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New treatment option for Metastatic Malignancy
Official title Neoadjuvant PD-1 Plus TIGIT Blockade in Patients With Cisplatin-Ineligible Operable High-Risk Urothelial Carcinoma
ClinicalTrials.gov ID: NCT05394337
What this study is testing
What is Atezolizumab?
Atezolizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic malignancy.
Also referred to as MPDL3280A, TECENTRIQ.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- people must be considered cisplatin ineligible as per treating physician (Eastern Cooperative Oncology Group performance status (ECOG-PS) 2...
You likely can't join if
- 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
- History of leptomeningeal disease
- Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis...
- 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.
See the full eligibility criteria
Who can join
- 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...
- people must be considered cisplatin ineligible as per treating physician (Eastern Cooperative Oncology Group performance status (ECOG-PS) 2, creatinine clearance (CrCl) \ 2 hearing loss, grade \> 2 neuropathy, or New...
- 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...
- 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
- 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...
- Predicted postoperative (ppo) forced expiratory volume in 1 second (FEV1) and ppo diffusion capacity of the lung for carbon monoxide (DLCO) \>40%
- Maximal oxygen consumption (VO2max) \>15 mL/kg/min
- If either ppoFEV1 or ppoDLCO is \ 15 mL/kg/min.
- If PFTs were performed before 6 months of planned resection or have not been previously performed, they must be performed during the screening period.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Normal life expectancy, excluding lung cancer mortality risk
- Adequate hematologic and -end organ and marrow function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment:
- ANC \> 1.5 x 109 /L (1500/µL) without granulocyte colony-stimulating factor support
- Lymphocyte count \>0.5 x 109 /L (500/µL)
- Platelet count \>100 x109 /L (100,000/µL) without transfusion
- Hemoglobin \>90 g/L (9 g/dL) 1\. Patients may be transfused to meet this criterion. e. AST, ALT, and ALP \ 3 xULN): who must have a baseline total bilirubin \ 45 mL/min (calculated using the Cockcroft-Gault formula) h...
- With a female partner of childbearing potential, men who are not surgically sterile must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \<1% per year...
- With a pregnant female partner, men must remain abstinent or use a condom during the treatment period for 90 days after the final dose of the study drugs to avoid exposing the embryo.
- The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation...
- Men who would like to father a child after study treatment initiation should be advised regarding the conservation of sperm prior to treatment because of the possibility of irreversible infertility resulting from drugs...
What rules you out
- 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
- History of leptomeningeal disease
- Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel...
- 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...
- 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
- Active tuberculosis
- Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment...
- Major surgical procedure, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
- History of malignancy other than urothelial cancer within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \>90%), such as adequately...
- Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia, or any active infection that, in...
- Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment a. Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive...
- Prior allogeneic stem cell or solid organ transplantation
- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render...
- Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during study treatment, within 90 days after the final dose of tiragolumab, or...
- Current treatment with anti-viral therapy for HBV
- Positive Epstein-Barr virus (EBV) viral capsid antigen immunoglobulin M (IgM) test at screening a. An EBV PCR test should be performed as clinically indicated to screen for acute infection or suspected chronic active...
- Treatment with investigational therapy within 42 days prior to initiation of study treatment
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, anti-TIGIT, and anti-PD-L1 therapeutic antibodies.
- Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and IL-2) within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment
- Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and antitumor necrosis factor- [TNF-] agents) within 2...
- Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for...
- Patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose (\< 10mg prednisone equivalent per day) corticosteroids for...
- History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
- Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab or tiragolumab formulation.
- Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment, within 90 days after the final dose of tiragolumab, 5 months after the final dose of atezolizumab. Women of childbearing potential...
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.