Combining a Tumor Treatment Vaccine with PD-1 therapy for advanced solid tumors

Clinical Efficacy of Tumour Treatment Vaccine (TTV) Combined With PD-1 in the Treatment of Relapsed Refractory Advanced Solid Tumours

This study is testing if a new tumor treatment vaccine works better when combined with PD-1 therapy for patients with advanced solid tumors that haven't responded to other treatments.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Wuxi People's Hospital (Academic / other)
• Locations: 1 site (Wuxi, Jiangsu)
• Trial ID: NCT06430502 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of a Tumor Treatment Vaccine (TTV) when used alongside PD-1/PD-L1 inhibitors in patients with relapsed and refractory advanced solid tumors. Previous research has shown that the TTV vaccine can enhance the anti-tumor effects of immune checkpoint inhibitors, achieving a tumor suppression rate of nearly 76%. The study aims to evaluate the clinical efficacy of this combination therapy from a clinical perspective, focusing on patients who have not responded to standard treatments.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-75 with advanced solid tumors that have progressed despite standard therapies.

Not a fit: Patients with early-stage tumors or those who have not yet received standard treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new treatment option for patients with advanced solid tumors who have limited alternatives.

How similar studies have performed: Previous studies have shown promising results with similar combinations of vaccines and PD-1 inhibitors, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. Male or female aged 18-75 years;
2. Subjects must have histologically- or cytologically-confirmed diagnosis of advanced solid tumor(s) and have progressed on or is not eligible for available standard therapy;
3. Subjects have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (non-nodal lesions with longest diameter ≥ 10 mm, or nodal lesions with short diameter ≥ 15 mm);
4. ECOG score of 0-2, lifespan \> 12 weeks;
5. Women of childbearing age who have a negative pregnancy test within 7 days before treatment. Female patients of childbearing age, and male patients with partners of childbearing age must agree to use at least one medically recognized contraceptive method during study treatment and within at least 6 months after the last dose of investigational drug;
6. Voluntarily participated in this study, signed the informed consent form, had good compliance, and cooperated with the follow-up.

Exclusion Criteria:

1. The patient is diagnosed with central nervous system leukemia(symptoms, signs, imaging, cerebrospinal fluid);
2. White blood cell count ≥ 50×10\^9/ L or patients with rapid disease progression can't be guaranteed to complete a full treatment cycle;
3. Patients with fungal, bacterial, viral or other uncontrollable infections or requiring four-level isolation treatment.
4. HIV, HBV and HCV positive;
5. Patients with diseases of the central nervous system or autoimmune central nervous system lesions, Including stroke, epilepsy, dementia;
6. Patients have myocardial infection, cardiac angiography or stents, active angina or other obvious clinical symptoms, or have cardiopathic asthma or cardiovascular lymphocytic infiltrates，within 12 months;
7. Patients are on anticoagulation or have severe coagulopathy (APTT\>70);
8. Patients in any condition requiring systemic treatment with corticosteroids or other immunosuppressive agents within 2weeks prior to investigational drug administration;
9. Patients were infected with covid-19 within 2weeks prior to investigational drug administration;
10. Subjects having any serious uncontrolled disease or in other conditions that would preclude them from receiving study treatment and are considered unsuitable for this study in the opinion of the investigator;
11. Subjects in other conditions that are considered unsuitable for this study by the investigator.

Where this trial is running

Wuxi, Jiangsu

• Wuxi People's Hospital — Wuxi, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Peihua Lu

Conditions Cancer; PD-L1 Gene Mutation