NCT07347444
Not yet recruiting
Phase 2
A Prospective, Single-arm, Multicenter, Phase II Clinical Study of Iparomlimab and Tuvoraleimab Injection in Combination With Bevacizumab, Albumin-bound Paclitaxel, and Carboplatin as First- or Second-line Treatment for Patients With Advanced Acral and Mucosal Melanoma
InterventionsIparomlimab and Tuvoraleimab injection+Bev+nab-PC
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Fudan University
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Objective response rate (ORR)
Overview
Brief Summary
This is a prospective, single-arm, multicenter, phase II clinical trial designed to evaluate the efficacy and safety of iparomlimab and tuvoraleimab, in combination with bevacizumab, albumin-bound paclitaxel, and carboplatin as first- or second-line treatment in patients with acral and mucosal melanoma.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects (or their legal representatives/guardians) must sign the informed consent form, indicating that they understand the purpose of this study, are aware of the necessary procedures involved, and are willing to participate.
- •Aged ≥18 years and ≤75 years, regardless of gender.
- •Histologically or pathologically confirmed mucosal or acral melanoma.
- •Braf, Nras, and Ckit gene mutation status is unrestricted.
- •Unresectable or metastatic melanoma, having received ≤1 prior line of systemic therapy (disease recurrence or metastasis within 6 months after completion of adjuvant therapy is considered as first-line therapy).
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 to
- •Expected survival of more than 3 months.
- •At least one measurable lesion according to RECIST v1.
- •Note: Brain metastases cannot serve as target lesions; Lesions previously treated with radiotherapy cannot serve as target lesions unless imaging demonstrates clear progression.
- •Laboratory test results within 7 days prior to screening (including day 7) must meet the following criteria: Neutrophil count ≥1.5×10⁹/L; Platelet count ≥90×10⁹/L; Hemoglobin ≥90 g/L (without transfusion within 14 days); Serum total bilirubin ≤1.25 × upper limit of normal (ULN); ALT and AST ≤ 2.5 × ULN (≤5 × ULN for patients with liver metastases); Serum creatinine ≤1.25 × ULN.
Exclusion Criteria
- •History or presence of other malignancies within the past 5 years, except for cured localized tumors (e.g., basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, etc.).
- •Participation in treatment with an investigational drug or use of an investigational device within 4 weeks prior to the first dose of study treatment.
- •Palliative local therapy for non-target lesions within 2 weeks prior to the first dose; Non-specific immunomodulatory therapy (e.g., interleukins, interferons, thymosin, etc., excluding IL-11 used for treating thrombocytopenia) within 2 weeks prior to the first dose; Treatment with Chinese herbal medicine or Chinese patent medicine with anti-tumor indications within 1 week prior to the first dose.
- •Patients who have previously received iparomlimab and tuvoraleimab or other dual immunotherapy, bevacizumab, albumin-bound paclitaxel, or carboplatin.
- •Active autoimmune disease that has required systemic treatment in the past two years (i.e., with disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
- •History of active or documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis) or chronic diarrhea.
- •History of immunodeficiency; Positive HIV antibody test; Current long-term use of systemic corticosteroids or other immunosuppressive agents.
- •Known active tuberculosis (TB); Subjects suspected of having active TB must undergo clinical evaluation to rule it out; Known active syphilis infection.
- •History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- •History of non-infectious pneumonitis/interstitial lung disease that required systemic corticosteroid treatment or current presence of non-infectious pneumonitis.
Arms & Interventions
Iparomlimab and Tuvoraleimab injection+Bev+nab-PC
Experimental
Intervention: Iparomlimab and Tuvoraleimab injection+Bev+nab-PC (Drug)
Outcomes
Primary Outcomes
Objective response rate (ORR)
Time Frame: up to 2 years
Defined as the percentage of participants in the analysis population who experienced a Complete Response or a Partial Response and was assessed using RECIST 1.1 based on investigator evaluation.
Secondary Outcomes
- Disease control rate (DCR)(up to 2 years)
- Duration of Response (DoR)(up to 2 years)
- Time to Response (TTR)(up to 2 years)
- Progression-Free Survival (PFS)(up to 2 years)
- Overall Survival (OS)(up to 2 years)
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0(up to 2 years)
Investigators
Zhiguo Luo, MD, PhD
Chief Physician
Fudan University
Study Sites (1)
Loading locations...
Similar Trials
Not yet recruiting
Phase 2
Firmonertinib Combined With Definitive Radiotherapy in Stage III Unresectable EGFR Uncommon Mutant Pulmonary AdenocarcinomaNCT07314216Hunan Cancer Hospital15
Not yet recruiting
Phase 2
A Phase II/III Randomized Double-Blind Multicenter Study Comparing UC-MSC-Derived Secretome and Sodium Hyaluronate in Patients With Knee OsteoarthritisNCT07337863Universitas Sriwijaya50
Not yet recruiting
Phase 2
A Phase II Study of Neoadjuvant Sacituzumab Tirumotecan in Combination With Iparomlimab and Tuvonralimab in Locally Advanced Cervical CancerNCT07348861Zheng Min25
Not yet recruiting
Not Applicable
Phase IIa Study of BRY812 Monotherapy in Advanced Gynecological MalignanciesNCT07311538BioRay Pharmaceutical Co., Ltd.56
Recruiting
Phase 2
NWRD06 DNA Plasmid for HCC After Curative Resection.NCT07324304Newish Technology (Beijing) Co., Ltd.30