Personalized Immunotherapy in Adults With Upper Gastrointestinal Tract Cancers (NCT05153304) | Clinical Trial Compass
WithdrawnPhase 1/2
Personalized Immunotherapy in Adults With Upper Gastrointestinal Tract Cancers
Stopped: funding
United States0Started 2024-06
Plain-language summary
The purpose of this study is to determine if it is possible to make and safely administer a 'personalized' cancer vaccine for people diagnosed with an upper gastrointestinal tract cancer.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically or cytologically documented gastroespohageal or gastric adenocarcinoma.
* Measurable disease as defined by RECIST 1.1
* Adequate organ function
* Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence)
Exclusion Criteria:
* Currently receiving or has received another anti-cancer therapy within 4 weeks prior to first dose of vaccine study treatment.
* Currently receiving or has received PD1/PDL1 inhibitor immunotherapy within 4 weeks prior to first dose of study treatment.
* Received an investigational agent within 28 days prior to the first dose of study drug.
* Untreated brain metastases; individuals with treated and stable metastases are eligible. Eligible subjects should have recovered from the acute effects of radiation therapy or surgery prior to study entry, have discontinued corticosteroid treatment for brain metastases for at least 4 weeks and are neurologically stable for 8 weeks (confirmed by MRI) prior to administration of experimental therapy
* Has known history of Human Immunodeficiency Virus (HIV).
* Received a diagnosis of hepatitis B or hepatitis C for which there is no clear evidence of natural immunity, immunity subsequent to vaccination, or successful eradication of the virus following antiviral therapy (individuals who are hepatitis C antibody positive may be enrolled if negative viral load conā¦