Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:46 PM
Ignite Modification Date:
2025-12-24 @ 7:46 PM
NCT ID:
NCT07002203
Brief Summary:
This clinical trial is studying the safety and efficacy of a personalized cancer vaccine called a neoantigen peptide vaccine in patients with solid tumors. These vaccines are custom-made for each patient using specific mutations (neoantigens) found in their own tumor. The goal is to help the patient's immune system recognize and attack their cancer.
The study will enroll adult patients (20 years or older) who have solid tumors that meet specific stage-related criteria. These include advanced cancers that are resistant to prior treatments and early-stage cancers at high risk of recurrence, where there are no standard adjuvant therapies available.
Participants will receive:
* A personalized neoantigen peptide vaccine designed from the mutations in their tumor tissue.
* Poly-ICLC (Hiltonol), a substance that stimulates the immune system.
* An anti-PD-1 immune checkpoint inhibitor, a drug that helps the immune system stay active against cancer.
The vaccine and drugs will be given through multiple injections over several months. Blood samples and imaging will be used to monitor the immune response and how the cancer responds to treatment. Participants will be followed for up to 12 months.
This study does not include a placebo group. Every participant will receive the personalized vaccine along with the other therapies.
The primary objectives of this study are:
1. To assess whether the treatment is safe and tolerable.
2. To evaluate whether this approach helps control the cancer and can be combined with other standard treatments in the future.
Study:
NCT07002203
Study Brief:
Protocol Section:
NCT07002203