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

NCT ID: NCT04884997

Last Updated: 2021-05-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-07
• Study Completion Date: 2024-09-07

Brief 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

Conditions

Malignant Melanoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A

toripalimab 3mg/kg, Q2w;

Group Type: ACTIVE_COMPARATOR

toripalimab

Intervention Type: DRUG

toripalimab 3mg/kg, Q2w;

Arm B

toripalimab 3mg/kg, Q2w; Temozolomide 150mg/m2,d1-5,Q4w

Group Type: EXPERIMENTAL

toripalimab

Intervention Type: DRUG

toripalimab 3mg/kg, Q2w;

Temozolomide Injection

Intervention Type: DRUG

Temozolomide 150mg/m2,d1-5,Q4w

Interventions

toripalimab

toripalimab 3mg/kg, Q2w;

Intervention Type: DRUG

Temozolomide Injection

Temozolomide 150mg/m2,d1-5,Q4w

Intervention Type: DRUG

Other Intervention Names

triprizumab; Temoda

Eligibility Criteria

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))

3. Active or uncontrolled severe infection (≥CTC AE grade 2 infection)

4. liver cirrhosis,active hepatitis*;*active hepatitis(Hepatitis B reference: HBsAg positive, and HBV DNA test value exceeds the normal valueHepatitis C reference: HCV antibody positive, and HCV virus titer detection value exceeds the upper limit of normal value

5. HIV infected

6. Poor diabetes control (fasting blood glucose (FBG) > 10mmol/L)

7. urine protein≥++,andConfirmated 24-hour urinary protein quantification>1.0 g

8. Subjects received a preventive vaccineor attenuated vaccine within 4 weeks

9. prior to first administration

10. Participated in other clinical trials within 4 weeks

11. Active autoimmune disease（Such as the following, but not limited to: autoimmune hepatitis interstitial pneumonia enteritis vasculitis, nephritis。Subjects with asthma requiring bronchodilators for medical intervention were not included） requiring systemic treatment（Such as the use of palliative drugs, corticosteroids, or immunosuppressants） occurred within 2 years prior to initial administration.Alternative therapy(Examples include thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) is not considered systemic therapy

12. Other conditions that investigators consider the patients are not suitable

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

Sponsors

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Yulong Zheng

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yulong Zheng, PhD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Zhejiang University

Locations

Department of Medical Onocology, First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yu Zheng, PhD

Role: CONTACT

drzhengyu@126.com

13588166206

Cheng Xiao, PhD

Role: CONTACT

drzhengyu@126.com

13588166206

Facility Contacts

CHENG XIAO, MD

Role: primary

21218159@zju.edu.cn

87235896

Other Identifiers

IIT20210021C-R1

Identifier Type: -

Identifier Source: org_study_id