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Phase II Study in the Treatment of Patients With Advanced Mucinous Melanoma | Clinical Trials | Clareo Health

UNKNOWNPHASE2

Phase II Study in the Treatment of Patients With Advanced Mucinous Melanoma

A Randomized, Controlled, Multicenter Phase II Clinical Study to Evaluate the Efficacy and Safety of Toripalimab Injection Combined With Axitinib in the First-Line Treatment of Patients With Advanced Mucosal Melanoma

NCT03941795•Peking University Cancer Hospital & Institute

View on ClinicalTrials.gov

Summary

This is a randomized, controlled, multicenter Phase II clinical study to evaluate the efficacy and safety of toripalimab injection combined with axitinib in the first-line treatment of patients with advanced mucosal melanoma. The target population is the patients with previously untreated, histopathologically confirmed, unresectable or metastatic mucosal melanoma. At the randomization, patients are randomized 1:1:1 into three groups with approximately 33 subjects in each group to receive toripalimab injection plus axitinib, toripalimab injection monotherapy (subjects who meet the criteria after disease progression may cross over to receive toripalimab plus axitinib), or axitinib monotherapy (subjects who meet the criteria after disease progression may cross over to receive toripalimab plus axitinib); when the patient has disease progression or intolerable toxicity, the treatment is terminated, and the survival follow-up will be initiated.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Men and women, aged 18 to 80 years.
•2. Patients with pathohistologically confirmed, unresectable or metastatic mucosal melanoma.
•3. No prior treatment with any systemic antineoplastic agents (prior adjuvant or neoadjuvant therapy is allowed, but should be completed at least 3 weeks prior to randomization and all related adverse events have returned to normal or CTC-AE Grade 1).
•4. Have a score of 0 or 1 on the ECOG scale.
•5. Tumor tissue samples must be available for PD-L1 expression testing.
•6. At least one measurable lesion according to RECIST 1.1, and the lesion has not been irradiated.
•7. Organ function must meet the following requirements (within 7 days prior to randomization):
•Peripheral blood: absolute neutrophil count (ANC) ≥1.5 × 109/L, platelets (PLT) ≥100 × 109/L, hemoglobin (HB) ≥9 g/dL (no blood transfusion or blood components within 14 days before testing); Liver: Serum bilirubin (TBIL) ≤1.5 x upper limit of normal (ULN),, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 x ULN (≤5 x ULN in case of liver metastases); Serum creatinine ≤1.5 x ULN; International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤1.5 x ULN (only for patients not receiving anticoagulant therapy; patients receiving anticoagulant therapy should keep the anticoagulant within the therapeutic requirements); Normal cardiac function, i.e., normal or abnormal electrocardiogram without clinical significance, and left ventricular ejection fraction (LVEF) greater than 50% on cardiac ultrasound.
•8. Women of childbearing age must have a negative pregnancy test within 7 days prior to treatment; men of reproductive potential or women of childbearing potential must use highly effective contraceptive methods (e.g., oral contraceptives, intrauterine contraceptive devices, abstinence or barrier contraception in combination with spermicides) throughout the trial and continue contraception for 3 months after the end of treatment.
•9. Subjects are willing to participate in this study and sign informed consent form, have good compliance and cooperate with the follow-up.
+11 more criteria

Exclusion Criteria

•1. Patients previously treated with anti-PD-1, anti-PD-L1, anti-PD-L2 therapy and/or VEGFR TKIs.
•2. Patients who have participated in or are participating in clinical trial of other drug/therapy within 4 weeks prior to this study treatment (before randomization).
•3. Major surgery, live vaccination, immunotherapy within 4 weeks prior to study start, and radiotherapy within 2 weeks prior to study start.
•4. History of malignancy other than mucosal melanoma within the past 3 years, with the exception of cured basal cell carcinoma of the skin, squamous cell carcinoma of the skin, early stage prostate cancer, and carcinoma in situ of the cervix.
•5. Patients who received hematopoietic stimulating factors, such as granulocyte colony-stimulating factor (G-CSF) and erythropoietin, within 1 week prior to study start.
•6. HIV test positive.
•7. Patients with active hepatitis B or C:
•* If HBsAg or HBcAb is positive, additionally test HBV DNA (results above the lower limit of detection at site);
•* If the result of HCV antibody test is positive, additionally test HCV RNA.
•8. Known to be allergic to recombinant humanized PD-1 monoclonal antibody drug and its components; known to be allergic to axitinib and any of its excipients.
+2 more criteria

Locations (2)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Baishen First Hospital of Jilin University

Shengyang, Liaoning, China

Key Dates

Start Date

November 11, 2019

Primary Completion Date

June 1, 2022

Completion Date

December 1, 2022

Last Updated

December 6, 2019

Enrollment

ESTIMATED participants

Conditions

Advanced Mucosal Melanoma

Interventions

JS001(Toripalimab Injection)

BIOLOGICAL

Axitinib 1 MG [Inlyta]

DRUG

JS001 and Axitinib

OTHER

Contacts

Jun Guo, MD,PhD

CONTACT

010-88121122 Guoj307@126.com

Xinan Sheng, MD

CONTACT

Time-of-Day Specified Immunotherapy for Advanced Melanoma, The TIME Trial

NCT07155317

Advanced Acral MelanomaAdvanced Cutaneous Melanoma+8 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 6, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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