Trial Summary
What is the purpose of this trial?
The purpose of this study is to determine if it is possible to make and administer safely a 'personalized' vaccine to treat patients that have been diagnosed with advanced cancer and are not candidates for curative therapy.
Eligibility Criteria
This trial is for adults with advanced, incurable solid tumors who have measurable disease or high risk of mortality. They must have a tumor site accessible for biopsy, good organ function, and agree to use contraception. Excluded are those with certain immune conditions, recent immunotherapy or major surgery, active hepatitis or HIV infection, untreated brain metastases, pregnancy/breastfeeding women.Inclusion Criteria
My condition worsened or I couldn't tolerate previous beneficial treatments.
My cancer can't be measured by scans and I have a high risk of dying within 5 years.
My cancer is not lymphoma and cannot be cured with surgery.
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Exclusion Criteria
I have been treated with PD1/PDL1 inhibitors within the last 4 weeks.
I have been treated with anti-PD1 or anti-CTLA4 drugs during the vaccine preparation period.
Received an investigational agent within 28 days prior to the first dose of study drug
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Treatment Details
Interventions
- Pembrolizumab (Monoclonal Antibodies)
- Personalized Vaccine (Cancer Vaccine)
Trial OverviewThe study tests the safety and effectiveness of a personalized vaccine combined with Pembrolizumab in treating advanced cancers. The vaccine is tailored to each patient's tumor makeup and aims to boost the body's immune response against cancer cells.
Participant Groups
4Treatment groups
Experimental Treatment
Group I: vaccine and anti-PD-1Experimental Treatment2 Interventions
personalized vaccine and anti-PD-1 administered concurrently at the start of study therapy
Group II: vaccineExperimental Treatment1 Intervention
personalized vaccine therapy
Group III: anti-PD1 before vaccineExperimental Treatment2 Interventions
anti-PD-1 antibody for 6 weeks followed by personalized vaccine therapy
Group IV: anti-PD1 and vaccineExperimental Treatment2 Interventions
anti-PD-1 antibody followed by personalized vaccine therapy
Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:
🇺🇸 Approved in United States as KEYTRUDA for:
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
🇪🇺 Approved in European Union as KEYTRUDA for:
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
🇬🇧 Approved in United Kingdom as KEYTRUDA for:
- Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UCSD Medical CenterSan Diego, CA
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Who Is Running the Clinical Trial?
Ezra CohenLead Sponsor