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New treatment option for Small Cell Carcinoma of the Bladder
Official title Sacituzumab Govitecan With or Without Atezolizumab Immunotherapy in Rare Genitourinary Tumors (SMART) Such as High Grade Neuroendocrine Carcinomas, Adenocarcinoma, and Squamous Cell Bladder/Urinary Tract Cancer, Renal Medullary Carcinoma and Penile C...
ClinicalTrials.gov ID: NCT06161532
What this study is testing
What is Sacituzumab govitecan?
Sacituzumab govitecan is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for small cell carcinoma of the bladder.
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
- Background: Rare tumors of the genitourinary (GU) tract can appear in the kidney, bladder, ureters, and penis. Rare tumors are difficult to study because there are not enough people to conduct large trials for new treatments.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 5 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 120
You may be able to join if
- Participants must have histologically confirmed diagnosis of a locally advanced unresectable or metastatic non-prostate genitourinary (GU) tumor of...
- HGNEC, including, but not limited to, small cell carcinoma and large cell neuroendocrine carcinoma of the bladder or urinary tract
- Squamous cell carcinoma of the bladder or urinary tract
- Primary adenocarcinoma of the bladder or urinary tract (urachal or non-urachal)
- Renal medullary carcinoma
You likely can't join if
- History of severe hypersensitivity or allergic reactions attributed to compounds of similar chemical or biologic composition to SG, SN-38...
- Symptomatic or untreated brain/CNS metastases.
- Positive serum or urine Beta-human chorionic gonadotropin (Beta-hCG) test at screening.
- Participants unwilling to accept blood products as medically indicated.
- For Cohort B: Active or history of autoimmune disease or immune deficiency that might recur, which might affect vital organ function or require...
- Participants with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.
See the full eligibility criteria
Who can join
- Participants must have histologically confirmed diagnosis of a locally advanced unresectable or metastatic non-prostate genitourinary (GU) tumor of the following histologies:
- HGNEC, including, but not limited to, small cell carcinoma and large cell neuroendocrine carcinoma of the bladder or urinary tract
- Squamous cell carcinoma of the bladder or urinary tract
- Primary adenocarcinoma of the bladder or urinary tract (urachal or non-urachal)
- Renal medullary carcinoma
- Squamous cell carcinoma of the penis Note: For the purposes of enrollment, the urinary tract is defined as the renal pelvis, ureter, bladder, and urethra.
- Pre-study treatment tissue availability (sufficient tissue for approximately 25 unstained slides is mandatory for enrollment. If tissue is determined to be insufficient/unsuitable, a fresh biopsy prior to study therapy...
- Locally advanced unresectable or metastatic disease. Participants who have received prior treatment must have evidence of progressive disease (PD; i.e., defined as new or progressive lesions evident on cross-sectional...
- Prior treatment as follows:
- Cohort A: Participants must have received prior ICIs (PD-1 or PD-L1) or be ineligible for treatment with ICIs.
- For Cohort B: Participants must be ICI naive but eligible to receive them.
- Participants must have measurable disease, per RECIST 1.1.
- Age \>= 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status \ = 70%.
- Adequate organ and marrow function as defined below:
- Hemoglobin (Hgb) \>= 9.0 g/dL
- Absolute neutrophil count (ANC) \>= 1,500/mcL
- Platelets \>= 100,000/mcL
- Total bilirubin \<= 1.5 x upper limit of normal (ULN) (\<= 3 x ULN in participants with known/suspected Gilbert s disease)
- AST/ ALT \<= 2.5 x ULN (or \<= 5 x ULN if considered to be related to liver metastases by the PI)
- Serum creatinine \ = 30 ml/min/1.73 m\^2 (glomerular filtration rate [GFR] may be used in place of CrCl. Creatinine clearance or eGFR should be calculated per institutional standard)
- Alkaline phosphatase \<= 2.5 x ULN (or \<= 5 x ULN if considered to be related to liver or bone metastases by the PI)
- Serum albumin \>= 25g/L
- For participants not receiving therapeutic anticoagulation: international normalized ratio (INR) or activated partial thromboplastin time (aPTT) \<= 1.5 x ULN
- For participants receiving therapeutic anticoagulation: stable anticoagulant regimen
- Participants may have received any number of prior anti-cancer treatments or be treatment na(SqrRoot) ve (except for participants with HGNEC of the bladder/urinary tract cancer, whom must have received a platinum-based...
- Treated central nervous system (CNS) lesions, provided that all of the following criteria are met:
- Measurable disease, per RECIST v1.1, must be present outside the CNS.
- The participant has no history of intracranial hemorrhage or spinal cord hemorrhage.
- The participant has not undergone stereotactic radiotherapy within 1 week prior to initiation of study treatment, whole-brain radiotherapy (WBXRT) within 2 weeks prior to initiation of study treatment, or neurosurgical...
- The participant has no ongoing requirement for corticosteroids as therapy for CNS disease.
- The participant may be receiving anti-convulsant therapy if appropriate and the dose is considered stable. Prior treatment as follows:
- Prior radionuclide treatment must have a washout period of at least 6 weeks prior to the first dose of study treatment.
- Prior treatment with chemotherapy must have a washout period of 2 weeks prior to the first dose of study treatment.
- Prior treatment with non-CNS-directed radiotherapy must have a washout period of 2 weeks prior to the first dose of study treatment (except palliative bone-directed radiotherapy which does not require any washout).
- Prior treatment with a small molecule kinase inhibitor must have a washout period of at least 2 weeks or five half-lives of the compound or active metabolites, prior to the first dose of study treatment.
- Prior treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 [IL-2]) must have a washout period of at least 4 weeks or 5 half-lives of the drug (whichever is...
- Major surgical procedure, other than for diagnosis, must not occur within 4 weeks prior to the first dose of study treatment.
- Prior treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-alpha agents) must have a washout...
- Participants 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...
- Participants who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal...
- FDA-approved hormonal therapy for the treatment or prevention of other malignancies (e.g., breast cancer, prostate cancer) are allowed to be continued where in the opinion of the treating investigator stopping such...
- Human immunodeficiency virus (HIV)-infected participants are eligible if on stable dose of highly active antiretroviral therapy (HAART), a CD4 count \>= 200 cells/microL, and an undetectable viral load.
- Hepatitis B virus (HBV) positive participants are eligible if they have been treated or are on an appropriate course of antivirals at study entry and with planned monitoring and management according to appropriate...
- Participants with a history of hepatitis C virus (HCV) infection (i.e., positive HCV antibody test) must have been treated and cured (negative HCV RNA test at screening). Participants with HCV infection who are...
- Individuals of child-bearing potential (IOCBP) and individuals able to father a child must agree to use an effective method of contraception as follows:
- IOCBP must agree to use one (1) highly effective methods of contraception (e.g., intrauterine device [IUD], hormonal, surgical sterilization) prior to study entry, for the duration of study participation, and for up to...
- Individuals able to father children must agree to use an effective method of contraception (barrier, surgical sterilization) for the duration of the study treatment and up to 6 months after the last dose of the study...
- Nursing participants must discontinue nursing and/or not begin nursing until 1 month after the last dose of study drug(s).
- Ability of participants to understand and the willingness to sign a written informed consent document.
What rules you out
- History of severe hypersensitivity or allergic reactions attributed to compounds of similar chemical or biologic composition to SG, SN-38, irinotecan, or atezolizumab, or hypersensitivity to Chinese hamster ovary cell...
- Symptomatic or untreated brain/CNS metastases.
- Positive serum or urine Beta-human chorionic gonadotropin (Beta-hCG) test at screening.
- Participants unwilling to accept blood products as medically indicated.
- For Cohort B: Active or history of autoimmune disease or immune deficiency that might recur, which might affect vital organ function or require immune suppressive treatment including systemic corticosteroids, when...
- Participants with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.
- Participants with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.
- Participants with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., participants with psoriatic arthritis are excluded) are eligible for the study provided all of...
- Rash must cover \< 10% of body surface area.
- Disease is well controlled at baseline and requires only low-potency topical corticosteroids.
- There has been no occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or...
- 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 computed...
- Anticipation of need for a major surgical procedure during the study.
- Prior allogeneic stem cell or solid organ transplantation.
- Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during SG or atezolizumab treatment or within 5 months after the final dose of...
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently) with the exception of participants with indwelling catheters (e.g., PleurX(R))...
- Uncontrolled or symptomatic hypercalcemia (ionized calcium \> 1.5 mmol/L, calcium \> 12 mg/dL or corrected serum calcium \> ULN).
- Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, cerebrovascular accident, unstable arrhythmia, or unstable angina) within 3 months prior...
- Prior treatment with immune checkpoint blockade therapies, including anti-PD-1, and anti-PD-L1 therapeutic antibodies (for Arm 2 only).
- Participants with prior malignancy within the previous 2 years except for locally curable cancers that have been apparently cured such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in...
- History of leptomeningeal disease
- Active tuberculosis
- Participants with severe uncontrolled intercurrent illness that would limit compliance with study requirements, evaluated by history, physical exam, and chemistry panel.
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, 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 study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 120 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
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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.