mucosal melanoma.
• • Gene mutation state is not limited, except BRAFV600 mutation.
• • Has not received first-line treatment for advanced melanoma, and temozolomide and cisplatin have been used in the adjuvant therapy phase, except that the adjuvant therapy phase has been over 6 months or more.
• • Eastern Cancer Cooperation Group (ECOG) physical condition score (PS) 0-1.
• • The estimated survival time is more than 3 months.
• • Within 7 days before screening (including 7 days), the laboratory data were required as follows: neutrophil count ≥ 1.5 × 109 shock L, platelet count ≥ 90 × 109 shock L, hemoglobin ≥ 90g/L (no blood transfusion within 14 days), serum total bilirubin ≤ 1.25x normal upper limit (ULN), ALT and AST ≤ 2.5xULN (patients with liver metastasis ≤ 5xULN); serum creatinine ≤ 1.25xULN.
• • Have at least one measurable focus (RECIST1.1 standard).
• • Subjects (or their legal representatives / guardians) must sign an informed consent form indicating that they understand the purpose of the study, understand the necessary procedures for the study, and are willing to participate in the study.
• Exclusion Criteria:
• • Patients who have previously used PD-L1 inhibitors, except those who progressed 1 year after the end of adjuvant therapy of PD-L1 monoclonal antibody;
• • Allergic to Envafolimab or recombinant human endostatin and experimental chemotherapeutic drugs;
• • Received any experimental drugs or antineoplastic drugs within 4 weeks before entering the group;
• • There is a risk of bleeding, bleeding events of clinical significance or other taboos in the use of antivascular drugs;
• • There is a history of other tumors in the past five years, except for cured cervical cancer or skin basal cell carcinoma;
• • There are tumor emergencies that require immediate radiotherapy, such as symptomatic brain or meningeal metastasis, bone-related events, etc;
• • Pregnant or lactating women; Fertile women who do not use adequate contraception;
• • Alcohol or drug addiction;
• • Patients with active, or history of autoimmune diseases that may recur (e.g. systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulonephritis, etc.), or patients at high risk (such as immunosuppressive therapy required for organ transplants). Except for autoimmune hypothyroidism that requires only hormone replacement therapy or skin diseases that do not require systemic treatment;
• • Patients who need to receive systemic corticosteroids (dose equivalent to \> 10mg prednisone / day) or other immunosuppressive drugs within 14 days before enrollment or during the study. The use of topical or inhaled corticosteroids, or short-term (≤ 7 days) use of glucocorticoids for the prevention or treatment of non-autoimmune and infrequent allergic diseases;
• • Important organ failure or other serious diseases, including interstitial pneumonia, clinically related coronary artery disease, cardiovascular disease or myocardial infarction, congestive heart failure, unstable angina pectoris, symptomatic pericardial effusion or unstable arrhythmia within 6 months before admission;
• • A history of human immunodeficiency virus infection, or other acquired, congenital immunodeficiency diseases, or a history of organ transplant or stem cell transplantation;
• • Patients with active chronic hepatitis B or active hepatitis C. HBV carriers, stable hepatitis B (DNA titer ≤ 103copies / ml) and cured hepatitis C patients (HCVRNA negative) can be enrolled in the group;
• • A history of severe neurological or psychiatric illness; severe infection; active disseminated intravascular coagulation or other concomitant diseases that, in the opinion of the researchers, seriously endanger the safety of patients or affect the completion of the study.