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 range18 Years
SexALL
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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
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