Published October 26, 2022
| Version v1
Dataset
Open
MITO END-3: A randomized phase II trial of avelumab plus carboplatin and paclitaxel compared to carboplatin and paclitaxel in advanced or recurrent endometrial cancer.
Creators
- Pignata Sandro1
- Scambia Giovanni2
- Schettino Clorinda3
- Arenare Laura4
- Pisano Carmela5
- Lombardi Davide6
- De Giorgi Ugo7
- Andreetta Claudia8
- Cinieri Saverio9
- DDe Angelis Carmine10
- Priolo Domenico11
- Casanova Claudia12
- Rosati Marta13
- Greco Filippo14
- Zafarana Elena15
- Schiavetto Ilaria16
- MMammoliti Serafina17
- Cecere Sabrina Chiara1
- Salutari Vanda18
- Scalone Simona6
- Farolfi Alberto7
- Di Napoli Marilena19
- Lorusso Domenica2
- Gargiulo Piera4
- Califano Daniela20
- Russo Daniela20
- Spina Anna20
- De Cecio Rossella21
- Gallo Ciro22
- Perrone Francesco3
- 1. Uro-Gynecological Medical Oncology, Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale, Napoli
- 2. Gynecologic Oncology Unit, Fondazione Policlinico Gemelli, IRCSS and Catholic Univeristy of Sacred Heart, Roma
- 3. Clinical Trials Unit, Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale, Napoli
- 4. Clinical Trials Unit, Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale, Napoli;
- 5. 1Uro-Gynecological Medical Oncology, Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale, Napoli
- 6. Medical Oncology and Oncological Prevention Unit, Centro di Riferimento Oncologico (CRO) IRCCS, Aviano
- 7. Clinical and Experimental Oncology Unit, Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola
- 8. Oncology Department, Azienda Sanitaria Universitaria Friuli Centrale, Udine
- 9. Medical Oncology Unit, "Senatore Antonio Perrino" Hospital, Brindisi
- 10. 8Medical Oncology Unit, Integrated Care Department of Clinical Medicine, Azienda Universitaria Policlinico Federico II, Napoli
- 11. Oncology Unit, "S. Vincenzo" Hospital, Taormina
- 12. Oncology Unit, S. Maria delle Croci Hospital, Ravenna;
- 13. 11 Medical Oncology Unit, Infermi Hospital, Rimini
- 14. Medical Oncology Unit, Mater Salutis Hospital, AULSS 21, Legnago
- 15. 13Medical Oncology Unit "Santo Stefano" Hospital, Prato
- 16. Oncology Unit, Niguarda ca' Granda Hospital, Milano
- 17. Medical Oncology Unit 1 – IRCCS Ospedale Policlinico San Martino, Genova
- 18. Department of Woman, Child and Public Health, Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma
- 19. 1Uro-Gynecological Medical Oncology, Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale, Napoli;
- 20. Microenvironment Molecular Targets Unit Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale, Napoli;
- 21. Pathological Anatomy and Cytopathology Unit, Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale, Napoli
- 22. Medical Statistics, Università degli Studi della Campania "Luigi Vanvitelli", Napoli;
Description
Adding checkpoint inhibitors to first-line chemotherapy might improve the outcome of advanced/recurrent endometrial cancer (EC) patients.
MITO END3 is a randomized phase II trial comparing avelumab plus carboplatin/paclitaxel versus carboplatin/paclitaxel in patients with advanced/recurrent EC and ECOG performance status 0-1. Primary endpoint was progression-free survival (PFS); superiority of the experimental arm was tested with 80% power and one-tailed alpha 0·20; subgroup analyses according to mismatch repair (MMR) status were planned. ClinicalTrials.gov NCT03503786.
Notes
This study was partially funded, and avelumab was supplied, by Pfizer as part of an alliance between Pfizer and Merck (CrossRef Funder ID: 10.13039/100009945).
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