Immunotherapy And Palliative Radiotherapy Combined In Patients With Advanced Malignancy

Study Overview
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Brief Summary
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Immunotherapy includes a class of medication called checkpoint inhibitors, which are a relatively new medication therapy for many types of cancer which are metastatic, meaning it has spread to other parts of the body.Immune therapy medication may be given safely with radiation treatment, and in rare cases it may even make radiotherapy more effective. When radiation therapy is given in the palliative setting it is given to treat pain/discomfort and not necessarily shrink or get rid of the tumour. Palliative radiotherapy may be given for many reasons, but common examples include painful bone or liver tumours, brain metastases, or symptoms from a chest tumour such as feeling breathless, cough, or bleeding. Palliative radiotherapy is usually given in smaller amounts and less frequently than other types of radiation therapy. Because checkpoint inhibitors are relatively new there is not a huge amount of evidence looking at how patients respond when the treatments are combined, or in which patients immune therapy may make radiation therapy even more effective. This study is looking at the way patients who are on or about to start immune therapy and who have been recommended for palliative radiotherapy, respond to the combination of these two treatments. The purpose of this study is to describe the treatment outcomes in patients with cancer that has spread who are managed with a combination of immune therapy medication and radiotherapy. This research is being done because there is limited information about the outcomes of combined immune therapy and radiotherapy treatment from a patient's perspective, but also in terms of which patients may have a better response to combined treatment. In particular, the study aims to describe how combined treatment affects cancer not only in the area where radiotherapy is given, but also outside the part of the body that receives radiotherapy (which is called abscopal effect).

Official Title
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Immunotherapy And Palliative Radiotherapy Combined In Patients With Advanced Malignancy

Conditions
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Palliative, Advanced Cancer, Immunotherapy, Radiation Therapy

Intervention / Treatment
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* Radiation: Palliative Radiation Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults aged 18 years or older Histologically or cytologically confirmed solid tumor malignancy Advanced disease (locally advanced and/or metastatic) Life expectancy > 3 months Patients planned to receive palliative radiotherapy (including whole liver radiotherapy) Patients who are already on or about to commence a checkpoint inhibitor Measurable disease according to irRECIST on CT or MRI ECOG performance status 0-2 Able to provide informed consent Able to complete telephone/email communication Additional criteria for subset of patients for abscopal analysis (to be done post hoc): Measurable disease outside irradiated volume Must be on same checkpoint inhibitor/immunotherapy (or same class of checkpoint inhibitor) for 3 months prior to radiotherapy and have stable disease or oligoprogression in past 3 months Availability of prior biopsy specimen (preferably fresh frozen tissue) for research and genotyping Exclusion Criteria: Medical conditions which may be contraindications to radiotherapy Any medical or non-medical issue that would affect the patient's ability to provide informed consent for study participation, or would interfere with the patient's treatment on study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: Palliative Radiation Therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients showing rates of grade 3 or higher toxicity | Toxicity and safety data for combined therapy with immunotherapy and palliative RT (documentation that the rates of grade 3 or higher toxicity with combined therapy is < 30%) using patient reported outcomes (symptoms, toxicities, quality of life measures), clinical outcomes (physical examination, and CT imaging results) at baseline, 1 and 3 months post radiotherapy. Only the highest toxicity/per patient will be used for analysis, regardless of the time point of when the information is collected | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-field response on imaging and evidence of out of field (abscopal) response. | Documentation of efficacy using CT imaging at 1 and 3 months post radiotherapy. | 4 months | 
| The number of ESAS questionnaires completed with the aid of a caregiver | Gather information on the efficacy collecting PRO's via in person or phone using questionnaires | 1 year | 
| biomarkers analyses as an indicator of abscopal response | Optional for consenting patients, done at 1 and 3 months post radiotherapy. | 4 months | 
| The number of EQ5D questionnaires completed with the aid of a caregive | Gather information on the efficacy collecting PRO's via in person or phone using questionnaires | 1 year |