Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04787991
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-17
First Post:
2021-03-04
Brief Title:
Exploratory Platform Trial to Evaluate Immunotherapy Combinations With Chemotherapy for the Treatment of Patients With Previously Untreated Metastatic Pancreatic Adenocarcinoma
Sponsor:
Cancer Insight LLC
Organization:
Cancer Insight LLC
Study Overview
Official Title:
A Multicenter Open-label ExploRatory Platform Trial to EValuate ImmunOtherapy Combinations With Chemotherapy for the Treatment of Patients With PreviousLy UnTreated MetastatIc Pancreatic AdenOcarciNoma REVOLUTION
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
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:
REVOLUTION
Brief Summary:
This trial is designed to evaluate multiple clinical hypotheses and mechanistically-defined combinations to evaluate the safety and efficacy of first-line chemo-immunotherapy combinations in participants with metastatic pancreatic ductal adenocarcinoma mPDAC
Detailed Description:
This is an open-label non-randomized exploratory platform trial designed to assess the safety and antitumor activity of immunotherapy in combination with standard of care chemotherapy in participants with mPDAC who have not received prior therapy Where supportive mechanistic data are available immunotherapy may also be combined with other treatment modalities eg radiation Each cohort of this platform trial will test a different immunotherapy combination and consist of up to 2 stages an initial stage Stage 1 to evaluate safety biomarkers andor clinical activity of the combination and an expanded cohort Stage 2 when warranted based on the safety clinical activity andor biomarker results from Stage 1 The Sponsor intends to modify andor add new combinations to the protocol as data emerge from scientific findings in this and other trials
This trial will be conducted in participants with histologically or cytologically documented diagnosis of mPDAC with measurable disease per Response Evaluation Criteria in Solid Tumors RECIST v11 who have not received prior systemic therapy for their disease in the metastatic setting Participants must have adequate organ and hematologic function and acceptable performance status Participants must consent to tumor biopsies including a pre-treatment baseline and on-treatment samples
This trial will be conducted in participants with histologically or cytologically documented diagnosis of mPDAC with measurable disease per Response Evaluation Criteria in Solid Tumors RECIST v11 who have not received prior systemic therapy for their disease in the metastatic setting Participants must have adequate organ and hematologic function and acceptable performance status Participants must consent to tumor biopsies including a pre-treatment baseline and on-treatment samples
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