A Phase 1 Open Label Trial of Intravenous Administration of MVA-BN-Brachyury Vaccine in Patients With Advanced Cancer

Completed · Phase 1

Conditions studied: Solid Metastatic Tumor

In brief

A Phase 1 open label trial of intravenous administration of MVA-BN-Brachyury vaccine in patients with advanced cancer. Patients with metastatic or unresectable locally advanced malignant solid tumors will be enrolled and treated according to a 3+3 dose escalation scheme. Up to 3 dose levels will be explored. Patients will receive MVA-BN-Brachyury every three weeks, three administrations in total. Patients will be hospitalized after each vaccination, over 48 hours. Trial duration will be approximately 24 weeks per patient including 3 months after the last vaccination follow up (FU) period.

Key facts

Study ID

NCT04134312

Run by

Bavarian Nordic

People needed

13

Starts

2020-01-08

Expected to finish

2021-04-06

Last updated by the study team

2021-07-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women > 18 years old.
• Patients must be able to understand and be willing to sign a written informed consent document.
• Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.
• Eligible patients must have one of the histologically confirmed cancers and treatment history as described:
• Chordoma
• Symptomatic, unresectable, locally recurrent, or metastatic tumors are acceptable for enrollment, given that this represents incurable disease.
• Only curative interventions are required as prior therapy (surgery or definitive radiation) as no known systemic therapies have proven benefit.
• Non-Small Cell Lung Cancer
• Metastatic or incurable locally advanced.
• Disease progression after indicated targeted therapy (EGFR-mut, ALK-fusion, BRAF-mut).
• Disease progression after one regimen of chemotherapy and anti-PD-1/L1 therapy either sequentially or concurrently.
• Small Cell Lung Cancer
• Metastatic disease.
• Disease progression after 1st line chemotherapy.
• Breast
• Metastatic disease considered to be incurable.
• Triple negative - disease progression after first line chemotherapy.
• ER+ disease - must have had disease progression through at least 2 lines of hormonal therapy and at least 1 chemotherapy regimen.
• Her2+ disease - must have had disease progression after at least 2 Her2-targeted therapy containing regimens.
• ER+ and Her2+ - must meet requirements of each tumor marker subtype (see above).
• Ovarian
• Metastatic disease.
• Disease progression after treatment with platinum-based chemotherapy.
• Prostate
• Metastatic Castration Resistant Prostate Cancer (mCRPC) AND

You may not qualify if…

• Receipt of an investigational agent within 28 days of the first planned dose of MVA-BN-Brachyury vaccine.
• Concurrent chemotherapy or radiotherapy or other immunotherapy not explicitly allowed by inclusion criteria for this trial.
• Known metastatic disease to the central nervous system, unless previously treated and well controlled for at least 3 months (clinically stable, no edema, no steroid treatment required).
• History of anaphylaxis or severe allergic reaction to any vaccine, aminoglycoside antibiotics or egg products.
• Active infection within 72 hours prior to vaccination.
• Administration of antibiotics within 7 days prior to initial vaccination.
• Subjects having known evidence of being immunocompromised as listed below:
• Human immunodeficiency virus (HIV) positivity, active chronic hepatitis infection, including B and C.
• Active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, and psoriasis not requiring systemic treatment are permitted.
• Immunosuppressive therapy for post-organ transplant.
• Chronic administration (defined as > 5 consecutive days of > 15 mg of prednisone (or equivalent) per day) of systemic corticosteroids within 14 days of the first planned dose of MVA-BN-Brachyury vaccine. Use of inhaled steroids, nasal sprays, eye drops, and topical creams is allowed. Steroids premedication for CT scans is allowed.
• Vaccinations or planned vaccinations with a live vaccine within 30 days prior to the trial vaccination or with an inactivated vaccine within 14 days prior to the trial vaccination.
• Patients with history of myocardial infarction, unstable angina pectoris, history of or existing CHF (NYHA Class II -IV), other cardiomyopathy, cardiac arrhythmia requiring medical treatment, clinically significant cardiac valvular disease, poorly controlled hypertension and hemodynamic effective pericardial effusion.
• Known history of, or any evidence of active, non-infectious pneumonitis or primary pulmonary fibrosis.
• Psychiatric illness/social situations that, in the opinion of the Investigator, would limit compliance with trial requirements.
• Pregnant or breastfeeding women.
• Any other condition, which in the opinion of the Investigator, would indicate the subject is a poor candidate for treatment with MVA-BN-Brachyury vaccine or would interfere with the evaluation of the trial endpoints.

Where it is running

• National Cancer Institute — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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