The Study of JS001 Compared to High-Dose Interferon In Patients With Mucosal Melanoma That Has Been Removed by Surgery

A Phase II Randomized, Control, Multi-center Study of Recombinant Humanized Anti-PD-1 mAb for Injection Compared to High-Dose Interferon In Patients With Mucosal Melanoma That Has Been Removed by Surgery

This is a phase II randomized, control, multi-center study of recombinant humanized anti-PD-1 mAb for injection compared to high-Dose interferon in patients with mucosal melanoma that has been removed by surgery.

Study Overview

• Status: Active, not recruiting
• Conditions: Mucosal Melanoma
• Intervention / Treatment: Biological: humanized anti-PD-1 monoclonal antibody Toripalimab; Biological: high-dose recombinant interferon a-2B

Detailed Description

This is a multi-centre，open, randomized, parallel-group study of mucosal melanoma adjuvant therapy to evaluate the efficacy of recombinant humanized anti-PD-1 mAb for injection compared to high-Dose interferon in patients with mucosal melanoma that has been removed by surgery.There will be 220 subjects enrolling the study, and randomized 1:1 grouped into recombinant humanized anti-PD-1 mAb for injection group (experimental group) or interferon group (control group).Each group will have 110 subjects.Random stratification factor is the disease stage (I vs II vs III).The whole research lasts about 60 months.

• Study Type: Interventional
• Enrollment (Anticipated): 220
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Beijing Cancer Hospital

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:

• Male and Female aged between 18 and 75 years are eligible;
• It was confirmed by histopathology that it was a mucosal melanoma;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
• Complete excision of primary focal area, surgical incision; All patients must have disease-free status documented by a complete physical examination and imaging studies prior to registration;
• No adjuvant therapy was received;
• No treatment contraindication, peripheral blood, normal liver, kidney function and electrocardiogram are normal; WBC≥4.0×10^9/L,PLT≥100×10^9/L,Hgb≥90g/L; serum urea nitrogen, cr≤ULN; ALT,AST,TBI≤1.5*ULN,
• Males or female of childbearing potential must: agree to use using a reliable form of contraception (eg, oral contraceptives, intrauterine device, control sex desire, double barrier method of condom and spermicidal) during the treatment period and for at least 12 months after the last dose of study drug;
• FT3,FT4 and TSH is normal;
• Must have read, understood, and provided written informed consent voluntarily. Willing to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol.

Exclusion Criteria:

• Prior treatment with anti-PD-1/PD-L1/PD-L2 antibody;
• Hypersensitivity to recombinant humanized anti-PD-1 monoclonal mAb or its components;
• Skin melanoma, ocular melanoma, original unknown melanoma;
• The primary lesion was incomplete;
• The examination suggests that the tumor remains or metastases;
• Pregnant or nursing;Women with fertility but not contraception;
• There are severe acute infections that are not controlled;There is a suppurative and chronic infection, and the wound is deferrable;
• Those who had serious heart disease;
• Psychiatric medicines abuse without withdrawal, or history of psychiatric illness.
• Patients with other tumor;
• Participate in other clinical studies at the same time;
• Positive tests for HIV, HCV, HBsAg or HBcAb with positive test for HBV DNA (>500IU/ml);
• Patients with any active autoimmune disease or a documented history of autoimmune disease, or history of syndrome that required systemic steroids or immunosuppressive medications, such as hypophysitis, pneumonia, colitis, hepatitis, nephritis, hyperthyroidism or hypothyroidism;
• Prior live vaccine therapy within past 4 weeks;
• Underlying medical condition that, in the Investigator's opinion, would increase the risks of study drug administration or obscure the interpretation of toxicity determination or adverse events

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: humanized anti-PD-1monoclonal antibody; humanized anti-PD-1 monoclonal antibody is to be injected intravenously 3mg/kg Q2w until disease progresses or unacceptable tolerability occurs for 1 year (27 treatments)	Biological: humanized anti-PD-1 monoclonal antibody Toripalimab; humanized anti-PD-1 monoclonal antibody (JS001) 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.; Other Names: JS001, TAB001
ACTIVE_COMPARATOR: high-dose recombinant interferon a-2B; Patients receive 15*10^9 U/m2/d recombinant interferon a-2B intravenously on days 1-5. Treatment repeats weekly for 4 weeks in the absence of disease progression or unacceptable toxicity.Then patients receive 15*10^9 U/m2/d recombinant interferon a-2B intravenously three times weekly for 48 weeks.	Biological: high-dose recombinant interferon a-2B; 15*10^9 U/m2/d recombinant interferon a-2B intravenously on days 1-5 weekly for 4 weeks.Then 15*10^9 U/m2/d recombinant interferon a-2B intravenously three times weekly for 48 weeks.; Other Names: Alfatronol; Glucoferon; Heberon Alfa; IFN alpha-2B; Intron A

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence-free survival rate	to evaluate the Recurrence free survival (RFS) of the patients with mucosal melanoma treated by JS001 and high-Dose interferon	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distant metastases-free survival	to evaluate the distant metastases-free survival of the patients with mucosal melanoma treated by JS001 and high-Dose interferon	5 years
recurrence - free survival rate at 3 years	to evaluate the recurrence - free survival rate at 3 years of the patients with mucosal melanoma treated by JS001 and high-Dose interferon	3 years
Overall survival (OS)	to evaluate the Overall survival (OS) of the patients with mucosal melanoma treated by JS001 and high-Dose interferon	5 years
Number of participants with treatment-related adverse events	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	5 years

Collaborators and Investigators

• Sponsor: Shanghai Junshi Bioscience Co., Ltd.
• Investigators: Principal Investigator: Jun Guo, MD, PhD, Peking University Cancer Hospital & Institute

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 31, 2017
• Primary Completion (ANTICIPATED): April 30, 2022
• Study Completion (ANTICIPATED): April 30, 2025

Study Registration Dates

• First Submitted: May 27, 2017
• First Submitted That Met QC Criteria: June 4, 2017
• First Posted (ACTUAL): June 6, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 30, 2020
• Last Update Submitted That Met QC Criteria: September 28, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Interferons; Mucosal Melanoma; anti-PD-1 monoclonal antibody
• 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; Anti-Infective Agents; Antiviral Agents; Antineoplastic Agents; Immunologic Factors; Interferons; Antibodies; Antibodies, Monoclonal
• Other Study ID Numbers: Junshi-JS001-010

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

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