Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06439485
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-05-28
Brief Title:
Phase II Trial of Pemigatinib in Combination With Atezolizumab and Bevacizumab for Treatment of Advanced Cholangiocarcinoma With FGFR2 Fusion
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase II Trial of Pemigatinib in Combination With Atezolizumab and Bevacizumab for Treatment of Advanced Cholangiocarcinoma With FGFR2 Fusion
Status:
NOT_YET_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:
To learn if pemigatinib in combination with atezolizumab and bevacizumab can help to control cholangiocarcinoma
Detailed Description:
Primary Objectives
To assess the antitumor activity of the treatment combinations based on objective response rate ORR Response Evaluation Criteria in Solid Tumors RECIST v11 This assessment will be confirmed in the next scheduled scan
Secondary Objectives
1 To determine the safety and recommended phase 2 dose RP2D of the triple combination of pemigatinib with bevacizumab and atezolizumab in participants with FGFR-altered metastatic CCA
2 To evaluate the duration of response in participants with best overall response of complete response CR or partial response PR
3 To evaluate PFS defined as the time from the start of study treatment to disease progression or death whichever occurs first
4 To evaluate the duration of OS defined as the time from the start of study treatment to death from any cause
5 To evaluate the clinical benefit rate defined as the proportion of participants with best overall response of CR PR or stable disease
6 To evaluate safety and endpoints 2-5 with the doublet of pemigatinib with atezolizumab
Exploratory Objectives
To examine the change of the immune microenvironment on treatment by the combination using a validated immune biomarker panel and end-of-treatment genomic markers using cfDNA to study resistance to pemigatinib and response markers from trial medications
To assess the antitumor activity of the treatment combinations based on objective response rate ORR Response Evaluation Criteria in Solid Tumors RECIST v11 This assessment will be confirmed in the next scheduled scan
Secondary Objectives
1 To determine the safety and recommended phase 2 dose RP2D of the triple combination of pemigatinib with bevacizumab and atezolizumab in participants with FGFR-altered metastatic CCA
2 To evaluate the duration of response in participants with best overall response of complete response CR or partial response PR
3 To evaluate PFS defined as the time from the start of study treatment to disease progression or death whichever occurs first
4 To evaluate the duration of OS defined as the time from the start of study treatment to death from any cause
5 To evaluate the clinical benefit rate defined as the proportion of participants with best overall response of CR PR or stable disease
6 To evaluate safety and endpoints 2-5 with the doublet of pemigatinib with atezolizumab
Exploratory Objectives
To examine the change of the immune microenvironment on treatment by the combination using a validated immune biomarker panel and end-of-treatment genomic markers using cfDNA to study resistance to pemigatinib and response markers from trial medications
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-2024-04693 | OTHER | NCI-CTRP Clinical Registry | None |