Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06444880
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-05-30
Brief Title:
Phase II Trial of Ubamatamab Alone or in Combination With Cemiplimab in MUC16-Expressing SMARCB1-Deficient Malignancies
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase II Trial of Ubamatamab Alone or in Combination With Cemiplimab in MUC16-Expressing SMARCB1-Deficient Malignancies
Status:
RECRUITING
Status Verified Date:
2024-10
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:
To find out if ubamatamab given by itself or in combination with cemiplimab can help to control the disease in participants with renal medullary carcinoma RMC and epithelioid sarcoma ES
Detailed Description:
Primary Objectives To determine the objective response rate ORR and disease control rate DCR per RECIST 11 of ubamatamab alone and in combination with cemiplimab in patients with locally advanced or metastatic MUC16-expressing SMARCB1-deficient malignancies RMC or ES who have progressed on at least one prior line of therapy
Secondary Objectives
To determine the efficacy and safety of ubamatamab alone or in combination with cemiplimab in participants with locally advanced or metastatic MUC16-expressing SMARCB1-deficient malignancies such as RMC or ES who have progressed on at least one prior line of therapy Efficacy will be measured by overall survival OS progression-free survival PFS and duration of response DOR
Exploratory Objectives
To determine the objective response rate ORR and disease control rate DCR per RECIST 11 of the overall strategy of ubamatamab alone followed by combination with cemiplimab in participants with locally advanced or metastatic MUC16-expressing SMARCB1-deficient malignancies RMC or ES who have progressed on at least one prior line of therapy
To evaluate potential biomarkers such as serum CA-125 and tumor tissue MUC16 expression levels for participant stratification and to determine via the molecular profiling of biopsy and blood specimens the mechanisms of resistance to ubamatamab alone or in combination with cemiplimab
Secondary Objectives
To determine the efficacy and safety of ubamatamab alone or in combination with cemiplimab in participants with locally advanced or metastatic MUC16-expressing SMARCB1-deficient malignancies such as RMC or ES who have progressed on at least one prior line of therapy Efficacy will be measured by overall survival OS progression-free survival PFS and duration of response DOR
Exploratory Objectives
To determine the objective response rate ORR and disease control rate DCR per RECIST 11 of the overall strategy of ubamatamab alone followed by combination with cemiplimab in participants with locally advanced or metastatic MUC16-expressing SMARCB1-deficient malignancies RMC or ES who have progressed on at least one prior line of therapy
To evaluate potential biomarkers such as serum CA-125 and tumor tissue MUC16 expression levels for participant stratification and to determine via the molecular profiling of biopsy and blood specimens the mechanisms of resistance to ubamatamab alone or in combination with cemiplimab
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-2024-04755 | OTHER | NCI-CTRP Clinical Registry | None |