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New treatment option for Urothelial Cancer
Official title Sacituzumab Govitecan Plus EV in Metastatic UC
ClinicalTrials.gov ID: NCT04724018
What this study is testing
What is Sacituzumab Govitecan (SG)?
Sacituzumab Govitecan (SG) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for urothelial cancer.
Also referred to as Trodelvy.
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
- Phase I of this research study will assess what doses of Sacituzumab Govitecan and Enfortumab Vedotin can be safely combined in the treatment of metastatic urothelial carcinoma (mUC). In Phase II of the study, patients in one of the two cohorts will receive Sacituzumab Govitecan, Enfortumab Vedotin, and Pembrolizumab to assess the efficacy of this drug combination.
- Phase 2: a mid-size study of how well it works
- 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
- Phase II Study Cohort A (dose expansion study to assess how well it works of Sacituzumab Govitecan (SG) and Enfortumab vedotin-ejfv (EV) combination)
- Participants must have histologically documented confirmed predominant urothelial carcinoma (i.e. of the bladder, renal pelvis, ureter or urethra)...
- Patient who are cisplatin eligible must have received prior treatment with platinum containing therapy defined as within the adjuvant/neoadjuvant...
- Patients who are cisplatin-ineligible need only have progressed on or since one line of therapy defined as therapy given in the adjuvant/neoadjuvant...
- Patient must be progressing on or since most recent therapy
You likely can't join if
- people meeting any of the following exclusion criteria at Screening/Day 1 of treatment will not be enrolled in the study.
- Women who are pregnant or lactating. Pregnant women are excluded from this study because SG and EV have potential for teratogenic or abortifacient...
- Have had a prior anti-cancer biologic agent (including immune checkpoint inhibitors) within 4 weeks prior to Cycle 1 Day 1 (C1D1) or have had prior...
- Presence of any toxicities attributed to prior anti-cancer therapy that are not resolved to Grade 1 or baseline that could impose serious risk for...
- Note: If people received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to...
- Have previously received topoisomerase 1 inhibitors, SG or EV
See the full eligibility criteria
Who can join
- Phase II Study Cohort A (dose expansion study to assess how well it works of Sacituzumab Govitecan (SG) and Enfortumab vedotin-ejfv (EV) combination)
- Participants must have histologically documented confirmed predominant urothelial carcinoma (i.e. of the bladder, renal pelvis, ureter or urethra). Patients with squamous differentiation or mixed cell types are eligible...
- Patient who are cisplatin eligible must have received prior treatment with platinum containing therapy defined as within the adjuvant/neoadjuvant setting with ≥ ypT2 disease at surgery or recurrent or progressive...
- Patients who are cisplatin-ineligible need only have progressed on or since one line of therapy defined as therapy given in the adjuvant/neoadjuvant setting within 12 months of progression or receiving therapy for...
- Patient must be progressing on or since most recent therapy
- Age ≥18 years. Children are excluded from this study, but will be eligible for future pediatric trials.
- ECOG performance status 0-1.
- Participants must have adequate organ and marrow function as defined below:
- Leukocytes ≥3,000/mcL
- Absolute neutrophil count ≥1,500/mcL
- Platelets ≥100,000/mcL
- Total bilirubin ≤ institutional upper limit of normal (ULN)
- AST(SGOT)/ALT(SGPT) ≤2.5x institutional ULN OR
- ≤5x ULN with liver metastases and serum albumin \> 3 g/dL
- Glomerular filtration rate (GFR) ≥30 mL/min/1.73 m2 (by Cockcroft Gault formula)
- Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
- For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
- Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV...
- Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association...
- Have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as per response evaluation criteria in solid tumors version 1.1 (RECIST 1.1 criteria). Tumor lesions situated in a previously...
- Female people of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as...
- Female people of childbearing potential must be willing to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity for the course of the study through 6 months after the last dose...
- The effects of SG and EV on the developing human fetus are unknown. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to...
- Ability to understand and the willingness to sign a written informed consent document.
What rules you out
- people meeting any of the following exclusion criteria at Screening/Day 1 of treatment will not be enrolled in the study.
- Women who are pregnant or lactating. Pregnant women are excluded from this study because SG and EV have potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse...
- Have had a prior anti-cancer biologic agent (including immune checkpoint inhibitors) within 4 weeks prior to Cycle 1 Day 1 (C1D1) or have had prior chemotherapy, targeted small molecule therapy, or radiation therapy...
- Presence of any toxicities attributed to prior anti-cancer therapy that are not resolved to Grade 1 or baseline that could impose serious risk for complications before administration of study drug agent
- Note: If people received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
- Have previously received topoisomerase 1 inhibitors, SG or EV
- Have an active second malignancy. people with a history of malignancy that have been completely treated, with no evidence of active cancer for 3 years prior to start of therapy on trial (Cycle 1 Day 1 [C1D1]), or people...
- Have known active central nervous system (CNS) metastases and/or carcinomatous meningitis. people with previously treated brain metastases may participate provided they have stable CNS disease for at least 4 weeks prior...
- Have active cardiac disease, defined as:
- Myocardial infarction or unstable angina pectoris within 6 months prior to C1D1
- History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring anti-arrhythmic medications (except for...
- New York Heart Association (NYHA) Class III or greater congestive heart failure or left ventricular ejection fraction of \< 40%
- Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or gastrointestinal (GI) perforation within 6 months of C1D1
- Have active serious infection requiring antibiotics (Contact sponsor-investigator for clarification)
- Have other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.
- Patients with conditions requiring high doses of steroids (\>10 mg/day of prednisone or equivalent) or other immunosuppressive medications are excluded. Inhaled or topical steroids are permitted in the absence of active...
- History of idiopathic pulmonary fibrosis; organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
- Participants who are receiving any other investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to EV or SG or any excipient contained in the drug formulations (including 2 (N morpholino) ethane sulfonic acid (MES)...
- Participants with uncontrolled intercurrent illness.
- Participants with psychiatric illness/social situations that would limit compliance with study requirements.
- Patients with uncontrolled diabetes. Uncontrolled diabetes is defined as hemoglobin A1C \>8% or 7-8% with associated diabetes symptoms that are otherwise not explained
- Uncontrolled tumor related bone pain or impending spinal cord compression. Phase II Study Cohort B (assessing Sacituzumab Govitecan (SG) + Enfortumab vedotin-ejfv (EV) + Pembrolizumab combination) Inclusion Criteria:
- Participants must have histologically documented confirmed predominant urothelial carcinoma (i.e. of the bladder, renal pelvis, ureter or urethra). Patients with squamous differentiation or mixed cell types are eligible...
- No prior therapy for metastatic urothelial carcinoma. Therapy in the perioperative setting is allowed with no time restrictions on platinum dosing. Prior immunotherapy is allowed provided it has been \> 6 months from...
- Age ≥18 years; children are excluded from this study, but will be eligible for future pediatric trials.
- ECOG performance status 0-1.
- Participants must have adequate organ and marrow function as defined below:
- Leukocytes ≥3,000/mcL
- Absolute neutrophil count ≥1,500/mcL
- Platelets ≥100,000/mcL
- Total bilirubin ≤ institutional upper limit of normal (ULN)
- AST(SGOT)/ALT(SGPT) ≤2.5x institutional ULN OR
- ≤5x ULN with liver metastases and serum albumin \> 3 g/dL
- Glomerular filtration rate (GFR) ≥30 mL/min/1.73 m2 (by Cockcroft Gault formula)
- Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
- For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
- Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV...
- Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association...
- Have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as per response evaluation criteria in solid tumors version 1.1 (RECIST 1.1 criteria). Tumor lesions situated in a previously...
- Female people of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as...
- Female people of childbearing potential must be willing to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity for the course of the study through 6 months after the last dose...
- The effects of Pembrolizumab, SG and EV on the developing human fetus are unknown. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control...
- Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: people meeting any of the following exclusion criteria at Screening/Day 1 of treatment will not be enrolled in...
- Women who are pregnant or lactating. Pregnant women are excluded from this study because SG and EV have potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse...
- Have had a prior anti-cancer biologic agent (including immune checkpoint inhibitors) or chemotherapy within 26 weeks prior to Cycle 1 Day 1 (C1D1) people participating in observational studies are eligible.
- Have previously received topoisomerase 1 inhibitors, SG or EV
- Have an active second malignancy. people with a history of malignancy that have been completely treated, with no evidence of active cancer for 3 years prior to start of therapy on trial (Cycle 1 Day 1 [C1D1]), or people...
- Have known active central nervous system (CNS) metastases and/or carcinomatous meningitis. people with previously treated brain metastases may participate provided they have stable CNS disease for at least 4 weeks prior...
- Have active cardiac disease, defined as:
- Myocardial infarction or unstable angina pectoris within 6 months prior to C1D1
- History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring anti-arrhythmic medications (except for...
- New York Heart Association (NYHA) Class III or greater congestive heart failure or left ventricular ejection fraction of \< 40%
- Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or gastrointestinal (GI) perforation within 6 months of C1D1
- Have active serious infection requiring antibiotics (Contact sponsor PI or Co-PI for clarification)
- Have other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.
- Patients with conditions requiring high doses of steroids (\>10 mg/day of prednisone or equivalent) or other immunosuppressive medications are excluded. Inhaled or topical steroids are permitted in the absence of active...
- History idiopathic pulmonary fibrosis; organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
- Participants who are receiving any other investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to pembrolizumab, EV or SG or any excipient contained in the drug formulations (including 2 (N morpholino) ethane...
- Participants with uncontrolled intercurrent illness.
- Participants with psychiatric illness/social situations that would limit compliance with study requirements.
- Patients with uncontrolled diabetes. Uncontrolled diabetes is defined as hemoglobin A1C \>8% or 7-8% with associated diabetes symptoms that are otherwise not explained
- Uncontrolled tumor related bone pain or impending spinal cord compression.
- History of autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).
- Replacement therapy (e.g., thyroxine, insulin, physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
- Brief (\<7 days) use of systemic corticosteroids is allowed when use is considered standard of care.
- people with vitiligo, psoriasis, type 1 diabetes mellitus, hypothyroidism, or resolved childhood asthma/atopy will not be excluded.
- people requiring intermittent use of bronchodilators, inhaled steroids, or local steroid injections will not be excluded.
- people with hypothyroidism that is stable with hormone replacement or Sjögren's syndrome will not be excluded.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, 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 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 Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.