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

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.

Study Overview

• Status: Recruiting
• Conditions: Pancreas Cancer
• Intervention / Treatment: Other: Treatment Plan

Detailed Description

This is a prospective, open-label, therapeutic interventional investigation designed to interrogate the efficacy and safety of personalized matched therapy in pancreatic cancer patients who have completed all intended multimodal therapy, including resection of the pancreatic cancer tumor. Potential participants must have their tumor tissue or blood molecularly profiled with the results discussed by the Molecular Tumor Board, whether convened in person, virtually (e.g., WebEx), or in an electronic forum (e.g., email). Only those patients who agree to receive the Molecular Tumor Board-recommended matched therapy (i.e., study treatment) will be eligible and enrolled on the study.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Medical College of Wisconsin Cancer Center Clinical Trials Office; Phone Number: 8900 866-680-0505; Email: cccto@mcw.edu

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Recruiting
      • Froedtert Hospital & the Medical College of Wisconsin
      • Contact: Mandana Kamgar, MD; Phone Number: 414-805-4600
      • Contact: Email: mkamgar@mcw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥18 years.
2. Pathologically confirmed pancreatic cancer (excluding neuroendocrine histology).

3. Pancreatic tumor is surgically removed and

   1. patient has received multimodal therapy (neoadjuvant, sandwich or adjuvant chemotherapy ± radiation) or
   2. patient is ineligible for or refuses multimodal therapy.

4. Patient has one of the following:

   1. 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
   2. High-risk pathological features, defined as positive surgical margin or lymph node involvement in cancer.
5. 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.

6. Laboratory values:

   1. Absolute neutrophil count (ANC) ≥ 1.0 × 109/L.
   2. Platelet count ≥ 75,000/mm^3 (125 × 109/L).
   3. Hemoglobin (Hgb) ≥ 8 g/dL.
   4. aspartate aminotransferase (AST) serum glutamic-oxaloacetic transaminase (SGOT), alanine transaminase (ALT) serum glutamate-pyruvate transaminase (SGPT) ≤ 5 × upper limit of normal range (ULN).
7. Eastern Cooperative Oncology Group (ECOG) Performance Status < 3.
8. At the time of treatment, patient should be off other anti-tumor agents for at least five half-lives of the agent or three weeks from the last day of treatment, whichever is shorter.
9. Able to swallow and retain oral medication, if needed.

10. Pregnancy It is not known what effects matched therapy has on human pregnancy or development of the embryo or fetus. Therefore, female subjects participating in this study should avoid becoming pregnant, and male subjects should avoid impregnating a female partner. Nonsterilized female subjects of reproductive age and male subjects should use effective methods of contraception through defined periods during and after study treatment as specified below.

    Female participants: A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:

    • Not a female of childbearing potential (FCBP), defined as all female patients that were not in post-menopause for at least one year or are surgically sterile, OR
    • An FCBP must have a negative serum pregnancy test and agree to use at least one form of pregnancy prevention during the study for at least one month after treatment discontinuation unless otherwise noted by the agent(s) USPI, which the FCBP must follow.

    Male participants: A male participant, even if surgically sterilized (i.e., status post vasectomy), must use a form of barrier pregnancy prevention approved by the investigator or treating physician during the study and for at least one month after treatment discontinuation and refrain from donating sperm during this period unless otherwise noted by the agent(s) USPI, which the male participant must follow.

11. Patient must be presented at the Molecular Tumor Board (MTB) and agree to receive the MTB-recommended therapy.

12. Ability to understand a written informed consent document, and the willingness to sign it.

    1. Patients presented at the MTB prior to signing consent are eligible to be on study. Patients do not need to be presented again at the MTB prior to starting therapy on trial unless six months elapse between consent and start of study treatment.

Exclusion Criteria:

A potential study subject who meets any of the following exclusion criteria is ineligible to participate in the study.

1. CA 19-9 non-producers, unless high-risk pathological features present.
2. Receiving concomitant investigational agent(s) for pancreatic ductal adenocarcinoma (PDAC).
3. Radiographic evidence of metastatic disease.
4. Inability to ingest study drugs by mouth.
5. Diarrheal bowel movements > 6 per day postoperatively on maximal medical therapy.
6. Patient has active, untreated, or uncontrolled bacterial, viral, or fungal infection(s) requiring systemic intravenous therapy.
7. 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.
8. Patient has a history of allergy or hypersensitivity to the study drug(s) or any of the excipients.
9. 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.
10. Is pregnant or breastfeeding or any patient with childbearing potential not using adequate pregnancy prevention.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Molecular Tumor Board (MTB)-recommended matched therapy; 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; A matched treatment regimen will be administered for approximately 12 weeks based on recommendations made by the MTB.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): February 29, 2024
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): January 31, 2029

Study Registration Dates

• First Submitted: January 18, 2024
• First Submitted That Met QC Criteria: January 18, 2024
• First Posted (Actual): January 29, 2024

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: pancreatic cancer; targeted therapy; molecular profile
• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: PRO00049951

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No