A Study to Assess the Ability of Stereotactic Radiotherapy to Restore the Efficacy of Immunotherapy in Patients With Metastatic Cancer.

Launched by ELSAN · Apr 9, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating whether a specific type of radiation therapy, called stereotactic radiotherapy, can help improve the effectiveness of immunotherapy in patients with metastatic cancer. Immunotherapy is a treatment that helps the body’s immune system fight cancer, but sometimes it stops working after a while. In this study, the researchers want to see if applying radiation to one tumor can also help shrink other tumors that are farther away, a phenomenon known as the "abscopal effect." Patients will receive three sessions of radiation, each lasting about 20 minutes, spaced about 3 days apart.

To participate in this study, patients must be 18 or older and have a solid tumor that has spread (metastasized) to other parts of the body. They should have been receiving immunotherapy for at least 6 months but experienced disease progression during treatment. The study is looking for patients who are in good overall health, specifically those who have a performance status (a measure of how well they can carry out daily activities) of 0 or 1. Participants will need to sign an informed consent form and be willing to follow all the study procedures. It's important to note that patients who have had previous radiation therapy or are currently pregnant or breastfeeding cannot participate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female, 18 years of age or older,
• • 2. Patient with a metastatic solid tumor,
• • 3. Patient with at least one target lesion (for radiotherapy) together with other secondary lesions that must be measurable,
• • 4. Measurable disease according to RECIST 1.1 and iRECIST criteria,
• • 5. Patient undergoing anti-PD1 immunotherapy as part of standard of care treatment,
• • 6. Disease progression with immunotherapy (progression assessed by iRECIST criteria) but having received at least 6 months of immunotherapy,
• • 7. Performance Status (PS) of 0 or 1,
• • 8. Patient eligible for stereotactic radiotherapy,
• • 9. Patient affiliated to or benefiting from a social security scheme,
• • 10. Patient having been informed of the investigation and having signed the informed consent form prior to any study-specific procedures,
• • 11. Patient willing and able to undergo all examinations and procedures in accordance with the clinical investigation plan.
• Exclusion Criteria:
• • 1. Patient having received previous radiotherapy since the start of immunotherapy,
• • 2. Patient for whom first disease progression (pre-inclusion stage) is not confirmed secondarily (inclusion stage),
• • 3. Patient with an active implantable medical device (e.g. pacemaker) or an active medical device worn on the body that could interact adversely with stereotactic radiotherapy treatment,
• • 4. Patient with hematological cancer,
• • 5. Symptomatic patient requiring a rapid change of systemic line according to the investigator's judgment,
• • 6. Concurrent participation in another clinical trial, or patient having received an investigational product within 30 days prior to inclusion,
• • 7. Pregnant or breast-feeding women,
• • 8. Patient under legal protection.