ConvitVax for Breast Cancer

Not yet recruiting at 2 trial locations

Overseen By Isaac Blanca, PhD

Age: 18+

Sex: Female

Trial Phase: Phase 1 & 2

Sponsor: Jacinto Convit World Organization Inc.

Must not be taking: Immunosuppressants, Anticoagulants

Disqualifiers: Brain metastases, Autoimmune diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of ConvitVax, a personalized breast cancer vaccine, in women with metastatic breast cancer that hasn't spread to the brain or spinal cord. ConvitVax is created from a small sample of the patient's tumor, combined with a bacterial strain used in vaccines and a small amount of preservative. It is intended for women who have tried at least one treatment without success. The trial administers four doses over two weeks. Women with advanced breast cancer who have not responded to standard treatments might be suitable candidates. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this innovative therapy.

Will I have to stop taking my current medications?

The trial requires a washout period (time without taking certain medications) of at least 3 weeks or 5 times the half-life of any cancer therapy, whichever is shorter. If you received immunotherapy, a 4-week recovery period is needed. Additionally, you cannot take immunosuppressive corticosteroids above a certain dose within 2 weeks before starting the trial.

Is there any evidence suggesting that ConvitVax is likely to be safe for humans?

Research has shown that ConvitVax, a personalized vaccine for breast cancer, is promising in terms of safety. Previous studies found that ConvitVax is generally well-tolerated with few or no side effects. The vaccine uses components such as a person's own tumor cells, a bacterium called BCG, and a substance called formalin. These elements work together to help the immune system fight cancer.

The vaccine is administered through a small injection under the skin. So far, data suggests that recipients have not experienced major negative reactions. Since this trial is in its early stages, the main focus is on ensuring safety before evaluating its effectiveness against cancer. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for breast cancer, which often involve chemotherapy, hormone therapy, or targeted therapies, ConvitVax uses a unique approach by leveraging the patient's own tumor cells to create a personalized vaccine. This vaccine includes components like autologous tumor cells, BCG, and formalin, aiming to stimulate the immune system to recognize and attack cancer cells specifically. Researchers are excited about ConvitVax because it represents a shift towards personalized medicine, potentially offering a treatment that is tailored to the individual's specific cancer profile, which could enhance effectiveness and minimize side effects compared to traditional therapies.

What evidence suggests that ConvitVax might be an effective treatment for breast cancer?

Research shows that ConvitVax, a personalized breast cancer vaccine, might be effective against advanced breast cancer. The vaccine uses a mix of a patient's own tumor cells and other ingredients to boost the immune system. Earlier studies found that ConvitVax, especially when combined with certain other treatments, reduced tumors in breast cancer models. These findings suggest that ConvitVax could train the body to identify and destroy cancer cells. Although more information is needed, early results offer hope for those with limited treatment options. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for women over 18 with metastatic breast cancer who have failed at least one standard treatment. They must not be pregnant or breastfeeding and agree to use effective contraception. Patients should not have brain metastases, severe liver or blood issues, an ECOG performance status of ≥1, life expectancy under 3 months, active infections, certain other cancers within the last 3 years, known HIV/AIDS or hepatitis A/B/C infection.

Inclusion Criteria

Ability to understand and willingness to sign written ICFs

My breast cancer diagnosis was confirmed through tissue analysis.

You have a tumor that can be measured and is at least 1 cm in two dimensions.

Exclusion Criteria

Current participation in another clinical trial

Previous enrollment in this study

Current pregnancy or breastfeeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 4 doses of ConvitVax via intradermal injection with a 2-week interval between each dose

8 weeks

Follow-up

Participants are monitored for disease recurrence and survival

1 year

What Are the Treatments Tested in This Trial?

Interventions

• ConvitVax

Trial Overview ConvitVax is being tested as a potential vaccine for advanced breast cancer. It's made from the patient's own tumor cells mixed with BCG (a tuberculosis vaccine) and formalin. The study involves giving patients four doses via skin injection every two weeks and monitoring them for a year.

How Is the Trial Designed?

Group I: ConvitVax Experimental Treatment 1 Intervention

ConvitVax 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.

Who Is Running the Clinical Trial?

Jacinto Convit World Organization Inc.

Lead Sponsor

Trials

1

Recruited

40+

Fundación Jacinto Convit

Collaborator

Trials

1

Recruited

40+

Instituto Oncologico Luis Razetti

Collaborator

Trials

2

Recruited

370+

Published Research Related to This Trial

Oral chemotherapy options like Xeloda (capecitabine) and oral vinorelbine improve access for patients with metastatic breast cancer, especially when hospital visits are challenging due to financial or logistical reasons.

Combination therapies using taxoids and anthracyclines have increased response rates in first-line treatments, but maintenance regimens with less toxic agents can prolong response duration and improve disease-free survival, making outpatient treatment more feasible.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing chemotherapy for patients with advanced breast cancer. Marty, M., Espie, M., Cottu, PH., et al.[2017]

The combination of ConvitVax, an autologous tumor cell vaccine, with anti-PD-1 therapy showed improved antitumor effects in a breast cancer model, evidenced by increased tumor necrosis and enhanced immune cell infiltration.

This study suggests that combining ConvitVax with checkpoint inhibitors like anti-PD-1 could lead to more effective and personalized breast cancer treatments, especially considering the vaccine's low cost and ease of preparation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a ConvitVax/anti-PD-1 combined immunotherapy for breast cancer treatment. Godoy-Calderón, MJ., González-Marcano, E., Carballo, J., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6859918/

Evaluation of a ConvitVax/anti-PD-1 combined ... Breast cancer therapies using checkpoints alone have not been highly effective. Based on previous experiences using the ConvitVax, an autologous ...

2. nature.com nature.com/articles/s41598-021-91995-6

Toxicity evaluation of ConvitVax breast cancer ... All these previous results demonstrated the likely effectiveness of ConvitVax against breast cancer, making it a potentially viable customized ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06023277

Study Details | NCT06023277 | A Phase 1b/2 ... 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 ( ...

4. withpower.com withpower.com/trial/phase-2-breast-neoplasms-3-2024-1f453

ConvitVax for Breast Cancer · Info for Participants The combination of ConvitVax, an autologous tumor cell vaccine, with anti-PD-1 therapy showed improved antitumor effects in a breast cancer model, evidenced by ...

5. researchgate.net researchgate.net/figure/ConvitVax-anti-PD-1-combined-treatment-enhances-tumor-elimination-without-tumor-arrest_fig1_337545342

ConvitVax/anti-PD-1 combined treatment enhances tumor... All these previous results demonstrated the likely effectiveness of ConvitVax against breast cancer, making it a potentially viable customized immunotherapy.

6. researchgate.net researchgate.net/publication/352462384_Toxicity_evaluation_of_ConvitVax_breast_cancer_immunotherapy

(PDF) Toxicity evaluation of ConvitVax breast cancer ... These results support the safety of ConvitVax with minimal to no side-effects.