Ignite Creation Date:
2024-05-06 @ 3:32 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04668300
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2020-08-18
Brief Title:
Oleclumab and Durvalumab for the Treatment of Recurrent Refractory or Metastatic Sarcoma
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase II Multi-Arm Study to Test the Efficacy of Oleclumab and Durvalumab in Multiple Sarcoma Subtypes
Status:
RECRUITING
Status Verified Date:
2024-07
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:
DOSa
Brief Summary:
This phase II trial investigates how well oleclumab and durvalumab work in treating patients with sarcoma that has come back recurrent or does not respond to treatment refractory or has spread to other places in the body metastatic Immunotherapy with monoclonal antibodies such as oleclumab and durvalumab may help the bodys immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread
Detailed Description:
PRIMARY OBJECTIVES
I To estimate the tumor response Response Evaluation Criteria in Solid Tumors RECIST at 4 months in patients with relapsedrefractory sarcoma Cohorts 1 and 2 II To determine the event-free survival EFS rate at 4 months after initiation of the treatment in patients with relapsedrefractory osteosarcoma receiving novel immunotherapeutic agents Cohort 3
SECONDARY OBJECTIVES
I To determine the progression-free survival PFS rate at 12 weeks after initiation of the treatment in patients with relapsedrefractory sarcoma receiving novel immunotherapeutic agents
II To estimate the tumor response Immune-related Response Criteria irRC and RECIST in patients with relapsedrefractory sarcoma
III To evaluate the safety and tolerability of receiving novel immunotherapeutic agents in patients with relapsedrefractory sarcoma
IV To estimate the median PFS and overall survival OS in patients with relapsedrefractory sarcoma receiving novel immunotherapeutic agents
EXPLORATORY OBJECTIVES
I To determine expression of biomarkers including but not limited to CD73 PD-1 and PD-L1 in pre post treatment tx samples
II Quantification and characterization of the immune infiltrate and other histologic and immunohistologic changes from tissue samples prior to treatment initiation and post treatment biopsy at week 6
III Identificationquantification of immunologic changes CD4 CD8 Teff Treg cells and NK cells in peripheral blood
IV Determining an immunoscore based on baseline tumor sample identification of molecular responseresistance patternsfuture therapy options
OUTLINE
Patients receive oleclumab intravenously IV over 1 hour every 2 weeks for 5 doses then every 4 weeks thereafter Patients also receive durvalumab IV over 1 hour every 4 weeks Cycle repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 30 days and then every 3 months for up to 5 years
I To estimate the tumor response Response Evaluation Criteria in Solid Tumors RECIST at 4 months in patients with relapsedrefractory sarcoma Cohorts 1 and 2 II To determine the event-free survival EFS rate at 4 months after initiation of the treatment in patients with relapsedrefractory osteosarcoma receiving novel immunotherapeutic agents Cohort 3
SECONDARY OBJECTIVES
I To determine the progression-free survival PFS rate at 12 weeks after initiation of the treatment in patients with relapsedrefractory sarcoma receiving novel immunotherapeutic agents
II To estimate the tumor response Immune-related Response Criteria irRC and RECIST in patients with relapsedrefractory sarcoma
III To evaluate the safety and tolerability of receiving novel immunotherapeutic agents in patients with relapsedrefractory sarcoma
IV To estimate the median PFS and overall survival OS in patients with relapsedrefractory sarcoma receiving novel immunotherapeutic agents
EXPLORATORY OBJECTIVES
I To determine expression of biomarkers including but not limited to CD73 PD-1 and PD-L1 in pre post treatment tx samples
II Quantification and characterization of the immune infiltrate and other histologic and immunohistologic changes from tissue samples prior to treatment initiation and post treatment biopsy at week 6
III Identificationquantification of immunologic changes CD4 CD8 Teff Treg cells and NK cells in peripheral blood
IV Determining an immunoscore based on baseline tumor sample identification of molecular responseresistance patternsfuture therapy options
OUTLINE
Patients receive oleclumab intravenously IV over 1 hour every 2 weeks for 5 doses then every 4 weeks thereafter Patients also receive durvalumab IV over 1 hour every 4 weeks Cycle repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 30 days and then every 3 months for up to 5 years
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 |
|---|---|---|---|
| NCI-2020-05660 | REGISTRY | None | None |
| 2020-0159 | OTHER | None | None |
| P30CA016672 | NIH | M D Anderson Cancer Center | httpsreporternihgovquickSearchP30CA016672 |