NCT 05911295
Brief Summary
This study will enroll participants with urothelial cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs (UC). UC can include cancer of the bladdera hollow, muscular sac in the pelvis that stores urine, kidneya pair of bean-shaped organs in the abdomen that are responsible for filtering excess water and waste products from the blood and converting them into urine to be removed from the body, or the tubes that carry pee through the body (ureter, urethrathe tube that carries urine from the bladder to outside of the body). This study will try to find out if the drugs disitamab vedotin with pembrolizumab works better than platinum-containing chemotherapya cancer treatment that uses drugs to kill or slow the growth of cancer cells, while minimising damage to healthy cells to treat patients with UC. This study will also test what side effects happen when participants take these drugs together. A side effectan unintended effect of medication or treatment, is often negative or unwanted is anything a drug does to the body besides treating the disease.
Participants in this study will have cancer that has spread through the body (metastatic) or spread near where it started (locally advancedat a late stage, far along).
In this study, there are 2 different groups. Participants will be assigned to a group randomly. Participants in the disitamab vedotin arm will get the study drug disitamab vedotin once every two weeks and pembrolizumab once every 6 weeks. Participants in the standard of care arm will get gemcitabine once a week for 2 weeks with either cisplatin or carboplatin once every 3 weeks.
Intervention / Treatment
- Drug: disitamab vedotin
- Drug: pembrolizumab
- Drug: gemcitabine
- Drug: cisplatin
- Drug: carboplatin
Inclusion Criteria:
- Histopathological confirmation of locally advanced unresectable or metastatic urothelial carcinomacancer arising from tissues that line organs (LA/mUC), including UC originating from the renal pelvis, ureters, bladder, or urethra.
- Measurable disease by investigator assessment per RECIST v1.1.
- Participant must not have received prior systemic therapy for LA/mUC. Exception will be made for neoadjuvant or adjuvant therapy, if disease recurrenceto occur or happen again/progression occurred more than 12 months after the last dosethe amount of medication taken of therapy.
- Eligible to receive cisplatin- or carboplatin-containing chemotherapy.
- Able to provide archived formalin-fixed paraffin-embedded tumor tissuea group of cells that work together to perform a function blocks from a muscle-invasive or metastatic UC lesion or biopsyremoval of a section of tissue to analyse for cancer cells of metastatic UC prior to treatment initiation. If archival tissue is not available a newly obtained baseline biopsy of an accessible tumor lesion is required within 28 days of cycle 1 day 1.
- HER2 expression of 1+ or greater on immunohistochemistry (IHC).
- Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) performance score of 0, 1, or 2 within 7 days prior to randomization.