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ORPHEUS

A MULTICENTER, OPEN-LABEL, SINGLE-ARM, PHASE II CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF INCMGA00012 IN ADVANCED PENILE SQUAMOUS CELL CARCINOMA – ORPHEUS

https://clinicaltrials.gov/study/NCT04231981

PENILE

13

18

II

Spain, Italy

Closing

CLINICAL TRIAL DETAILS

ORPHEUS IS AN INTERNATIONAL, MULTICENTER, OPEN-LABEL, SINGLE-ARM, PHASE II CLINICAL TRIAL IN MEN WITH LOCALLY ADVANCED UNRESECTABLE OR METASTATIC PENILE SQUAMOUS CELL CARCINOMA (PSCC). THE PRIMARY GOAL IS TO ASSESS THE EFFICACY –AS DETERMINED BY THE OBJECTIVE RESPONSE RATE (ORR)– OF INCMGA00012 IN THE STUDY POPULATION. IN ADDITION, THIS STUDY WILL ALSO EVALUATE THE SAFETY AND TOLERABILITY OF INCMGA00012 IN THESE PATIENTS.

TUMOR TYPE

PHASE

N

SITES

COUNTRY

STATUS

PRESS RELEASE

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2021 Press Release: https://www.medsir.org/post/orpheus-study-penile

SCIENTIFIC IMPACT

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ASCO 2023 poster: https://d9ec78c0-6610-4e58-b628-a2262f2019e2.usrfiles.com/ugd/d9ec78_bf207fdaa5e64fa8a40a86feebee5001.pdf | ASCO 2023 lay language summary: https://d9ec78c0-6610-4e58-b628-a2262f2019e2.usrfiles.com/ugd/d9ec78_5054e60e39f84909b1417a9a0a1f5bb9.pdf | ASCO GU 2022 poster: https://39f1664e-7766-40bf-9b5a-e3575d54bba6.usrfiles.com/ugd/39f166_a58706cb12c348f69d59fd572d270b87.pdf | Eur Urol Oncol 2025 publication: https://pubmed.ncbi.nlm.nih.gov/38749903/

BLOG ARTICLES RELATED

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Promising Advancements in Oncology Research Unveiled at ASCO Annual Meeting: https://www.medsir.org/post/promising-advancements-in-oncology-research-unveiled-at-asco-annual-meeting | Spotlight - ORPHEUS Penile carcinoma trial: https://www.medsir.org/post/spotlight-orpheus-penile-carcinoma-trial | MEDSIR’s Experience at ASCO GU 2022: Update on our 2 GU trials: https://www.medsir.org/post/medsir-s-experience-at-asco-gu-2022-update-on-our-2-gu-trials | We’re presenting at ASCO GU 2022!: https://www.medsir.org/post/we-re-presenting-at-asco-gu-2022 | ORPHEUS: A study of the efficacy of immunotherapy for advanced cases of penile cancer: https://www.medsir.org/post/orpheus-a-study-of-the-efficacy-of-immunotherapy-for-advanced-cases-of-penile-cancer | ORPHEUS Study: Evaluation of Retifanlimab In Penile Cancer: https://www.medsir.org/post/orpheus-study-evaluation-of-retifanlimab-in-penile-cancer | A New Trial On Board: The ORPHEUS Study: https://www.medsir.org/post/a-new-trial-on-board-the-orpheus-study

PHERGAIN SITES

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ICO L'Hospitalet, Catalan Institute of Oncology (Spain) | Hospital Insular de Gran Canaria (Spain) | Hospital Virgen de la Arrixaca (Spain) | Hospital Virgen del Rocío (Spain) | Hospital Miguel Servet (Spain) | Instituto Valenciano de Oncología (Spain) | Hospital de la Santa Creu i Sant Pau (Spain) | Hospital Universitario Doce de Octubre (Spain) | Hospital Clínico San Carlos (Spain) | Hospital Universitari Son Espases (Spain) | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano (Italy) | AUSL Reggio Emilia (Italy) | Ospedale San Raffaele (Italy)
Dr. Cortes and Dr. Llombart PHERain interview
Beyond Chemotherapy
Dr. Vanes Quiroga
Dr. Sofia Braga
Dr. Silvi Antolín
Dr. Escrivá de Romaní
Dr. Philipp Aftimos
Dr. Manuel Ruiz
Prof. Daniele Generali PHEGain interview
Dr. Jacques Medioni
Dr. Dunca Wheatley
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