Advanced/Recurrent Endometrial Cancer Patients with Disease Progression after Prior Therapy with Platinum-based Chemotherapy
Conditions
Brief summary
Phase I Stage: Determination of MTD and RD: • The MTD will be the lowest dose level explored during dose escalation at which one third or more of evaluable patients experience a DLT during Cycle 1. • The RD will be the highest dose level explored during dose escalation at which less than one third of evaluable patients experience a DLT during Cycle 1., Phase II Stage: The primary objective of this stage is to assess the antitumor activity of the lurbinectedin and dostarlimab combination in terms of ORR, defined as the percentage of evaluable patients with a confirmed response, either complete (CR) or partial (PR).
Detailed description
• Safety: patients will be evaluable for safety if they have received at least one partial infusion of dostarlimab and lurbinectedin. AEs will be graded according to the NCI-CTCAE v.5 and coded using MedDRA dictionary version in force., • Efficacy: antitumor activity of the combination will be evaluated in terms of: Progression-free survival (PFS) Duration of response (DoR) Clinical benefit Overall survival (OS) Mid- and long-term survival, • Pharmacokinetics: PK parameters will be evaluated in plasma by standard non-compartmental and/or population methods., • Pharmacogenomics: the mutational status and the expression levels of potential predictive biomarkers of response and/or resistance to lurbinectedin and dostarlimab treatment will be analyzed from available tumor and blood samples obtained from all patients.
Interventions
DRUGlurbinectedin
DRUGJEMPERLI 500 mg concentrate for solution for infusion
Sponsors
Vall D Hebron Institute Of Oncology
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I Stage: Determination of MTD and RD: • The MTD will be the lowest dose level explored during dose escalation at which one third or more of evaluable patients experience a DLT during Cycle 1. • The RD will be the highest dose level explored during dose escalation at which less than one third of evaluable patients experience a DLT during Cycle 1., Phase II Stage: The primary objective of this stage is to assess the antitumor activity of the lurbinectedin and dostarlimab combination in terms of ORR, defined as the percentage of evaluable patients with a confirmed response, either complete (CR) or partial (PR). | — |
Secondary
| Measure | Time frame |
|---|---|
| • Safety: patients will be evaluable for safety if they have received at least one partial infusion of dostarlimab and lurbinectedin. AEs will be graded according to the NCI-CTCAE v.5 and coded using MedDRA dictionary version in force., • Efficacy: antitumor activity of the combination will be evaluated in terms of: Progression-free survival (PFS) Duration of response (DoR) Clinical benefit Overall survival (OS) Mid- and long-term survival, • Pharmacokinetics: PK parameters will be evaluated in plasma by standard non-compartmental and/or population methods., • Pharmacogenomics: the mutational status and the expression levels of potential predictive biomarkers of response and/or resistance to lurbinectedin and dostarlimab treatment will be analyzed from available tumor and blood samples obtained from all patients. | — |
Countries
Spain
Outcome results
None listed