Neoadjuvant PD-1 Plus TIGIT Blockade in Patients With Cisplatin-Ineligible Operable High-Risk Uro… (NCT05394337) | Clinical Trial Compass
RecruitingPhase 1/2
Neoadjuvant PD-1 Plus TIGIT Blockade in Patients With Cisplatin-Ineligible Operable High-Risk Urothelial Carcinoma
United States10 participantsStarted 2023-02-23
Plain-language summary
To learn if the combination of atezolizumab and tiragolumab can help to control bladder cancer when it is given before surgery to remove the bladder and tumor.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Signed Informed Consent Form
✓. Age \>18 years at time of signing Informed Consent Form
✓. Ability to comply with the study protocol
✓. Histologically or cytologically confirmed proof of muscle invasive urothelial cancer. This may include any patient requiring cystectomy (or nephroureterectomy to resect tumors), including muscle invasive disease (cT2-4aN0M0). Patients with the following high-risk features who are not candidates for traditional neoadjuvant chemotherapy will be included for this trial: micropapillary, sarcomatoid and plasmacytoid features; 3-D mass on exam under anesthesia (EUA); lymphovascular invasion; hydronephrosis (unless in the opinion of the treating physician, this is not due to tumor); high grade (grade 3) tumors of the ureter, renal pelvis, or tumors in these areas with radiographic abnormality large enough to recognize as an abnormal mass by CT or MRI imaging5; direct invasion of the prostatic stroma or the vaginal wall (i.e. cT4a disease). For patients in whom eligibility is unclear, final arbitration will be determined by the Principal Investigator.
✓. Subjects must be considered cisplatin ineligible as per treating physician (Eastern Cooperative Oncology Group performance status (ECOG-PS) 2, creatinine clearance (CrCl) \<60 mL/min, grade \> 2 hearing loss, grade \> 2 neuropathy, or New York Heart Association (NYHA) class III heart failure. See FDA draft guidance n adjuvant therapy in bladder cancer https://www.fda.gov/media/142544/download) or have refused cisplatinbased chemotherapy as a neoadjuvant therapy.
✓. Tissue resected by transurethral resection of bladder tissue (TURBT) at the MD Anderson Cancer Center; if completed TURBT at the outside facility, it must be within three months and must transfer outside TURBT tumor tissues to MD Anderson for correlative research on this trial.
✓. Eligible for R0 resection with curative intent at the time of screening, as confirmed by the operating attending surgeon and involved medical oncologist prior to study enrollment
Exclusion criteria
✕. Illness or condition that may interfere with a patient's capacity to understand, follow, and/or comply with study procedures
✕. Any prior therapy for urothelial cancer, including immunotherapy, chemotherapy, or radiotherapy
✕. Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.
✕. Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.
✕. Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:
✕. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
What they're measuring
1
To evaluate relapse-free survival (RFS)
Timeframe: Through study completion, an average of 1 year
2
To evaluate overall survival (OS).
Timeframe: Through study completion, an average of 1 year
. Adequate pulmonary function to be eligible for surgical resection with curative intent, as assessed by PFTs performed within 6 months of planned resection and repeated at screening, if clinically indicated, including lung volumes, spirometry, and a diffusion capacity; and meeting at least one of the following criteria: