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UNKNOWNPHASE2

Toripalimab in Combination With Axitinib in Patients With Localized Mucosal Melanoma

A Monocentric, Single-arm, Open, Phase II Clinical Study on the Efficacy and Safety of Toripalimab Combined With Axitinib as Neoadjuvant Therapy in Patients With Localized Mucosal Melanoma

NCT04180995•Peking University Cancer Hospital & Institute

View on ClinicalTrials.gov

Summary

This study is one monocentric, single-arm, open, phase Ⅱ clinical study to evaluate the safety and efficacy of Toripalimab monoclonal injection (Tuo Yi) combined with axitinib tablet (Inlyta®) as neoadjuvant therapy for localized mucosal melanoma. Primary objective: To evaluate pathological response (pCR+pPR) rate of Toripalimab combined with axitinib as neoadjuvant therapy for localized mucosal melanoma. The subjects will receive Toripalimab and Axitinib combined therapy after enrollment, and receive operation 2 weeks after the last dose of Axitinib. Toripalimab will be given for a total of 4 cycles (8 weeks), whereas Axitinib will be given for a total of 8 weeks.The subjects can receive Toripalimab for up to one year after the operation.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Being voluntary to sign the informed consent form, with good compliance and willingness to cooperate with follow-up;
•2. Age of 18-75 years, male or female;
•3. Histopathologically diagnosed mucosal melanoma;
•4. ECOG PS score 0 or 1;
•5. Being considered to be able to be completely resected after multidisciplinary (including surgeon, oncologist and radiologist) discussion, and systemic staging examination improved prior to enrollment (need to include cranial enhanced CT/MRI, bone scan, thoracic, abdominal and pelvic enhanced CT/MRI (enhanced MRI of head and neck, gynecological examination additionally needed for female genital melanoma, colonoscopy additionally needed for rectal melanoma), B mode ultrasonography of superficial lymph node, or systemic PET-CT) demonstrated no regional or distant metastasis;
•6. No contraindications for the treatment, including normal peripheral hemogram, basically normal hepatic and renal function as well as ECG:
•* Peripheral hemogram: white blood cell (WBC) ≥3.5×109/L, neutrophil (ANC) ≥1.5×109/L, platelet (PLT) ≥100×109/L, hemoglobin (Hgb) ≥90 g/L;
•* Liver function: alanine aminotransferase (ALT) ≤1.5×ULN, aspartate aminotransferase (AST) ≤1.5×ULN, and total bilirubin (TBil) ≤1.5×ULN;
•* Renal function: blood urea nitrogen ≤ ULN, creatinine ≤ ULN;
•7. Use of highly-effective contraceptive methods during the whole study for men of reproduction ability or women of pregnant possibility (e.g. oral contraceptives, intrauterine contraceptive device, abstinence of sexual intercourse or barrier contraception in combination with spermatocide), and continuation of contraception for 12 months after the end of study treatment.

Exclusion Criteria

•1. Previously treated with anti-PD-1, anti-PD-L1, anti-PD-L2, or antiangiogenic drugs;
•2. Known allergy to Toripalimab or Axitinib or excipient of the study drug;
•3. Patients with ocular melanoma or melanoma with unknown primary foci;
•4. Pregnant and breastfeeding women;
•5. Abnormal coagulation function \[activated partial thromboplastin time (APTT)\> 43 s, or international normalized ratio (INR) \> 1.5×ULN\], or hemorrhagic tendency or hemorrhagic event occurred within two months prior to enrollment (e.g., gastrointestinal hemorrhage, hemorrhagic gastric ulcer, etc.), or receiving thrombolytic or anticoagulation therapy;
•6. Currently having serious and uncontrolled acute infection, or suppurative infection, chronic infection, or prolonged wound healing;
•7. Having serious heart disease, including congestive heart failure, uncontrollable high-risk arrhythmia, unstable angina pectoris, myocardial infarction, severe valvular heart disease and refractory hypertension;
•8. Having neurological, mental disease or psychiatric disorder that can not be easily controlled, poor compliance, inability to cooperate and narrate therapeutic response;
•9. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
•10. Concomitantly other Malignancies;
+5 more criteria

Locations (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

August 6, 2019

Primary Completion Date

July 6, 2022

Completion Date

December 30, 2022

Last Updated

January 31, 2022

Enrollment

ESTIMATED participants

Conditions

Mucosal Melanoma

Interventions

TORIPALIMAB INJECTION(JS001 ) Axitinib tablet (Inlyta®)

DRUG

Contacts

Chuanliang Cui, Dr

CONTACT

'+8613691489319 1008ccl@163.com

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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: January 31, 2022Data 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.

View ClinicalTrials.gov Terms and Conditions

Toripalimab in Combination With Axitinib in Patients With Localized Mucosal Melanoma

Inclusion Criteria

Exclusion Criteria

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