Platform Study of Neoadjuvant and Adjuvant Immunotherapy for Patients With Resectable Adenocarcin… (NCT02451982) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Platform Study of Neoadjuvant and Adjuvant Immunotherapy for Patients With Resectable Adenocarcinoma of the Pancreas
United States76 participantsStarted 2016-03-28
Plain-language summary
This platform trial will evaluate various immunotherapy combinations given in the neo-adjuvant and adjuvant setting in patients with surgically resectable pancreatic ductal adenocarcinoma.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Newly diagnosed or clinically-suspected adenocarcinoma of the head, neck, or uncinate process of the pancreas
* Tumor must be surgically resectable
* ECOG Performance Status of 0 to 1
* Adequate organ function as defined by study-specified laboratory tests
* Must agree to use acceptable form of birth control
Exclusion Criteria:
* Received any type of anti-cancer treatment or immunotherapy for pancreas cancer
* History of autoimmune disease (Graves or Hashimoto's disease, vitiligo, and type I diabetes are allowed)
* Systemically steroid use within 14 days
* Evidence of active infection
* Pregnant or lactating
* Diagnosed with another cancer or myeloproliferative disorder (some exceptions)
* History of severe hypersensitivity reaction to any monoclonal antibody or known component of the study drugs
* Known history of infection with HIV, hepatitis B, or hepatitis C
* Oxygen saturation of \<92% on room air by pulse oximetry
* On home oxygen
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
IL17A expression
Timeframe: 4 years
2
Intratumoral CD8+CD137+cells
Timeframe: 4 years
3
Intratumoral granzyme B+PD-1+CD137+ cells
Timeframe: 4 years
4
Pathologic Response
Timeframe: 4 years
Trial details
NCT IDNCT02451982
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins