Sequential or up-front triple treatment with durvalumab, tremelimumab and bevacizumab for non-resectable hepatocellular carcinoma (HCC) patients (MONTBLANC)

Conditions

non-resectable hepatocellular carcinoma (HCC)

Brief summary

Objective response rate (ORR)

Detailed description

Overall survival (OS), Progression-free survival (PFS), Time to progression (TTP), Objective response rate acc. to BICR (ORR-BICR), Duration of response (DOR), Disease control rate (DCR), Proportion of patients alive at 18 months (OS-18m), Proportion of patients alive at 24 months ((OS-24m), Progression-free survival from escalation treatment (PFS-E), PFS on next treatment, time to failure of strategy (TTFS), quality of life (a) European Organisation for Research and Treatment of Cancer (EORTC) 30-item core quality of life questionnaire (QLQC30): Change compared to baseline, Time to deterioration in global health status/QoL, functioning scales. b) EORTC 18-item hepatocellular cancer health-related quality of life questionnaire (QLQ-HCC18): Change compared to baseline)., Time to deterioration of liver function, defined as time from randomization to worsening of CTCAE grade compared with baseline and persisting for ≥ 30 days for any of these parameters: aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, albumin, and international normalized ratio (INR), Adverse events and laboratory findings

Related papers

No related papers found yet.

Interventions

DRUGIMFINZI 50 mg/mL concentrate for solution for infusion.

DRUGTREMELIMUMAB

DRUGAybintio 25 mg/ml concentrate for solution for infusion.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Objective response rate (ORR)	—

Secondary

Measure	Time frame
Overall survival (OS), Progression-free survival (PFS), Time to progression (TTP), Objective response rate acc. to BICR (ORR-BICR), Duration of response (DOR), Disease control rate (DCR), Proportion of patients alive at 18 months (OS-18m), Proportion of patients alive at 24 months ((OS-24m), Progression-free survival from escalation treatment (PFS-E), PFS on next treatment, time to failure of strategy (TTFS), quality of life (a) European Organisation for Research and Treatment of Cancer (EORTC) 30-item core quality of life questionnaire (QLQC30): Change compared to baseline, Time to deterioration in global health status/QoL, functioning scales. b) EORTC 18-item hepatocellular cancer health-related quality of life questionnaire (QLQ-HCC18): Change compared to baseline)., Time to deterioration of liver function, defined as time from randomization to worsening of CTCAE grade compared with baseline and persisting for ≥ 30 days for any of these parameters: aspartate aminotransferase (AST),	—

Measure

Time frame

Overall survival (OS), Progression-free survival (PFS), Time to progression (TTP), Objective response rate acc. to BICR (ORR-BICR), Duration of response (DOR), Disease control rate (DCR), Proportion of patients alive at 18 months (OS-18m), Proportion of patients alive at 24 months ((OS-24m), Progression-free survival from escalation treatment (PFS-E), PFS on next treatment, time to failure of strategy (TTFS), quality of life (a) European Organisation for Research and Treatment of Cancer (EORTC) 30-item core quality of life questionnaire (QLQC30): Change compared to baseline, Time to deterioration in global health status/QoL, functioning scales. b) EORTC 18-item hepatocellular cancer health-related quality of life questionnaire (QLQ-HCC18): Change compared to baseline)., Time to deterioration of liver function, defined as time from randomization to worsening of CTCAE grade compared with baseline and persisting for ≥ 30 days for any of these parameters: aspartate aminotransferase (AST),

—

Countries

Germany, Italy

Outcome results

None listed