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

Malignant Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04884997
• Other study ID #: IIT20210021C-R1
• Status: Recruiting
• Phase: Phase 2
• Start date: March 7, 2021
• Est. completion date: September 7, 2024

Study information

• Verified date: May 2021
• Source: First Affiliated Hospital of Zhejiang University
• Contact: Yu Zheng, PhD
• Phone: 13588166206
• Email: drzhengyu[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: September 7, 2024
• Est. primary completion date: March 7, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Malignant Melanoma
• Melanoma

Intervention

Drug:
• toripalimab
toripalimab 3mg/kg, Q2w;
• Temozolomide Injection
Temozolomide 150mg/m2,d1-5,Q4w

Locations

Country	Name	City	State
China	Department of Medical Onocology, First Affiliated Hospital of Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR	objective response rate	8 weeks
Secondary	OS	overall survival	3 years
Secondary	PFS	Progression free survival	1 years
Secondary	DCR	Disease contral rate	8 weeks
Secondary	1-year PFS	progression free survival at 1 year (1year PFS) rate	1 year after treatment initiation
Secondary	6-month PFS	progression free survival at 6 months (6-month PFS) rate	6 months after treatment initiation
Secondary	1-year OS	overall survival at 1 year (1 year OS) rate	1 year after treatment initiation
Secondary	2-year OS	overall survival at 2 years (2 year OS) rate	2 year after treatment initiation