Long Term Follow-Up Study for Subjects Previously Treated With Algenpantucel-L (HyperAcute-Pancreas) Immunotherapy

NCT ID: NCT03165188

Last Updated: 2022-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

29 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-01

Study Completion Date

2020-12-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This protocol (NLG0705) provides a mechanism for the 15-year follow-up period that the FDA requires for all participants in gene transfer protocols and assures that adequate follow-up can be maintained for subjects who have received at least one dose of algenpantucel-L.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pancreatic Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Receipt of at least one dose of algenpantucel-L within the past 15 years
* Signed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

NewLink Genetics Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status

Stanford University Cancer Center

Palo Alto, California, United States

Site Status

UF Health Cancer Center

Gainesville, Florida, United States

Site Status

Moffitt Cancer Center

Tampa, Florida, United States

Site Status

Northwestern University

Chicago, Illinois, United States

Site Status

NorthShore University HealthSystem

Evanston, Illinois, United States

Site Status

Indiana University Health Goshen Center for Cancer Care

Goshen, Indiana, United States

Site Status

University of Louisville

Louisville, Kentucky, United States

Site Status

Washington University

St Louis, Missouri, United States

Site Status

Oregon Health and Science University

Portland, Oregon, United States

Site Status

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Site Status

UT Southwestern Medical Center

Dallas, Texas, United States

Site Status

Baylor College of Medicine

Houston, Texas, United States

Site Status

UT Health Cancer Center

San Antonio, Texas, United States

Site Status

University of Wisconsin

Madison, Wisconsin, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NLG0705

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.