Postoperative Adjuvant Treatment of Completely Resected Mucosal Melanoma Phase II Study

NCT ID: NCT04462965

Last Updated: 2022-01-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 294 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-30
• Study Completion Date: 2025-06-30

Brief Summary

A mucosal melanoma postoperative adjuvant treatment of multicenter, randomized, double-blind, placebo-controlled phase II study, evaluation of mucosal melanoma patients accept completely resected, Toripalima Combined with Temozolomide and Cisplatin postoperative adjuvant therapy efficacy and safety

Conditions

Mucosal Melanoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Test group

Toripalima Combined with Temozolomide and Cisplatin. Toripalima3 mg/kg intravenous infusion, administered once every 2 weeks (1 treatment cycle every 2 weeks) for a maximum of 1 year. Temozolomide, Oral 200mg/m2 1-5 days and Cisplatin, Iv infusion 25 mg/m2/d for a period of 1 to 3 days, 28 days for 1 cycle, lasting 6 cycles;

Group Type: EXPERIMENTAL

Toripalimab

Intervention Type: COMBINATION_PRODUCT

Injection,Specification 240mg/6ml, 3 mg/kg for the dose, iV, every 2 weeks a dose cycle, up to 1 year; Temozolomide: 100mg or 20mg, Every 4 weeks a dose cycle, up to 6 cycles Cisplatin: Injection, 20mg,Every 4 weeks a dose cycle, up to 6 cycles

Placebo group

Placebo Combined with Temozolomide and Cisplatin. Toripalima3 mg/kg intravenous infusion, administered once every 2 weeks (1 treatment cycle every 2 weeks) for a maximum of 1 year. Temozolomide, Oral 200mg/m2 1-5 days and Cisplatin, Iv infusion 25 mg/m2/d for a period of 1 to 3 days, 28 days for 1 cycle, lasting 6 cycles;

Group Type: PLACEBO_COMPARATOR

Temozolomide

Intervention Type: COMBINATION_PRODUCT

Placebo：Injection,Specification 240mg/6ml, 3 mg/kg for the dose, iV, every 2 weeks a dose cycle, up to 1 year; Temozolomide: 100mg or 20mg, Every 4 weeks a dose cycle, up to 6 cycles Cisplatin: Injection, 20mg,Every 4 weeks a dose cycle, up to 6 cycles

Interventions

Toripalimab

Injection,Specification 240mg/6ml, 3 mg/kg for the dose, iV, every 2 weeks a dose cycle, up to 1 year; Temozolomide: 100mg or 20mg, Every 4 weeks a dose cycle, up to 6 cycles Cisplatin: Injection, 20mg,Every 4 weeks a dose cycle, up to 6 cycles

Intervention Type: COMBINATION_PRODUCT

Temozolomide

Placebo：Injection,Specification 240mg/6ml, 3 mg/kg for the dose, iV, every 2 weeks a dose cycle, up to 1 year; Temozolomide: 100mg or 20mg, Every 4 weeks a dose cycle, up to 6 cycles Cisplatin: Injection, 20mg,Every 4 weeks a dose cycle, up to 6 cycles

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

1. Age 18-75 years, male or female；

2. Histopathologically confirmed and diagnosed as mucosal melanoma;

3. ECOG score 0 or 1;

4. The primary lesion is completely resected and the surgical margin is (-); Complete whole-body staging examination (including: brain enhanced CT or MRI, chest, abdomen, pelvic enhanced CT (nasopharyngeal MRI or CT, oropharyngeal MRI or CT), superficial lymph node b-ultrasound; or whole body PET-CT) should be performed before enrollment to confirm there are no regional or distant metastases (patients with contrast media allergy may choose plain CT);

5. The patient is not receiving standard adjuvant treatment；

6. No contraindications, having adequate organ and marrow function；

7. Use of highly-effective contraceptive methods during the whole study for men of reproduction ability or women of childbearing potential (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 treatment；

8. Enrolled for treatment within 4 months post-procedure;

9. The subject is voluntary to participate in the study, sign the informed consent form, with good compliance and willingness to cooperate with follow-up.

Exclusion Criteria

1. Previously treated with anti-PD-1, anti-PD-L1, anti-PD-L2;

2. Known allergy to recombinant humanized anti-PD-1 monoclonal antibody drug and its components;

3. High dose of interferon therapy or adjuvant chemotherapy (Temozolomide + Cisplatin) was performed after surgery;

4. Skin melanoma, eye melanoma(except the conjunctival), melanoma with unknown primary foci;

5. The primary lesion is not completely resected;

6. Staging examination indicated residual or metastatic tumor;

7. Female patients who are pregnant or lactating, or of childbearing potential but not using appropriate contraceptive measures;

8. Currently having serious and uncontrolled acute infection; or suppurative infection and chronic infection with prolonged wound healing;

9. Having serious heart disorder, including cardiac failure congestive, uncontrollable high-risk arrhythmia, unstable angina pectoris, infarct myocardial, severe cardiac valve disease and refractory hypertension;

10. Having neurological, mental disease or mental disorder that can not be easily controlled, poor compliance, inability to cooperate and narrate therapeutic response;

11. Patients with other malignant tumors at the same time;

12. Patients paticipated in other clinical trials at the same time;

13. Positive HIV; positive HCV; positive HBsAg or HBcAb whilst positive HBV DNA copies detected (limit of quantitation 500 IU/mL);

14. Active autoimmune diseases requiring systemic treatment in the past two years (e.g., use of disease-regulating drug, corticosteroid or immunosuppressant), relevant replacement therapy is allowed (e.g., thyroxine, insulin or physiological corticosteroid replacement therapy for renal or pituitary insufficiency);

15. Having received live vaccine within 4 weeks prior to the start of treatment;

16. Other severe, acute or chronic medical diseases or mental diseases or abnormalities in laboratory examination possibly increasing the relevant risk in study participation or possibly interfering the interpretation of study results as judged by the investigators..

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role: lead

Responsible Party

Jun Guo

Associate Director of Beijing University Cancer Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jun Guo

Role: CONTACT

guoj307@126.com

86 010 88196951

Facility Contacts

Jun Guo

Role: primary

guoj307@126.com

010-88196951

Other Identifiers

JS001-ISS-CO148

Identifier Type: -

Identifier Source: org_study_id