Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06422806
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-05-18
Brief Title:
Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Patients With Aggressive Poorly Differentiated Sarcomas
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Phase III Trial of Doxorubicin Pembrolizumab Versus Doxorubicin Alone for the Treatment of Undifferentiated Pleomorphic Sarcoma UPS and Related Poorly Differentiated Sarcomas
Status:
RECRUITING
Status Verified Date:
2024-09
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:
This phase II trial compares the effect of immunotherapy pembrolizumab plus chemotherapy doxorubicin to chemotherapy doxorubicin alone in treating patients with undifferentiated pleomorphic sarcoma UPS or a related poorly differentiated sarcoma that has spread from where it first started to other places in the body metastatic or that cannot be removed by surgery unresectable Doxorubicin is in a class of medications called anthracyclines Doxorubicin damages the cells DNA and may kill tumor cells It also blocks a certain enzyme needed for cell division and DNA repair A monoclonal antibody is a type of protein that can bind to certain targets in the body such as molecules that cause the body to make an immune response antigens 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 Adding immunotherapy pembrolizumab to the standard chemotherapy doxorubicin may help patients with metastatic or unresectable UPS or a related poorly differentiated sarcoma live longer without having disease progression
Detailed Description:
PRIMARY OBJECTIVE
I To assess whether the combination of doxorubicin and pembrolizumab will improve progression free survival PFS in UPS and related poorly differentiated sarcomas relative to doxorubicin alone
KEY SECONDARY OBJECTIVE
I To assess whether the combination of doxorubicin and pembrolizumab versus vs the re-introduction of pembrolizumab in the doxorubicin alone arm at disease progression ie upfront pembrolizumab vs second line pembrolizumab improves overall survival OS
SECONDARY OBJECTIVES
I To evaluate the safety and tolerability in each treatment arm II To quantify overall response rate ORR and durability of response DOR in each treatment
OUTLINE Patients are randomized to 1 of 2 arms
ARM A Patients receive doxorubicin intravenously IV over 3-10 minutes or up to 3 hours on day 1 of each cycle Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity Patients also receive pembrolizumab IV over 30 minutes on day 1 of each cycle Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity
ARM B Patients receive doxorubicin IV over 3-10 minutes or up to 3 hours on day 1 of each cycle Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity At time of disease progression patients may begin receiving pembrolizumab alone IV over 30 minutes on day 1 of each cycle Cycles repeat every 21 days for 2 years in the absence of additional progression or unacceptable toxicity
Patients in both arms also undergo echocardiogram ECHO or multigated acquisition MUGA scan during screening as well as standard imaging scans and blood sample collection throughout the study
After completion of study treatment patients are followed up every 3 months for 2 years and then every 6 months in years 2-10
I To assess whether the combination of doxorubicin and pembrolizumab will improve progression free survival PFS in UPS and related poorly differentiated sarcomas relative to doxorubicin alone
KEY SECONDARY OBJECTIVE
I To assess whether the combination of doxorubicin and pembrolizumab versus vs the re-introduction of pembrolizumab in the doxorubicin alone arm at disease progression ie upfront pembrolizumab vs second line pembrolizumab improves overall survival OS
SECONDARY OBJECTIVES
I To evaluate the safety and tolerability in each treatment arm II To quantify overall response rate ORR and durability of response DOR in each treatment
OUTLINE Patients are randomized to 1 of 2 arms
ARM A Patients receive doxorubicin intravenously IV over 3-10 minutes or up to 3 hours on day 1 of each cycle Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity Patients also receive pembrolizumab IV over 30 minutes on day 1 of each cycle Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity
ARM B Patients receive doxorubicin IV over 3-10 minutes or up to 3 hours on day 1 of each cycle Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity At time of disease progression patients may begin receiving pembrolizumab alone IV over 30 minutes on day 1 of each cycle Cycles repeat every 21 days for 2 years in the absence of additional progression or unacceptable toxicity
Patients in both arms also undergo echocardiogram ECHO or multigated acquisition MUGA scan during screening as well as standard imaging scans and blood sample collection throughout the study
After completion of study treatment patients are followed up every 3 months for 2 years and then every 6 months in years 2-10
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2023-06412 | REGISTRY | None | None |
| EA7222 | OTHER | None | None |
| EA7222 | OTHER | None | None |
| U10CA180820 | NIH | CTEP | httpsreporternihgovquickSearchU10CA180820 |