NCT05319730Recrutement en cours
A Study to Evaluate Investigational Agents With or Without Pembrolizumab (MK-3475) in Participants With Advanced Esophageal Cancer Previously Exposed to Programmed Cell Death 1 Protein (PD-1)/ Programmed Cell Death Ligand 1 (PD-L1) Treatment (MK-3475-06B)
Résumé
This is a Phase 1/2, multicenter, randomized, open-label umbrella platform study to evaluate the safety and efficacy of investigational agents with or without pembrolizumab and/or chemotherapy, for the treatment of participants with second line (2L) esophageal squamous cell carcinoma (ESCC) who have previously been exposed to PD-1/PD-L1 based treatment.
Critères d'inclusion
The main inclusion and exclusion criteria include but are not limited to the following: • Histologically or cytologically confirmed diagnosis of metastatic or locally advanced unresectable esophageal squamous cell carcinoma (ESCC) • Has experienced investigator documented radiographic or clinical disease progression on one prior line of standard therapy, that includes a platinum agent and previous exposure to an anti-programmed cell death 1 (PD1)/programmed cell death ligand 1 (PD-L1) based immune oncology (IO) therapy • Has provided an archival or most recent tumor tissue sample obtained as part of clinical practice • Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible
Critères d'exclusion
• Direct invasion into adjacent organs such as the aorta or trachea • Has experienced weight loss \>10% over approximately 2 months prior to first dose of study therapy • Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing • Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease • Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration • Known additional malignancy that is progressing or has required active treatment within the past 3 years, except basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ that has undergone potentially curative therapy • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis • Participants with human immunodeficiency virus (HIV) with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease • History of allogenic tissue/solid organ transplant • Clinically significant cardiovascular disease within 12 months from first dose of study intervention • Has risk for significant gastrointestinal (GI) bleeding such as a serious nonhealing wound, peptic ulcer, or bone fracture within 28 days prior to allocation/randomization, significant bleeding disorders, vasculitis, or has had a significant bleeding episode from the GI tract within 12 weeks prior to allocation/randomization
Contacts
Les coordonnées de l'équipe de l'essai s'affichent sur demande.
Voir la fiche officielle de l'essai- Statut
- Recrutement en cours
- Phase
- Phase 1 · Phase 2
- Type d'étude
- Interventionnelle
- Pays
- Suisse, Allemagne, Italie, États-Unis, Brésil, Chili, Chine, Japon, Norvège, Singapour, Corée du Sud, Taïwan, Thaïlande, Turquie
- Promoteur
- Merck Sharp & Dohme LLC(Industrie)
- N° de protocole
- 3475-06B
- Pathologies
- Esophageal Squamous Cell Carcinoma
- Interventions
- Médicament, Biologique
Traitements évalués
- Paclitaxel
- Irinotecan
- Pembrolizumab
- MK-4830
- Lenvatinib
- Sacituzumab tirumotecan
- Antihistamine
- H2 Receptor Antagonist
- Acetaminophen (or equivalent)
- Dexamethasone (or equivalent)
- Steroid Mouthwash (dexamethasone or equivalent)
- Supportive care measures
Lieux · 48
- Geneva, SuisseHôpitaux Universitaires de Genève (HUG) ( Site 4702)Recrute dans ce centre
- Chur, SuisseKantonsspital Graubünden-Medizin ( Site 4700)Recrute dans ce centre
- Erdgeschoss, AllemagneHOPE Hamburg/Norddeutsches Studienzentrum fuer Innovative Onkologie ( Site 4807)Recrute dans ce centre
- Meldola, ItalieIRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 3207)Recrute dans ce centre
- Milan, ItalieFondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 3200)Recrute dans ce centre
- Pisa, ItalieAzienda Ospedaliero Universitaria Pisana ( Site 3206)Recrute dans ce centre
- Padova, ItalieIstituto Oncologico Veneto IRCCS-Oncologia Medica 1 ( Site 3203)Recrute dans ce centre
- Milan, ItalieOspedale San Raffaele-Oncologia Medica ( Site 3202)Recrute dans ce centre
- Tucson, États-UnisUniversity of Arizona Cancer Center-University of Arizona Cancer Center ( Site 4927)Recrute dans ce centre
- Los Angeles, États-UnisUCLA Hematology/Oncology - Santa Monica ( Site 4905)Recrute dans ce centre
- East Syracuse, États-UnisHematology-Oncology Associates of Central NY, P.C. ( Site 4925)Recrute dans ce centre
- Pittsburgh, États-UnisUPMC Hillman Cancer Center-UPMC ( Site 4904)Recrute dans ce centre
- Natal, BrésilLiga Norte Riograndense Contra o Câncer ( Site 4303)Recrute dans ce centre
- Porto Alegre, BrésilHospital Nossa Senhora da Conceição ( Site 4301)Recrute dans ce centre
- São Paulo, BrésilICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 4300)Recrute dans ce centre
- Santiago, ChiliFALP-UIDO ( Site 4400)Recrute dans ce centre
- Santiago, ChiliCentro de Oncología de Precisión-Oncology ( Site 4404)Recrute dans ce centre
- Santiago, ChiliClínica UC San Carlos de Apoquindo ( Site 4405)Recrute dans ce centre
- Hefei, ChineAnhui Provincial Hospital ( Site 3501)Recrute dans ce centre
- Beijing, ChineBeijing Cancer hospital-Digestive Oncology ( Site 3500)Recrute dans ce centre
- Xiamen, ChineThe First Affiliated Hospital of Xiamen University ( Site 3516)Recrute dans ce centre
- Xinxiang, ChineThe First Affiliated Hospital of Xinxiang Medical University-Oncology ( Site 3510)Recrute dans ce centre
- Zhengzhou, ChineHenan Cancer Hospital ( Site 3518)Recrute dans ce centre
- Huai'an, ChineFirst Huai'an Hospital Affiliated to Nanjing Medical University ( Site 3506)Recrute dans ce centre
- Shanghai, ChineShanghai Chest Hospital-Esophageal surgery department ( Site 3513)Recrute dans ce centre
- Hangzhou, ChineZhejiang Cancer Hospital-Thoracic oncology ( Site 3511)Recrute dans ce centre
- Nagoya, JaponAichi Cancer Center ( Site 3702)Recrute dans ce centre
- Kashiwa, JaponNational Cancer Center Hospital East ( Site 3701)Recrute dans ce centre
- Kitaadachi-gun, JaponSaitama Prefectural Cancer Center ( Site 3703)Recrute dans ce centre
- Nagaizumi-cho,Sunto-gun, JaponShizuoka Cancer Center ( Site 3704)Recrute dans ce centre
Au total, dans le monde, 48 des 58 centres listés au registre recrutent ; les 10 autres ne recrutent pas actuellement.
Statut par centre selon le registre ClinicalTrials.gov (dernière mise à jour publiée : 7 octobre 2026).
Ce statut peut avoir changé et ne dit rien de votre éligibilité : avant toute démarche, vérifiez avec votre oncologue ou le centre.
+ 18 autres lieux
Autres identifiants
- jRCT2031220582 · autre registre
- 2023-505189-26-00 · autre registre
- U1111-1291-1987 · autre registre
- MK-3475-06B · autre identifiant
- KEYMAKER-U06B · autre identifiant
- 2021-005443-76 · n° EudraCT
- 2023 · financement NIH
Voir aussi
Autres versions
Ces résultats sont indicatifs et ne remplacent pas un avis médical — à discuter avec votre médecin.