Pilot, Exploratory, Prospective Study to Assess the Ability of Stereotactic Radiotherapy to Restore the Efficacy of Anti-PD1 Immunotherapy in Initially Long-responder Patients With Metastatic Progression.

Elsan1 site in 1 country35 target enrollmentJanuary 2025

ConditionsMetastatic Cancer

Overview

Phase: N/A
Intervention: Not specified
Conditions: Metastatic Cancer
Sponsor: Elsan
Enrollment: 35
Locations: 1
Primary Endpoint: Objective Response Rate according to iRECIST criteria at 3 months after stereotactic radiotherapy in patients with confirmed progression after initial response to immunotherapy.
Status: Not Yet Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study aims at enrolling patients with solid tumors at metastatic stage, considered long responders to immunotherapy (> 6 months) and displaying disease progression.

In this study, the investigator wants to evaluate specific modalities of stereotactic radiotherapy, with 3 sessions, each of 8 Gy, lasting 20 minutes and spaced 72 hours apart (Day 1, Day 4, Day 7). The radiotherapy device itself is not the subject of this study and will be used in accordance with its CE mark and indications.

The objective of the study is to assess the ability of stereotactic radiotherapy to restore the lost efficacy of immunotherapy. In particular, the abscopal effect will be assessed, i.e. the action of irradiating a particular target lesion and observing an effect on other distant metastases.

Registry

clinicaltrials.gov

Start Date

January 2025

End Date

January 2027

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Elsan

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female, 18 years of age or older,
•Patient with a metastatic solid tumor,
•Patient with at least one target lesion (for radiotherapy) together with other secondary lesions that must be measurable,
•Measurable disease according to RECIST 1.1 and iRECIST criteria,
•Patient undergoing anti-PD1 immunotherapy as part of standard of care treatment,
•Disease progression with immunotherapy (progression assessed by iRECIST criteria) but having received at least 6 months of immunotherapy,
•Performance Status (PS) of 0 or 1,
•Patient eligible for stereotactic radiotherapy,
•Patient affiliated to or benefiting from a social security scheme,
•Patient having been informed of the investigation and having signed the informed consent form prior to any study-specific procedures,

Exclusion Criteria

•Patient having received previous radiotherapy since the start of immunotherapy,
•Patient for whom first disease progression (pre-inclusion stage) is not confirmed secondarily (inclusion stage),
•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,
•Patient with hematological cancer,
•Symptomatic patient requiring a rapid change of systemic line according to the investigator's judgment,
•Concurrent participation in another clinical trial, or patient having received an investigational product within 30 days prior to inclusion,
•Pregnant or breast-feeding women,
•Patient under legal protection.

Outcomes

Primary Outcomes

Objective Response Rate according to iRECIST criteria at 3 months after stereotactic radiotherapy in patients with confirmed progression after initial response to immunotherapy.

Time Frame: At 3 months after stereotactic radiotherapy

Assessment of Objective Response Rate (Complete Response and Partial Response with iRECIST criteria) according to a centralised independent reading.

Secondary Outcomes

Overall Survival(Up to 12 months after stereotactic radiotherapy)
Objective Response Rate according to RECIST 1.1 criteria at 3 months after stereotactic RT in patients with progression after initial response to immunotherapy.(At 3 months after stereotactic radiotherapy)
Objective Response Rate according to iRECIST criteria up to 12 months after stereotactic radiotherapy in patients with confirmed progression after initial response to immunotherapy.(Up to 12 months after stereotactic radiotherapy)
Objective Response Rate according to RECIST 1.1 criteria up to 12 months after stereotactic radiotherapy in patients with confirmed progression after initial response to immunotherapy.(Up to 12 months after stereotactic radiotherapy)
Duration until new systemic treatment start.(Up to 12 months after stereotactic radiotherapy)
Incidence of Adverse Events (safety)(Up to 12 months after stereotactic radiotherapy)
Progression-Free Survival(Up to 12 months after stereotactic radiotherapy)
Objective Response Rate according to RECIST 1.1 criteria on the irradiated lesion only.(Up to 12 months after stereotactic radiotherapy)
Objective Response Rate according to iRECIST criteria on all untreated lesion(s) (abscopal effect).(Up to 12 months after stereotactic radiotherapy)
Objective Response Rate according to RECIST 1.1 criteria on all untreated lesion(s) (abscopal effect).(Up to 12 months after stereotactic radiotherapy)
Objective Response Rate according to iRECIST criteria on the irradiated lesion only.(Up to 12 months after stereotactic radiotherapy)
Objective Response Rate according to iRECIST criteria on each untreated lesion taken independently from others (abscopal effect).(Up to 12 months after stereotactic radiotherapy)
Objective Response Rate according to RECIST 1.1 criteria on each untreated lesion taken independently from others (abscopal effect).(Up to 12 months after stereotactic radiotherapy)