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GEMINI - Protocollo principale di nuovi immunomodulatori in monoterapia e in combinazione con agenti antitumorali in partecipanti con carcinoma epatobiliare avanzato (D7987C00001)

Studio Clinico

Patologia: Epatocarcinoma

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: II

Richiesta mandatoria di tessuto: 

Linee di trattamento: Non applicabile

Criteri di inclusione: 

- Partecipanti di età ≥ 18 anni al momento della firma del consenso
- Compilazione del Consenso Informato scritto, firmato e datato
- Tumore solido localmente avanzato o metastatico confermato nel sottostudio sulla base dell'istopatologia.
- Adeguata funzionalità d'organo e midollare
- Almeno 1 lesione misurabile non precedentemente irradiata per RECIST 1.1
- Aspettativa di vita di almeno 12 settimane al momento dello screening
- Disponibile ed in grado di fornire un campione tumorale adeguato.

Criteri di esclusione: 

- Storia del trapianto d'organo allogenico
- Disordini autoimmuni o infiammatori attivi o precedentemente documentati
- Malattia intercorrente non controllata
- Anamnesi di un altro tumore maligno primario, carcinomatosi leptomeningea e immunodeficienza primaria attiva
- Infezione attiva, metastasi cerebrali o compressione del midollo spinale
- Partecipanti con coinfezione HBV e virus dell'epatite D (HDV)
- Trattamento precedente nel presente studio
- Per il sottostudio 1, storia di encefalopatia epatica nei 12 mesi precedenti l’assegnazione del trattamento.

Numero di pazienti previsti: 

180

Schema di trattamento: 

Cohort 1A: MEDI5752 monotherapy
Cohort 1B: MEDI5752 combination with bevacizumab
Cohort 1C: MEDI5752 combination with lenvatinib
Cohort 2A: AZD2936 combination with Gemcitabine and Cisplatin
Cohort 2B: MEDI5752 combination with Gemcitabine and Cisplatin.

Trattamento sperimentale: 

MEDI5752
Bevacizumab
Lenvatinib
AZD2936
Gemcitabine
Cisplatin.

Trattamento di controllo: 

NA

Obiettivi primari dello studio: 

- Objective response rate (ORR) [Time Frame: Through study completion, an average of 2 years]
ORR is defined as the proportion of participants who have a confirmed CR (complete response) or confirmed PR (partial response), determined by the Investigator at local site per RECIST 1.1 (For HCC sub-study 1)
- The number of participants with adverse events/serious adverse events [Time Frame: Through study completion, an average of 2 years]
Number of participants with adverse events and with serious adverse events including abnormal clinical observations, abnormal Electrocardiogram (ECG) parameters, abnormal laboratory assessments and abnormal vital signs that changed from baseline.
- Progression free survival (PFS) [Time Frame: Through study completion, an average of 2 years]
PFS is defined as the time from the start of studyintervention until progression per RECIST 1.1 as assessed by the Investigator at the local site or death due to any cause in the absence of progression, whichever occurs first. (For BTC sub-study 2).

Obiettivi secondari dello studio: 

- Duration Of Response (DOR) [Time Frame: Through study completion, an average of 2 years]
DoR is defined as the time from the date of first documented confirmed response until date of documented progression per RECIST 1.1 by the Investigator at local site or death due to any cause in the absence of disease progression, whichever occurs first.
- Disease Control Rate (DCR) [Time Frame: At 12 and 24 weeks]
DCR at 12 and 24 weeks is defined as the percentage of participants who have a Complete response (CR) or Partial response (PR) in the first 13 and 25 weeks or who have Stable disease (SD) for at least 11 and 23 weeks after the date of first dose respectively, per RECIST 1.1 as assessed by the investigator at local site and derived from the raw tumour data.
- Progression free survival (PFS) [Time Frame: Through study completion, an average of 2 years]
PFS is defined as the time from the start of study intervention until progression per RECIST 1.1 as assessed by the Investigator at the local site or death due to any cause in the absence of progression, whichever occurs first.
- Overall Survival (OS) [Time Frame: Through study completion, an average of 2 years]
OS is defined as the time from the start of study intervention until the date of death due to any cause, whichever occurs first.
- Anti Drug Antibody (ADA) [Time Frame: Through study completion, an average of 2 years]
Incidences of ADAs against novel immunomodulators in serum.
- Pharmacokinetics of novel immunomodulators: Maximum plasma concentration of the study drug (Cmax) [Time Frame: From the first dose of study intervention, at predefined intervals throughout the administration of novel immunomodulators ( approx 2 years )]
Maximum observed plasma concentration of the study drug
- Pharmacokinetics of novel immunomodulators: Time to maximum plasma concentration of the study drug (T-max) [Time Frame: From the first dose of study intervention, at predefined intervals throughout the administration of novel immunomodulators ( approx 2 years )]
Time to maximum observed plasma concentration of the study drug
- lmmunogenicity of novel immunomodulators [Time Frame: From the first dose of study intervention, at predefined intervals throughout the administration of novel immunomodulators ( approx 2 years)]
The number and percentage of participants who develop ADAs.
- Objective response rate (ORR) [Time Frame: Through study completion, an average of 2 years]
ORR is defined as the proportion of participants who have a confirmed CR (complete response) or confirmed PR (partial response), determined by the Investigator at local site per R.

Centri partecipanti

Nord Italia

Ospedale San Raffaele di Milano
Via Olgettina 60 - 20132 Milano - MI

 

Istituto Clinico Humanitas Rozzano
Via Manzoni 56 - 20089 Rozzano - MI

 

Centro Italia

AOU Careggi
Largo Brambilla 3 - 50134 Firenze - FI

 

Sud Italia e isole

Istituto Nazionale Tumori IRCCS Fondazione Pascale
Via Mariano Semmola - 80131 Napoli - NA

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2022-502317-29-00

Data di inserimento: 22.12.2023

Promotore

AstraZeneca

Principal Investigator ITALIA

Riferimento: Dr. Info non disponibile

Telefono: 00000

Email: nd@nd.it

Localita: nd

 

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