UnknownPhase 2

Toripalimab Combined With Anlotinib in Unresectable Locally Advanced or Metastatic Acral Malignant Melanoma

China29 participantsStarted 2021-11-01

Plain-language summary

Evaluate PFS of PD-1 Toripalimab Combined With Anlotinib in Subjects With unresectable locally advanced or metastatic acral malignant melanoma

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓.18 and 75 years; Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; Life expectancy ≥ 3 months.
✓.Histologically or cytologically confirmed unresectable locally advanced or metastatic acral malignant melanoma.
✓.At least one measurable lesion, as defined by RECIST v1.1, that has not been irradiated. New lesions that have developed in a previously irradiated field may be used as sites of measurable disease assuming all other criteria are met.
✓.The main organs function are normally. Adequate bone marrow, hepatic, and renal function documented within 4 weeks prior to treatment as documented by:absolute neutrophil count ≥ 1.5\*10\^9/L; platelets ≥ 100 x 10\^9/ L; hemoglobin ≥ 90 g/L(no blood transfusion within 14 days before enrollment) serum creatinine ≤1.5×ULN，total bilirubin ≤ 1.5 x upper limit of normal (ULN); aspartic transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN , unless there are liver metastases in which case AST and ALT ≤5.0 x ULN;INR, aPTT, PT≤1.5 x ULN; left ventricular ejection fraction (LVEF) ≥50%. serum creatinine ≤1╳ULN，creatinine clearance \>50 umol/L；urinary protein \<2+ by urine dipstick. If dipstick is ≥2+ then a 24-hour urine collection can be done and the patient may enter only if urinary protein is \<2 g per 24 hours；Women of childbearing potential must have a negative serum or urine pregnancy test are received within 7 days before the randomization. Women of non childbearing age are defined as having been postmenopausal for at least 1 year, or having undergone sterilization or hysterectomy.Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 1 year after the last dose of study with an annual failure rate of less than 1% (such as intrauterine devices , contraceptives or condoms) .
✓.Written and voluntary informed consent. 8.No evidence of preexisting uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart. The baseline systolic blood pressure readings must be ≤140, and the baseline diastolic blood pressure readings must be ≤90. Patients whose hypertension is controlled by antihypertensive therapies are eligible

Exclusion criteria

✕. Any component of this study was not tolerated in the past.
✕. Participated in other clinical trials within 4 weeks
✕. Hypersensitivity to recombinant humanized anti-PD-1 monoclonal Abm or its components.
✕. Has received chemotherapy, surgery, radiotherapy, the last treatment from the first dose less than 4 weeks, or oral targeted drugs for less than 5 half-lives, or oral fluorouracil pyridine drugs for less than 14 days, mitomycin C and nitrosourea for less than 6 weeks.
✕. Prior therapy with VEGFR-target TKI included anlotinib or an anti-programmed cell death (PD)-1, anti-PD-L1, anti-PD-L2, anti-tumor necrosis factor CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody ,or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways. Previous treatment with anti-angiogenesis agents including thalidomide, or inhibitors of epidermoid growth factor (EGF), platelet derived growth factor (PDGF), or fibroblast growth factors (FGF) receptors.
✕. Any other form of systemic or local antitumor therapy is planned for the duration of the study.
✕. Immunosuppressive therapy with immunosuppressive agents or systemic or absorbable local hormones (dosage \> 10 mg/day prednisone or other therapeutic hormones) is required for the purpose of immunosuppression, and is still in use for 2 weeks after the first administration.
✕. Has diagnosed and/or treated additional malignancy within 5 years prior to randomization. Exceptions include cured basal cell carcinoma of skin and carcinoma in situ of cervix.

What they're measuring

Progression-Free-Survival

Timeframe: up to 2 year

Trial details

NCT IDNCT05087602

SponsorQilu Hospital of Shandong University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-09-30

Contact for this trial

cuihua yi

18560082871 552029978@qq.comqq.com

View on ClinicalTrials.gov More Locally Advanced or Metastatic Acral Malignant Melanoma trials