Postoperative Adjuvant Treatment of Completely Resected Mucosal Melanoma Phase II Study

STATUS

Recruiting
days left to enroll

78
participants needed

294
sponsor

Beijing Cancer Hospital

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Updated on 19 February 2024

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metastasis

PET-CT

adjuvant therapy

temozolomide

toripalimab

immunostimulants

mucosal melanoma

adjuvant

oral contraceptives

melanoma

cisplatin

Summary

Show definitions

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

Details

Condition	Mucosal Melanoma
Age	18years - 75years
Treatment	Temozolomide, Toripalimab
Clinical Study Identifier	NCT04462965
Sponsor	Beijing Cancer Hospital
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Age 18-75 years, male or female
	Histopathologically confirmed and diagnosed as mucosal melanoma
	ECOG score 0 or 1
	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)
	The patient is not receiving standard adjuvant treatment
	No contraindications, having adequate organ and marrow function
	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
	Enrolled for treatment within 4 months post-procedure
	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
	Previously treated with anti-PD-1, anti-PD-L1, anti-PD-L2
	Known allergy to recombinant humanized anti-PD-1 monoclonal antibody drug and its components
	High dose of interferon therapy or adjuvant chemotherapy (Temozolomide + Cisplatin) was performed after surgery
	Skin melanoma, eye melanoma, melanoma with unknown primary foci
	The primary lesion is not completely resected
	Staging examination indicated residual or metastatic tumor
	Female patients who are pregnant or lactating, or of childbearing potential but not using appropriate contraceptive measures
	Currently having serious and uncontrolled acute infection; or suppurative infection and chronic infection with prolonged wound healing
	Having serious heart disorder, including cardiac failure congestive, uncontrollable high-risk arrhythmia, unstable angina pectoris, infarct myocardial, severe cardiac valve disease and refractory hypertension
	Having neurological, mental disease or mental disorder that can not be easily controlled, poor compliance, inability to cooperate and narrate therapeutic response
	Patients with other malignant tumors at the same time
	Patients paticipated in other clinical trials at the same time
	Positive HIV; positive HCV; positive HBsAg or HBcAb whilst positive HBV DNA copies detected (limit of quantitation 500 IU/mL)
	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)
	Having received live vaccine within 4 weeks prior to the start of treatment
	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

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Postoperative Adjuvant Treatment of Completely Resected Mucosal Melanoma Phase II Study