A Study to Assess the Ability of Stereotactic Radiotherapy to Restore the Efficacy of Immunotherapy in Patients With Metastatic Cancer. (RESTO-IMMUNO)

April 15, 2024 updated by: Elsan

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.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Charente
      • Soyaux, Charente, France, 16800
        • Centre Clinical

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stereotactic radiotherapy
Patients will perform stereotactic radiotherapy with 3 sessions (8 Gy) during 20 minutes each and with 72 hours in-between, alongside anti-PD1 immunotherapy.
Radiation: Stereotactic Radiotherapy

Patients will perform stereotactic radiotherapy with 3 sessions (8 Gy) during 20 minutes each and with 72 hours in-between.

Patients enrolled in the study would not have received this stereotactic radiotherapy outside the study, that is why this procedure is additional (compared to Standard of care) and considered as burdensome (as this is radiation). Before performing the stereotactic radiotherapy, patients will do a radiotherapy CT scanner (no injected) in order to prepare precisely the radiotherapy (treatment plan).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At 3 months after stereotactic radiotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate according to RECIST 1.1 criteria at 3 months after stereotactic RT in patients with 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 RECIST 1.1 criteria) according to a centralised independent reading.
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.
Time Frame: Up to 12 months after stereotactic radiotherapy
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.
Time Frame: Up to 12 months after stereotactic radiotherapy
Up to 12 months after stereotactic radiotherapy
Duration until new systemic treatment start.
Time Frame: Up to 12 months after stereotactic radiotherapy
Duration (in days) before introduction of a new systemic treatment.
Up to 12 months after stereotactic radiotherapy
Progression-Free Survival
Time Frame: Up to 12 months after stereotactic radiotherapy
Up to 12 months after stereotactic radiotherapy
Overall Survival
Time Frame: Up to 12 months after stereotactic radiotherapy
Up to 12 months after stereotactic radiotherapy
Objective Response Rate according to iRECIST criteria on the irradiated lesion only.
Time Frame: Up to 12 months after stereotactic radiotherapy
Up to 12 months after stereotactic radiotherapy
Objective Response Rate according to RECIST 1.1 criteria on the irradiated lesion only.
Time Frame: Up to 12 months after stereotactic radiotherapy
Up to 12 months after stereotactic radiotherapy
Objective Response Rate according to iRECIST criteria on all untreated lesion(s) (abscopal effect).
Time Frame: Up to 12 months after stereotactic radiotherapy
Up to 12 months after stereotactic radiotherapy
Objective Response Rate according to RECIST 1.1 criteria on all untreated lesion(s) (abscopal effect).
Time Frame: Up to 12 months after stereotactic radiotherapy
Up to 12 months after stereotactic radiotherapy
Objective Response Rate according to iRECIST criteria on each untreated lesion taken independently from others (abscopal effect).
Time Frame: Up to 12 months after stereotactic radiotherapy
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).
Time Frame: Up to 12 months after stereotactic radiotherapy
Up to 12 months after stereotactic radiotherapy
Incidence of Adverse Events (safety)
Time Frame: Up to 12 months after stereotactic radiotherapy
Collection of adverse events (AEs) up to 12 months after radiotherapy.
Up to 12 months after stereotactic radiotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elsan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

April 9, 2024

First Submitted That Met QC Criteria

April 9, 2024

First Posted (Actual)

April 12, 2024

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RESTO-IMMUNO
  • 2023-A02451-44 (Other Identifier: ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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