Renal Cell CarcinomaPhase 2MoonlandingNCT07593040
Pembrolizumab Plus Belzutifan With or Without Lenvatinib in Localized Renal Cell Carcinoma
A Phase 2 study testing Neoadjuvant Pembrolizumab, Belzutifan and Lenvatinb in people with Renal Cell Carcinoma, run by Vall d'Hebron Institute of Oncology at 14 sites in Spain.
Trial summary
This study is designed to evaluate the efficacy of belzutifan in combination with pembrolizumab with or without lenvatinib in the neoadjuvant setting, followed by adjuvant pembrolizumab versus adjuvant pembrolizumab alone, as treatment for participants with intermediate-high and high risk clear cell renal cell… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- Neoadjuvant Pembrolizumab, Belzutifan and Lenvatinb
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 14 sitesSpain
- Study dates
- Jun 2026to Jun 2031
- 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
- Male/female participants who are at least 18 years of age on the day of signing informed consent.
- 2. Willing to provide written informed consent. They may also provide consent for Future Biomedical Research; however, the participant may participate in the main trial without participating in the Future Biomedical Research.
- 3. Histologically confirmed diagnosis of RCC with a clear cell component with or without sarcomatoid features. Diagnosis is to be made by the investigator and does not require central histology review.
- 4. Tumours must be T2 with grade 4, T3, T4, or any T with N1, M0 on radiographic imaging using TNM staging (8th edition)
- T2 is defined as a tumour >7cm but limited to the kidney; grade 4 is per the International Society of Urological Pathology (ISUP) grading.
- T3 is defined as tumour extension into major veins or perinephric tissues, but not into ipsilateral adrenal gland or beyond Gerota's fascia.
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- T4 is defined as a tumour involving the ipsilateral adrenal gland or invading beyond Gerota's fascia.
- N1 is defined as metastatic involvement of regional lymph nodes. 5. Archival tumour tissue sample or newly obtained core, incisional, or excisional biopsy of a tumour lesion not previously irradiated has been provided. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue.
- 6. Have an Eastern Cooperation Oncology Group (ECOG) Performance Status of 0 to 1.
- Evaluation of ECOG is to be performed within 14 days prior to the first dose of study intervention.
- 7. Have been considered suitable for curative intent surgery (partial or total nephrectomy), as evaluated by a surgeon. 8. Have adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤150/90 mm Hg.
- 9. Have adequate organ function as defined in the following table (Table 7). Specimens must be collected within 14 days prior to the start of study intervention.
- 10.Participants agree to the contraception guidelines outlined in section 5.1.3.2.
- 11.Participants who are HBsAg positive are eligible if they have received hepatitis B virus (HBV) anti-viral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization.
- Note: Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention.
- Hepatitis B screening tests are not required unless:
- Known history of HBV infection As mandated by local health authority 12.Participants with a history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening.
- Note: Participants must have completed curative anti-viral therapy at least 4 weeks prior to randomization.
- Hepatitis C screening tests are not required unless:
- Known history of HCV infection As mandated by local health authority 13.HIV-infected participants must have well-controlled HIV on antiretroviral therapy (ART), defined as:
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- Participants on ART must have a CD4+ T-cell count ≥350 cells/mm3 at the time of screening.
- Participants on ART must have achieved and maintained virologic suppression defined as confirmed HIV RNA level below 50 or the lower limit of quantification (LLOQ) (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks before screening
- It is advised that participants must not have had any AIDS-defining opportunistic infections within the past 12 months.
- Participants on ART must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks before study entry (Day 1) and agree to continue ART throughout the stud
Who cannot join
- 1. Has evidence of metastatic disease on screening imaging. 2. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137).
- 3. Has received prior systemic anti-cancer therapy including investigational agents within 3 years prior to randomization.
- 4. Known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded.
- Participants with low-risk early-stage prostate cancer either treated with definitive intent or untreated in active surveillance with stable disease are not excluded.
- 5. Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed. COVID-19 and influenza vaccinations are allowed provided they are not live vaccines 6. Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
- 7. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug 8. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients, and/or lenvatinib, and/or belzutifan.
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- 9. Has active autoimmune disease that has required immunosuppressive systemic treatment in the past 2 years except replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid).
- 10.Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease11.Has any of the following:
- A pulse oximeter reading <92% at rest, or
- Requires intermittent supplemental oxygen, or
- Requires chronic supplemental oxygen. 12.Has an active infection requiring systemic intravenous therapy. 13.Has moderate to severe hepatic impairment (Child-Pugh B or C). 14.Concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV DNA) and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection.
- Note: Hepatitis B and C screening tests are not required unless:
- Known history of HBV and HCV infection
- As mandated by local health authority
- 15.Has urine protein ≥1 g/24 hours.
- Note: Participants with proteinuria ≥2+ (≥100 mg/dL) on urine dipstick testing (urinalysis) will undergo 24-hour urine collection for quantitative assessment of proteinuria.
- Note: Urine dipstick is the preferred method for testing urinary protein, however, urinalysis may be used if the use of urine dipsticks is not feasible.
- 16.Has had major surgery within 3 weeks prior to first dose of study interventions.
- Note: Adequate wound healing after major surgery must be assessed clinically, independent of time elapsed for eligibility 17.Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.
- 18.Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- 19.Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.
- 20.Has had an allogenic tissue/solid organ transplant. 21.Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula22.Has a left ventricular ejection fraction (LVEF) below the institutional (or local laboratory) normal range, as determined by multigated acquisition (MUGA) or echocardiogram (ECHO).
- 23.Prolongation of QTcF interval to >480 ms. 24.Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability. Note: Medically controlled arrhythmia would be permitted.
- 25.Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug.
- 26.Gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib 27.Is currently receiving either strong (phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort)
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
Spain14 sites
Hospital Universitari Vall D Hebron
Barcelona, Catalonia, 08035
Cristina Suárez, Dr, +34 932543450, csuarez@vhio.net
Cristina Suárez, Dr
Hospital Clinic De Barcelona
Barcelona, Catalonia, 08036
Oscar Reig, Dr, +34 932275402, oreig@clinic.cat
Oscar Reig, Dr
Hospital Universitario Reina Sofia
Córdoba, Andalusia, 14004
Mª José Méndez, Dr, +34 957010380, mjosemv@yahoo.es
Mª José Méndez, Dr
Institut Catala D'oncologia
L'Hospitalet de Llobregat, Catalonia, 08908
Mayra Lizbeth Orrillo, Dr, +34 932607136, mayralizbethorrillo@iconcologia.net
Mayra Lizbeth Orrillo, Dr
Hospital Universitario Lucus Augusti
Lugo, Galicia, 27003
Sergio Vazquez, Dr, +34 982296459, Sergio.Vazquez.Estevez@sergas.es
Sergio Vazquez, Dr
Hospital Universitario Ramon Y Cajal
Madrid, Madrid, 28034
Javier Molina, Dr, +34 913368897, javier.molinace@gmail.com
Javier Molina, Dr
Hospital Universitario 12 De Octubre
Madrid, Madrid, 28041
Guillermo de Velasco, Dr, +34 913908547, gdvelasco.gdv@gmail.com
Guillermo de Velasco, Dr
Complejo Hospitalario Universitario De Ourense
Ourense, Galicia, 32005
Ovidio Fernandez, Dr, +34 986217450, ovidiofernandezcalvo@yahoo.es
Ovidio Fernandez, Dr
Hospital Universitario Central De Asturias
Oviedo, Principality of Asturias, 33011
Carlos Alvarez, Dr, +34 985108000, carlos.alvfer@gmail.com
Carlos Alvarez, Dr
Hospital Universitario De Navarra
Pamplona, Navarre, 31008
Nuria Lainez, Dr, +34 848422222, Nuria.lainez.milagro@cfnavarra.es
Nuria Lainez, Dr
Parc Tauli Hospital Universitari
Sabadell, Catalonia, 08208
Enrique Gallardo, Dr, +34 937240084, egallardo@tauli.cat
Enrique Gallardo, Dr
Hospital Universitario Marques De Valdecilla
Santander, Cantabria, 39008
Ignacio Durán, Dr, +34 942315515, ignaciojose.duran@scsalud.es
Ignacio Durán, Dr
Hospital Universitario Y Politecnico La Fe
Valencia, Valencia, 46026
Regina Girones, Dr, +34 961244674, girones_reg@gva.es
Regina Girones, Dr.
Hospital Clinico Universitario Lozano Blesa
Zaragoza, Aragon, 50009
Julio Lambea, Dr, +34 976765769, juliolambea@yahoo.es
Julio Lambea, Dr
About this study
Official title: A Randomized Phase 2 Trial of Neoadjuvant Pembrolizumab Plus Belzutifan With or Without Lenvatinib in Patients With Localized Renal Cell Carcinoma
This study is designed to evaluate the efficacy of belzutifan in combination with pembrolizumab with or without lenvatinib in the neoadjuvant setting, followed by adjuvant pembrolizumab versus adjuvant pembrolizumab alone, as treatment for participants with intermediate-high and high risk clear cell renal cell carcinoma (ccRCC).
- Conditions
- Renal Cell Carcinoma
- Being tested
- Neoadjuvant Pembrolizumab, Belzutifan, Lenvatinb
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant PembrolizumabDrug
400mg q6w of Pembrolizumab will be administered before nephrectomy in cohorts A and B
BelzutifanDrug
120mg daily for 12w of Belzutifan will be administered before nephrectomy in Cohorts A and B
LenvatinbDrug
20mg daily for 12 weeks of lenvatinib will be administered before nephrectomy in Cohort A
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | Neoadjuvant therapy with Pembrolizumab (400mg q6w) + Lenvatinib (20mg daily for 12w) + Belzutifan (120mg daily for 12w). Followed by nephrectomy and pembrolizumab (400mg q6w for 9 months) Receives: Drug: Neoadjuvant Pembrolizumab; Drug: Belzutifan; Drug: Lenvatinb |
| Cohort B | Experimental | Neoadjuvant therapy with Pembrolizumab (400mg q6w) + Belzutifan (120mg daily for 12w). Followed by nephrectomy and pembrolizumab (400mg q6w for 9 months) Receives: Drug: Neoadjuvant Pembrolizumab; Drug: Belzutifan |
| Cohort C | Active comparator | Nephrectomy folloewd by pembrolizumab (400mg q6w for 12 months) Receives: Drug: Neoadjuvant Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate
Radiographic response defined as a decrease of initial tumour size ≥30% from baseline to week 12 CT scan
Measured: At 12 weeks from start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study startJun 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies 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
- Randomised
- Intervention model
- Crossover
- Model description
- This study is a randomized, multi-arm, open label design to evaluate the efficacy of belzutifan in combination with pembrolizumab with or without lenvatinib in the neoadjuvant setting, followed by adjuvant pembrolizumab versus adjuvant pembrolizumab alone, as treatment for participants with intermediate-high and high risk clear cell renal cell carcinoma (ccRCC), defined as T2 with grade 4, T3, T4, or TxN1, M0 disease
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vall d'Hebron Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cristina Suárez, Dr, Principal investigator, Hospital Vall d'Hebron
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07593040
- Sponsor's protocol ID
- VHIO24002
- Other IDs
- 2024-519673-18-00
- Acronym
- Moonlanding
- Status last verified
- Nov 2025
- First submitted
- 11 May 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase 2 Trial of Neoadjuvant Pembrolizumab Plus Belzutifan With or Without Lenvatinib in Patients With Localized Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07593040
- Acronym / sponsor ID
- Moonlanding / VHIO24002
- Conditions
- Renal Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Vall d'Hebron Institute of OncologyUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jun 2031 (estimated)
- First posted
- 18 May 2026 (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 to evaluate the efficacy of belzutifan in combination with pembrolizumab with or without lenvatinib in the neoadjuvant setting, followed by adjuvant pembrolizumab versus adjuvant pembrolizumab alone, as treatment for participants with intermediate-high and high risk clear cell renal cell carcinoma (ccRCC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This study is a randomized, multi-arm, open label design to evaluate the efficacy of belzutifan in combination with pembrolizumab with or without lenvatinib in the neoadjuvant setting, followed by adjuvant pembrolizumab versus adjuvant pembrolizumab alone, as treatment for participants with intermediate-high and high risk clear cell renal cell carcinoma (ccRCC), defined as T2 with grade 4, T3, T4, or TxN1, M0 disease
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Drug: Neoadjuvant Pembrolizumab, Drug: Belzutifan, Drug: LenvatinbNeoadjuvant therapy with Pembrolizumab (400mg q6w) + Lenvatinib (20mg daily for 12w) + Belzutifan (120mg daily for 12w). Followed by nephrectomy and pembrolizumab (400mg q6w for 9 months) |
| Cohort B | Experimental | Drug: Neoadjuvant Pembrolizumab, Drug: BelzutifanNeoadjuvant therapy with Pembrolizumab (400mg q6w) + Belzutifan (120mg daily for 12w). Followed by nephrectomy and pembrolizumab (400mg q6w for 9 months) |
| Cohort C | Active comparator | Drug: Neoadjuvant PembrolizumabNephrectomy folloewd by pembrolizumab (400mg q6w for 12 months) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Male/female participants who are at least 18 years of age on the day of signing informed consent.
- 2. Willing to provide written informed consent. They may also provide consent for Future Biomedical Research; however, the participant may participate in the main trial without participating in the Future Biomedical Research.
- 3. Histologically confirmed diagnosis of RCC with a clear cell component with or without sarcomatoid features. Diagnosis is to be made by the investigator and does not require central histology review.
- 4. Tumours must be T2 with grade 4, T3, T4, or any T with N1, M0 on radiographic imaging using TNM staging (8th edition)
- 6. Have an Eastern Cooperation Oncology Group (ECOG) Performance Status of 0 to 1.
Key exclusion criteria (25 listed)
- 1. Has evidence of metastatic disease on screening imaging. 2. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137).
- 3. Has received prior systemic anti-cancer therapy including investigational agents within 3 years prior to randomization.
- 4. Known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded.
- Participants with low-risk early-stage prostate cancer either treated with definitive intent or untreated in active surveillance with stable disease are not excluded.
- 5. Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed. COVID-19 and influenza vaccinations are allowed provided they are not live vaccines 6. Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
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 |
|---|---|---|
| Neoadjuvant Pembrolizumab400mg q6w of Pembrolizumab will be administered before nephrectomy in cohorts A and B | Drug | Cohort A, Cohort B, Cohort C |
| Belzutifan120mg daily for 12w of Belzutifan will be administered before nephrectomy in Cohorts A and B | Drug | Cohort A, Cohort B |
| Lenvatinb20mg daily for 12 weeks of lenvatinib will be administered before nephrectomy in Cohort A | Drug | Cohort A |
Primary outcome
Response Rate
Time frame: At 12 weeks from start of treatment
Radiographic response defined as a decrease of initial tumour size ≥30% from baseline to week 12 CT scan
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 20 May 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Renal Cell Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
Nonmetastatic Locally Advanced Non-Clear Cell Renal Cell Carcinoma
Not yet recruitingPhase 2
Pucotenlimab, Lenvatinib, and SBRT Before Surgery for Localized Clear Cell Renal Cell Carcinoma
Localized Clear Cell Renal Cell Carcinoma
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.
Cristina Suárez, Dr principal investigator
Hospital Vall d'Hebron
14 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 Neoadjuvant Pembrolizumab, Belzutifan and Lenvatinb in people with Renal Cell Carcinoma, run by Vall d'Hebron Institute of Oncology at 14 sites in Spain.
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 25 inclusion and 25 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 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Spain. 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?
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 Cristina Suárez, Dr (+34 932543450, csuarez@vhio.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response Rate (time frame: At 12 weeks from start of treatment). 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 20 May 2026.