Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06524544
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-26
Brief Title:
A Study Comparing the Combination of Pembrolizumab and Sacituzumab Govitecan Versus Sacituzumab Govitecan Alone in the Treatment of Advanced Urothelial Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase III Randomized Trial of Pembrolizumab in Combination With Sacituzumab Govitecan vs Sacituzumab Govitecan Alone in Anti-PDL1-Resistant Advanced Urothelial Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase III trial compares the effectiveness of pembrolizumab and sacituzumab govitecan to sacituzumab govitecan alone 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 bodys immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread Sacituzumab govitecan is a monoclonal antibody called sacituzumab linked to a chemotherapy drug called govitecan Sacituzumab attaches to TROP2 positive tumor cells in a targeted way and delivers govitecan to kill them Giving pembrolizumab and sacituzumab govitecan may be more effective than sacituzumab govitecan alone in treating patients with locally advanced or metastatic urothelial cancer
Detailed Description:
PRIMARY OBJECTIVE
I To compare overall survival OS between the sacituzumab govitecan monotherapy arm and the sacituzumab govitecan pembrolizumab arm
SECONDARY OBJECTIVES
I To compare the progression free survival PFS between the sacituzumab govitecan monotherapy arm and the sacituzumab govitecan pembrolizumab arm
II To evaluate overall response rate ORR between the sacituzumab govitecan monotherapy arm and the sacituzumab govitecan pembrolizumab arm
III To evaluate clinical benefit rate complete response CRpartial response PR stable disease SD between the sacituzumab govitecan monotherapy arm and the sacituzumab govitecan pembrolizumab arm
IV To evaluate duration of response DoR between the sacituzumab govitecan monotherapy arm and the sacituzumab govitecan pembrolizumab arm
V To evaluate toxicity of the sacituzumab govitecan pembrolizumab arm using the National Cancer Institute NCI Common Terminology Criteria for Adverse Events CTCAE
CORRELATIVE OBJECTIVE
I To evaluate the potential association between tumor tissue-based blood and urine-based biomarkers with clinical endpoints eg OS PFS ORR in each arm
EXPLORATORY OBJECTIVE
I To assess clinical outcomes OS PFS ORR clinical benefit rate in prespecified subsets based on 1 prior checkpoint inhibitor therapy response primary versus vs secondary resistance 2 prior enfortumab vedotin 3 prior platinum-based chemotherapy cisplatincarboplatin and 4 Bellmunt score risk factors
EXPLORATORY HEALTH RELATED QUALITY OF LIFE HRQOL OBJECTIVES
I To compare HRQOL as assessed by the National Comprehensive Cancer NetworkFunctional Assessment of Cancer Therapy Bladder Symptom Index-18 FBISI-18 summary score between patients on the sacituzumab govitecan arm versus the sacituzumab govitecan pembrolizumab arm at 6 months
II To compare HRQOL change from baseline as assessed by the FBISI-18 summary score for patients on the sacituzumab govitecan arm versus the sacituzumab govitecan pembrolizumab arm at baseline 3 6 and 12 months
III To compare the change in patient-reported fatigue from baseline and across 3 6 and 12 months as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue FACIT-Fatigue summary score change from baseline will be compared between patients on the sacituzumab govitecan arm versus the sacituzumab govitecan pembrolizumab arm
IV To compare quality-adjusted survival overall survival x health utility score assessed by the European Quality of Life Five Dimension Five Level EQ-5D-5L between patients on the sacituzumab govitecan arm versus the sacituzumab govitecan pembrolizumab arm
V To compare time to HRQOL deterioration in global HRQOL as measured by the FBISI-18 disease-related physical symptom subscale FBISI-18 disease-related symptoms DRS in the physical emotional domains DRS-P between patients on the sacituzumab govitecan arm versus the sacituzumab govitecan pembrolizumab arm
OUTLINE Patients are randomized to 1 of 2 arms
ARM A Patients receive sacituzumab govitecan intravenously IV over 1-3 hours on days 1 and 8 of each cycle Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity Patients additionally undergo blood sample collection and computed tomography CT or magnetic resonance imaging MRI throughout the study
ARM B Patients receive pembrolizumab IV over 30 minutes on day 1 and sacituzumab govitecan IV over 1-3 hours on days 1 and 8 of each cycle Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity Patients additional undergo blood sample collection and CT or MRI throughout the study
After completion of study treatment patients are followed up for 5 years from the date of randomization
I To compare overall survival OS between the sacituzumab govitecan monotherapy arm and the sacituzumab govitecan pembrolizumab arm
SECONDARY OBJECTIVES
I To compare the progression free survival PFS between the sacituzumab govitecan monotherapy arm and the sacituzumab govitecan pembrolizumab arm
II To evaluate overall response rate ORR between the sacituzumab govitecan monotherapy arm and the sacituzumab govitecan pembrolizumab arm
III To evaluate clinical benefit rate complete response CRpartial response PR stable disease SD between the sacituzumab govitecan monotherapy arm and the sacituzumab govitecan pembrolizumab arm
IV To evaluate duration of response DoR between the sacituzumab govitecan monotherapy arm and the sacituzumab govitecan pembrolizumab arm
V To evaluate toxicity of the sacituzumab govitecan pembrolizumab arm using the National Cancer Institute NCI Common Terminology Criteria for Adverse Events CTCAE
CORRELATIVE OBJECTIVE
I To evaluate the potential association between tumor tissue-based blood and urine-based biomarkers with clinical endpoints eg OS PFS ORR in each arm
EXPLORATORY OBJECTIVE
I To assess clinical outcomes OS PFS ORR clinical benefit rate in prespecified subsets based on 1 prior checkpoint inhibitor therapy response primary versus vs secondary resistance 2 prior enfortumab vedotin 3 prior platinum-based chemotherapy cisplatincarboplatin and 4 Bellmunt score risk factors
EXPLORATORY HEALTH RELATED QUALITY OF LIFE HRQOL OBJECTIVES
I To compare HRQOL as assessed by the National Comprehensive Cancer NetworkFunctional Assessment of Cancer Therapy Bladder Symptom Index-18 FBISI-18 summary score between patients on the sacituzumab govitecan arm versus the sacituzumab govitecan pembrolizumab arm at 6 months
II To compare HRQOL change from baseline as assessed by the FBISI-18 summary score for patients on the sacituzumab govitecan arm versus the sacituzumab govitecan pembrolizumab arm at baseline 3 6 and 12 months
III To compare the change in patient-reported fatigue from baseline and across 3 6 and 12 months as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue FACIT-Fatigue summary score change from baseline will be compared between patients on the sacituzumab govitecan arm versus the sacituzumab govitecan pembrolizumab arm
IV To compare quality-adjusted survival overall survival x health utility score assessed by the European Quality of Life Five Dimension Five Level EQ-5D-5L between patients on the sacituzumab govitecan arm versus the sacituzumab govitecan pembrolizumab arm
V To compare time to HRQOL deterioration in global HRQOL as measured by the FBISI-18 disease-related physical symptom subscale FBISI-18 disease-related symptoms DRS in the physical emotional domains DRS-P between patients on the sacituzumab govitecan arm versus the sacituzumab govitecan pembrolizumab arm
OUTLINE Patients are randomized to 1 of 2 arms
ARM A Patients receive sacituzumab govitecan intravenously IV over 1-3 hours on days 1 and 8 of each cycle Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity Patients additionally undergo blood sample collection and computed tomography CT or magnetic resonance imaging MRI throughout the study
ARM B Patients receive pembrolizumab IV over 30 minutes on day 1 and sacituzumab govitecan IV over 1-3 hours on days 1 and 8 of each cycle Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity Patients additional undergo blood sample collection and CT or MRI throughout the study
After completion of study treatment patients are followed up for 5 years from the date of randomization
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None