Immune PET and Proteomics for the Assessment of Response to Spatially Fractionated or Palliative Radiotherapy With or Without Immunotherapy

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Immune PET and Proteomics for the Assessment of Response to Spatially Fractionated or Palliative Radiotherapy With or Without Immunotherapy

Study Purpose

The aim of the study is to evaluate the response to four schemes of treatment with novel diagnostic tools

- Immuno-PET and proteomics as well as standard imaging (magnetic resonsonce imaging and computed tomography).

Two fractionation schedules of radiotherapy will be used. The first will be a common standard of palliative irradiation

- 20 Gy delivered in five fractions of 4 Gy (SHORT).

The other is called Spatially Fractionated Radiotherapy (SFRT). SFRT is delivered in one fraction of 20 Gy but the dose is diversified inside the tumor to produce areas of high and low doses distributed alternately. This kind of irradiation may be able to stimulate immune response and improve the efficiency of immunotherapy. A drug belonging to the class of immunotherapeutic agents

- Pembrolizumab will be added to the treatment scheme in two arms of the study to check that assumption.

The response of the target tumor will be evaluated with PET study using Pembrolizumab labeled with zirconium-89 which will show the spatial distribution of immune receptors within the target tumor and other involved sites if there are any. The examination will be repeated after the treatment to evaluate changes in distribution of the immune receptors necessary for the drug to work. Additionally, the researchers will repeatedly test the presence and concentration of a wide panel of proteins in blood to evaluate response to the treatment more precisely.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Pathologically confirmed diagnosis of clear cell renal cell carcinoma, melanoma, cervical cancer, endometrial cancer or triple negative breast cancer. 2. Patients nnot eligible for radical treatment with radiotherapy (including stereotactic radiotherapy of the tumor in the potential planned area of irradiation in the study), chemotherapy and palliative immunotherapy in accordance with applicable national standards but who qualify for palliative radiation treatment. 3. General condition according to Karnofsky scale: 60-100. 4. Patients with tumor (index lesion) larger than 5 cm in size that can be irradiated with either SHORT or SFRT technique (presence of other tumors that may be independently treated locally is not an exclusion criterion) 5. The tumor may be assessed using iRECIST. 6. Age over 18 years. 7. Granted written, informed consent to participate in the research experiment. 8. No contraindications to treatment with Pembrolizumab (according to the information provided in the product characteristics). 9. Expected survival time over 6 months. Exclusion criteria. 1. Lack of consent to participate in the experiment. 2. Contraindications to Pembrolizumab according to the product characteristics. 3. Pregnancy and lactation. 4. Inability of the patient to cooperate, including claustrophobia that prevents imaging tests from being performed as planned. 5. Women of childbearing potential who are unwilling or unable to use an acceptable method of contraception to avoid pregnancy throughout treatment and for 5 months after its completion. 6. Condition after organ transplantation

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06976021
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Maria Sklodowska-Curie National Research Institute of Oncology
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Sławomir Blamek, MD, PhD, MBA
Principal Investigator Affiliation	Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Triple Negative Breast Cancer, Uterine Cervical Cancer, Uterine Corpus Cancer, Malignant Melanoma, Clear Cell Renal Cell Carcinoma

Arms & Interventions

Arms

Experimental: SFRT with immunotherapy

Active Comparator: SHORT with immunotherapy

Experimental: SFRT

Active Comparator: SHORT

Interventions

Diagnostic Test: - Baseline 89-Zr Pembrolizumab Immuno PET-CT

Diagnostic imaging with novel radiotracer - drug (Pembrolizumab) labeled with zirconium-89

Diagnostic Test: - Proteomic assay

Assessment of the proteomic profile before and periodically after treatment

Diagnostic Test: - Follow-up 89-Zr Pembrolizumab Immuno PET-CT

Diagnostic imaging with novel radiotracer - drug (Pembrolizumab) labeled with zirconium-89 after radiotherapy performed in patients who are not treated with immunotherapy