Registrationsdatum der Studie
Einschluss der ersten teilnehmenden Person
Authorised-recruitment may be ongoing or finished
Wissenschaftlicher Titel (Datenquelle: WHO)
An Open-Label, Multi-Centre, Safety Study of Fixed-Dose Durvalumab + Tremelimumab Combination Therapy or Durvalumab Monotherapy in Advanced Solid Malignancies - STRONG
Studientyp (Datenquelle: WHO)
Interventional clinical trial of medicinal product
Design der Studie (Datenquelle: WHO)
If controlled, specify comparator, Other Medicinial Product:
Phase (Datenquelle: WHO)
Human pharmacology (Phase I): noTherapeutic exploratory (Phase II): noTherapeutic confirmatory - (Phase III): yesTherapeutic use (Phase IV): no
Primäre Endpunkte (Datenquelle: WHO)
Main Objective: To assess the incidence, severity, nature, seriousness, intervention/treatment, outcome, and causality, including immunerelatedness, of adverse events of special interest (AESIs) in patients who are treated with durvalumab and tremelimumab combination therapy or durvalumab monotherapy, using fixed dosing.
;Secondary Objective: 1. To assess the incidence, severity, nature, seriousness,
intervention/treatment, outcome, and causality of AEs (including SAEs).
2. To assess the incidence and frequency of durvalumab and
tremelimumab (as applicable to each tumor Module) interruption and
discontinuation due to treatment-emergent AEs (including SAEs).
3. To assess overall survival (OS).
;Primary end point(s): AESI outcome measures will be assessed, in order to further characterize safety objectives related to AESIs.;Timepoint(s) of evaluation of this end point: - at each visit (every 4 weeks) + safety-follow up visit (90 days after last dose)
Sekundäre Endpunkte (Datenquelle: WHO)
Secondary end point(s): SAE: Number and proportion of patients with SAEs in total and by causality and severity AEs leading to death: Number and proportion of patients with AEs leading to death
AEs leading to treatment interruption or discontinuation: Number and proportion of patients with AEs leading to treatment interruption and/or discontinuation
Overall Survival: defined as the time from the first date of treatment until death due to any cause. OS (days) = Death date or Censor date – treatment start date + 1. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive.
Objective Response Rate (ORR) and Disease Control Rate (DCR): based on investigator assessed response to treatment of CR and PR or CR, PR and SD respectively based on RECIST 1.1.;Timepoint(s) of evaluation of this end point: - at each visit (every 4 weeks) + safety-follow up visit (90 days after last dose)
- survival follow up (every 3 month for up to 5 years)
Kontakt für Auskünfte (Datenquelle: WHO)