Molecular Profile-related Individualized Targeted Therapy in Resected Pancreatic Cancer With High-Risk of Cancer Recurrence

NCT06228599 | Recruiting DMC

• 1 other identifier: PRO00049951
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, open-label therapeutic interventional investigation designed to interrogate the efficacy and safety of individualized matched therapies in patients with pancreatic cancer at high risk of disease recurrence post-surgery.

Conditions

Pancreas Cancer

Keywords

pancreatic cancer; molecular profile; targeted therapy

Outcome Measures

Primary Outcomes (2)

• Disease-free Survival

  The number of subjects exhibiting disease-free survival at six months. Disease-free survival is defined as the time from study therapy initiation until disease recurrence or death from any cause.

  Six months

• Adverse Events

  The number of clinically relevant Grade 3 to 4 adverse events and serious adverse events that are at least possibly related to the study therapy per investigator assessment.

  Up to 12 months

Study Arms (1)

Molecular Tumor Board (MTB)-recommended matched therapy

EXPERIMENTAL

The MTB, a multidisciplinary group composed of medical oncologists (including those with expertise in precision oncology), surgical oncologists, and a pathologist, convenes periodically to discuss and recommend an individualized treatment plan that targets specific molecular alterations (e.g., genomic mutations) found in the patient's cancer while considering patient clinical and laboratory factors.

Other: Treatment Plan

Interventions

Treatment Plan OTHER

A matched treatment regimen will be administered for approximately 12 weeks based on recommendations made by the MTB.

Molecular Tumor Board (MTB)-recommended matched therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years.
• Pathologically confirmed pancreatic cancer (excluding neuroendocrine histology).
• Pancreatic tumor is surgically removed and
• patient has received multimodal therapy (neoadjuvant, sandwich or adjuvant chemotherapy ± radiation) or
• patient is ineligible for or refuses multimodal therapy.
• Patient has one of the following:
• Post-surgical cancer antigen (CA) 19-9 elevation (\> 35 U/mL at least 6 weeks post-surgical resection) in the setting of bilirubin \< 2 mg/dL (unless bilirubin elevation is consistent with Gilbert's syndrome) OR
• High-risk pathological features, defined as positive surgical margin or lymph node involvement in cancer.
• Patient has no definitive measurable disease recurrence or metastatic disease at the time of first post-surgical imaging (in those with high-risk pathological features) or within four weeks of elevated CA 19-9 value as evidenced by appropriate imaging.
• Laboratory values:
• Absolute neutrophil count (ANC) ≥ 1.0 × 109/L.
• Platelet count ≥ 75,000/mm\^3 (125 × 109/L).
• Hemoglobin (Hgb) ≥ 8 g/dL.
• aspartate aminotransferase (AST) serum glutamic-oxaloacetic transaminase (SGOT), alanine transaminase (ALT) serum glutamate-pyruvate transaminase (SGPT) ≤ 5 × upper limit of normal range (ULN).
• Eastern Cooperative Oncology Group (ECOG) Performance Status \< 3.

You may not qualify if:

• CA 19-9 non-producers, unless high-risk pathological features present.
• Receiving concomitant investigational agent(s) for pancreatic ductal adenocarcinoma (PDAC).
• Radiographic evidence of metastatic disease.
• Inability to ingest study drugs by mouth.
• Diarrheal bowel movements \> 6 per day postoperatively on maximal medical therapy.
• Patient has active, untreated, or uncontrolled bacterial, viral, or fungal infection(s) requiring systemic intravenous therapy.
• Patient has undergone or planned major surgery other than diagnostic surgery (i.e., surgery done to obtain a biopsy for diagnosis without removal of an organ) within four weeks prior to Day 1 of study therapy.
• Patient has a history of allergy or hypersensitivity to the study drug(s) or any of the excipients.
• Uncontrolled concurrent illness, including, but not limited to, unstable angina pectoris, uncontrolled and clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Is pregnant or breastfeeding or any patient with childbearing potential not using adequate pregnancy prevention.

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Froedtert Hospital & the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Mandana Kamgar, MD, MPH

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

• Razelle Kurzrock, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

• Douglas Evans, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Medical College of Wisconsin Cancer Center Clinical Trials Office

CONTACT

866-680-0505; cccto@mcw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: January 29, 2024
• Study Start: February 29, 2024
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): January 31, 2029
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)