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A Study of Toripalimab or Combining With Temozolomide（iv） in the Treatment of Advanced/Metastatic Malignant Melanoma | Clinical Trials | Clareo Health

UNKNOWNPHASE2

A Study of Toripalimab or Combining With Temozolomide（iv） in the Treatment of Advanced/Metastatic Malignant Melanoma

An Exploratory Study of PD-1 Antibody(Toripalimab) or Combining With Temozolomide for Injection in the Treatment of Advanced/Metastatic Malignant Melanoma

NCT04884997•First Affiliated Hospital of Zhejiang University

View on ClinicalTrials.gov

Summary

This study evaluate toripalimab or combining with temozolomide for injection in the treatment of advanced/metastatic malignant melanoma. Participants in arm A receive toripalimab, in arm B receive toripalimab plus temozolomide

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

••Confirmed pathologic or cytologic diagnosis of advanced/metastatic malignant melanomawithout BRAF V600E mutation
•* ECOG PS 0-1;
•* Age :18 \~75 years old;
•* There were measurable lesions according to RECIST 1.1 and the lesions that had been irradiated showed definite progression after radiotherapy and the lesion was considered measurable only if it was not the only lesion
•* Proper function of the cardiovascular system, liver, kidney and bone marrow ;
•* Subject with at most one systemic therapy for advanced/metastatic malignant melanoma
•* Survival is expected to exceed 3 months
•* The subjects showing good compliance voluntarily participated in the study and signed the informed consent

Exclusion Criteria

••Previously treated with TMZ, PD-1, or PD-L1;
•* Complicated with other malignant tumors;
•* Subjects with central nervous system metastases and/or cancerous meningitis;(Unless the subjects are asymptomatic or have been treated , no radiographic evidence of new BMs or BMs enlargement is found at least 2 weeks after BMs treatment.If the subjects have active or new untreated asymptomatic central nervous system (CNS) metastases found on imaging during the screening phase,they must receive radiotherapy
•* Uncontrolled pleural effusion ,pericardial effusion or ascites requiring repeated drainage
•* Received major surgical treatment or significant traumatic injury within Random 28 days prior
•* Severe arterial/venous thrombosis events，Such as cerebrovascular accident (including temporary ischemic attack) ,deep vein thrombosis and pulmonary embolismwithin Random 6 months prior
•* Subjects with a history of psychotropic substance abuse and being unable to get rid of it or with mental disorders
•* Subjects with any severe and/or uncontrolled disease,including :
•1. Subjects with poor blood pressure control (systolic≥ 150 mmHg or diastolic ≤100mmHg)
•2. Subjects with myocardial ischemia or myocardial infarction or arrhythmia above grade I (including male QTC ≥450ms(male) and female QTC ≥470ms) And ≥grade 2 congestive heart failure (New York Heart Association (NYHA))
+10 more criteria

Locations (1)

Department of Medical Onocology, First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Key Dates

Start Date

March 7, 2021

Primary Completion Date

March 7, 2024

Completion Date

September 7, 2024

Last Updated

May 13, 2021

Enrollment

ESTIMATED participants

Conditions

Malignant Melanoma

Interventions

toripalimab

DRUG

Temozolomide Injection

DRUG

Contacts

Yu Zheng, PhD

CONTACT

13588166206 drzhengyu@126.com

Cheng Xiao, PhD

CONTACT

13588166206 drzhengyu@126.com

An Phase Ib/II Clinical Trial of TCC1727 Combination Therapy in Advanced Solid Tumors

NCT07371663

Solid CancersNSCLC (Advanced Non-small Cell Lung Cancer)+3 more

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RECRUITINGPHASE1/PHASE2

Modified Vaccine for High Risk or Low Residual Melanoma Patients

NCT01898039

Malignant Melanoma

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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: May 13, 2021Data 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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A Study of Toripalimab or Combining With Temozolomide（iv） in the Treatment of Advanced/Metastatic Malignant Melanoma

Inclusion Criteria

Exclusion Criteria

An Phase Ib/II Clinical Trial of TCC1727 Combination Therapy in Advanced Solid Tumors

Modified Vaccine for High Risk or Low Residual Melanoma Patients

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