Clear-cell Metastatic Renal Cell CarcinomaPhase 2NCT05567588
Pembrolizumab Plus Radiotherapy for Advanced Renal Cancer
A Phase 2 study testing Drug: Pembrolizumab in people with Clear-cell Metastatic Renal Cell Carcinoma, run by Nanfang Hospital, Southern Medical University at 2 sites in China.
Trial summary
This study is designed as a phase-II proof of clinical trial to investigate if a treatment strategy where stereotactic body radiation therapy (SBRT) is given with pembrolizumab is sufficiently active to warrant further investigation in randomized phase II or III studies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clear-cell Metastatic Renal Cell Carcinoma
- What is being tested?
- Drug: Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 2 sitesChina
- Study dates
- 31 Oct 2022to 31 Oct 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
- Age> 18 years at the time of signing informed consent;
- ECOG score of 0 or 1;
- Histologically confirmed, advanced ccRCC of stage IV (AJCC 8);
- Life expectancy of more than 12 weeks;
- Evidence of measurable metastatic kidney cancer according to RECIST 1.1 criteria. Patients should have an adequate number of non-irradiated metastatic sites in order to adequately assess the activity of the pembrolizumab therapy;
- If central nervous system (CNS) metastases are treated before inclusion and the patient's neurological system is present Return of symptoms to baseline levels (except for signs or symptoms associated with CNS therapy)At least 14 days, such patients may be included. In addition, patients must stop taking glucocorticoids or prednisone in a stable dose and ≤ 10 mg per day;
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- Main organ function meets the following criteria within 7 days before treatment:
- blood examination criteria (in the state without blood transfusion within 14 days): ① Hemoglobin(HB) ≥ 70 g/L; ② Absolute Neutrophil Count(ANC) ≥ 1.0×109/L; ③ Platelet (PLT) ≥ 60×109/L.
- Biochemical examination shall meet the following criteria: ① total bilirubin within 1.5×the upper limit of normal(ULN); ② serum transaminase≤2.5×the Upper Limit of Normal(ULN), If associated with liver metastasis, serum transaminase≤5.0×the Upper Limit of Normal(ULN);③ serum creatine ≤ 1.5 x Upper Limit of Normal(ULN),creatinine clearance rate ≥ 60ml/min;
- Women of childbearing age should agree to use contraception (e. g. intrauterine device, contraceptive or condom) within 6 months after study completion, the pregnancy test results (serum or urine) within 7 days before enrolment must be negative;
- Men should agree that contraception must be used during and within 6 months of the end of the study period;
- With consent and have signed the informed consent, willing and able to comply with the planned visits, research treatment, laboratory tests, and other experimental procedures.
Who cannot join
- Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2;
- Any active or recently diagnosed clear or suspected autoimmune disorder disease, or symptoms requiring glucocorticoids (> 10 mg/day) or immunosuppressive drugs for systemic therapy;
- Active brain metastases and/or cancerous meningitis;
- Has had a prior monoclonal antibody within 4 weeks prior to the first dose of trial treatment or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier;
- Has more than one previous chemotherapy,targeted small molecule therapy, or radiation therapy within 2 weeks prior to the first dose of trial treatment or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent;
- Diagnosed with immunodeficiency within 2 weeks prior to study or being treated with systemic glucocorticoids or any other form of immunosuppressive therapy;
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- Have a positive history of human immunodeficiency virus (HIV) test or have acquired immunodeficiency syndrome (AIDS);
- Has known active Hepatitis B or Hepatitis C;
- Has a known additional malignancy that is progressing or requires active treatment;
- Have interstitial lung disease, active pulmonary infectious pneumonia, or grade 3 or higher pneumonia;
- Patients with mental or physical illnesses (such as infectious diseases) requiring compulsory isolation treatment;
- Has received a live vaccine within 30 days prior to the first dose of trial treatment; · · According to the investigator, there may be increased risk associated with participation in the study, or other severe, acute or chronic medical or psychiatric disorders that may interfere with the interpretation of the findings.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Guozhu,Xie
Guangzhou, Guangdong
guozhu xie, +8613242801662, xieguozhu@126.com
- Recruiting
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong
Dehua Wu, 020-62787693, 18602062748@163.com
About this study
Official title: A Phase II,Single-arm Study to Evaluate the Safety and Efficacy of Pembrolizumab and Stereotactic Radiotherapy (SBRT) in Patients Advanced Metastatic Renal Clear Cell Carcinoma.
This study is designed as a phase-II proof of clinical trial to investigate if a treatment strategy where stereotactic body radiation therapy (SBRT) is given with pembrolizumab is sufficiently active to warrant further investigation in randomized phase II or III studies. Metastatic renal cell cancer (mRCC) patients with PD-1 expressing immune cells are more likely to have larger more aggressive tumours and reduced survival. Pembrolizumab is designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. SBRT will be given to the 1-5 most clinically significant lesions after the 1nd course of pembrolizumab treatment in an effort to improve the activity of pembrolizumab.
- Being tested
- Drug: Pembrolizumab
- Keywords
- pembrolizumab, stereotactic radiotherapy
- Medical subject headings
- Clear-cell metastatic renal cell carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug: PembrolizumabCombination product
Also called Keytruda
200mg(body weight >75kg) or 100mg(body weight≤75kg) given intravenously over 30 minutes day 1 of every 3 week cycle until progression as per immune related response criteria.
| Study group | Role | What they receive |
|---|---|---|
| Pembrolizumab + RT (5 fractions, 8 Gy) + Pembrolizumab | Experimental | Pembrolizumab will be started. Stereotactic Body Radiation Therapy will be given before the 2nd course of pembrolizumab and pembrolizumab will be continued.
Pembrolizumab will continue until progression as per immune related response criteria (irRC). Receives: Combination Product: Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective response rate by immune related response criteria (irRC), and RECIST 1.1 criteria
Measured: Approximately 2 months
Secondary outcomes (3)
Overall survival
Measured: up to 24 months
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: up to 24 months
The disease control rate
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start31 Oct 2022
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clear-cell Metastatic Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- 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
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05567588
- Sponsor's protocol ID
- NFEC-2022-248
- Status last verified
- Jan 2024
- First submitted
- 2 Oct 2022
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II,Single-arm Study to Evaluate the Safety and Efficacy of Pembrolizumab and Stereotactic Radiotherapy (SBRT) in Patients Advanced Metastatic Renal Clear Cell Carcinoma.
- ClinicalTrials.gov ID
- NCT05567588
- Acronym / sponsor ID
- NFEC-2022-248
- Keywords
- pembrolizumab, stereotactic radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 31 Oct 2022 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 5 Oct 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.
This study is designed as a phase-II proof of clinical trial to investigate if a treatment strategy where stereotactic body radiation therapy (SBRT) is given with pembrolizumab is sufficiently active to warrant further investigation in randomized phase II or III studies. Metastatic renal cell cancer (mRCC) patients with PD-1 expressing immune cells are more likely to have larger more aggressive tumours and reduced survival. Pembrolizumab is designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. SBRT will be given to the 1-5 most clinically significant lesions after the 1nd course of pembrolizumab treatment in an effort to improve the activity of pembrolizumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pembrolizumab + RT (5 fractions, 8 Gy) + Pembrolizumab | Experimental | Combination Product: Drug: PembrolizumabPembrolizumab will be started. Stereotactic Body Radiation Therapy will be given before the 2nd course of pembrolizumab and pembrolizumab will be continued. Pembrolizumab will continue until progression as per immune related response criteria (irRC). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age> 18 years at the time of signing informed consent;
- ECOG score of 0 or 1;
- Histologically confirmed, advanced ccRCC of stage IV (AJCC 8);
- Life expectancy of more than 12 weeks;
- Evidence of measurable metastatic kidney cancer according to RECIST 1.1 criteria. Patients should have an adequate number of non-irradiated metastatic sites in order to adequately assess the activity of the pembrolizumab therapy;
Key exclusion criteria (12 listed)
- Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2;
- Any active or recently diagnosed clear or suspected autoimmune disorder disease, or symptoms requiring glucocorticoids (> 10 mg/day) or immunosuppressive drugs for systemic therapy;
- Active brain metastases and/or cancerous meningitis;
- Has had a prior monoclonal antibody within 4 weeks prior to the first dose of trial treatment or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier;
- Has more than one previous chemotherapy,targeted small molecule therapy, or radiation therapy within 2 weeks prior to the first dose of trial treatment or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent;
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 |
|---|---|---|
| Drug: PembrolizumabAlso: Keytruda200mg(body weight >75kg) or 100mg(body weight≤75kg) given intravenously over 30 minutes day 1 of every 3 week cycle until progression as per immune related response criteria. | Combination product | Pembrolizumab + RT (5 fractions, 8 Gy) + Pembrolizumab |
Primary outcome
ORR
Time frame: Approximately 2 months
Objective response rate by immune related response criteria (irRC), and RECIST 1.1 criteria
3 secondary outcomes
Overall survival
Time frame: up to 24 months
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: up to 24 months
The disease control rate
Time frame: up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Drug: Pembrolizumab in people with Clear-cell Metastatic Renal Cell Carcinoma, run by Nanfang Hospital, Southern Medical University at 2 sites in China.
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 12 inclusion and 12 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 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Guozhu Xie (13242801662, xieguozhu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: Approximately 2 months). 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 1 Feb 2024.