Metastatic Solid TumorPhase 2NCT05530200
PRaG Regimens Rechallenge for Patients With Resistance to PD1/PD-L1 Inhibitors in Refractory Advanced Solid Tumors.
A Phase 2 study testing Hypofractionated radiotherapy, PD-L1 inhibitor and GM-CSF in people with Metastatic Solid Tumor, run by Second Affiliated Hospital of Soochow University.
Trial summary
Finding an effective treatment to rescue with resistance of PD-1/PD-L1 inhibitor has been an urgent problem.The PRaG trial as a salvage therapy in advanced solid tumors has obtained satisfactory results.We found that patients with PD-1/PD-L1 inhibitors resistance are more likely to benefit from the PRaG regimens(PD-1… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Solid Tumor
- What is being tested?
- Hypofractionated radiotherapy, PD-L1 inhibitor and GM-CSF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Sep 2022to Jun 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Aged≥18 years;
- The patients must conform to the advanced solid cancer with multiple metastases(may be accompanied by metastasis of other organs),progression after first-line systemic therapy and have clear pathological diagnosis report;
- Disease progression after PD-1/PD-L1 therapy in the past, except for the permanent discontinuation of the drug due to immune-related toxicity of grade 3 or above;
- Enrolled patients must improve the detection of PD-L1, TMB, MSI and other immune-related indicators;
- No congestive heart failure, unstable angina pectoris, unstable arrhythmia within the past 6 months;
- Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-3, and life expectancy 3 months or more;
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- There was no history of serious hematopoietic function, abnormal heart, lung, liver, kidney function and immune deficiency;
- One week before enrollment,absolute value of T lymphocytes≥0.5 times of normal lower limit,neutrophil ≥ 1.0×109/L,AST and ALT ≤3.0 times normal upper limit(Liver cancer/liver metastasis patients ≤5.0 times normal upper limit),creatinine ≤ 3.0 times normal upper limit,serum calcium≥2.0mmol/L;
- Patients must have the ability to understand and voluntarily sign an informed consent form.
Who cannot join
- Pregnant or lactating women;
- Patients with a history of other malignant diseases in the last 2 years,except cured skin cancer and carcinoma in situ;
- Patients with a history of uncontrolled epilepsy, central nervous system diseases or mental disorders, whose clinical severity may hinder the signing of informed consent or affect the patient's compliance with drug treatment as judged by the investigator;
- Clinically significant (ie, active) heart disease, such as symptomatic coronary heart disease, congestive heart failure New York Heart Association (NYHA) Class II or greater, or severe arrhythmia requiring drug intervention, or a history of myocardial infarction within the last 12 months;
- Organ transplantation requiring immunosuppressive therapy;
- Known active infection, or significant hematological, renal, metabolic,gastrointestinal, endocrine function or metabolic disorders, or other serious uncontrolled concomitant diseases as judged by the investigator;
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- Hypersensitivity to any component of the study drug;
- History of immunodeficiency, including positive HIV test or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation, or other related diseases requiring long-term oral hormone therapy (greater than 10 mg/d prednisone);
- Patients who are in the period of acute and chronic tuberculosis infection(patients with positive T-spot test and suspicious tuberculosis lesions on chest radiography), are in the period of acute hepatitis infection or have chronic hepatitis B virus copy number higher than the normal range;
- Other conditions considered unsuitable by the investigator.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Phase II Multi-center Clinical Study of PD-1 Inhibitor Combined With Hypofractionated Radiotherapy and GM-CSF With IL-2(PRaG2.0 Regimens) Rechallenge for Patients With Resistance to PD1/PD-L1 Inhibitors in Refractory Advanced Solid Tumors.
Finding an effective treatment to rescue with resistance of PD-1/PD-L1 inhibitor has been an urgent problem.The PRaG trial as a salvage therapy in advanced solid tumors has obtained satisfactory results.We found that patients with PD-1/PD-L1 inhibitors resistance are more likely to benefit from the PRaG regimens(PD-1 inhibitors combined with radiotherapy and GM-CSF with IL-2). Further phase II clinical trial was conducted to confirm the efficacy and safety of PRaG regimen rechallenge for patients with resistance to PD1/PD-L1 inhibitors in refractory advanced solid tumors.
Read the detailed description
Patinets with PD-1/PD-L1 inhibitors resistance have limited treatment.ICIs rechallenge is one of the attractive and challenging selection strategies.The efficacy and safety of PD-1/PD-L1 inhibitor rechallenge remain unclear.PRaG regimens realize the sensitization of the efficacy of PD-1 inhibitors, broaden the anti-cancer spectrum of PD-1 immunotherapy, and achieve precise and minimally invasive tumor treatment.PRaG regimens might benefit the survival of patients with resistance to PD1/PD-L1 inhibitors in refractory advanced solid tumors.A phase II clinical study is planned to explore the efficacy and safety of PRaG regimens in advanced refractory solid malignancies after resistance of PD-1/PD-L1 therapy.
- Conditions
- Metastatic Solid Tumor
- Being tested
- Hypofractionated radiotherapy, PD-L1 inhibitor, GM-CSF, IL-2
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated radiotherapyRadiation
24Gy/8Gy/3f
PD-L1 inhibitorDrug
q3w
GM-CSFDrug
200μg, D1-D7
IL-2Drug
at a dose of 2 million IU, D8-D14
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy, PD-L1 inhibitors Sequential GM-CSF and IL-2 | Experimental | Not described Receives: Radiation: Hypofractionated radiotherapy; Drug: PD-L1 inhibitor; Drug: GM-CSF; Drug: IL-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
objective response rate
Measured: Up to 3 years
Secondary outcomes (4)
PFS
progression-free survival
Measured: Up to 3 years
DCR
CR+PR+SD(RECIST 1.1)
Measured: Up to 3 years
OS
overall survival
Measured: Up to 3 years
Treatment Related Severe Adverse Effects
Number of participants with treatment-related severe adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study startSep 2022 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Solid TumorStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Soochow University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05530200
- Sponsor's protocol ID
- JD-LK-2022-102-01
- Status last verified
- Sep 2022
- First submitted
- 3 Sep 2022
- Last updated
- 7 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Multi-center Clinical Study of PD-1 Inhibitor Combined With Hypofractionated Radiotherapy and GM-CSF With IL-2(PRaG2.0 Regimens) Rechallenge for Patients With Resistance to PD1/PD-L1 Inhibitors in Refractory Advanced Solid Tumors.
- ClinicalTrials.gov ID
- NCT05530200
- Acronym / sponsor ID
- JD-LK-2022-102-01
- Conditions
- Metastatic Solid Tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 7 Sep 2022 (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.
Finding an effective treatment to rescue with resistance of PD-1/PD-L1 inhibitor has been an urgent problem.The PRaG trial as a salvage therapy in advanced solid tumors has obtained satisfactory results.We found that patients with PD-1/PD-L1 inhibitors resistance are more likely to benefit from the PRaG regimens(PD-1 inhibitors combined with radiotherapy and GM-CSF with IL-2). Further phase II clinical trial was conducted to confirm the efficacy and safety of PRaG regimen rechallenge for patients with resistance to PD1/PD-L1 inhibitors in refractory advanced solid tumors.
Detailed description
Patinets with PD-1/PD-L1 inhibitors resistance have limited treatment.ICIs rechallenge is one of the attractive and challenging selection strategies.The efficacy and safety of PD-1/PD-L1 inhibitor rechallenge remain unclear.PRaG regimens realize the sensitization of the efficacy of PD-1 inhibitors, broaden the anti-cancer spectrum of PD-1 immunotherapy, and achieve precise and minimally invasive tumor treatment.PRaG regimens might benefit the survival of patients with resistance to PD1/PD-L1 inhibitors in refractory advanced solid tumors.A phase II clinical study is planned to explore the efficacy and safety of PRaG regimens in advanced refractory solid malignancies after resistance of PD-1/PD-L1 therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy, PD-L1 inhibitors Sequential GM-CSF and IL-2 | Experimental | Radiation: Hypofractionated radiotherapy, Drug: PD-L1 inhibitor, Drug: GM-CSF, Drug: IL-2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged≥18 years;
- The patients must conform to the advanced solid cancer with multiple metastases(may be accompanied by metastasis of other organs),progression after first-line systemic therapy and have clear pathological diagnosis report;
- Disease progression after PD-1/PD-L1 therapy in the past, except for the permanent discontinuation of the drug due to immune-related toxicity of grade 3 or above;
- Enrolled patients must improve the detection of PD-L1, TMB, MSI and other immune-related indicators;
- No congestive heart failure, unstable angina pectoris, unstable arrhythmia within the past 6 months;
Key exclusion criteria (10 listed)
- Pregnant or lactating women;
- Patients with a history of other malignant diseases in the last 2 years,except cured skin cancer and carcinoma in situ;
- Patients with a history of uncontrolled epilepsy, central nervous system diseases or mental disorders, whose clinical severity may hinder the signing of informed consent or affect the patient's compliance with drug treatment as judged by the investigator;
- Clinically significant (ie, active) heart disease, such as symptomatic coronary heart disease, congestive heart failure New York Heart Association (NYHA) Class II or greater, or severe arrhythmia requiring drug intervention, or a history of myocardial infarction within the last 12 months;
- Organ transplantation requiring immunosuppressive therapy;
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 |
|---|---|---|
| Hypofractionated radiotherapy24Gy/8Gy/3f | Radiation | Radiotherapy, PD-L1 inhibitors Sequential GM-CSF and IL-2 |
| PD-L1 inhibitorq3w | Drug | Radiotherapy, PD-L1 inhibitors Sequential GM-CSF and IL-2 |
| GM-CSF200μg, D1-D7 | Drug | Radiotherapy, PD-L1 inhibitors Sequential GM-CSF and IL-2 |
| IL-2at a dose of 2 million IU, D8-D14 | Drug | Radiotherapy, PD-L1 inhibitors Sequential GM-CSF and IL-2 |
Primary outcome
ORR
Time frame: Up to 3 years
objective response rate
4 secondary outcomes
PFS
Time frame: Up to 3 years
DCR
Time frame: Up to 3 years
OS
Time frame: Up to 3 years
Treatment Related Severe Adverse Effects
Time frame: Up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hypofractionated radiotherapy, PD-L1 inhibitor and GM-CSF in people with Metastatic Solid Tumor, run by Second Affiliated Hospital of Soochow University.
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 10 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: status not confirmed, as of the sponsor's last update on 7 Sep 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meiling Xu (+8615106203097, xumeiling1115@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: Up to 3 years). 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 7 Sep 2022.