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Lorigerlimab (MGD019) in Patients With Pancreatic Adenocarcinoma and Homologous Recombination Deficiency

ConditionsPancreatic AdenocarcinomaHomologous Recombination Deficiency
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Miami

About this trial

The purpose of this research study is to see the effects (good or bad) of Lorigerlimab on patients with pancreatic adenocarcinoma (PDAC) and homologous recombination deficiency (HRD).

Eligibility criteria

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Lorigerlimab

    Drug

    Participants will be administered 6mg/kg of Lorigerlimab intravenously (IV) on day 1 of every three (3) week cycle (Q3W).

Treatment groups

40 Participants
are divided into 1 treatment group
Group 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 according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.

Time frame
Up to 24 months

Secondary outcomes

1

Progression-Free Survival (PFS)

Progression-Free Survival (PFS) is elapsed time in months from day 1 of starting treatment until the date of documented progressive disease (PD) or death. For event-free patients, PFS will be censored at the last date of documented event-free status. The Kaplan-Meier method will be used to estimate median PFS.

Time frame
Up to 24 months
2

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. The Kaplan-Meier method will be used to estimate the median OS.

Time frame
Up to 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Miami

Lead sponsor

MacroGenics

Collaborator

United States Department of Defense

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: