Lorigerlimab (MGD019) in Patients With Pancreatic Adenocarcinoma and Homologous Recombination Deficiency (NCT07565155)
๐ฉบ Plain-English Summary (8th-Grade Level)
The purpose of this study is to determine the objective response rate (ORR) to lorigerlimab in patients with refractory pancreatic ductal adenocarcinoma (PDAC) and pathogenic germline variants (PGVs) in breast cancer type 1 or 2 susceptibility protein (BRCA1/2), Partner and Localizer of BRCA2 (PALB2) and radiation sensitive protein 51 C or D (RAD51C/D).
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (22 items) and avoid the listed exclusions (32 items).
Location: University of Miami โ Miami, Florida
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Has received any prior therapy with an anti-PD-1/PD-L1 antibody or an anti-cytotoxic T lymphocyte-associated (CTLA) protein 4 (anti-CTLA-4) antibody.
- Has clinically significant ascites defined as requiring 1 or more therapeutic paracenteses in the last 4 weeks prior to study entry.
- Grade 2 or higher peripheral neuropathy
- Clinically significant gastrointestinal disorders including:
- Any history of gastrointestinal perforation unless the affected area has been deemed by the investigator to no longer be a risk for perforation.
- History of clinically significant gastrointestinal bleeding within 4 weeks prior to initiation of study treatment.
- History of acute pancreatitis within 4 weeks prior to the initiation of study treatment.
- Diverticulitis that is clinically significant in the opinion of the investigator based on the extent or severity of known disease and/or the occurrence of clinically significant disease flares within 4 weeks prior to the initiation of study treatment administration.
- Bowel obstruction or impending bowel obstruction within the past 3 months.
- Clinically significant (i.e. active) cardiovascular disease:
- Cerebral vascular accident/stroke or myocardial infarction within 6 months of enrollment, unstable angina, congestive heart failure (New York Heart Association class โฅ III), or serious uncontrolled cardiac arrhythmia requiring medication.
๐ Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
๐ All Participating Trial Locations (1 Sites)
- University of Miami โ Miami, Florida
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.