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Metastatic Breast CancerPhase 1/2NCT06023277

A Phase 1b/2 Clinical Trial to Evaluate the Safety and Efficacy of ConvitVax in Metastatic Breast Cancer

A Phase 1/2 study testing ConvitVax in people with Metastatic Breast Cancer, run by Jacinto Convit World Organization Inc. at 3 sites in 2 countries.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This is a proof-of-concept, single-center, non-randomized, open-label, phase 1b/2 study to evaluate the safety and efficacy of ConvitVax, a simple, low cost (of manufacture), personalized, potentially safe and effective breast cancer vaccine made of three components: autologous tumor cells homogenate obtained from 0.3… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Metastatic Breast Cancer
What is being tested?
ConvitVax
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
3 sitesin 2 countries
Study dates
1 Apr 2024to 31 Mar 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female patients who are ≥18 years of age at the time of signing the informed consent forms (ICFs).
  • Histologically- or cytologically-confirmed diagnosis of adenocarcinoma of the breast.
  • Female patients with evidence of either locally advanced (not amenable to radiation therapy or surgery in a curative intent), inoperable, and/or metastatic disease who have either progressed, recurred after standard of care treatment, have refused, or are otherwise ineligible for standard of care treatment.
  • Measurable disease with bidimensional measurements of at least 1 × 1 cm.
  • Patients with a ≤10 mm diameter PPD response of skin induration.
  • For patients who consent to paired biopsies (before treatment and during treatment): for baseline samples, a formalin-fixed and paraffin-embedded (FFPE) archived biopsy sample can be used, but fresh biopsies from primary or recurrence or metastasis are preferred.
  • Female patients must not be pregnant, breastfeeding, nor be planning a pregnancy during their participation in the study. The use of an effective contraceptive method is mandatory in patients capable of having children. It is known that avoiding sexual activity (true abstinence) is the only secure method to prevent pregnancy; however, when patients choose to be sexually active, the participant must agree to use an appropriate "double-barrier" contraceptive method (such as the use of a diaphragm, intrauterine device [IUD], or contraceptive sponge, as well as the use of condom) or pills, injections or implants prescribed for birth control.
  • Ability to understand and willingness to sign written ICFs.

Who cannot join

  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≥1.
  • Life expectancy <3 months.
  • Patients with known brain metastases, leptomeningeal carcinomatosis, and/or spinal cord compression. Participants with brain metastases that have been previously totally resected or irradiated are eligible provided no progression or relapse is observed within 4-weeks of the last treatment.
  • Non-resolution of any prior treatment-related toxicity to Grade <2, except for alopecia according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
  • Major surgery within 4-weeks before first study treatment administration.
  • Washout period of at least 3-weeks or 5 times the half-life, whichever is shorter, of any cancer therapy (including anticancer therapy, vaccination, or any investigational agent). For patients who received immunotherapy (including anti-programmed death-1 [anti-PD-1] therapy) a washout of at least a 4-week recovery period is required.
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  • Immunosuppressive corticosteroid doses (prednisone >7.5 mg daily orally [PO] or intravenously [IV], or equivalent) within 2-weeks before the first dose of ConvitVax and maintenance therapy with prednisolone >7.5 mg/day PO or equivalent during the study.
  • Inadequate hematological function including neutrophils <1.5 × 109/L; hemoglobin ˂9 gr/dL, and platelet count <100 × 109/L.
  • Inadequate liver function test with total bilirubin ˃1.5 × upper limit of normal (ULN), unless Gilbert's syndrome (in which case, total bilirubin ˃2.5 × ULN or alanine aminotransferase [ALT], aspartate aminotransferase [AST], or alkaline phosphatase [ALP] ˃2.5 × ULN in the absence of hepatic metastases). In the presence of hepatic metastases, total bilirubin ˂3 × ULN and ALT (or AST) ˂5 × ULN are acceptable. ALP ˂5 × ULN would be acceptable only if related to the presence of bone metastases, as judged by the investigator.
  • Inadequate renal function with serum creatinine ≥1.5 × ULN or between 1.0 and 1.5 × ULN with estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 as estimated using the abbreviated Modification of Diet in Renal Disease formula.
  • Inadequate coagulation test: prothrombin time (PT) or international normalized ratio (INR) value ˃1.5 × ULN. Patients with anticoagulant therapy are excluded. Patients with low dose aspirin (˂100 mg) and prophylactic low dose heparin are allowed.
  • Patients with any other cancer. However, adequately treated basal, squamous carcinoma of the skin or in situ cervical cancer, or any other cancer from which the patient has been disease free for >3 years are allowed.
  • Patient is deemed unsuitable for participation, whatever the reason, as judged by the investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to the study procedures (e.g., unwilling and unable to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restriction).
  • Known or suspected contraindication to BCG and/or formalin.
  • History of known acquired immunodeficiency syndrome (AIDS) related illnesses or known human immunodeficiency virus (HIV) disease requiring antiretroviral treatment, or active hepatitis A, B (defined as either positive HBsAg or negative HBsAg with positive HBc antibody), or C (defined as a known positive hepatitis C antibody result and known quantitative HCV RNA results greater than the lower limits of detection of the assay) infection.
  • Patients positive for Covid-19 or those who had the disease within a month before their inclusion in the study.
  • Patients with previous or current active autoimmune disease requiring immunosuppressive treatment (e.g., inflammatory bowel disease, ulcerative colitis, Crohn's disease, systemic vasculitis, scleroderma, polymyositis, dermatomyositis, insulin-dependent diabetes mellitus [IDDM] or infant- juvenile diabetes, vasculitis syndrome, psoriasis, multiple sclerosis, hemolytic anemia, immune-mediated thrombocytopenia, rheumatoid arthritis, systemic lupus erythematosus, Sjögren's syndrome, sarcoidosis or other rheumatic diseases or any other related medical disorder.)
  • Active infection that requires the continuous use of antibiotic therapy.
  • Current pregnancy or breastfeeding.
  • Known or proven adverse reaction to vaccines, such as anaphylaxis or other severe reaction.
  • Any prior organ transplant.
  • Prior treatment with live, attenuated vaccines within 4-weeks before initiation of study intervention and during treatment.
  • Patients who had a splenectomy.
  • Patients with known or suspected congenital immunodeficiency.
  • Current participation in another clinical trial.
  • Individuals accommodated in an institution because of regulatory or legal order; prisoners or subjects who are legally institutionalized.
  • Active infections, including unexplained fever (temperature >38.1°C), or antibiotics therapy within 1-week before enrollment.
  • Presence of any significant and uncontrolled medical, psychiatric, chronic condition, or laboratory abnormalities that may denote a risk associated with the patient's participation in the study, or that may interfere with the interpretation of the results, as judged by the investigator.
  • Previous enrollment in this study.
  • The patient is on the staff (or relative thereof) directly involved in the conduct of the protocol.

Trial locations and contacts

3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Jeismar Carballo, PhD contact

+34643794364

jcwo@jacintoconvit.org

Isaac Blanca, PhD contact

+582122355122

jefaturadeinvestigacion@jacintoconvit.org

3 sites in 2 countries

Venezuela2 sites

  • Instituto de Oncología Dr. Luis Razetti

    Caracas, Distrito Federal, 1010

  • Fundación Jacinto Convit

    Caracas, Miranda, 1071

    Isaac Blanca, Phd, +582122355122, jefaturadeinvestigacion@jacintoconvit.org

Other trials in Venezuela

United States1 site

  • Jacinto Convit World Organization, Inc.

    Pompano Beach, Florida, 33069

    Jeismar Carballo, PhD, 954-970-9176, jcwo@jacintoconvit.org

Other trials in United States

About this study

This is a proof-of-concept, single-center, non-randomized, open-label, phase 1b/2 study to evaluate the safety and efficacy of ConvitVax, a simple, low cost (of manufacture), personalized, potentially safe and effective breast cancer vaccine made of three components: autologous tumor cells homogenate obtained from 0.3 g of tumor tissue, 0.0625 mg of bacillus Calmette-Guérin Danish strain 1331 (BCG D1331), and 0.02% of formalin, for patients with metastatic breast cancer (MBC) except for brain metastases, leptomeningeal carcinomatosis, and/or spinal cord compression. The primary aim is to determine the overall safety and tolerability of ConvitVax when administered via an intradermal (id) injection as monotherapy in female patients with MBC who have failed at least one line of therapy. This study will give access to an immunotherapy, to underprivileged women with MBC, particularly in poor developing countries where patients may not have the opportunity to be treated with modern therapies or, in many cases, standard of care treatments. Breast cancer patients at Instituto de Oncología "Dr. Luis Razetti" (Oncological Institute "Dr. Luis Razetti") (IOLR) who meet the eligibility criteria will be consented and asked to have a biopsy of the primary tumor. This fragment will be divided for the preparation of each dose of the vaccine. A total of 40 patients with confirmed MBC will be treated with ConvitVax. The final volume per dose of the vaccine is 0.5 ml, with a total of 4 doses. ConvitVax will be applied via id injection with a 2-week interval between each dose. Patients will be monitored for disease recurrence and survival, for a period of 1 year after initiating the treatment.

Being tested
ConvitVax
Keywords
Immunotherapy, BCG, Tumor cells
Medical subject headings
Breast Neoplasms

What participants receive

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

  • ConvitVaxBiological

    ConvitVax is a personalized vaccine designed to treat women with breast cancer. The vaccine is composed of three widely commonly used components: autologous tumor cells obtained from the patient's own tumor tissue, BCG D1331, plus a low concentration of formalin.

Study groups in NCT06023277
Study groupRoleWhat they receive
ConvitVaxExperimentalConvitVax is a vaccine made of three components: autologous tumor cells homogenate obtained from 0.3 g of tumor tissue, 0.0625 mg of BCG D1331, and 0.02% of formalin. There is no dose escalation in this study. Four doses of 0.5 mL of ConvitVax will be applied via id injection with a 2-week interval between each dose.
Receives: Biological: ConvitVax

What is being measured

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

  1. Criteria for disease recurrence

    Recurrence of the disease established by the Response Evaluation Criteria in Solid Tumors (RECIST) guide will be followed.

    Measured: 3 months

Secondary outcomes (1)

  1. Antitumor effect

    Tumor size will be measured (in centimeters) using a computed tomography (CT) scan with contrast.

    Measured: 48 days

Timeline

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

  1. First posted5 Sep 2023
  2. Study start1 Apr 2024 (estimated)
  3. Primary completion31 Mar 2025 (estimated)
  4. Study completion31 Mar 2027 (estimated)

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Interventional
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06023277
Sponsor's protocol ID
JCWO-ConvitVax1b2
Status last verified
Aug 2023
First submitted
21 Aug 2023
Last updated
5 Sep 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: The plan for IPD will not be shared at an individal level.

Publications

  • Duarte C MA, Carballo O JM, De Gouveia YM, Garcia A, Ruiz D, Gledhill T, Gonzalez-Marcano E, Convit AF. Toxicity evaluation of ConvitVax breast cancer immunotherapy. Sci Rep. 2021 Jun 16;11(1):12669. doi: 10.1038/s41598-021-91995-6.

    PubMed 34135375

  • Godoy-Calderon MJ, Salazar V, Gonzalez-Marcano E, Convit AF. Autologous tumor cells/bacillus Calmette-Guerin/formalin-based novel breast cancer vaccine induces an immune antitumor response. Oncotarget. 2018 Apr 17;9(29):20222-20238. doi: 10.18632/oncotarget.25044. eCollection 2018 Apr 17.

    PubMed 29755647

  • Godoy-Calderon MJ, Gonzalez-Marcano E, Carballo J, Convit AF. Evaluation of a ConvitVax/anti-PD-1 combined immunotherapy for breast cancer treatment. Oncotarget. 2019 Nov 12;10(61):6546-6560. doi: 10.18632/oncotarget.27283. eCollection 2019 Nov 12.

    PubMed 31762937

  • Convit J, Montesinos H, Oviedo H, Romero G, Maccarone B, Essenfeld E, Convit A, Palacios LE. Autologous tumor lysate/Bacillus Calmette-Guerin immunotherapy as an adjuvant to conventional breast cancer therapy. Clin Transl Oncol. 2015 Nov;17(11):884-7. doi: 10.1007/s12094-015-1320-0. Epub 2015 Jun 16.

    PubMed 26077120

  • Convit J, Pinardi ME, Rodriguez Ochoa G, Ulrich M, Avila JL, Goihman M. Elimination of Mycobacterium leprae subsequent to local in vivo activation of macrophages in lepromatous leprosy by other mycobacteria. Clin Exp Immunol. 1974 Jun;17(2):261-5.

    PubMed 4619359

  • Convit J, Aranzazu N, Pinardi M, Ulrich M. Immunological changes observed in indeterminate and lepromatous leprosy patients and Mitsuda-negative contacts after the inoculation of a mixture of Mycobacterium leprae and BCG. Clin Exp Immunol. 1979 May;36(2):214-20.

    PubMed 383331

  • Convit J, and Ulrich M. Desarrollo de una autovacuna + BCG y su posible uso en el tratamiento del cáncer. Gaceta Médica Caracas. 2006; 114, 300-304.

  • Convit, J. Inmunidad celular y su importancia en el cáncer de la mama. Gaceta Médica Caracas. 2008; 116, 248-249.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ConvitVax in people with Metastatic Breast Cancer, run by Jacinto Convit World Organization Inc. at 3 sites in 2 countries.

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 8 inclusion and 30 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: opening soon, as of the sponsor's last update on 5 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Venezuela, 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Jeismar Carballo, PhD (+34643794364, jcwo@jacintoconvit.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Criteria for disease recurrence (time frame: 3 months). 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 NCT06023277, which also lists 8 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 5 Sep 2023.

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