protocolSection identificationModule nctId: NCT06363773, orgStudyIdInfo id: RESTO-IMMUNO, secondaryIdInfos id: 2023-A02451-44, type: OTHER, domain: ANSM, briefTitle: A Study to Assess the Ability of Stereotactic Radiotherapy to Restore the Efficacy of Immunotherapy in Patients With Metastatic Cancer., acronym: RESTO-IMMUNO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Elsan, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Metastatic Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Pilot, exploratory, prospective, monocentric study, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 35, type: ESTIMATED, armsInterventionsModule interventions name: Stereotactic Radiotherapy, outcomesModule primaryOutcomes measure: Objective Response Rate according to iRECIST criteria at 3 months after stereotactic radiotherapy in patients with confirmed progression after initial response to immunotherapy., secondaryOutcomes measure: Objective Response Rate according to RECIST 1.1 criteria at 3 months after stereotactic RT in patients with progression after initial response to immunotherapy., secondaryOutcomes measure: Objective Response Rate according to iRECIST criteria up to 12 months after stereotactic radiotherapy in patients with confirmed progression after initial response to immunotherapy., secondaryOutcomes measure: 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., secondaryOutcomes measure: Duration until new systemic treatment start., secondaryOutcomes measure: Incidence of Adverse Events (safety), secondaryOutcomes measure: Progression-Free Survival, secondaryOutcomes measure: Overall Survival, secondaryOutcomes measure: Objective Response Rate according to iRECIST criteria on the irradiated lesion only., secondaryOutcomes measure: Objective Response Rate according to RECIST 1.1 criteria on the irradiated lesion only., secondaryOutcomes measure: Objective Response Rate according to iRECIST criteria on all untreated lesion(s) (abscopal effect)., secondaryOutcomes measure: Objective Response Rate according to RECIST 1.1 criteria on all untreated lesion(s) (abscopal effect)., secondaryOutcomes measure: Objective Response Rate according to iRECIST criteria on each untreated lesion taken independently from others (abscopal effect)., secondaryOutcomes measure: Objective Response Rate according to RECIST 1.1 criteria on each untreated lesion taken independently from others (abscopal effect)., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre Clinical, city: Soyaux, state: Charente, zip: 16800, country: France, geoPoint lat: 45.65, lon: 0.2, hasResults: False