Metastatic Pancreatic Adenocarcinoma Clinical Trial
— REVOLUTIONOfficial 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)
Verified date | January 2024 |
Source | Cancer Insight, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Active, not recruiting |
Enrollment | 45 |
Est. completion date | January 11, 2025 |
Est. primary completion date | October 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Core Inclusion Criteria 1. Participant has histologically or cytologically documented diagnosis of pancreatic adenocarcinoma with metastatic disease. Participants with locally advanced disease are not eligible. a. Participants with recurrent locally advanced disease are eligible, provided: i. the last dose of chemotherapy and/or radiotherapy occurred > 4 months prior to the first dose of study intervention, and; ii. no systemic or radiotherapy has been administered in the metastatic setting. 2. Participant must have measurable disease by RECIST v1.1. 3. Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4. A baseline tumor tissue sample is mandatory for enrollment. If archival tumor tissue is not available, then a fresh tumor biopsy must be provided. 5. Participant must be age 18 years or older. 6. Participant must have adequate organ function. Core Exclusion Criteria 1. Participant must not have received any prior treatment, including chemotherapy, biological therapy, or targeted therapy for mPDAC, with the following exceptions and notes: 1. Participants who have received prior neoadjuvant or adjuvant therapy for pancreatic adenocarcinoma are eligible if neoadjuvant and adjuvant therapy (including chemotherapy and/or radiotherapy) was completed more than 4 months before the start of study intervention. 2. Prior surgical resection is permitted. 3. Participants who have received treatment with any other enadenotucirev-based therapy or anti-CD40 antibody at any time are not eligible for the study (cohort C only). 2. Prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast. 3. Participants with an active, known or suspected autoimmune disease. Participants with: type I diabetes mellitus; hypothyroidism only requiring hormone replacement; a history of Hashimoto syndrome, within 3 years of the first dose of study intervention, which resolved to hypothyroidism alone; skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment; or conditions not expected to recur in the absence of an external trigger are permitted to enroll. |
Country | Name | City | State |
---|---|---|---|
United States | M.D. Anderson Cancer Center | Houston | Texas |
United States | University of California, Los Angeles | Los Angeles | California |
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
United States | University of Pennsylvania, Abramson Cancer Center | Philadelphia | Pennsylvania |
United States | University of California, San Francisco | San Francisco | California |
United States | Stanford University | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Cancer Insight, LLC | Akamis Bio, Bristol-Myers Squibb, Cancer Research Institute, New York City |
United States,
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* Note: There are 36 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence and severity of adverse events | Up to 2.5 years | ||
Secondary | Objective response rate (ORR) | Defined as the proportion of participants who achieve a confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. | Up to 2.5 years | |
Secondary | Disease control rate (DCR) | Defined as the proportion of participants who achieve confirmed CR or PR or stable disease (SD) lasting at least 16 weeks | At 9 months | |
Secondary | Duration of response (DOR) | Defined as the time from first documentation of response (CR or PR) to first radiographic documentation of progressive disease (PD) or death due to any cause. | Up to 2.5 years | |
Secondary | Progression-free survival (PFS) | Defined as the time from initiation of study intervention to date of first documented radiographic progression of disease or death due to any cause. | Up to 2.5 years | |
Secondary | Overall survival (OS) | Defined as the time from initiation of study intervention until death due to any cause. | Up to 2.5 years | |
Secondary | Overall survival (OS) at 12 months | Defined as the time from initiation of study intervention until death due to any cause. | At 12 months |
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