Lorigerlimab (MGD019) in Patients With Pancreatic Adenocarcinoma and Homologous Recombination Deficiency
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeter Hosein, MD
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Lorigerlimab
Drug6mg/kg every 3 weeks (Q3W) Intravenous
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Lorigerlimab GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective Response Rate (ORR)
Objective Response Rate (ORR) is defined as the proportion or percentage of patients with confirmed partial (PR) or complete (CR) best overall response.
Time frame
Baseline, Up to 60 monthsSecondary outcomes
1
Progression-Free Survival (PFS)
Progression-Free Survival (PFS) is elapsed time from day 1 of starting treatment until the date of documented PD or death. For event-free patients, PFS will be censored at the last date of documented event-free status.
Time frame
Up to 60 months2
Overall Survival (OS)
Overall Survival (OS) is the elapsed time in months from the date of surgery until the date of date. For alive patients, OS will be censored at the last date known to be alive.
Time frame
Up to 60 monthsSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: