Postoperative Adjuvant Treatment of Completely Resected Mucosal Melanoma Phase II Study

Mucosal Melanoma Clinical Trial

Official title:

A Phase II, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of Toripalimab Combined With Temozolomide and Cisplatin in the Postoperative Adjuvant Treatment of Completely Resected Mucosal Melanoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04462965
• Other study ID #: JS001-ISS-CO148
• Status: Recruiting
• Phase: Phase 2
• Start date: May 30, 2020
• Est. completion date: June 30, 2025

Study information

• Verified date: January 2022
• Source: Beijing Cancer Hospital
• Contact: Jun Guo
• Phone: 86 010 88196951
• Email: guoj307[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 294
• Est. completion date: June 30, 2025
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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..

Related Conditions & MeSH terms

• Melanoma
• Mucosal Melanoma

Intervention

Combination Product:
• 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
• 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

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RFS assessment per RECIST 1.1.	To Compare the recurrence free survival (RFS) per response evaluation crieria in solid tumors(RECIST 1.1) in subjects of the postoperative adjuvant treatment of completely resected mucosal melanoma treated between Toripalima combined with Temozolomide and Cisplatin and placebo combined with Temozolomideand Cisplatin .	2 years
Secondary	RFS assessment per RECIST1.1 in 1 year and 2 year;	1 year and 2 year recurrence free survival rate of completely resected mucosal melanoma with postoperative adjuvant treatment, will be assessed using RECIST1.1 to evaluate tumor recurrence.	2 years
Secondary	DMFS assessed by investigator per RECIT1.1;	Distant metastasis free survival (DMFS) of completely resected mucosal melanoma with postoperative adjuvant treatment per RECIST 1.1;	2 years
Secondary	Overall survival (OS) per death time;	Overall survival (OS) of completely resected mucosal melanoma with postoperative adjuvant treatment per death time;	2 years
Secondary	.Incidence and grade of AEs and SAEs related to study drugs per NCI-CTCAE version 5.0, AEs = grade 3 related to the study drugs.	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 for safty evaluation.	2 years