ACTIVE_NOT_RECRUITING

Platform Study of Neoadjuvant and Adjuvant Immunotherapy for Patients With Resectable Adenocarcinoma of the Pancreas

Talk to us

Conditions

Pancreatic Cancer

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This platform trial will evaluate various immunotherapy combinations given in the neo-adjuvant and adjuvant setting in patients with surgically resectable pancreatic ductal adenocarcinoma.

Official Title

A Platform Study of Combination Immunotherapy for the Neoadjuvant and Adjuvant Treatment of Patients With Surgically Resectable Adenocarcinoma of the Pancreas

Quick Facts

Study Start:2016-03-28
Study Completion:2026-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT02451982

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Newly diagnosed or clinically-suspected adenocarcinoma of the head, neck, or uncinate process of the pancreas
  2. * Tumor must be surgically resectable
  3. * ECOG Performance Status of 0 to 1
  4. * Adequate organ function as defined by study-specified laboratory tests
  5. * Must agree to use acceptable form of birth control
  1. * Received any type of anti-cancer treatment or immunotherapy for pancreas cancer
  2. * History of autoimmune disease (Graves or Hashimoto's disease, vitiligo, and type I diabetes are allowed)
  3. * Systemically steroid use within 14 days
  4. * Evidence of active infection
  5. * Pregnant or lactating
  6. * Diagnosed with another cancer or myeloproliferative disorder (some exceptions)
  7. * History of severe hypersensitivity reaction to any monoclonal antibody or known component of the study drugs
  8. * Known history of infection with HIV, hepatitis B, or hepatitis C
  9. * Oxygen saturation of \<92% on room air by pulse oximetry
  10. * On home oxygen

Contacts and Locations

Principal Investigator

Ana De Jesus-Acosta, MD
PRINCIPAL_INVESTIGATOR
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University

Study Locations (Sites)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
United States

Collaborators and Investigators

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  • Ana De Jesus-Acosta, MD, PRINCIPAL_INVESTIGATOR, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-03-28
Study Completion Date2026-05-31

Study Record Updates

Study Start Date2016-03-28
Study Completion Date2026-05-31

Terms related to this study

Additional Relevant MeSH Terms

  • Pancreatic Cancer