Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06161532
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2023-12-02
Brief Title:
Sacituzumab Govitecan With or Without Atezolizumab Immunotherapy in Rare Genitourinary Tumors SMART Such as Small Cell Adenocarcinoma and Squamous Cell BladderUrinary Tract Cancer Renal Medullary Carcinoma and Penile Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
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 BladderUrinary Tract Cancer Renal Medullary Carcinoma and Penile Cancer
Status:
RECRUITING
Status Verified Date:
2024-10-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
Rare tumors of the genitourinary GU tract can appear in the kidney bladder ureters and penis Rare tumors are difficult to study because there are not enough people to conduct large trials for new treatments Two drugs-sacituzumab govitecan SG and atezolizumab-are each approved to treat other cancers Researchers want to find out if the two drugs used together can help people with GU
Objective
To test SG either alone or combined with atezolizumab in people with rare GU tumors
Eligibility
Adults aged 18 years and older with rare GU tumors These may include small cell carcinoma of the bladder squamous cell carcinoma of the bladder primary adenocarcinoma of the bladder renal medullary carcinoma or squamous cell carcinoma of the penis
Design
Participants will be screened They will have a physical exam with blood and urine tests They will have tests of heart function They will have imaging scans They may need a biopsy A small needle will be used to remove a sample of tissue from the tumor
Both SG and atezolizumab are given through a tube attached to a needle inserted into a vein in the arm
All participants will receive SG on days 1 and 8 of each 21-day treatment cycle Some participants will also receive atezolizumab on day 1 of each cycle
Blood and urine tests imaging scans and other exams will be repeated during study visits
Treatment may continue for up to 5 years
Follow-up visits will continue for 5 more years
Rare tumors of the genitourinary GU tract can appear in the kidney bladder ureters and penis Rare tumors are difficult to study because there are not enough people to conduct large trials for new treatments Two drugs-sacituzumab govitecan SG and atezolizumab-are each approved to treat other cancers Researchers want to find out if the two drugs used together can help people with GU
Objective
To test SG either alone or combined with atezolizumab in people with rare GU tumors
Eligibility
Adults aged 18 years and older with rare GU tumors These may include small cell carcinoma of the bladder squamous cell carcinoma of the bladder primary adenocarcinoma of the bladder renal medullary carcinoma or squamous cell carcinoma of the penis
Design
Participants will be screened They will have a physical exam with blood and urine tests They will have tests of heart function They will have imaging scans They may need a biopsy A small needle will be used to remove a sample of tissue from the tumor
Both SG and atezolizumab are given through a tube attached to a needle inserted into a vein in the arm
All participants will receive SG on days 1 and 8 of each 21-day treatment cycle Some participants will also receive atezolizumab on day 1 of each cycle
Blood and urine tests imaging scans and other exams will be repeated during study visits
Treatment may continue for up to 5 years
Follow-up visits will continue for 5 more years
Detailed Description:
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 bladderurinary 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 advancedmetastatic UC in patients ineligible to receive platinum therapy
There are currently no clinical trials for SG monotherapy or SGatezolizumab 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 tumors
Eligibility
Age 18 years
ECOG performance status 1
Histologically 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-1PD-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-1PD-L1 axis ICI checkpoint inhibitor naSqrRoot ve will be eligible to receive concurrent atezolizumab
SG will be administered intravenously IV at 10 mgkg 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
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 bladderurinary 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 advancedmetastatic UC in patients ineligible to receive platinum therapy
There are currently no clinical trials for SG monotherapy or SGatezolizumab 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 tumors
Eligibility
Age 18 years
ECOG performance status 1
Histologically 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-1PD-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-1PD-L1 axis ICI checkpoint inhibitor naSqrRoot ve will be eligible to receive concurrent atezolizumab
SG will be administered intravenously IV at 10 mgkg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 001535-C | None | None | None |