Sacituzumab Govitecan + Nivolumab for Bladder Cancer
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: University of California, Irvine
Stay on your current meds
No Placebo Group
Prior Safety Data
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?This is a phase 2 study, single-arm study of adjuvant combination therapy with Sacituzumab Govitecan and Nivolumab in patients with muscle-invasive urothelial carcinoma of the bladder, ureter, or upper tract, who are high risk for cancer recurrence post curative-intent surgery based on surgical pathology.
Is the drug Sacituzumab Govitecan + Nivolumab a promising treatment for bladder cancer?Yes, Sacituzumab Govitecan is a promising drug for bladder cancer. It targets a protein called Trop-2, which is found in many cancer cells, and delivers a powerful cancer-fighting agent directly to them. This approach has shown positive results in early studies, especially for patients who have limited treatment options.12346
What safety data is available for Sacituzumab Govitecan and Nivolumab in bladder cancer treatment?Sacituzumab Govitecan (SG) has been studied for its safety profile, particularly in breast and urothelial cancers. A pharmacovigilance study using the FDA adverse event reporting system identified 114 adverse event signals across 20 systems, with common issues including neutropenia, diarrhea, colitis, and sepsis. The median onset of adverse events was 6-7 days after treatment initiation, with over 80% occurring within 30 days. Risk factors for hospitalization included male gender and conditions like colitis, pneumonitis, febrile neutropenia, pyrexia, sepsis, dehydration, and diarrhea. This data suggests a need for close monitoring of these adverse reactions when using SG. However, specific safety data for the combination of Sacituzumab Govitecan and Nivolumab in bladder cancer is not detailed in the provided research.23678
What data supports the idea that Sacituzumab Govitecan + Nivolumab for Bladder Cancer is an effective drug?The available research shows that Sacituzumab Govitecan has shown preliminary activity in patients with metastatic urothelial carcinoma, a type of bladder cancer, who have limited options after other treatments. While specific data on the combination of Sacituzumab Govitecan and Nivolumab is not provided, Sacituzumab Govitecan alone has been noted for its potential effectiveness. It is also being explored for other cancers, indicating its potential as a versatile treatment option.24567
Do I have to stop taking my current medications for this trial?The trial protocol does not specify if you need to stop taking your current medications. However, you cannot take systemic high-dose corticosteroids or other immunosuppressive medications within 14 days of starting the study treatment.
Eligibility Criteria
This trial is for individuals with muscle-invasive urothelial carcinoma, which includes cancers of the bladder, ureter, or upper tract. It's specifically for those at high risk of cancer coming back after surgery meant to cure them.Inclusion Criteria
I am 18 years old or older.
My cancer started in the bladder, ureter, or renal pelvis and is not small cell carcinoma.
I am using birth control if I or my partner can become pregnant.
I can care for myself and am up and about more than 50% of my waking hours.
Exclusion Criteria
I have had radiation therapy for urinary cancer.
I had surgery to remove part of my bladder or kidney.
I've had platinum-based chemotherapy or another treatment after surgery for UC.
I have or might have an autoimmune disease.
I have a history of lung conditions or signs of lung inflammation on a recent scan.
I have not had any major or minor surgery recently before starting the study treatment.
My organ and bone marrow function is not adequate.
I do not have any uncontrolled illnesses.
I haven't taken high-dose steroids or immunosuppressants in the last 14 days.
I have been treated with PD-1/PD-L1 inhibitors or Sacituzumab Govitecan before.
My cancer has spread to other parts of my body, as shown by imaging tests.
Treatment Details
The study is testing a combination therapy using two drugs: Sacituzumab Govitecan and Nivolumab. As it's a phase 2 single-arm study, all participants will receive this combo treatment to see how effective it is in preventing cancer recurrence.
1Treatment groups
Experimental Treatment
Group I: Sacituzumab Govitecan PLUS NivolumabExperimental Treatment2 Interventions
Patients eligible for this study treatment will receive combination therapy with Sacituzumab Govitecan with Nivolumab for 4 cycles, followed by single-agent Nivolumab for an additional 11 cycles.
Find a clinic near you
Research locations nearbySelect from list below to view details:
Chao Family Comprehensive Cancer Center, University of California, IrvineOrange, CA
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Who is running the clinical trial?
University of California, IrvineLead Sponsor
Gilead SciencesIndustry Sponsor
References
First-in-Human Trial of a Novel Anti-Trop-2 Antibody-SN-38 Conjugate, Sacituzumab Govitecan, for the Treatment of Diverse Metastatic Solid Tumors. [2022]Sacituzumab govitecan (IMMU-132) is an antibody-drug conjugate (ADC) targeting Trop-2, a surface glycoprotein expressed on many epithelial tumors, for delivery of SN-38, the active metabolite of irinotecan. This phase I trial evaluated this ADC as a potential therapeutic for pretreated patients with a variety of metastatic solid cancers.
Sacituzumab Govitecan: First Approval. [2021]Sacituzumab govitecan (sacituzumab govitecan-hziy; Trodelvy™) is a Trop-2-directed antibody conjugated to a topoisomerase I inhibitor (SN-38) that is being developed by Immunomedics for the treatment of solid tumours, including breast cancer. In April 2020, sacituzumab govitecan received accelerated approval in the USA for the treatment of adult patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease. Sacituzumab govitecan is undergoing phase III development for breast cancer in the USA and EU, and phase II development for urothelial cancer. It is also being explored for brain metastases, glioblastoma, endometrial cancer and prostate cancer. This article summarizes the milestones in the development of sacituzumab govitecan leading to this first approval for mTNBC.
Sacituzumab Govitecan-hziy: An Antibody-Drug Conjugate for the Treatment of Refractory, Metastatic, Triple-Negative Breast Cancer. [2021]To review the pharmacology, efficacy, and safety of sacituzumab govitecan (-hziy; IMMU-132, Trodelvy) for patients with metastatic triple-negative breast cancer (mTNBC) who have received at least 2 prior therapies for metastatic disease.
TROPHY-U-01: A Phase II Open-Label Study of Sacituzumab Govitecan in Patients With Metastatic Urothelial Carcinoma Progressing After Platinum-Based Chemotherapy and Checkpoint Inhibitors. [2022]Patients with metastatic urothelial carcinoma (mUC) who progress on platinum-based combination chemotherapy (PLT) and checkpoint inhibitors (CPIs) have limited options that offer objective response rates (ORRs) of approximately 10% with a median overall survival (OS) of 7-8 months. Sacituzumab govitecan (SG) is a TROP-2-directed antibody-drug conjugate with an SN-38 payload that has shown preliminary activity in mUC.
The role of enfortumab vedotin and sacituzumab govitecan in treatment of advanced bladder cancer. [2022]The treatment landscape of advanced bladder cancer continues to evolve with novel therapeutics approved in recent years and many in the pipeline. Here we review the role of the novel agents enfortumab vedotin and sacituzumab govitecan in treatment of advanced disease.
Current and emerging role of sacituzumab govitecan in the management of urothelial carcinoma. [2022]Despite rapid advances in the treatment landscape of urothelial cancer, there is a substantial unmet need for safe and effective therapies for patients with locally advanced and metastatic urothelial cancer. Sacituzumab govitecan (SG) is an antibody-drug conjugate, consisting of a Trop-2 directed monoclonal antibody linked to SN-38, the active metabolite of irinotecan. Trop-2 is a glycoprotein overexpressed in various carcinomas, including urothelial carcinomas.
The Double Antibody Drug Conjugate (DAD) phase I trial: sacituzumab govitecan plus enfortumab vedotin for metastatic urothelial carcinoma. [2023]The antibody-drug conjugates sacituzumab govitecan (SG) and enfortumab vedotin (EV) are standard monotherapies for metastatic urothelial carcinoma (mUC). Given the different targets and payloads, we evaluated the safety and efficacy of SG + EV in a phase I trial in mUC (NCT04724018).
Postmarketing safety of Sacituzumab govitecan: a pharmacovigilance study based on FDA adverse event reporting system (FAERS). [2023]Sacituzumab govitecan(SG)is wide used for the treatment of breast cancer and urothelial carcinoma, but available information regarding AEs is limited. We aim to explore the AE induced by SG by mining the FAERS database.The association between SG and adverse events (AEs) were evaluated using the information component (IC). A multivariate logistic regression analysis was conducted for all identified signals to explore the risk factors associated with AEs leading to hospitalization.In total1884 reports related to SG were retrieved, and 114 AE signals involving 20 systems were identified. The median time for onset of AEs was around 6-7 days after initiating treatment with SG, with over 80% of AEs occurring within 30 days. Subgroup analysis revealed that 14 signals were reported in the males and 110 in the females. There were 58 signals reported in patients under 65 following the use of SG, 59 signals in patients over 65, and 31 signals were present in both groups. Multivariable analysis showed that the males and the occurrence of Colitis, Pneumonitis, Febrile Neutropenia, Pyrexia, Sepsis, Dehydration, and Diarrhea were risk factors leading to hospitalization with an AUC of 0.89. Additionally, sensitivity analysis revealed that this study had good robustness.This is the first retrospective analysis based on FAERS to review the safety of SG. The results highlight the need to closely monitor adverse reactions such as neutropenia, diarrhea, colitis, and sepsis when using SG.