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Compares treatment options for Locally Advanced Urothelial Carcinoma
Official title A Study Comparing the Combination of Pembrolizumab and Sacituzumab Govitecan-hziy Versus Standard of Care in the Treatment of Advanced Urothelial Cancer
ClinicalTrials.gov ID: NCT06524544
What this study is testing
What is Carboplatin?
Carboplatin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for locally advanced urothelial carcinoma.
Also referred to as Blastocarb, Carboplat.
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
- This phase III trial compares the effectiveness of pembrolizumab and sacituzumab govitecan-hziy to standard of care in treating patients with urothelial cancer that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
- Phase 3: a large, late-stage study
- 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 and older
You may be able to join if
- Patient must be ≥ 18 years of age
- Patient must have Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Patient must have locally advanced (unresectable and/or not amenable to curative intent therapy) or metastatic urothelial cancer
- Patient must have histologically proven conventional urothelial carcinoma (UC) of any urinary tract origin [any histologic subtype except...
- Patient must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Baseline imaging must be obtained ≤ 35...
See the full eligibility criteria
Who can join
- Patient must be ≥ 18 years of age
- Patient must have Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Patient must have locally advanced (unresectable and/or not amenable to curative intent therapy) or metastatic urothelial cancer
- Patient must have histologically proven conventional urothelial carcinoma (UC) of any urinary tract origin [any histologic subtype except neuroendocrine (small or large cell)] are permitted so long as tumors include ≥...
- Patient must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Baseline imaging must be obtained ≤ 35 days prior to randomization
- Patient must have the following prior treatment(s). Patient must have had progression on or after the immediate prior anti-cancer therapy
- Patient must have had prior exposure to anti-PD(L)1 therapy [anti -PD(L)1 monotherapy or as a combination regimen in any disease/therapy setting for UC]. Patients must have received at least 1 dose of anti-PD(L)1 therapy
- NOTE: Anti-PD(L)1 therapy does not need to be the most recent therapy received prior to enrollment on this protocol
- NOTE: Patient must not have had progression within 12 weeks of starting their first anti-PD(L) 1 therapy, even if anti-PD-(L)1 treatment was given in more than one lines of therapy
- Patient must have had ≥ 1 line of systemic therapy given in the advanced/metastatic disease setting, except for patients who had received anti-PD(L)1 + enfortumab vedotin in the localized disease setting (e.g...
- For tumors with known FGFR3+ susceptible alteration (for FGFR inhibitor), patients must have received a prior FGFR inhibitor unless contraindicated per physician discretion
- Patient must have received prior enfortumab vedotin or any other Nectin-4 directed therapy or other MMAE-containing therapy in any disease/therapy setting unless contraindicated per physician
- Patient must have had no prior exposure to Sacituzumab govitecan-hziy or other TROP-2 directed therapies or antibody-drug conjugate that contains topo-isomerase I inhibitor, e.g. trastuzumab deruxtecan
- Patient must have Bellmunt score of 0-2. The Bellmunt score assesses a patient's risk and is calculated based on ECOG PS, hemoglobin level and presence of liver metastases
- Patient must not have history of grade 3 or higher immune-related adverse events on prior anti-PD1/L1, except for endocrinopathies on adequate hormone therapy repletion and/or clinically insignificant laboratory...
- Patient must have recovered (i.e., ≤ grade 1) from clinically significant AEs due to previously administered systemic therapy agent, except for endocrinopathies on adequate hormone therapy repletion
- NOTE: Patients with ≤ grade 2 neuropathy, any grade of alopecia, or any grade of non-clinically significant laboratory abnormality are exceptions to this criterion and are allowed in this trial.
- Examples of non-clinically significant laboratory abnormalities include, but are not limited to:
- Lymphopenia or monopenia
- Lymphocytosis or monocytosis
- Increase in amylase or lipase with no clinical correlation
- Any other abnormal laboratory findings that have no clinical relevance per the treating investigator.
- NOTE: If patient has undergone major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to randomization
- Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing...
- Patient must not expect to conceive or father children by using an accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study...
- Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or...
- Absolute neutrophil count (ANC) ≥ 1,500/uL (obtained ≤ 14 days prior to randomization)
- Platelets ≥ 100,000/uL (obtained ≤ 14 days prior to randomization)
- Albumin ≥ 3 g/dL (obtained ≤ 14 days prior to randomization)
- Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (obtained ≤ 14 days prior to randomization)
- Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase [SGPT]) ≤ 3 × institutional ULN or ≤ 5.0 x institutional ULN if...
- Creatinine clearance (CrCl) ≥ 30 mL/min (obtained ≤ 14 days prior to randomization) NOTE: CrCl is estimated using the Cockcroft-Gault formula (or can be measured by 24-hour urine collection if needed)
- Hemoglobin (Hb) ≥ 8.5 g/dl (obtained ≤ 14 days prior to randomization)
- Patient must not have a known genetic UGT1A1 deficiency (Gilbert's syndrome). Patients with variant type UGT1A1\ 28 allele may have increased levels of SN-38 metabolite (due to reduced SN-38 metabolism and clearance)...
- NOTE: If a patient's UGT1A1 status is unknown, they are eligible to enroll (the study does not require this test as part of screening)
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- Patients with history of hepatitis C virus (HCV) infection must have been treated and considered cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV...
- Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression and are not using steroids \> 10 mg of prednisone (or...
- Patients with prior or concurrent malignancy that is not considered clinically significant and whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment...
- Patient must not be on systemic immunosuppressive medication, including steroids (if doses exceed the equivalent of prednisone 10 mg daily). Short courses of steroids, e.g. "burst", which are discontinued prior to...
- Patient must be English or Spanish speaking to be eligible for the HRQOL component of the study.
- NOTE: Sites cannot translate the associated HRQOL forms
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Irvine, California, United States
- Orange, California, United States
- Gainesville, Florida, United States
- Atlanta, Georgia, United States
- Coeur d'Alene, Idaho, United States
- Post Falls, Idaho, United States
- Sandpoint, Idaho, United States
- Chicago, Illinois, United States
- Danville, Illinois, United States
- Decatur, Illinois, United States
- Effingham, Illinois, United States
- Mattoon, Illinois, United States
- Normal, Illinois, United States
- O'Fallon, Illinois, United States
- Shiloh, Illinois, United States
- Springfield, Illinois, United States
- Urbana, Illinois, United States
- Ames, Iowa, United States
- Boone, Iowa, United States
+ 108 more site(s).
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 Phoenix, Arizona, United States; Irvine, California, United States; Orange, California, United States; Gainesville, Florida, United States; Atlanta, Georgia, United States; Coeur d'Alene, Idaho, United States and 122 more location(s). 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.