New Vaccine-Immunotherapy combo targets multiple cancers in early trial
NCT ID NCT02432963
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 1 trial tests a vaccine (p53MVA) that trains the immune system to attack cancer cells with a p53 mutation, given together with the immunotherapy drug pembrolizumab (Keytruda). The study includes 11 people with advanced solid tumors like lung, head and neck, liver, kidney, melanoma, bladder, sarcoma, triple-negative breast, colorectal, and pancreatic cancers that have not responded to prior treatments. The main goal is to check safety and side effects, and to see if the combination can shrink tumors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- p53MVA vaccine and pembrolizumab (Keytruda)
- What this could lead to
- If it works, this could point toward a new treatment option for several hard-to-treat cancers that have stopped responding to other therapies.
- What could go wrong
- This is a very early, small phase 1 trial with only 11 participants, so safety and effectiveness are not yet proven. The vaccine uses a modified virus, which may cause side effects, and the combination may not work for all cancer types.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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11 people
The number who actually took part.
- Started
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Jun 2016
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Since p53 mutations occur in a wide variety of tumor types, this is a mixed histology study for incurable tumors; subjects with the following solid tumors are eligible for screening: non-small cell lung cancer, squamous cell carcinoma of the head and neck, hepatocellular carcinoma, renal cell carcinoma, melanoma, bladder, soft tissue sarcoma, triple-negative breast cancer, and colorectal carcinoma displaying microsatellite instability and pancreatic cancer * Advanced (unresectable) solid tumors: patients must have failed or been intolerant to at least one line of standard therapy or refuse standard treatment * Performance status: patients must have an Eastern Cooperative Oncology Group (ECOG) =\< 2 (Karnofsky \>= 60%) * Informed consent: all subjects must have the ability to understand and the willingness to sign an Institutional Review Board (IRB) approved consent form * Absolute neutrophil count: \>= 1,500/ul * Platelets \>= 100,000/ul * Hemoglobin level: must be greater than 9 g/dL * Renal function: calculated or measured creatinine clearance \>= 50 ml/min and/or serum creatinine =\< 1.6 mg/dl * Total bilirubin =\< 1.5 x institutional upper limit of normal * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3 times institutional upper normal level (AST and ALT =\< 5 times institutional upper normal level, if there is evidence of liver metastasis) * Confirmed p53 involvement: patients with p53 over-expression by immunohistochemistry (\>= 10% of cells within the tumor staining positive) or those with a p53 mutation as determined by mutational analysis of tumor tissue will be eligible; patients with prior exposure to p53-based vaccines will be eligible * Agreement to use adequate contraception: women of child-bearing potential must use contraception prior to study entry and for six months after study participation; men that are sexually active whose partners are women of childbearing age must use condoms Exclusion Criteria: * Patients may not be receiving any additional investigational agents or radiation therapy * Pregnancy: pregnant women are excluded from this study; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately; women who are pregnant or breastfeeding are excluded * Patients with known brain metastasis * Radiotherapy within 4 weeks prior to entering the study * Patients with previous exposure to anti-programmed cell death (PD)-1 or anti-programmed cell death ligand 1 (PDL-1) will not be eligible * History of allergy to egg proteins * Patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier * Concurrent use of systemic corticosteroids (nasal corticosteroids, inhaled steroids, adrenal replacement steroids, and topical steroids are allowed) * History of immunodeficiency or autoimmune disease: patients with a history of immunodeficiency, including organ grafts and human immunodeficiency virus (HIV), will not be eligible * Patients with a history of autoimmune disease will also be excluded, specifically those with any active autoimmune disease or a condition that requires systemic corticosteroids; exceptions to this are subjects with vitiligo and type I diabetes mellitus, who will be permitted to enroll * Patients with a history of severe immune-mediated adverse reactions with ipilimumab: this will be defined as any grade 4 toxicity requiring treatment with corticosteroids (greater than 10 mg/day prednisone or equivalent dose) for greater than 12 weeks * Patients with a history of cardiac disease are excluded; baseline electrocardiography and assessment of serum troponin (I) are included the screening exams; subjects in whom these assays are abnormal (electrocardiogram \[EKG\] excluding 1st degree bundle branch block, sinus bradycardia, sinus tachycardia or non-specific T wave changes, serum troponin \>= grade 2) are ineligible * Non-compliance: if it is the opinion of the investigator that a subject may be unable to comply with the safety monitoring requirements of the study, they will be excluded
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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City of Hope Medical Center
Duarte, California, 91010, United States
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