recurrent/metastatic endometrial cancer MedDRA version: 20.0 Level: PT Classification code 10014734 Term: Endometrial cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10014736 Term: Endometrial cancer recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10014741 Term: En
Conditions
Interventions
Trade Name: Caelyx
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Caelyx
CAS Number: C50664300
Other descriptive name: PEGYLATED LIPOSOMAL DOXORUBICIN
Concentration un
Sponsors
GEICO (Grupo Español de Investigación en Cáncer de Ovario)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Be willing and able to provide written informed consent/assent for the trial. 2.Be at least 18 years of age on day of signing informed consent. 3.Have a histologically or cytologically-documented, advanced (metastatic and/or unresectable) endometrial carcinoma that is incurable. All epithelial endometrial histologies are eligible including: endometrioid, serous, clear-cell carcinoma or squamous. Sarcomas and mesenchymal tumors are excluded. 4.Received only 1 prior line of systemic platinum-based treatment based chemotherapy for advanced, recurrent or metastatic endometrial cancer. 5.Have measurable disease based on RECIST 1.1, (See Appendix 3) 6.Availability of fresh or archival FFPE tumor specimens for analysis for biomarker analysis from a tumor lesion not previously irradiated. 7.ECOG Performance Status (PS) 0 or 1. 8.Demonstrate adequate organ function as defined by the following criteria: Hematologic: Absolute neutrophil count (ANC) = 1.5 × 109/L, platelet count = 100 × 109/L, and hemoglobin = 9 g/dL (without recent transfusion) Hepatic: Total bilirubin level = 1.5 × the upper limit of normal (ULN) range and AST and ALT levels = 2.5 × ULN or AST and ALT levels = 5 x ULN (for subjects with documented metastatic disease to the liver). Renal: Estimated creatinine clearance = 30 mL/min according to the Cockcroft-Gault formula (or local institutional standard method) 9.Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Patients of childbearing potential must be willing to use an adequate method of contraception as outlined in Section 4.3.1 – Contraception, for the course of the study through 60 days after the last dose of study medication. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 14 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 34
Exclusion criteria
Exclusion criteria: 1.Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment. 2.Receipt of 2 or more prior chemotherapy regimens for advanced, recurrent, or metastatic endometrial cancer 3.History of Clinically significant: cardiovascular disease: cerebral vascular accident/stroke, myocardial infarction, unstable angina, congestive heart failure, or serious cardiac arrhythmia requiring medication. 4.Impaired cardiac function defined as left ventricular ejection fraction (LVEF) 1); however, alopecia, sensory neuropathy Grade = 2, or other Grade = 2 not constituting a safety risk based on investigator’s judgment are acceptable. 21.Has received a live vaccine within 4 weeks of planned start of study therapy. 22.Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment. 23.Other severe acute or chronic medical or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior, or l
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To evaluate the efficacy of anti-PDL1 blockade with avelumab in combination with PDL in patients with endometrial cancer.;Secondary Objective: * To evaluate anti-tumor activity of avelumab and PLD in endometrial cancer patients. •To evaluate the differences in efficacy of the study combination according to the groups by the genomic-The Cancer Genome Atlas (TCGA) classification; namely POLE, MSI, and Microsatellite Stable (MSS). •To determine the safety and tolerability of the combination of avelumab and PDL across subjects with advanced endometrial tumors.;Primary end point(s): •Progression Free Survival rate at 6 months according to RECIST 1.1 criteria;Timepoint(s) of evaluation of this end point: at 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Efficacy: Objective response (OR), Progression-Free Survival (PFS), Duration of Response (DR), according to RECIST 1.1 as assessed by the investigator; median Overall Survival (mOS), and OS rate at 1 and 2 years. •Efficacy endpoints will be used to evaluate differences between the TCGA groups. •Safety: AEs (as graded by NCI CTCAE v.4.03); laboratory abnormalities (as graded by NCI CTCAE v.4.03); vital signs (blood pressure, pulse rate); electrocardiograms(ECGs), ECHO or MUGA scans.;Timepoint(s) of evaluation of this end point: Eficacy: at 1 and 2 years Safety: countinously during the trial | — |
Countries
Spain
Contacts
Public ContactCRS Unit (VHIO)
CRS Unit. Vall d' Hebron Institute of Oncology (VHIO)
Outcome results
None listed