Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06353997
Status:
RECRUITING
Last Update Posted:
2024-04-09
First Post:
2024-03-26
Brief Title:
Neoadjuvant INBRX-106 Hexavalent OX40 Agonist in Combination With Pembrolizumab as a Chemotherapy-sparing Regimen for Stage II TNBC Triple Negative Breast Cancer Patients
Sponsor:
Providence Health Services
Organization:
Providence Health Services
Study Overview
Official Title:
A Phase 2a Single-arm Multi-center Open-label Study of Neoadjuvant INBRX-106 Hexavalent OX40 Agonist in Combination With Pembrolizumab as a Chemotherapy-sparing Regimen for Stage II TNBC Patients
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 is a Phase II trial to assess feasibility of pembrolizumab INBRX-106 as a chemotherapy-sparing neoadjuvant therapy One therapeutic arm is being evaluated to provide an informal comparison of pharmacodynamic and clinical effects of concurrent dosing schedule
Detailed Description:
A Simon 2-stage design is implemented to minimize exposure if the treatment regimen is futile If feasibility is established with responses exceeding futility parameters study will expand to stage 2 Additional arms may be introduced in a protocol amendment
Below shows the sample size required using Simons 2-stage design 80 power and 5 one-sided significance level
Null hypothesis 5 pCR
Alternative hypothesis 35 pCR
Stage I n r 6 0
Stage I II total n r 12 2
Criteria Minimax
Minimum responses to proceed to stage II 1
Note r and r represents the threshold for declaring futility ie greater than r or r responses would be required to consider ongoing investigation
The null hypothesis of 5 is based upon the assumption that virtually no subjects would experience pCR if the therapy was not effective The alternative hypothesis of 35 is based upon the assumption that complete responses in the absence of chemotherapy in approximately one-third of subjects would be clinically meaningful encouraging further development of the treatment paradigm
If no responses are observed a second feasibility run-in may be considered using a biomarker enrichment strategy such as with the 27-gene IO score
The arm will be terminated from further development if an unacceptable proportion of patients experience rapid clinicalradiographic progression defined as progression of disease or clinical evidence of progression or other toxicities that interfere with curative-intent therapy defined as 16 evaluable subjects in stage I or 212 in stage II evaluated for each arm This is a Pocock-type stopping boundary that yields the probability of cross the boundary at most 23 when the rate of dose-limiting toxicity is equal to 10
Below shows the sample size required using Simons 2-stage design 80 power and 5 one-sided significance level
Null hypothesis 5 pCR
Alternative hypothesis 35 pCR
Stage I n r 6 0
Stage I II total n r 12 2
Criteria Minimax
Minimum responses to proceed to stage II 1
Note r and r represents the threshold for declaring futility ie greater than r or r responses would be required to consider ongoing investigation
The null hypothesis of 5 is based upon the assumption that virtually no subjects would experience pCR if the therapy was not effective The alternative hypothesis of 35 is based upon the assumption that complete responses in the absence of chemotherapy in approximately one-third of subjects would be clinically meaningful encouraging further development of the treatment paradigm
If no responses are observed a second feasibility run-in may be considered using a biomarker enrichment strategy such as with the 27-gene IO score
The arm will be terminated from further development if an unacceptable proportion of patients experience rapid clinicalradiographic progression defined as progression of disease or clinical evidence of progression or other toxicities that interfere with curative-intent therapy defined as 16 evaluable subjects in stage I or 212 in stage II evaluated for each arm This is a Pocock-type stopping boundary that yields the probability of cross the boundary at most 23 when the rate of dose-limiting toxicity is equal to 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?:
None
Is an FDA AA801 Violation?:
None