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| ID | Type | Description | Link |
|---|---|---|---|
| RECF-005767 | Registry Identifier | INCA |
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| Name | Class |
|---|---|
| Institut Curie | OTHER |
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LARENA is a multicentric retrospective study (secondary use of data) of consecutive patients prospectively registered in the lenvatinib plus pembrolizumab French early access program (Temporary Authorisation for Use). The source of data will be the patient's medical file. We will manually review all files of the participating centers.
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| Measure | Description | Time Frame |
|---|---|---|
| Median progression free survival (PFS) | Time from the first administration of lenvatinib + pembrolizumab to the date of the first documented disease progression according to RECIST1.1 or death due to any cause whichever occurs first. | An estimated median follow-up of 5 months from March 2022 to May 2024. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | Time from the initial diagnosis of metastatic endometrial cancer to the date of death | An estimated median follow-up of 5 months from March 2022 to May 2024. |
| Clinical benefit rate (CBR: SD, CR, PR). |
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Inclusion Criteria:
Exclusion Criteria:
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Patient who received lenvatinib with pembrolizumab in metatstatic endometrial cancer.
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| Name | Affiliation | Role |
|---|---|---|
| Diana BELLO ROUFAI | Institut Curie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICO Paul Papin | Angers | 49055 | France | |||
| Sainte Catherine - Institut du Cancer Avignon |
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Time from the first administration of lenvatinib + pembrolizumab to the date of the first documented disease progression according to RECIST1.1 or death due to any cause whichever occurs first.
| An estimated median follow-up of 5 months from March 2022 to May 2024. |
| Safety according to NCI CTCAE criteria v5.0. | Time from the first administration of lenvatinib + pembrolizumab to the date of the first documented disease progression according to RECIST1.1 or death due to any cause whichever occurs first. | An estimated median follow-up of 5 months from March 2022 to May 2024. |
| Frequency and type of oncogeriatric testing. | Time from the first administration of lenvatinib + pembrolizumab to the date of the first documented disease progression according to RECIST1.1 or death due to any cause whichever occurs first. | an estimated median follow-up of 5 months from March 2022 to May 2024. |
| Objective response rate (ORR: CR, PR) | Time from the first administration of lenvatinib + pembrolizumab to the date of the first documented disease progression according to RECIST1.1 or death due to any cause whichever occurs first. | An estimated median follow-up of 5 months from March 2022 to May 2024. |
| PFS with lenvatinib+pembrolizumab according to MMR/MSI status. | Time from the first administration of lenvatinib + pembrolizumab to the date of the first documented disease progression according to RECIST1.1 or death due to any cause whichever occurs first. | An estimated median follow-up of 5 months from March 2022 to May 2024. |
| Frequency and type of medical and paramedical follow-up procedures. | Time from the first administration of lenvatinib + pembrolizumab to the date of the first documented disease progression according to RECIST1.1 or death due to any cause whichever occurs first. | an estimated median follow-up of 5 months from March 2022 to May 2024. |
| Avignon |
| 84918 |
| France |
| CHU Jean Minjoz | Besançon | 25000 | France |
| ICONE | Bezannes | 51430 | France |
| Clinique TIVOLI | Bordeaux | 33000 | France |
| Centre François Baclesse | Caen | 14000 | France |
| Centre Hospitalier William Morey | Chalon-sur-Saône | 71100 | France |
| Centre Jean Perrin | Clermont-Ferrand | 63011 | France |
| CHU de DIJON | Dijon | 21079 | France |
| Centre Georges François Leclerc | Dijon | 77980 | France |
| Centre Léon Bérard | Lyon | 69008 | France |
| Institut Paoli Calmettes | Marseille | 13009 | France |
| ICM Val d'Aurelle | Montpellier | 34298 | France |
| Hôpital Européen George Pompidou | Paris | 75015 | France |
| Centre CARIO-HPCA | Plérin | 22190 | France |
| CHU de Poitiers - Hôpital de la Milétrie | Poitiers | 86021 | France |
| CHI de Cornouaille | Quimper | 29107 | France |
| Centre Eugène Marquis | Rennes | 35000 | France |
| Institut Curie | Saint-Cloud | 92210 | France |
| CHU Saint-Etienne - Hôpital Bellevue | Saint-Etienne | 42100 | France |
| ICANS | Strasbourg | 67033 | France |
| Oncopole Claudius Regaud - IUCT Oncopole | Toulouse | 31059 | France |
| CHU Tours - Hôpital Bretonneau | Tours | 37044 | France |
| Centre Hospitalier de Valence | Valence | 26953 | France |
| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| D009362 | Neoplasm Metastasis |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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