Pancreas CancerPROTECT-PANCNCT06228599
Molecular Profile-related Individualized Targeted Therapy in Resected Pancreatic Cancer With High-Risk of Cancer Recurrence
A study testing Treatment Plan in people with Pancreas Cancer, run by Medical College of Wisconsin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Cancer
- What is being tested?
- Treatment Plan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Feb 2024to 31 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
- 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.
- Able to swallow and retain oral medication, if needed.
- 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.
- Patient must be presented at the Molecular Tumor Board (MTB) and agree to receive the MTB-recommended therapy.
- Ability to understand a written informed consent document, and the willingness to sign it.
- 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.
Who cannot join
- A potential study subject who meets any of the following exclusion criteria is ineligible to participate in the study.
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Medical College of Wisconsin Cancer Center Clinical Trials Office contact
United States1 site, 1 recruiting
- Recruiting
Froedtert Hospital & the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Mandana Kamgar, MD, 414-805-4600
mkamgar@mcw.edu
About this study
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.
Read the 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.
- Conditions
- Pancreas Cancer
- Being tested
- Treatment Plan
- Keywords
- pancreatic cancer, molecular profile, targeted therapy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment PlanOther
A matched treatment regimen will be administered for approximately 12 weeks based on recommendations made by the MTB.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Treatment Plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start29 Feb 2024
- Primary completion31 Jan 2029 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mandana Kamgar, MD, Medical College of Wisconsin
- Investigators
- Mandana Kamgar, MD, MPH, Principal investigator, Medical College of WisconsinRazelle Kurzrock, MD, Principal investigator, Medical College of WisconsinDouglas Evans, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06228599
- Sponsor's protocol ID
- PRO00049951
- Acronym
- PROTECT-PANC
- Status last verified
- Apr 2026
- First submitted
- 18 Jan 2024
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Profile-related Individualized Targeted Therapy in Resected Pancreatic Cancer With High-Risk of Cancer Recurrence
- ClinicalTrials.gov ID
- NCT06228599
- Acronym / sponsor ID
- PROTECT-PANC / PRO00049951
- Conditions
- Pancreas Cancer
- Keywords
- pancreatic cancer, molecular profile, targeted therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 29 Feb 2024 (actual)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 29 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Molecular Tumor Board (MTB)-recommended matched therapy | Experimental | Other: Treatment PlanThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Age ≥18 years.
- Pathologically confirmed pancreatic cancer (excluding neuroendocrine histology).
- Pancreatic tumor is surgically removed and
- Patient has one of the following:
- 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.
Key exclusion criteria (11 listed)
- A potential study subject who meets any of the following exclusion criteria is ineligible to participate in the study.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment PlanA matched treatment regimen will be administered for approximately 12 weeks based on recommendations made by the MTB. | Other | Molecular Tumor Board (MTB)-recommended matched therapy |
Primary outcome
Disease-free Survival
Time frame: Six months
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.
Adverse Events
Time frame: Up to 12 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Medical College of Wisconsin Cancer Center Clinical Trials Office contact
Mandana Kamgar, MD, MPH principal investigator
Medical College of Wisconsin
Razelle Kurzrock, MD principal investigator
Medical College of Wisconsin
Douglas Evans, MD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment Plan in people with Pancreas Cancer, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Medical College of Wisconsin Cancer Center Clinical Trials Office (866-680-0505 ext. 8900, cccto@mcw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free Survival (time frame: Six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.