Ignite Creation Date:
2024-10-25 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06526104
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-23
Brief Title:
Study of Tremelimumab and Durvalumab MEDI4736 T300D in Advanced Hepatocellular Carcinomas With Child-Pugh-B Cirrhosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase II Single Arm Study of Tremelimumab and Durvalumab MEDI4736 T300D in Advanced Hepatocellular Carcinomas With Child-Pugh-B Cirrhosis STRIDE in CP-B
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
This is a single-arm phase II study of patients with advanced liver cancer or hepatocellular carcinoma HCC who are eligible for first-line treatment with T300D The invesitgators hypothesize that T300D will be safe and tolerated in CP-B patients with HCC HCC mostly affects disadvantaged populations with higher rates among racialethnic minorities who are often not included in clinical trials ie Hispanics Blacks underserved low socioeconomic status and present with more severe disease Given there is not much data in the US patient cohort this study provides a chance to gain that knowledge
Detailed Description:
Priming dose of tremelimumab 300 mg IV once Cycle 1 Day 1 only with durvalumab 1500 mg IV on Day 1 of each 4-week cycle Patients will stay on study treatment until evidence of disease progression unacceptable toxicity or death
All eligible patients who consent to this study must have a baseline evaluation CT or MRI within 28 days of the start of treatment
Follow-up A repeat CTMRI scan will be performed after 2 cycles of treatment regimen to evaluate response based on RECIST 11 criteria See Appendix for definitions of response12 Serum tumor marker AFP every cycle and CTMRI scans will be repeated at least every 2 cycles or 8 weeks to ensure no progression of disease Patients will continue treatment until disease progression unacceptable toxicity withdrawal of consent by the patient or decision of physician for patients best interest Each patient will be followed for survival for up to one year
All eligible patients who consent to this study must have a baseline evaluation CT or MRI within 28 days of the start of treatment
Follow-up A repeat CTMRI scan will be performed after 2 cycles of treatment regimen to evaluate response based on RECIST 11 criteria See Appendix for definitions of response12 Serum tumor marker AFP every cycle and CTMRI scans will be repeated at least every 2 cycles or 8 weeks to ensure no progression of disease Patients will continue treatment until disease progression unacceptable toxicity withdrawal of consent by the patient or decision of physician for patients best interest Each patient will be followed for survival for up to one year
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None