Is NCT06524544 recruiting in Orange, CA?

Yes, NCT06524544 is currently recruiting participants at its Orange, CA location. This locally advanced urothelial carcinoma clinical trial is actively enrolling qualified participants.

Is participation in this Orange clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Locally Advanced Urothelial Carcinoma Clinical Trial in Orange, CA

Q: How do I join the locally advanced urothelial carcinoma clinical trial in Orange?

To join this clinical trial in Orange, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Locally Advanced Urothelial Carcinoma Study in Orange

This phase III trial compares the effectiveness of pembrolizumab and sacituzumab govitean-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. Sacituzumab govitean-hziy is a monoclonal antibody, called sacituzumab, linked to a chemotherapy drug called govitean-hziy. Sacituzumab attaches to TROP2 positive tumor cells in a targeted way and delivers govitean-hziy to kill them. The usual treatment approach is treatment with chemotherapy such as cisplatin, carboplatin, gemcitabine, docetaxel or paclitaxel. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid and may kill tumor cells. Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Giving pembrolizumab and sacituzumab govitean-hziy may be more effective than usual care of carboplatin or cisplatin with gemcitabine, docetaxel or paclitaxel in treating patients with locally advanced or metastatic urothelial cancer.

Sponsor: National Cancer Institute (NCI)

Who Can Participate

Inclusion Criteria

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 ≥ 1% conventional urothelial histology). NOTE: Pure non-urothelial histology is excluded

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., neoadjuvant and/or adjuvant) and had cancer progression within 12 months from the last systemic therapy dose

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 vedotinor 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 govitean-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, hemogloblin 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 abnormalities

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 potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy. A patient of childbearing potential is defined as anyone, regardless of whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months). Patient must not nurse infants while on protocol treatment and for 4 months after the last dose of protocol treatment

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. Patients of childbearing potential must continue contraceptive method(s) or abstain for 6 months after the last dose of protocol treatment. Patients with partners who could become pregnant should use effective contraception during therapy and for 3 months after the last dose of protocol treatment

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 caregiver and/or family member available will also be considered eligible

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 known liver metastases (obtained ≤ 14 days prior to randomization)

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 mg/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) and are at higher risk for severe adverse events when compared to wild-type.

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 viral load

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 equivalent) daily for brain metastases for at least 7 days prior to randomization

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 efficacy assessment of the investigational regimen (at the discretion of the treating physician) are eligible

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 randomization are acceptable. Patients on inhaled, intranasal, intra-articular and/or topical steroids are eligible

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Orange?

Yes, this clinical trial (NCT06524544) has an active research site in Orange, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Locally Advanced Urothelial Carcinoma Treatment Options in Orange, CA

If you're searching for locally advanced urothelial carcinoma treatment options in Orange, CA, this clinical trial (NCT06524544) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Orange research site is actively enrolling participants for this clinical trial. You'll receive care from experienced locally advanced urothelial carcinoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all locally advanced urothelial carcinoma clinical trials near you to find additional studies recruiting in your area.

Locally Advanced Urothelial Carcinoma Clinical Trial in Orange, CA

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