Personalized Vaccine with Pembrolizumab for Treating Advanced Solid Tumors

Sponsor: Mayo Clinic

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05269381

Provider View

This clinical trial is testing a new personalized vaccine combined with pembrolizumab to treat advanced solid tumors. The vaccine targets specific proteins on cancer cells, and pembrolizumab helps the immune system attack the cancer. The study aims to see if this combination is safe and effective.

Patient Parameters

Program Overview

This study is exploring a new treatment for advanced solid tumors using a personalized vaccine that targets specific proteins on cancer cells, combined with pembrolizumab, an immunotherapy drug. The goal is to determine if this combination is safe and can help the immune system fight cancer more effectively. Participants will receive the vaccine and pembrolizumab in cycles, with regular follow-ups to monitor their health and the treatment's impact.

Description

The main goal of this study is to evaluate the safety of a personalized vaccine that targets specific proteins on cancer cells, used together with pembrolizumab, in patients with advanced solid tumors. Researchers also want to see if this combination can effectively trigger the immune system to fight cancer.

Participants will receive an initial dose of cyclophosphamide, followed by the personalized vaccine and pembrolizumab. The treatment is given in cycles every 21 days, as long as the cancer does not progress and there are no severe side effects. After completing the treatment, patients will have follow-up visits to check their health and the treatment's effects.

The study will also explore how well the immune system responds to the vaccine and how long this response lasts. Researchers will look at the overall effectiveness of the treatment by measuring tumor response rates and other health indicators.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 and older with advanced solid tumors that cannot be surgically removed.
  • Cancer must have progressed after at least one standard treatment.
  • For certain cancers, pembrolizumab must be an approved treatment option.
  • Willing to provide tissue and blood samples for research purposes.
  • Must have measurable disease according to specific criteria.
  • Must not be pregnant and agree to use effective contraception during the study and for six months after.
  • Must have a life expectancy of more than six months and be in relatively good health.
  • Must have recovered from any previous cancer treatments.
  • Must agree to return for follow-up visits and comply with study requirements.

Exclusion Criteria

  • Pregnant or breastfeeding individuals.
  • Individuals with severe health conditions that could interfere with the study.
  • Recent heart attack or severe heart failure.
  • Active infections or psychiatric conditions that could affect participation.
  • Individuals with a history of severe allergic reactions to study medications.
  • Individuals with other active cancers within the last three years, except for certain skin or cervical cancers.
  • Individuals with active autoimmune diseases requiring treatment.
  • Recent use of other investigational drugs or treatments that could interfere with the study.

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