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

NCT03178123 | Unknown Phase 2 DMC

• 1 other identifier: Junshi-JS001-010
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mucosal Melanoma

Keywords

anti-PD-1 monoclonal antibody; Mucosal Melanoma; Interferons

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Distant metastases-free survival

  5 years

• recurrence - free survival rate at 3 years

  3 years

• Overall survival (OS)

  5 years

• Number of participants with treatment-related adverse events

  5 years

Study Arms (2)

humanized anti-PD-1monoclonal antibody

EXPERIMENTAL

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

high-dose recombinant interferon a-2B

ACTIVE COMPARATOR

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

Interventions

humanized anti-PD-1 monoclonal antibody Toripalimab BIOLOGICAL

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.

Also known as: JS001, TAB001

humanized anti-PD-1monoclonal antibody

high-dose recombinant interferon a-2B BIOLOGICAL

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.

Also known as: Alfatronol, Glucoferon, Heberon Alfa, IFN alpha-2B, Intron A

high-dose recombinant interferon a-2B

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Junshi Bioscience Co., Ltd.: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

MeSH Terms

Interventions

Introns

Intervention Hierarchy (Ancestors)

DNA, Intergenic; Genome Components; Genome; Genetic Structures; Genetic Phenomena; Gene Components; Genes

Study Officials

• Jun Guo, MD, PhD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2017
• First Posted: June 6, 2017
• Study Start: May 31, 2017
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2025
• Last Updated: September 30, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)