Apply to Trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

40 Participants Needed

ConvitVax for Breast Cancer

Recruiting at 2 trial locations

Overseen ByIsaac 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 GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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.

What data supports the effectiveness of the treatment ConvitVax for breast cancer?

Research suggests that combining ConvitVax with anti-PD-1, a type of immunotherapy, can improve its effectiveness in fighting breast cancer. In animal studies, this combination led to more tumor cell death and changes in immune cell activity, indicating a stronger anti-cancer effect.¹ ² ³ ⁴ ⁵

What is the purpose of this trial?

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.

Eligibility Criteria

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.

See 5 more

Exclusion Criteria

Current participation in another clinical trial

Previous enrollment in this study

Current pregnancy or breastfeeding

See 27 more

Timeline

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

Treatment Details

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.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: ConvitVaxExperimental Treatment1 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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Jacinto Convit World Organization Inc.

Lead Sponsor

Trials

Recruited

40+

Fundación Jacinto Convit

Collaborator

Trials

Recruited

40+

Instituto Oncologico Luis Razetti

Collaborator

Trials

Recruited

370+

Findings from Research

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]