Triple Negative Breast CancerPhase 2INTROSPECTIONNCT06976021
Immune PET and Proteomics for the Assessment of Response to Spatially Fractionated or Palliative Radiotherapy With or Without Immunotherapy
A Phase 2 study testing Baseline 89-Zr Pembrolizumab Immuno PET-CT, Proteomic assay and Follow-up 89-Zr Pembrolizumab Immuno PET-CT in people with Triple Negative Breast Cancer and Uterine Cervical Cancer, run by Maria Sklodowska-Curie National Research Institute of Oncology.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Triple Negative Breast Cancer, Uterine Cervical Cancer, Uterine Corpus Cancer
- What is being tested?
- Baseline 89-Zr Pembrolizumab Immuno PET-CT, Proteomic assay and Follow-up 89-Zr Pembrolizumab Immuno PET-CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jun 2025to Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed diagnosis of clear cell renal cell carcinoma, melanoma, cervical cancer, endometrial cancer or triple negative breast cancer.
- 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
- General condition according to Karnofsky scale: 60-100
- 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)
- The tumor may be assessed using iRECIST
- Age over 18 years
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- Granted written, informed consent to participate in the research experiment
- No contraindications to treatment with Pembrolizumab (according to the information provided in the product characteristics).
- Expected survival time over 6 months.
Who cannot join
- Lack of consent to participate in the experiment
- Contraindications to Pembrolizumab according to the product characteristics
- Pregnancy and lactation
- Inability of the patient to cooperate, including claustrophobia that prevents imaging tests from being performed as planned.
- 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.
- Condition after organ transplantation
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Immune PET and Proteomics for the Assessment of Response to Spatially Fractionated or Palliative Radiotherapy With or Without Immunotherapy Ocena Efektu immunomodulującego Radioterapii Paliatywnej, w Tym Radioterapii z Przestrzennym zróżnicowaniem Dawki, Podanej Samodzielnie Lub z immunoterapią, u Chorych którzy Wyczerpali możliwość Leczenia Systemowego i Radioterapii Radykalnej, Przy Wykorzystaniu Immuno-PET i badań Proteomicznych
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.
- Conditions
- Triple Negative Breast Cancer, Uterine Cervical Cancer, Uterine Corpus Cancer, Malignant Melanoma, Clear Cell Renal Cell Carcinoma
- Being tested
- Baseline 89-Zr Pembrolizumab Immuno PET-CT, Proteomic assay, Follow-up 89-Zr Pembrolizumab Immuno PET-CT
- Keywords
- spatially fractionated radiotherapy, immunotherapy, immuno-PET, proteomics, signaling pathways
- Medical subject headings
- Triple Negative Breast Neoplasms, Uterine Cervical Neoplasms, Melanoma, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baseline 89-Zr Pembrolizumab Immuno PET-CTDiagnostic test
Diagnostic imaging with novel radiotracer - drug (Pembrolizumab) labeled with zirconium-89
Proteomic assayDiagnostic test
Assessment of the proteomic profile before and periodically after treatment
Follow-up 89-Zr Pembrolizumab Immuno PET-CTDiagnostic test
Diagnostic imaging with novel radiotracer - drug (Pembrolizumab) labeled with zirconium-89 after radiotherapy performed in patients who are not treated with immunotherapy
| Study group | Role | What they receive |
|---|---|---|
| SFRT with immunotherapy | Experimental | Not described Receives: Diagnostic Test: Baseline 89-Zr Pembrolizumab Immuno PET-CT; Diagnostic Test: Proteomic assay |
| SHORT with immunotherapy | Active comparator | Not described Receives: Diagnostic Test: Baseline 89-Zr Pembrolizumab Immuno PET-CT; Diagnostic Test: Proteomic assay |
| SFRT | Experimental | Not described Receives: Diagnostic Test: Baseline 89-Zr Pembrolizumab Immuno PET-CT; Diagnostic Test: Proteomic assay; Diagnostic Test: Follow-up 89-Zr Pembrolizumab Immuno PET-CT |
| SHORT | Active comparator | Not described Receives: Diagnostic Test: Baseline 89-Zr Pembrolizumab Immuno PET-CT; Diagnostic Test: Proteomic assay; Diagnostic Test: Follow-up 89-Zr Pembrolizumab Immuno PET-CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in expression of PD-1 receptors expressed as a ratio of SUV values
The expression of PD-1 receptors will be measured with Immuno-PET basing on Zr-89 labeled Pembrolizumab and expressed as the ratio of initial and post-treatment SUV
Measured: one year
Change in number of areas with PD-1 receptors expressed as number of lesions
The localization of regions expressing PD-1 receptors will be identified with Immuno-PET basing on Zr-89 labeled Pembrolizumab and expressed as the number of lesions
Measured: one year
Change of proteome expression profile after treatment expressed in NPX (Normalized Protein eXpression) values
The difference between proteome expression profile before treatment and after the last infusion of Pembrolizumab or after a year in arms without immunotherapy. The Proximity Extension Assay (PEA) technology will be used. Following sequencing, the raw data will be converted to counts, assigning an integer value to each assay-sample combination based on the detected copy numbers. These raw data counts will be converted into NPX values, enabling the identification of protein level changes within different sample sets, and establishing protein signatures.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study startJun 2025 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sławomir Blamek, MD, PhD, MBA, Principal investigator, Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06976021
- Sponsor's protocol ID
- 23/ABM/01/00078
- Acronym
- INTROSPECTION
- Status last verified
- Apr 2025
- First submitted
- 27 Apr 2025
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual patient data can be shared upon request. The basic demographic data, type of intervention and outcome measures will be available.
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune PET and Proteomics for the Assessment of Response to Spatially Fractionated or Palliative Radiotherapy With or Without Immunotherapy Ocena Efektu immunomodulującego Radioterapii Paliatywnej, w Tym Radioterapii z Przestrzennym zróżnicowaniem Dawki, Podanej Samodzielnie Lub z immunoterapią, u Chorych którzy Wyczerpali możliwość Leczenia Systemowego i Radioterapii Radykalnej, Przy Wykorzystaniu Immuno-PET i badań Proteomicznych
- ClinicalTrials.gov ID
- NCT06976021
- Acronym / sponsor ID
- INTROSPECTION / 23/ABM/01/00078
- Conditions
- Triple Negative Breast Cancer, Uterine Cervical Cancer, Uterine Corpus Cancer, Malignant Melanoma, Clear Cell Renal Cell Carcinoma
- Keywords
- spatially fractionated radiotherapy, immunotherapy, immuno-PET, proteomics, signaling pathways
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of OncologyUniversity, hospital or other
- Study start
- Jun 2025 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SFRT with immunotherapy | Experimental | Diagnostic Test: Baseline 89-Zr Pembrolizumab Immuno PET-CT, Diagnostic Test: Proteomic assay |
| SHORT with immunotherapy | Active comparator | Diagnostic Test: Baseline 89-Zr Pembrolizumab Immuno PET-CT, Diagnostic Test: Proteomic assay |
| SFRT | Experimental | Diagnostic Test: Baseline 89-Zr Pembrolizumab Immuno PET-CT, Diagnostic Test: Proteomic assay, Diagnostic Test: Follow-up 89-Zr Pembrolizumab Immuno PET-CT |
| SHORT | Active comparator | Diagnostic Test: Baseline 89-Zr Pembrolizumab Immuno PET-CT, Diagnostic Test: Proteomic assay, Diagnostic Test: Follow-up 89-Zr Pembrolizumab Immuno PET-CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Pathologically confirmed diagnosis of clear cell renal cell carcinoma, melanoma, cervical cancer, endometrial cancer or triple negative breast cancer.
- 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
- General condition according to Karnofsky scale: 60-100
- 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)
- The tumor may be assessed using iRECIST
Key exclusion criteria (6 listed)
- Lack of consent to participate in the experiment
- Contraindications to Pembrolizumab according to the product characteristics
- Pregnancy and lactation
- Inability of the patient to cooperate, including claustrophobia that prevents imaging tests from being performed as planned.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baseline 89-Zr Pembrolizumab Immuno PET-CTDiagnostic imaging with novel radiotracer - drug (Pembrolizumab) labeled with zirconium-89 | Diagnostic test | SFRT, SFRT with immunotherapy, SHORT, SHORT with immunotherapy |
| Proteomic assayAssessment of the proteomic profile before and periodically after treatment | Diagnostic test | SFRT, SFRT with immunotherapy, SHORT, SHORT with immunotherapy |
| Follow-up 89-Zr Pembrolizumab Immuno PET-CTDiagnostic imaging with novel radiotracer - drug (Pembrolizumab) labeled with zirconium-89 after radiotherapy performed in patients who are not treated with immunotherapy | Diagnostic test | SFRT, SHORT |
Primary outcome
Change in expression of PD-1 receptors expressed as a ratio of SUV values
Time frame: one year
The expression of PD-1 receptors will be measured with Immuno-PET basing on Zr-89 labeled Pembrolizumab and expressed as the ratio of initial and post-treatment SUV
Change in number of areas with PD-1 receptors expressed as number of lesions
Time frame: one year
The localization of regions expressing PD-1 receptors will be identified with Immuno-PET basing on Zr-89 labeled Pembrolizumab and expressed as the number of lesions
Change of proteome expression profile after treatment expressed in NPX (Normalized Protein eXpression) values
Time frame: one year
The difference between proteome expression profile before treatment and after the last infusion of Pembrolizumab or after a year in arms without immunotherapy. The Proximity Extension Assay (PEA) technology will be used. Following sequencing, the raw data will be converted to counts, assigning an integer value to each assay-sample combination based on the detected copy numbers. These raw data counts will be converted into NPX values, enabling the identification of protein level changes within different sample sets, and establishing protein signatures.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Individual participant dataSharing planned: Yes. The individual patient data can be shared upon request. The basic demographic data, type of intervention and outcome measures will be available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sławomir Blamek, MD, PhD, MBA principal investigator
Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Baseline 89-Zr Pembrolizumab Immuno PET-CT, Proteomic assay and Follow-up 89-Zr Pembrolizumab Immuno PET-CT in people with Triple Negative Breast Cancer and Uterine Cervical Cancer, run by Maria Sklodowska-Curie National Research Institute of Oncology.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sławomir Blamek, MD, PhD, MBA (+48322788052, slawomir.blamek@gliwice.nio.gov.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in expression of PD-1 receptors expressed as a ratio of SUV values (time frame: one year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.