Maintenance Treatment of Toripalimab(JS001) in Patients With Unresectable Locally Advanced or Metastatic Mucosal Melanoma (MTAM)

A Multicenter, Single-arm, Open, Phase II Clinical Study on the Efficacy and Safety of Toripalimab(JS001) After Chemotherapy in Combination With Endostar in Patients With Unresectable Locally Advanced or Metastatic Mucosal Melanoma

This study is a multicenter, single-arm, open, phase Ⅱ clinical study to evaluate the safety and efficacy of Toripalimab(JS001) monoclonal injection after chemotherapy in combination with Endostar for Locally Advanced or Metastatic Mucosal Melanoma.

Study Overview

• Status: Recruiting
• Conditions: Mucosal Melanoma
• Intervention / Treatment: Drug: Toripalimab; Drug: chemotherapy in combination with Endostar

• Study Type: Interventional
• Enrollment (Anticipated): 31
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Zhiguo Luo
      • Contact: Zhiguo Luo, MD,PhD; Phone Number: 8908 862164175590; Email: luozhiguo88@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age 18-75 years, male or female；
2. Histopathologically confirmed and diagnosed as mucosal melanoma;
3. ECOG score 0 or 1;
4. Life expectancy of at least 12 weeks；
5. SD/PR/CR after chemotherapy in combination with Endostar;
6. No contraindications, having adequate organ and marrow function；
7. 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；
8. 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:

1. Previously treated with anti-PD-1, anti-PD-L1, anti-PD-L2;
2. Known allergy to recombinant humanized anti-PD-1 monoclonal antibody drug and its components;
3. Skin melanoma, eye melanoma, melanoma with unknown primary foci;
4. Symptomatic brain or meningeal metastases, unless the patient has been treated for > 6 months, the imaging results are negative within 4 weeks before entering the study, and the clinical symptoms associated with the tumor are stable at the time of entering the study;
5. Female patients who are pregnant or lactating, or of childbearing potential but not using appropriate contraceptive measures;
6. Currently having serious and uncontrolled acute infection; or suppurative infection and chronic infection with prolonged wound healing;
7. Having serious heart disorder, including cardiac failure congestive, uncontrollable high-risk arrhythmia, unstable angina pectoris, infarct myocardial, severe cardiac valve disease and refractory hypertension;
8. Having neurological, mental disease or mental disorder that can not be easily controlled, poor compliance, inability to cooperate and narrate therapeutic response;
9. Patients with other malignant tumors at the same time;
10. Patients participated in other clinical trials at the same time;
11. Positive HIV; positive HCV; positive HBsAg or HBcAb whilst positive HBV DNA copies detected (limit of quantitation 500 IU/mL);
12. 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);
13. Having received live vaccine within 4 weeks prior to the start of treatment;
14. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: chemotherapy+Endostar+Toripalimab(JS001)

Drug: Toripalimab; Toripalimab, humanized anti-PD-1 monoclonal antibody is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2, resulting in the activation of lymphocytes and elimination of malignancy theoretically. Toripalimab treatment after chemotherapy in combination with Endostar, 240 mg, Q3W, up to 2 years.; Other Names: JS001; Drug: chemotherapy in combination with Endostar; chemotherapy+ Endostar

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival, PFS	PFS is defined as the time from the date of first treatment to the first occurrence of disease progression or death from any cause.	Approximately 1 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate, ORR	ORR is defined as the proportion of patients with a complete response (CR) or partial response (PR) on two consecutive occasions >= 4 weeks apart, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).	Approximately 2 years
Overall Survival, OS	OS is defined as the time from the date of first treatment to death from any cause.	Approximately 2 years
Incidence of AEs/SAEs	Percentage of Participants With Adverse Events/Severe Adverse Events	Approximately 2 years

Collaborators and Investigators

• Sponsor: Fudan University
• Collaborators: Zhejiang Cancer Hospital; Fujian Cancer Hospital; The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2020
• Primary Completion (Anticipated): June 20, 2022
• Study Completion (Anticipated): June 20, 2023

Study Registration Dates

• First Submitted: July 9, 2020
• First Submitted That Met QC Criteria: July 12, 2020
• First Posted (Actual): July 15, 2020

Study Record Updates

• Last Update Posted (Actual): July 15, 2020
• Last Update Submitted That Met QC Criteria: July 12, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Endostar protein
• Other Study ID Numbers: ZLuo

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No