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Solid Metastatic TumorPhase 1NCT04134312

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

A Phase 1 study testing MVA-BN-Brachyury in people with Solid Metastatic Tumor, run by Bavarian Nordic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Metastatic Tumor
What is being tested?
MVA-BN-Brachyury
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteUnited States
Study dates
8 Jan 2020to 6 Apr 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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
  • Disease progression after at least one line of treatment of abiraterone or enzalutamide and docetaxel.
  • Colorectal
  • Metastatic disease.
  • Must have received chemotherapy regimens containing 5-FU, oxaliplatin, irinotecan, and EGFR-targeted antibodies when indicated (absence of RAS mutation) with evidence of disease progression or AEs that preclude further treatment with standard therapies.
  • Pancreatic
  • Metastatic disease.
  • Disease progression after or intolerance to standard chemotherapy regimens of known benefit (FOLFIRINOX or Gemcitabine and Abraxane).
  • Hepatocellular
  • Incurable disease: liver only or metastatic.
  • Disease progression after at least one systemic therapy of known benefit (e.g. sorafenib).
  • Bladder
  • Metastatic disease.
  • At least one line of chemotherapy and immune checkpoint inhibitors second line.
  • Kidney
  • Metastatic disease.
  • After VEGF inhibitors, immune check-point inhibitors, m-TOR inhibitors.
  • Patients must have measurable or evaluable disease. Measurable disease is defined by RECIST 1.1. In the case of evaluable disease, patients should have cancer-related symptoms to justify risk.
  • Evaluable disease is defined as any of the following:
  • Elevated serum tumor marker known to be related to the patient's tumor.
  • Clear radiographic or physical exam evidence of tumor which does not meet RECIST 1.1 measurement requirements.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  • Patients must have normal organ and bone marrow function as defined below:
  • Renal function:
  • Serum creatinine ≤ 1.5 x upper limit of normal (ULN) OR creatinine clearance (CrCl) ≥ 40 mL/min (if using the Cockcroft-Gault formula below):
  • Female CrCl = [(140 - age in years) x weight in kg x 0.85] / [72 x serum creatinine in mg/dL]
  • Male CrCl = [(140 - age in years) x weight in kg x 1.00] / [72 x serum creatinine in mg/dL]
  • Liver function:
  • Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 3 x the ULN.
  • Total bilirubin ≤ 1.5 x ULN (in subjects with Gilbert's syndrome a total bilirubin ≤ 3.0 x ULN), or < 5 x ULN, if liver metastases are present.
  • Hematological parameters (within one week of starting therapy):
  • Hemoglobin > 9 g/dL.
  • Platelet count ≥ 100,000/µL.
  • Absolute neutrophil count (ANC) ≥ 1/ µL.
  • Troponin I within normal limits.
  • Electrocardiogram (ECG) without clinically significant findings.
  • Any prior chemotherapy, immunotherapy and/or radiation must be completed at least 4 weeks prior to the first planned dose of MVA-BN-Brachyury vaccine, with the following exceptions, assuming any toxicity related to these therapies is well controlled or resolved and the patient has been on that therapy for at least 8 weeks at the time of enrollment:
  • Prostate cancer - patients must continue to receive Gonadotropin-Releasing-Hormone (GnRH) agonist or antagonist therapy (unless orchiectomy has been done). Patients on abiraterone or enzalutamide may continue those therapies.
  • Breast cancer - patients may remain on hormonal therapy if indicated (Estrogen Receptor/Progesterone Receptor positive [ER/PR+]).
  • A minimum of 6 weeks from any prior antibody therapies (such as ipilimumab or anti-Programmed Death 1/Programmed Death Ligand 1[PD1/PD-L1]) is required due to prolonged half-life.
  • Patients must have recovered (grade 1 or baseline) from any clinically significant toxicity associated with prior therapy.
  • Women of child-bearing potential (WOCBP) must have a negative serum or urine pregnancy test within 48 hours prior to administration of MVA-BN-Brachyury vaccine. Both men and women must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) through the trial treatment period and for at least three months after the last vaccination with MVA-BN-Brachyury vaccine.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Cancer Institute

    Bethesda, Maryland, 20892

Other trials in United States

About this study

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.

Being tested
MVA-BN-Brachyury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MVA-BN-BrachyuryBiological

    MVA-BN-Brachyury will be administered intravenously every three weeks with three administrations in total at the dose indicated by the enrolled cohort.

Study groups in NCT04134312
Study groupRoleWhat they receive
MVA-BN-Brachyury IVExperimentalMVA-BN-Brachyury will be administered intravenously every three weeks with three administrations in total at the dose indicated by the enrolled cohort.
Receives: Biological: MVA-BN-Brachyury

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patients with Dose Limiting Toxicity (DLT)

    Frequency of patients with DLTs

    Measured: DLT assessment is done 7 days after 2nd vaccination of last patient in each dose level

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2019
  2. Study start8 Jan 2020
  3. Primary completion12 Jan 2021
  4. Study completion6 Apr 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04134312
Sponsor's protocol ID
MVA-BN-BRACHY-IV-001
Status last verified
Jul 2021
First submitted
18 Oct 2019
Last updated
14 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • DeMaria PJ, Lee-Wisdom K, Donahue RN, Madan RA, Karzai F, Schwab A, Palena C, Jochems C, Floudas C, Strauss J, Marte JL, Redman JM, Dombi E, Widemann B, Korchin B, Adams T, Pico-Navarro C, Heery C, Schlom J, Gulley JL, Bilusic M. Phase 1 open-label trial of intravenous administration of MVA-BN-brachyury-TRICOM vaccine in patients with advanced cancer. J Immunother Cancer. 2021 Sep;9(9):e003238. doi: 10.1136/jitc-2021-003238.

    PubMed 34479925

  • Wedekind MF, Widemann BC, Cote G. Chordoma: Current status, problems, and future directions. Curr Probl Cancer. 2021 Aug;45(4):100771. doi: 10.1016/j.currproblcancer.2021.100771. Epub 2021 Jul 1.

    PubMed 34266694

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MVA-BN-Brachyury in people with Solid Metastatic Tumor, run by Bavarian Nordic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 66 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patients with Dose Limiting Toxicity (DLT) (time frame: DLT assessment is done 7 days after 2nd vaccination of last patient in each dose level). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04134312, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2021.

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