Lenvatinib And Stereotactic radiothErapy With pembRolizumab in Metastatic Kidney Cancer Patients
Key facts
- Where
- Kazan', Moscow, Orenburg, Saint Petersburg, Tyumen, Ufa, and Ulyanovsk, RussiaSee the 8 sites
- Phase
- Phase 2
Where in Russia
- Republican Dispensary of TatarstanKazan', RussiaTaking people
- N.N.Blokhin National Medical Research Center of OncologyMoscow, RussiaTaking people
- STOONCO clinicMoscow, RussiaTaking people
- Orenburg Regional Cancer CenterOrenburg, RussiaTaking people
- SBHI "Leningrad Regional Clinical Hospital"Saint Petersburg, RussiaTaking people
- Cancer Center "Medical City"Tyumen, RussiaTaking people
- Republican Clinical Oncology DispensaryUfa, RussiaTaking people
- "ErSpace" Radiation Therapy CenterUlyanovsk, RussiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Kidney Cancer Research Bureau
- Trial code
- NCT07928167
- Record updated
- 10 November 2026
- Original description
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.Read full original descriptionShow less
A Randomized Phase 2 Trial of Lenvatinib Plus Pembrolizumab With or Without Stereotactic Radiation Therapy in Patients With Clear-cell Metastatic Renal Cell Carcinoma, Low Tumor Burden, and Stable Disease.
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.
Inclusion: Age ≥ 18 years; Histologically confirmed clear-cell renal cell carcinoma; Presence of measurable lesions per RECIST 1.1; Sum of diameters of target lesions ≤ 7 cm; ECOG 0-2; No prior systemic therapy for metastatic disease.
Exclusion: Prior SBRT to the lesions planned for irradiation, rendering re-irradiation unsafe; Active autoimmune diseases requiring systemic immunosuppressants; Uncontrolled comorbidities that preclude the use of TKI/IO or SBRT; Symptomatic CNS metastases (patients with asymptomatic metastases may be included).