Last updated 58 days ago
A Study of Disitamab Vedotin Alone or With Pembrolizumab in Urothelial Cancer That Expresses HER2
332 patients around the world
Available in Argentina, Chile, United States
Seagen Inc.
8Research sites
332Patients around the world
This study is for people with
Urothelial cancer
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Cohorts A and BCohorts A and B Histopathologically-confirmed, locally-advanced, unresectable or metastatic urothelial cancer (LA/mUC), including UC originating from the renal pelvis, ureters, bladder, or urethra.Cohorts A and B Participants must have received only 1 or 2 lines of prior systemic treatment for LA/mUC, including 1 line of platinum-containing chemotherapy.Cohorts A and B At least one measurable lesion by investigator assessment based on RECIST version 1.1.Cohorts A and B HER2-expression status determined by the central laboratory to be IHC 1+, 2+ or 3+, in the provided tumor sample.Cohorts A and B Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.Cohort CCohort C Histopathologically-confirmed LA/mUC, including UC originating from the renal pelvis, ureters, bladder, or urethra.Cohort C No prior systemic therapy for LA/mUC.Cohort C Neoadjuvant or adjuvant therapy, including PD-(L)1 inhibitors, is acceptable, if disease recurrence/progression occurred more than 12 months after the last dose of systemic therapy.Cohort C At least one measurable lesion by investigator assessment based on RECIST v1.1.Participant is eligible to receive cisplatin- or carboplatin- containing chemotherapy per investigator evaluation.Cohort C HER2-expression status determined by the central laboratory to be IHC 1+, 2+ or 3+, on the provided tumor tissue sample.Cohort C ECOG performance status of 0, 1, or 2.Cohort DCohort D Histopathologically-confirmed LA/mUC, including UC originating from the renal pelvis, ureters, bladder, or urethra.Cohort D Based on a participant's eligibility to receive treatment with standard of care therapies in Japan, participants must have received all of the following lines of therapy for LA/mUC.Cohort D a. One prior line of platinum-containing chemotherapy.Cohort D b. Prior therapy with PD-(L)1 inhibitors as (neo)adjuvant therapy, first-line maintenance therapy or as second line treatment.Cohort D c. Prior enfortumab vedotin therapy.Cohort D At least one measurable lesion by investigator assessment based on RECIST v1.1.Cohort D ECOG performance status of 0 or 1.Cohort ECohort E Histopathologically-confirmed LA/mUC, including UC originating from the renal pelvis, ureters, bladder, or urethra.Cohort E No prior systemic therapy for LA/mUC.a) Neoadjuvant or adjuvant therapy, including PD-(L)1 inhibitors, is acceptable, if disease recurrence/progression occurred more than 12 months after the last dose of systemic therapy.Cohort E At least one measurable lesion by investigator assessment based on RECIST v1.1.Cohort E Participant is eligible to receive cisplatin- or carboplatin- containing chemotherapy per investigator evaluation.Cohort E HER2-expression status determined by the central laboratory to be IHC 1+, 2+ or 3+, in the provided tumor sample.Cohort E ECOG performance status of 0 or 1.
- Cohorts A and BCohorts A and B Known hypersensitivity to disitamab vedotin or any of their components.Cohorts A and B Prior antitumor treatment (including chemotherapy, radiotherapy, targeted therapy, immunotherapy etc.) within 2 weeks of start of study (defined as Cycle 1 Day 1 for Cohorts A and B).Cohorts A and B Toxicity from a previous treatment has not returned to Grades 0 or 1 (except for Grade 2 alopecia).Cohorts A and B Prior MMAE-based ADCs (eg, enfortumab vedotin) or HER2-directed therapy.Cohorts A and B Major surgery that has not fully recovered within 4 weeks prior to dose administration.Cohorts A and B Peripheral sensory or motor neuropathy ≥ Grade 2 at baseline.Cohort CCohort C Known hypersensitivity to disitamab vedotin, pembrolizumab, or any of their components.Cohort C Prior antitumor treatment (including chemotherapy, radiotherapy, targeted therapy, immunotherapy etc.) within 2 weeks of start of study defined as Cycle 1 Day 1 for the single-arm part of Cohort C and as randomization date for the randomized part of Cohort C.Cohort C Toxicity from a previous treatment has not returned to Grades 0 or 1 (except for Grade 2 alopecia).Cohort C Prior MMAE-based ADCs (eg, enfortumab vedotin) or HER2-directed therapy.Cohort C Major surgery that has not fully recovered within 4 weeks prior to dose administration.Cohort C Peripheral sensory or motor neuropathy ≥ Grade 2 at baseline.Cohort C Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug.Cohort C Participants who have previously received any prior treatment with an agent directed to another stimulatory or co-inhibitory T cell receptor (including but not limited to CD137 agonists, CAR-T cell therapy, CTLA-4 inhibitors, or OX-40 agonists) are excluded.Cohort DCohort D Known hypersensitivity to disitamab vedotin or any of their components.Cohort D Prior antitumor treatment (including chemotherapy, radiotherapy, targeted therapy, immunotherapy etc.) within 2 weeks of start of study (defined as Cycle 1 Day 1 for Cohort D).Cohort D Toxicity from a previous treatment has not returned to Grades 0 or 1 (except for Grade 2 alopecia).Cohort D Prior HER2-directed therapy.Cohort D Any prior history of ≥ Grade 3 non-hematological AEs related to prior therapy.Cohort D Major surgery that has not fully recovered within 4 weeks prior to dose administration.Cohort D Peripheral sensory or motor neuropathy ≥ Grade 1 at baseline.Cohort ECohort E Known hypersensitivity to disitamab vedotin, pembrolizumab, or any of their components.Cohort E Prior antitumor treatment (including chemotherapy, radiotherapy, targeted therapy, immunotherapy etc.) within 2 weeks of start of study (defined as Cycle 1 Day 1 for Cohort E).Cohort E Toxicity from a previous treatment has not returned to Grades 0 or 1 (except for Grade 2 alopecia).Cohort E Any prior history of ≥ Grade 3 non-hematological AEs related to prior therapy.Cohort E Prior MMAE-based ADCs (eg, enfortumab vedotin) or HER2-directed therapy.Cohort E Major surgery that has not fully recovered within 4 weeks prior to dose administration.Cohort E Peripheral sensory or motor neuropathy ≥ Grade 1 at baseline.Cohort E Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug.
Sites
Hospital Asociación de Beneficencia Hospital Sirio Libanes - CABA, Buenos Aires
Recruiting
Centro de Investigaciones Clínicas - Clínica Viedma - Río Negro
Recruiting
Instituto Médico Especializado Alexander Fleming - CABA, Buenos Aires
Recruiting
Fundación CENIT para la Investigación en Neurociencias
Recruiting
Centro de Oncología e Investigación Buenos Aires COIBA
Recruiting
Hospital Alemán
Recruiting
Instituto Oncológico FALP (Fundación Arturo Lopez Perez)
Recruiting
Hospital Clínico Pontificia Universidad Católica de Chile - Santiago, Región Metropolitana
Recruiting
StudyKEYNOTE-D78
SponsorSeagen Inc.
Study typeInterventional
Conditions
Urothelial cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT04879329
