Sacituzumab Govitecan With or Without Atezolizumab Immunotherapy in Rare Genitourinary Tumors (SMART) Such as Small Cell, Adenocarcinoma, and Squamous Cell Bladder/Urinary Tract Cancer, Renal Medullary Carcinoma and Penile Cancer : A Phase II Study of Sacituzumab Govitecan With or Without Atezolizumab Immunotherapy in Rare Genitourinary Tumors (SMART) Such as Small Cell, Adenocarcinoma, and Squamous Cell Bladder/Urinary Tract Cancer, Renal Medullary Carcinoma and Penile Cancer
Background:Urothelial carcinoma (UC) represents the most common histology for tumors of the bladder and urinary tract.A minority of patients have primary tumors of the bladder/urinary tract consisting of rare histological variants, including small cell carcinoma, primary adenocarcinoma of the bladder (urachal or non-urachal), or squamous cell carcinoma. Some tumors may contain elements of UC mixed with these variants or may be entirely composed of such variants.Clear cell renal cell carcinoma (ccRCC) is the most common histology for cancers of the renal parenchyma. Renal medullary carcinoma is a rare histology of kidney cancer, which is associated with sickle cell trait and other hemoglobinopathies.Rare tumors of the genitourinary (GU) tract often have more aggressive clinical course, but lack standard of care treatment regimens, since these patient populations are poorly represented or excluded from most clinical trials.Sacituzumab govitecan (SG) is an antibody-drug conjugate of an IgG 1 monoclonal antibody targeting trophoblastic cell surface antigen 2 (Trop2) with a chemotherapeutic payload of SN-38. SN-38 is an active metabolite of irinotecan and acts as a topoisomerase I inhibitor.SG has demonstrated clinical activity in solid tumors. In phase II clinical trials, SG has demonstrated efficacy in metastatic UC after progression on platinum-based chemotherapy and immune checkpoint inhibitor (ICI) therapy.Atezolizumab is an anti- programmed death-ligand 1 (PD-L1) ICI that is approved for advanced/metastatic UC in patients ineligible to receive platinum therapy.There are currently no clinical trials for SG monotherapy or SG/atezolizumab combination in rare GU tumors.Objective:-To determine clinical efficacy of sacituzumab govitecan (SG), either alone or in combination with atezolizumab, as defined by objective response rate (ORR), in participants with rare metastatic non-prostate genitourinary tumorsEligibility:Age >= 18 yearsECOG performance status <= 1Histologically confirmed diagnosis of locally advanced (unresectable) or metastatic GU tumors of the following histologies: small cell carcinoma, squamous cell carcinoma, or primary adenocarcinoma of the bladder or urinary tract; or renal medullary carcinoma or squamous cell carcinoma of the penis.Participants must have locally advanced unresectable or metastatic disease on cross-sectional imaging.Participants may have received any prior programmed cell death protein 1 (PD-1)/PD-L1 axis ICI treatment.Design:This is an open label, non-randomized phase II trial with two arms.All participants will receive SG.Participants without prior treatment with any PD-1/PD-L1 axis ICI (checkpoint inhibitor na(SqrRoot) ve) will be eligible to receive concurrent atezolizumab.SG will be administered intravenously (IV) at 10 mg/kg on D1 and D8 of 21-day cycles.Atezolizumab will be administered IV at 1200mg on D1 of 21-day cycles.Treatment will be given in 21-day cycles continuously for a maximum of 5 years, or until signs of progression or intolerable side effects.The accrual ceiling will be set at 60 to allow for inevaluable participants and screen failure..
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Klinische Studie| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
ClinicalTrials.gov - (2024) vom: 02. Apr. Zur Gesamtaufnahme - year:2024 |
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| Sprache: |
Englisch |
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| Links: |
Volltext [kostenfrei] |
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| Anmerkungen: |
Source: Link to the current ClinicalTrials.gov record., First posted: December 8, 2023, Last downloaded: ClinicalTrials.gov processed this data on April 03, 2024, Last updated: April 03, 2024 |
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| Study ID: |
NCT06161532 |
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| Veröffentlichungen zur Studie: |
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| PPN (Katalog-ID): |
CTG000014141 |
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| 245 | 1 | 0 | |a Sacituzumab Govitecan With or Without Atezolizumab Immunotherapy in Rare Genitourinary Tumors (SMART) Such as Small Cell, Adenocarcinoma, and Squamous Cell Bladder/Urinary Tract Cancer, Renal Medullary Carcinoma and Penile Cancer |b A Phase II Study of Sacituzumab Govitecan With or Without Atezolizumab Immunotherapy in Rare Genitourinary Tumors (SMART) Such as Small Cell, Adenocarcinoma, and Squamous Cell Bladder/Urinary Tract Cancer, Renal Medullary Carcinoma and Penile Cancer |
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| 500 | |a Source: Link to the current ClinicalTrials.gov record., First posted: December 8, 2023, Last downloaded: ClinicalTrials.gov processed this data on April 03, 2024, Last updated: April 03, 2024 | ||
| 520 | |a Background:Urothelial carcinoma (UC) represents the most common histology for tumors of the bladder and urinary tract.A minority of patients have primary tumors of the bladder/urinary tract consisting of rare histological variants, including small cell carcinoma, primary adenocarcinoma of the bladder (urachal or non-urachal), or squamous cell carcinoma. Some tumors may contain elements of UC mixed with these variants or may be entirely composed of such variants.Clear cell renal cell carcinoma (ccRCC) is the most common histology for cancers of the renal parenchyma. Renal medullary carcinoma is a rare histology of kidney cancer, which is associated with sickle cell trait and other hemoglobinopathies.Rare tumors of the genitourinary (GU) tract often have more aggressive clinical course, but lack standard of care treatment regimens, since these patient populations are poorly represented or excluded from most clinical trials.Sacituzumab govitecan (SG) is an antibody-drug conjugate of an IgG 1 monoclonal antibody targeting trophoblastic cell surface antigen 2 (Trop2) with a chemotherapeutic payload of SN-38. SN-38 is an active metabolite of irinotecan and acts as a topoisomerase I inhibitor.SG has demonstrated clinical activity in solid tumors. In phase II clinical trials, SG has demonstrated efficacy in metastatic UC after progression on platinum-based chemotherapy and immune checkpoint inhibitor (ICI) therapy.Atezolizumab is an anti- programmed death-ligand 1 (PD-L1) ICI that is approved for advanced/metastatic UC in patients ineligible to receive platinum therapy.There are currently no clinical trials for SG monotherapy or SG/atezolizumab combination in rare GU tumors.Objective:-To determine clinical efficacy of sacituzumab govitecan (SG), either alone or in combination with atezolizumab, as defined by objective response rate (ORR), in participants with rare metastatic non-prostate genitourinary tumorsEligibility:Age >= 18 yearsECOG performance status <= 1Histologically confirmed diagnosis of locally advanced (unresectable) or metastatic GU tumors of the following histologies: small cell carcinoma, squamous cell carcinoma, or primary adenocarcinoma of the bladder or urinary tract; or renal medullary carcinoma or squamous cell carcinoma of the penis.Participants must have locally advanced unresectable or metastatic disease on cross-sectional imaging.Participants may have received any prior programmed cell death protein 1 (PD-1)/PD-L1 axis ICI treatment.Design:This is an open label, non-randomized phase II trial with two arms.All participants will receive SG.Participants without prior treatment with any PD-1/PD-L1 axis ICI (checkpoint inhibitor na(SqrRoot) ve) will be eligible to receive concurrent atezolizumab.SG will be administered intravenously (IV) at 10 mg/kg on D1 and D8 of 21-day cycles.Atezolizumab will be administered IV at 1200mg on D1 of 21-day cycles.Treatment will be given in 21-day cycles continuously for a maximum of 5 years, or until signs of progression or intolerable side effects.The accrual ceiling will be set at 60 to allow for inevaluable participants and screen failure. | ||
| 650 | 2 | |a Carcinoma | |
| 650 | 2 | |a Carcinoma, Squamous Cell | |
| 650 | 2 | |a Adenocarcinoma | |
| 650 | 2 | |a Urinary Bladder Neoplasms | |
| 650 | 2 | |a Carcinoma, Small Cell | |
| 650 | 2 | |a Small Cell Lung Carcinoma | |
| 650 | 2 | |a Penile Neoplasms | |
| 650 | 2 | |a Carcinoma, Medullary | |
| 650 | 2 | |a Thyroid Neoplasms | |
| 650 | 2 | |a Carcinoma, Neuroendocrine | |
| 650 | 2 | |a Urologic Neoplasms | |
| 650 | 2 | |a Kidney Neoplasms | |
| 650 | 4 | |a Study Type: Interventional | |
| 650 | 4 | |a Recruitment Status: Not yet recruiting | |
| 650 | 4 | |a Phase: Phase 2 | |
| 650 | 4 | |a 610 | |
| 773 | 0 | 8 | |i Enthalten in |t ClinicalTrials.gov |g (2024) vom: 02. Apr. |
| 773 | 1 | 8 | |g year:2024 |g day:02 |g month:04 |
| 856 | 4 | 0 | |u https://clinicaltrials.gov/show/NCT06161532 |z kostenfrei |3 Volltext |
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