Vaccine + Pembrolizumab for Cancer

Recruiting in Palo Alto (17 mi)

Overseen byVincent Chung

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: City of Hope Medical Center

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial studies a combination of a special vaccine and pembrolizumab to treat patients with advanced solid tumors that haven't responded to other treatments. The vaccine helps the immune system recognize and attack cancer cells, while pembrolizumab boosts the immune system's ability to fight the cancer. Pembrolizumab has shown effectiveness in patients who have already received other treatments, with better outcomes and fewer side effects compared to some standard treatments.

Eligibility Criteria

This trial is for adults with advanced solid tumors that can't be removed by surgery or have spread and didn't respond to previous treatments. Participants must understand the study, sign consent, have certain blood counts and organ function levels, use contraception if needed, and not be pregnant. They should also not have severe allergies to egg proteins or a history of certain immune reactions.

Inclusion Criteria

All subjects must have the ability to understand and the willingness to sign an Institutional Review Board (IRB) approved consent form

You must have enough neutrophils in your blood, at least 1,500 per microliter.

Women of child-bearing potential must use contraception prior to study entry and for six months after study participation; sexually active men whose partners are women of childbearing age must use condoms

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Exclusion Criteria

Radiotherapy within 4 weeks prior to entering the study is an exclusion criterion

Non-compliance with the safety monitoring requirements of the study will result in exclusion

Patients receiving any additional investigational agents or radiation therapy are excluded

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Participant Groups

The trial tests a vaccine therapy using a modified virus expressing p53 combined with pembrolizumab (a monoclonal antibody) against various solid tumors. The goal is to see if this combination helps the immune system destroy cancer cells more effectively than current treatments.

1Treatment groups

Experimental Treatment

Group I: Treatment (p53MVA, pembrolizumab)Experimental Treatment3 Interventions

Patients receive pembrolizumab IV over 30 minutes followed by modified vaccinia virus Ankara vaccine expressing p53 SC at least 30 minutes later once in weeks 1, 4, and 7. Patients may receive additional doses of pembrolizumab in weeks 10, 13, 16, and 19, for a maximum of 7 doses if there are no signs of progressive disease. Treatment continues in the absence of disease progression or unacceptable toxicity.