💬In plain words
What the trial is, and whether it could suit you
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. Two drugs-sacituzumab govitecan (SG) and atezolizumab-are each approved to treat other cancers. Researchers want to find out if the two drugs used together can help people with GU.
Objective:
To test SG, either alone or combined with atezolizumab, in people with rare GU tumors.
Eligibility:
Adults aged 18 years and older with rare GU tumors. These may include high grade neuroendocrine carcinomas; squamous cell carcinoma of the bladder; primary adenocarcinoma of the bladder; renal medullary carcinoma; or squamous cell carcinoma of the penis.
Design:
Participants will be screened. They will have a physical exam with blood and urine tests. They will have tests o
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
* INCLUSION CRITERIA:
* 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 will be required.
* 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 imaging).
* 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 \<= 1 (Karnofsky \>= 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 \<= 2 x ULN or creatinine clearance \>= 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 combination regimen either as neoadjuvant, adjuvant or first-line treatment in the locally advanced/metastatic setting).
* 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 resection within 4 weeks prior to initiation of study treatment.
* 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 longer) prior to the first dose of study treatment.
* 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 period of at least 2 weeks prior to initiation of study treatment or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions:
* 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 for the study.
* 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 insufficiency are eligible for the study.
* 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 therapies may increase the risk of disease progression. Potential drug-drug interactions with the hormonal agent will be assessed by
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