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

NCT04884997 | Unknown Phase 2

• 1 other identifier: IIT20210021C-R1
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Keywords

malignant melanoma; PD-1 antibody; temozolomide for injection; toripalimab

Outcome Measures

Primary Outcomes (1)

• ORR

  objective response rate

  8 weeks

Secondary Outcomes (7)

• OS

  3 years

• PFS

  1 years

• DCR

  8 weeks

• 1-year PFS

  1 year after treatment initiation

• 6-month PFS

  6 months after treatment initiation

Study Arms (2)

Arm A

ACTIVE COMPARATOR

toripalimab 3mg/kg, Q2w;

Drug: toripalimab

Arm B

EXPERIMENTAL

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

Drug: toripalimab; Drug: Temozolomide Injection

Interventions

toripalimab DRUG

toripalimab 3mg/kg, Q2w;

Also known as: triprizumab

Arm A; Arm B

Temozolomide Injection DRUG

Temozolomide 150mg/m2,d1-5,Q4w

Also known as: Temoda

Arm B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 :
• Subjects with poor blood pressure control (systolic≥ 150 mmHg or diastolic ≤100mmHg)
• 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))
• Active or uncontrolled severe infection (≥CTC AE grade 2 infection)
• 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
• HIV infected
• Poor diabetes control (fasting blood glucose (FBG) \> 10mmol/L)
• urine protein≥++,andConfirmated 24-hour urinary protein quantification\>1.0 g

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

Department of Medical Onocology, First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Conditions

Melanoma

Interventions

toripalimab; Temozolomide

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Yulong Zheng, PhD

  First Affiliated Hospital of Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu Zheng, PhD

CONTACT

13588166206; drzhengyu@126.com

Cheng Xiao, PhD

CONTACT

13588166206; drzhengyu@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 10, 2021
• First Posted: May 13, 2021
• Study Start: March 7, 2021
• Primary Completion: March 7, 2024
• Study Completion: September 7, 2024
• Last Updated: May 13, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)