Health Trials

About this trial

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).

Eligibility criteria

Qualifiers

Voluntarily agree to participate by giving signed, dated, and written informed consent prior to any study-specific procedures.

≥ 18 years of age.

Histologically confirmed pancreas carcinoma with metastatic disease. Neuroendocrine neoplasms are not eligible. Adenosquamous, squamous and acinar histologies are allowed provided criteria #5 is fulfilled, and these histologies comprise no more than 10% of the total accrual.

Measurable disease on baseline imaging by CT (or MRI where CT is contraindicated) based on RECIST 1.1.

Disqualifiers

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

Any history of gastrointestinal perforation unless the affected area has been deemed by the investigator to no longer be a risk for perforation.

Trial design

Treatments tested in this trial

  • Lorigerlimab

Treatment groups

40 Participants
are divided into 1 treatment group

Locations

1
University of Miami33136, MiamiFlorida, United States

Sponsors and collaborators

Peter Hosein, MD

Lead sponsor

University of Miami

Sponsor institution

MacroGenics

Collaborator

Source ClinicalTrials.gov