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Le groupe d'étude des tumeurs endocrines est une société savante créée en 2002 réunissant les différentes spécialités impliquées dans la prise en charge des tumeurs neuro-endocrines (TNE) : anatomopathologistes, biologistes, chirurgiens, endocrinologues, gastroentérologues, généticiens, médecins nucléaires, oncologues et radiologues.

PDR01

CPDR001E2201 (NET): An open label phase II study to evaluate the efficacy and safety of PDR001 in patients with advanced or metastatic non-functional neuroendocrine tumors of pancreatic, gastrointestinal (GI), or thoracic origin who have progressed on prior treatment.

Type d'étude Promoteur Etat actuel de l'étude
Phase II-R Novartis En cours d'ouverture

 

CPDR001E2201 (NET) : An open label phase II study to evaluate the efficacy and safety of PDR001 in patients with advanced or metastatic non-functional neuroendocrine tumors of pancreatic, gastrointestinal (GI), or thoracic origin who have progressed on prior treatment

Code de l’étude

CPDR001E2201 (NET)

Sponsor

Novartis

Coordinator

Lyon : Dr. Lombard-Bohas    Mail Lombard-Bohas

Centres Français

Clichy, Villejuif, Lyon, Marseille, Toulouse

Objectives

Primary :
Overall response rate [ Time Frame: 1 year after last patient first treatment ] [ Designated as safety issue: No ]
overall response rate is defined as the proportion of patients with best overall response (BOR) of complete response (CR) or partial response (PR), as per RECIST 1.1 and blinded independent central review.
Secondary:
• Duration of response [ Time Frame: baseline, every 8 weeks up to 1 year after last patient first treatment ] [ Designated as safety issue: No ]
  Duration of Response by RECIST 1.1 and as per BIRC
• Disease Control [ Time Frame: Baseline, every 8 weeks up to 1 year after last patient first treatment ] [ Designated as safety issue: No ]
  Disease Control is defined as the proportion of patients with best overall response of CR, PR or SD according to RECIST 1.1 criteria and as per central review
• Time to response [ Time Frame: Baseline, every 8 weeks up to 1 year after last patient first treatment ] [ Designated as safety issue: No ]
  Time to response (TTR) is defined as the time from the date of start of treatment to the first documented response of either complete response (CR) or partial response (PR), which must be subsequently confirmed (although date of initial response is used, not date of confirmation). TTR will be evaluated according to RECIST 1.1
• Progression-free survival [ Time Frame: Baseline, every 8 weeks up to 1 year after last patient first treatment ]
[ Designated as safety issue: No ]
   Progression-free survival is defined as the time from the date of first dose to the date of the first documented radiological progression or death due to any cause
• Overall survival [ Time Frame: Every 3 months after last visit up to 2 year after last patient first treatment ] [ Designated as safety issue: No ]
   Overall survival is defined as the time from date of start of treatment to date of death due to any cause
• Immune Response Criteria by irRECIST(immune response overall response rate) [ Time Frame: Baseline, every 8 weeks up to 1 year after last patient first treatment ] [ Designated as safety issue: No ]
   Immune Response Criteria by irRECIST and as per BIRC (immune response objective response rate)
• Immune Response Criteria by irRECIST (immune response duration of response) [ Time Frame: Baseline, every 8 weeks up to 1 year after last patient first treatment ] [ Designated as safety issue: No ]
   Immune Response Criteria by irRECIST and as per BIRC (immune response duration of response)
• Immune Response Criteria by irRECIST (immune response time to response) [ Time Frame: Baseline, every 8 weeks up to 1 year after last patient first treatment ] [ Designated as safety issue: No ]
   Immune Response Criteria by irRECIST and as per BIRC (immune response time to response)
• Immune Response Criteria by irRECIST (immune response disease control rate) [ Time Frame: Baseline, every 8 weeks up to 1 year after last patient first treatment ] [ Designated as safety issue: No ]
   Immune Response Criteria by irRECIST and as per BIRC (immune response disease control rate)
• Patient's health-related quality of life [ Time Frame: Baseline, every 8 weeks up to 1 year after last patient first treatment ] [ Designated as safety issue: No ]
   Global health status/quality of life score of the EORTC QLQ-C30 and the index score of the EQ-5D-5L
• Biochemical response [ Time Frame: Baseline, every 28 days until treatment completion (2 yrs max) ] [ Designated as safety issue: No ]
   Changes from baseline in chromogranin-A and neuron-specific enolase

Methodology/Design of the Research

This is a study to investigate the efficacy and safety of PDR001 in patients with advanced or metastatic non-functional neuroendocrine tumors of pancreatic, gastrointestinal (GI), or thoracic origin.

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Drug: PDR001: is a high-affinity, ligand-blocking, humanized IgG4 antibody directed against Programmed Death-1 (PD-1) receptor that blocks the binding of PD-L1 and PD-L2. PDR001 dose is 400 mg infusion every 4 weeks.

Inclusion criteria

• Pathologically confirmed, well-differentiated advanced, non-functional neuroendocrine tumor of GI, pancreatic or thoracic origin.
• No history of, and no active symptoms related to carcinoid syndrome.
• Patients must have been pretreated for advanced disease - the number of prior systemic therapy/regimen depends on which origin.
• Patients must be willing to provide biopsy material.
• Radiological documentation of disease progression while on/or after the last treatment; progression must have been observed within 6 months prior to start of study treatment

Non-Inclusion criteria

• Poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoid, large cell neuroendocrine carcinoma and small cell carcinoma.
• Pretreatment with interferon as last treatment prior to start of study treatment.
• Prior treatment for study indication with:
• Antibodies or immunotherapy within 6 weeks before the first dose of study treatment.
• PRRT administered within 6 months of the first dose.
• Systemic antineoplastic therapy
• Tyrosine kinase inhibitors within 14 days or 5 half-lives, whichever is longer, before the first dose of study treatment.
• Prior PD-1- or PD-L1-directed therapy.
• Cryoablation, radiofrequency ablation, or trans-arterial chemoembolization of hepatic metastases
• History of severe hypersensitivity reactions to other monoclonal antibodies which in the opinion of the investigator may pose an increased risk of a serious infusion reaction.

Number of subjects

90 patients