- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03013101
Safety and Efficacy of Recombinant Humanized Anti-PD-1 mAb for Patients With Locally Advanced or Metastatic Melanoma
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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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Beijing
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Beijing, Beijing, Chine, 100142
- Beijing Cancer Hospital
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Guangdong
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Guangzhou, Guangdong, Chine
- Sun Yat-Sen University Cancer Center
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Hubei
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Wuhan, Hubei, Chine
- Wuhan Union Hospital
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Jiangsu
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Nanjing, Jiangsu, Chine
- The 81st Hospital of Chinese People's Liberation Army
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Jilin
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Changchun, Jilin, Chine
- The First Hospital of Jilin University
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Yunnan
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Kunming, Yunnan, Chine
- Yunnan Cancer Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: anticorps monoclonal anti-PD-1 humanisé
l'anticorps monoclonal anti-PD-1 humanisé doit être injecté par voie intraveineuse à raison de 3 mg/kg Q2w jusqu'à ce que la maladie progresse ou qu'une tolérance inacceptable se produise
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L'anticorps monoclonal humanisé anti-PD-1 (JS001) est un anticorps inhibiteur de point de contrôle immunitaire de la mort programmée-1 (PD-1), qui interfère sélectivement avec la combinaison de PD-1 avec ses ligands, PD-L1 et PD-L2, résultant dans l'activation des lymphocytes et l'élimination de la malignité théoriquement.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Objective response rate (ORR) by RECIST 1.1 and irRECIST Objective response rate (ORR) by RECIST 1.1 and irRECIST
Délai: 3 years
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3 years
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
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Survie globale (SG)
Délai: 3 années
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3 années
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Nombre de participants présentant des événements indésirables liés au traitement, évalués par CTCAE v4.0
Délai: 1,5 ans
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1,5 ans
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Duration of response (DOR) by RECIST1.1 and irRECIST
Délai: 3 years
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3 years
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Progression free survival (PFS) by RECIST1.1 and irRECIST
Délai: 3 years
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3 years
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Immunogenicity of anti-PD-1 monoclonal antibody
Délai: 1.5 years
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1.5 years
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Autres mesures de résultats
Mesure des résultats |
Délai |
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Correlation analysis of PD-L1 expression of tumor by Immunohistochemistry and ORR
Délai: 3 years
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3 years
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Jun Guo, PhD, MD, Peking University Cancer Hospital & Institute
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Junshi-JS001-BJZL-II
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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