Melanoma
Conditions
Interventions
Experimental group:Iparomlimab and Tuvonralimab+albumin-bound paclitaxel + carboplatin + bevacizumab
Sponsors
Shanghai Tenth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male and female, age 18-75 years old; 2. Histologically proven unresectable stage III or IV melanoma; 3. No prior systemic antitumor therapy (prior adjuvant or neoadjuvant therapy for melanoma is permitted, adjuvant or neoadjuvant therapy has been completed for >= 4 months, and all associated adverse events have returned to baseline or stabilized); 4. Have at least one measurable lesion according to RECIST v1.1 standards; 5. The subject is known to have BRAF V600 mutation status or agrees to be tested for BRAF V600 mutation in accordance with local institutional standards; 6. Expected survival >= 12 weeks; 7.ECOG PS score: 0-1; 8.Major organs are functioning normally. 9. Subjects agrees use effective contraception for contraception from the time of signing the informed consent form until 120 days after the last use of study drug. 10. Subjects voluntarily join this study, sign the informed consent form, had good compliance, and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Ocular melanoma; 2. Previously received immunotherapy, including immune checkpoint inhibiting antibodies (such as anti-PD-1, PD-L1, CTLA-4 antibodies, etc.), immune checkpoint activating antibodies (such as anti-ICOS, CD40, CD137, GITR, OX40 antibodies, etc.), and immune cell therapy. 3. The patient is known to have a past allergy to macromolecular protein preparations. Contraindicated and allergic to any of the components of epafolitovorellimab, albumin-bound paclitaxel, carboplatin, bevacizumab. 4. Major surgery is performed within 28 days prior to initial dosing (except for diagnostic laparoscopy, where local surgery for isolated lesions is acceptable). 5. History of allogeneic tissue/solid organ transplantation. 6. The presence of disease requiring systemic treatment with corticosteroids (>10 mg daily or equivalent of prednisone) or other immunosuppressive agents (e.g. Cyclophosphamide, azathioprine, methotrexate, thalidomide, TNF-a inhibitors, etc.) within 2 weeks prior to initial administration. Topical corticosteroids, nasal sprays and inhaled steroids are allowed. Systemic corticosteroids are permitted to prevent hypersensitivity to contrast media. 7. Autoimmune diseases that are active or likely to recur, except for vitiligo, alopecia, psoriasis or eczema that do not require systemic treatment; 1.Hypothyroidism due to autoimmune thyroiditis requires only stable dose hormone replacement therapy; 2.Only a steady dose of insulin replacement is required for type 1 diabetes. 8. Other malignant active tumors within the last 5 years, except locally treatable cancers that have been cured (such as basal or squamous cell skin cancer, superficial bladder cancer, or cervical or breast cancer in situ) and breast cancer that has not recurred for more than 3 years after radical surgery. 9. History of pulmonary interstitial disease and/or pneumonia or pulmonary hypertension. 10. Symptomatic, untreated BMS or meningeal metastases that have not reached clinical stability. 11. Poorly controlled hypertension (systolic blood pressure > 150mmHg and/or diastolic blood pressure > 100mmHg) and diabetes, uncontrolled or symptomatic arrhythmias even when given standard treatment. 12. Study the occurrence of thrombotic or embolic events, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction) or pulmonary embolism, within 6 months before the start of treatment. 13. Myocardial infarction, severe/unstable angina pectoris, symptomatic congestive heart failure (NYHA Class III or IV) within the past 12 months. 14. Participate in other clinical investigators for the first 60 days and during treatment. 15. Known active HIV, HBV, or HCV infection. The investigator determines other circumstances that may affect the conduct of the clinical study and the determination of the study results. Other conditions judged by the researchers were not suitable for inclusion in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival,PFS;Overall survival, OS;Disease control rate, DCR;Safety Evaluation; | — |
Countries
China
Contacts
Public ContactXianling Guo
Shanghai Tenth People's Hospital
Outcome results
None listed