A Phase 2 interventional study of Lenvatinib and Pembrolizumab in Metastatic Renal Cell Carcinoma ( mRCC), sponsored by Kidney Cancer Research Bureau. Recruiting at 8 sites in Russia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Kidney Cancer Research Bureau · Phase 2, Interventional, and Treatment
Metastatic clear-cell renal cell carcinoma (ccRCC) is sensitive to therapy with lenvatinib and pembrolizumab. The CLEAR trial demonstrated positive outcomes even in patients with a low tumor burden. In a subset of patients with metastatic ccRCC, the presence of a low tumor burden suggests that incorporating stereotactic body radiotherapy (SBRT) into systemic therapy could be a strategy to enhance the anti-tumor response, while maintaining an acceptable toxicity profile. This study evaluates the contribution of SBRT in a subgroup of patients who have achieved stable disease while receiving lenvatinib and pembrolizumab.
Metastatic clear cell renal cell carcinoma (mRCC) is sensitive to combination of lenvatinib and pembrolizumab. The CLEAR study showed positive results in patients with low tumor burden. However, around 20% of patients do not respond and have stable disease. In the VOLGA study, we demonstrated better outcomes in patients with irradiation of even a single lesion during targeted therapy. Thus, investigators hypothesize that stereotactic radiotherapy (SBRT) to multiple lesions in patients undergoing ongoing therapy with pembrolizumab and lenvatinib will increase the objective response rate, which may correlate with improved overall survival.
LASER is a randomized multicenter phase 2 study. Initially, all patients with histologically confirmed mRCC, the median sum of the diameters of target lesions ≥ 7 cm, ECOG 0-2, and the absence of prior systemic therapy for metastatic disease will receive a 12-week induction with lenvatinib and pembrolizumab, followed by radiological assessment according to RECIST 1.1 and allocation by outcome (response, stable disease, or disease progression). Patients with stable disease (SD) will be randomized in a 1:1 ratio into two groups: 1) lenvatinib + pembrolizumab + SBRT (N=27) or 2) lenvatinib + pembrolizumab alone (N=27). In the SBRT group, the choice of target for irradiation - up to 3 (three) lesions - is determined by a multidisciplinary team. The primary endpoint is the objective response rate (ORR) of unirradiated lesions after randomization among patients with stable disease (assessed every 12 weeks according to RECIST 1.1). The statistical hypothesis is based on an expected ORR of 15% in the control group versus 50% in the SBRT group. A two-sided α of 0.05 and a power of 80% require 27 patients in each group (54 randomized). The total enrollment will be 150 patients.
2,037 studies on the registry are indexed under Carcinoma, Renal Cell; 395 are open to participants now.
This study's planned enrollment of 150 is above the median of 43 across 1,564 interventional studies indexed under Carcinoma, Renal Cell.
Browse Carcinoma, Renal Cell studies →Kidney Cancer Research Bureau is the lead sponsor of 14 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Lenvatinib · Drug: Pembrolizumab · Radiation: Stereotactic Body Radiation Therapy (SBRT)
Drug: Lenvatinib · Drug: Pembrolizumab
20 mg orally once daily.
200 mg intravenously every 3 weeks
The dosage regimen is determined by a radiation oncologist and depends on the location of the lesion.
Number of Participants with Response of unirradiated lesions according to RECIST v1.1
Objective response rate (ORR) of unirradiated lesions after randomization among patients with stable disease
Time frame: Percentage of patients with response at week 12
Median progression-free survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.
Median overall survival
Time frame: From date of randomization until the date of death from any cause, whichever came first, assessed up to 60 months.
Median duration of response
Time frame: From the first response to the date of disease progression or death for any reason, whichever came first, assessed up to 36 months.
Rate of local control of irradiated lesions
Time frame: Percentage of stable irradiated lesions at week 12
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Time frame: Rate of treatment-related adverse events at week 24
Plan to share: No — In accordance with local legislation
Started Aug 2025 (actual). Primary completion is estimated for Jan 2027, 16 months after the start.
Of 183 non-industry phase 2 interventional studies under Carcinoma, Renal Cell, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 41 and three quarters within 98. This study's planned 16 months is below that.
Counting every sponsor, half of 230 studies reached it within 58 months; a quarter within 33 and three quarters within 94.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Kidney Cancer Research Bureau