- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03013101
Safety and Efficacy of Recombinant Humanized Anti-PD-1 mAb for Patients With Locally Advanced or Metastatic Melanoma
28. september 2020 opdateret af: Shanghai Junshi Bioscience Co., Ltd.
A Phase II, Open, Multi-center and Single Arm Study Investigating Safety and Efficacy of Recombinant Humanized Anti-PD-1 mAb for Injection in Patients With Locally Advanced or Metastatic Melanoma and Standard Treatment Failure
This is a multi-center, open-label, phase 2 study evaluating the humanized anti-PD-1 antibody JS001, as a monotherapy in patients with locally advanced or metastatic melanoma who have failed in routine systemic treatment.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This is a multiple-center, open-label, phase 2 study evaluating the humanized anti-PD-1 antibody JS001, as a monotherapy in patients with locally advanced or metastatic melanoma who have failed in previous routine systemic treatment.
Patients are injected with JS001 with 3mg/kg every 2 weeks until disease progresses or unacceptable toxicity occurs.
Response assessment is conducted by every 8 weeks.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
128
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Beijing
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Beijing, Beijing, Kina, 100142
- Beijing Cancer Hospital
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Guangdong
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Guangzhou, Guangdong, Kina
- Sun Yat-sen University Cancer Center
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Hubei
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Wuhan, Hubei, Kina
- Wuhan Union Hospital
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Jiangsu
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Nanjing, Jiangsu, Kina
- The 81st Hospital of Chinese People's Liberation Army
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Jilin
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Changchun, Jilin, Kina
- The First Hospital of Jilin University
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Yunnan
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Kunming, Yunnan, Kina
- Yunnan Cancer Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Male and Female aged 18 and older are eligible;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
- Histologic diagnosis of locally advanced or metastatic melanoma, while ocular melanoma is excluded, and the overall rate of mucousal melanoma is no more than 25%.
- Have failed at least 1 prior routine regimen for advanced disease.
- Providing with tumor specimen (for testing the expression of PD -L1 and the infiltrating lymphocytes);
- documentary evidence of BRAF mutation status;
- At least 1 measurable lesion (only 1 measurable lymph node lesion is excluded) (routine CT scan >=20mm, spiral CT scan >=10mm, no prior radiation to measurable lesions) Predicted survival >=3 months;
- Brain or meningeal metastases must be disposed with surgery or radiation, and be stable clinically for at least 3 months (prior systemic steroids was allowed, but concurrent administration of systemic steroids with the study drug is excluded).
- Screening laboratory values must meet the following criteria(within past 14 days):
hemoglobin ≥ 9.0 g/dL; neutrophils ≥ 1500 cells/ µL; platelets ≥ 100 x 10^3/ µL; total bilirubin ≤ 1.5 x upper limit of normal (ULN); aspartic transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN without, and ≤ 5 x ULN with hepatic metastasis; serum creatinine ≤1╳ULN,creatinine clearance >50ml/min (Cockcroft-Gault equation) PT/INR, aPTT≤1.5 x ULN;
- Without systemic steroids within past 4 weeks
- 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.
- 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 Ab or its components.
- Prior treatment with mAb within past 4 weeks.
- Prior antitumor therapy (including corticosteroids and immunotherapy) or participation in other clinical trials within past 4 weeks, or have not recovered from toxicities since the last treatment;
- Pregnant or nursing;
- Positive tests for HIV, HCV, HBsAg or HBcAb with positive test for HBV DNA (>500IU/ml)
- History with tuberculosis;
- 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.
- Severe, uncontrolled medical condition that would affect patients' compliance or obscure the interpretation of toxicity determination or adverse events, including active severe infection, uncontrolled diabetes, angiocardiopathy (heart failure > class II NYHA, heart block >II grade, myocardial infarction, unstable arrhythmia or unstable angina within past 6 months, cerebral infarction within past 3 months) or pulmonary disease ( interstitial pneumonia, obstructive pulmonary disease or symptomatic bronchospasm).
- Evidence with active CNS disease.
- meningeal carcinomatosis;
- Prior treatment with bone marrow stimulating factors,such as CSF (colony stimulating factor), EPO (erythropoietin), within past 2 weeks
- Prior live vaccine therapy within past 4 weeks.
- Prior major surgery within past 4 weeks (diagnostic surgery excluded).
- Psychiatric medicines abuse without withdrawal, or history of psychiatric illness.
- Prior malignancy active within the previous 5 years except for locally curable cancers that have been apparently cured, such as basal cell skin cancer or carcinoma in situ of the cervix.
- 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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: humaniseret anti-PD-1 monoklonalt antistof
humaniseret anti-PD-1 monoklonalt antistof skal injiceres intravenøst 3mg/kg Q2w, indtil sygdommen skrider frem eller uacceptabel tolerabilitet opstår
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humaniseret anti-PD-1 monoklonalt antistof (JS001) er et programmeret død-1 (PD-1) immun checkpoint inhibitor antistof, som selektivt interfererer med kombinationen af PD-1 med dets ligander, PD-L1 og PD-L2, hvilket resulterer i i aktivering af lymfocytter og eliminering af malignitet teoretisk.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Objective response rate (ORR) by RECIST 1.1 and irRECIST Objective response rate (ORR) by RECIST 1.1 and irRECIST
Tidsramme: 3 years
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3 years
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Samlet overlevelse (OS)
Tidsramme: 3 år
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3 år
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Antal deltagere med behandlingsrelaterede uønskede hændelser vurderet af CTCAE v4.0
Tidsramme: 1,5 år
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1,5 år
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Duration of response (DOR) by RECIST1.1 and irRECIST
Tidsramme: 3 years
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3 years
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Progression free survival (PFS) by RECIST1.1 and irRECIST
Tidsramme: 3 years
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3 years
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Immunogenicity of anti-PD-1 monoclonal antibody
Tidsramme: 1.5 years
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1.5 years
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Andre resultatmål
Resultatmål |
Tidsramme |
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Correlation analysis of PD-L1 expression of tumor by Immunohistochemistry and ORR
Tidsramme: 3 years
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3 years
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Jun Guo, PhD, MD, Peking University Cancer Hospital & Institute
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Topalian SL, Hodi FS, Brahmer JR, Gettinger SN, Smith DC, McDermott DF, Powderly JD, Carvajal RD, Sosman JA, Atkins MB, Leming PD, Spigel DR, Antonia SJ, Horn L, Drake CG, Pardoll DM, Chen L, Sharfman WH, Anders RA, Taube JM, McMiller TL, Xu H, Korman AJ, Jure-Kunkel M, Agrawal S, McDonald D, Kollia GD, Gupta A, Wigginton JM, Sznol M. Safety, activity, and immune correlates of anti-PD-1 antibody in cancer. N Engl J Med. 2012 Jun 28;366(26):2443-54. doi: 10.1056/NEJMoa1200690. Epub 2012 Jun 2.
- Topalian SL, Sznol M, McDermott DF, Kluger HM, Carvajal RD, Sharfman WH, Brahmer JR, Lawrence DP, Atkins MB, Powderly JD, Leming PD, Lipson EJ, Puzanov I, Smith DC, Taube JM, Wigginton JM, Kollia GD, Gupta A, Pardoll DM, Sosman JA, Hodi FS. Survival, durable tumor remission, and long-term safety in patients with advanced melanoma receiving nivolumab. J Clin Oncol. 2014 Apr 1;32(10):1020-30. doi: 10.1200/JCO.2013.53.0105. Epub 2014 Mar 3.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
28. december 2016
Primær færdiggørelse (Faktiske)
16. september 2018
Studieafslutning (Forventet)
1. december 2021
Datoer for studieregistrering
Først indsendt
4. januar 2017
Først indsendt, der opfyldte QC-kriterier
5. januar 2017
Først opslået (Skøn)
6. januar 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
30. september 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. september 2020
Sidst verificeret
1. september 2020
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Junshi-JS001-BJZL-II
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
UBESLUTET
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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National Cancer Institute (NCI)ExelisisAfsluttetStage IV Uveal Melanoma AJCC v7 | Tilbagevendende uveal melanom | Stage III Uveal Melanoma AJCC v7 | Stage IIIA Uveal Melanoma AJCC v7 | Stadie IIIB Uveal Melanoma AJCC v7 | Stage IIIC Uveal Melanoma AJCC v7Forenede Stater, Canada
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Association Pour La Recherche des Thérapeutiques...AfsluttetClear Cell Metastatic Renal Cell CarcinomaFrankrig
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Academic and Community Cancer Research UnitedNational Cancer Institute (NCI)AfsluttetMetastatisk melanom | Fase IV kutan melanom AJCC v6 og v7 | Uoperabelt melanom | Slimhinde melanom | Stage IV Uveal Melanoma AJCC v7Forenede Stater
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