30 Participants Needed

Personalized Immunotherapy for Advanced Cancers

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

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.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as other anti-cancer therapies, immunotherapies, and immunosuppressive treatments, for a specific period before starting the study. If you are on these medications, you may need to stop them for 2 to 4 weeks before the trial begins.

Is pembrolizumab (Keytruda) generally safe for humans?

Pembrolizumab (Keytruda) has been approved for use in various cancers and is generally considered safe, but it can cause side effects like fatigue, cough, and nausea. Some serious immune-related side effects, such as pneumonitis (lung inflammation) and thyroid disorders, have been reported in a small percentage of patients.12345

What makes the drug pembrolizumab unique for treating advanced cancers?

Pembrolizumab is unique because it is a personalized immunotherapy that works by blocking the PD-1 pathway, which helps the immune system recognize and attack cancer cells more effectively. This approach is different from traditional treatments as it enhances the body's own immune response to fight cancer.13567

What data supports the effectiveness of the drug pembrolizumab (Keytruda) for treating advanced cancers?

Pembrolizumab has been shown to improve survival rates in patients with advanced non-small cell lung cancer, as demonstrated in clinical trials where it significantly increased overall survival compared to chemotherapy. Additionally, pembrolizumab has shown antitumor activity in various solid tumors, indicating its potential effectiveness in treating advanced cancers.5891011

Who Is on the Research Team?

EC

Erza Cohen, MD

Principal Investigator

University of California, San Diego

Are You a Good Fit for This Trial?

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.
See 4 more

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
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a personalized vaccine in combination with an anti-PD1 antibody, pembrolizumab, to increase anti-cancer immunity

6 weeks
Multiple visits for administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of immune response and adverse events

1 year

What Are the Treatments Tested in This Trial?

Interventions

  • Pembrolizumab
  • Personalized Vaccine
Trial Overview The 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.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Group I: vaccine and anti-PD-1Experimental Treatment2 Interventions
Group II: vaccineExperimental Treatment1 Intervention
Group III: anti-PD1 before vaccineExperimental Treatment2 Interventions
Group IV: anti-PD1 and vaccineExperimental Treatment2 Interventions

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

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Approved in United States as KEYTRUDA for:
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Approved in European Union as KEYTRUDA for:
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Approved in United Kingdom as KEYTRUDA for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ezra Cohen

Lead Sponsor

Trials
5
Recruited
70+

Published Research Related to This Trial

In the phase Ib KEYNOTE-001 study, pembrolizumab monotherapy showed durable antitumor activity in advanced non-small-cell lung cancer (NSCLC), with a median overall survival (OS) of 22.3 months for treatment-naive patients and 10.5 months for previously treated patients, and 5-year OS rates of 23.2% and 15.5%, respectively.
Patients with a PD-L1 tumor proportion score of 50% or greater had even better outcomes, with 5-year OS rates of 29.6% for treatment-naive and 25.0% for previously treated patients, while the treatment maintained a favorable safety profile with minimal late-onset adverse events.
Five-Year Overall Survival for Patients With Advanced Non‒Small-Cell Lung Cancer Treated With Pembrolizumab: Results From the Phase I KEYNOTE-001 Study.Garon, EB., Hellmann, MD., Rizvi, NA., et al.[2022]
Pembrolizumab (Keytruda) was approved by the FDA for treating metastatic non-small cell lung cancer (mNSCLC) in patients with tumors expressing PD-L1, showing significant improvements in overall survival (OS) and progression-free survival (PFS) in two major clinical trials with thousands of participants.
In the KEYNOTE-024 trial, pembrolizumab demonstrated a 40% reduction in the risk of death compared to chemotherapy, while in the KEYNOTE-010 trial, it also showed a significant survival advantage over chemotherapy in patients who had previously progressed on treatment.
FDA Approval Summary: Pembrolizumab for Treatment of Metastatic Non-Small Cell Lung Cancer: First-Line Therapy and Beyond.Pai-Scherf, L., Blumenthal, GM., Li, H., et al.[2022]
In a phase Ib trial involving 26 patients with advanced PD-L1-positive ovarian cancer, pembrolizumab demonstrated a confirmed objective response rate of 11.5%, indicating some level of antitumor activity, with 1 complete response and 2 partial responses observed.
The treatment was generally well-tolerated, with 73.1% of patients experiencing treatment-related adverse events, but no deaths or treatment discontinuations due to these events, suggesting that pembrolizumab has a manageable safety profile.
Pembrolizumab in patients with programmed death ligand 1-positive advanced ovarian cancer: Analysis of KEYNOTE-028.Varga, A., Piha-Paul, S., Ott, PA., et al.[2019]

Citations

Five-Year Overall Survival for Patients With Advanced Non‒Small-Cell Lung Cancer Treated With Pembrolizumab: Results From the Phase I KEYNOTE-001 Study. [2022]
FDA Approval Summary: Pembrolizumab for Treatment of Metastatic Non-Small Cell Lung Cancer: First-Line Therapy and Beyond. [2022]
Pembrolizumab in patients with programmed death ligand 1-positive advanced ovarian cancer: Analysis of KEYNOTE-028. [2019]
Phase Ib study of patients with metastatic castrate-resistant prostate cancer treated with different sequencing regimens of atezolizumab and sipuleucel-T. [2022]
Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions. [2017]
FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma. [2021]
Recurrent and atypical immune checkpoint inhibitor-induced pneumonitis. [2023]
Programmed Cell Death-1 Inhibitor-Induced Type 1 Diabetes Mellitus. [2022]
FDA Approval Summary: Pembrolizumab for the Treatment of Patients with Unresectable or Metastatic Melanoma. [2022]
Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Biophysical and Immunological Characterization and In Vivo Pharmacokinetics and Toxicology in Nonhuman Primates of the Anti-PD-1 Antibody Pembrolizumab. [2021]
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