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CompletedNCT03066427INMUNOSUNUpdated Nov 13, 2020

Study to Evaluate Efficacy and Safety of Sunitinib in Renal Cell Carcinoma Progressed to 1L Immunotherapy Treatment.

A Phase 2 interventional study of Sunitinib in Clear Cell Renal Carcinoma, sponsored by Spanish Oncology Genito-Urinary Group. Completed at 9 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-13.

Sponsored by Spanish Oncology Genito-Urinary Group · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
23
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The therapeutic scenario of metastatic renal cancer is undergoing a new revolution with the appearance of a novel therapeutic strategy after the antiangiogenic treatments, that is the immunotherapy, in addition to the approval of new active drugs in the following lines of treatment.

There are currently two phase III trials in the first line of treatment in metastatic renal cancer that include different combinations of treatment based on immunotherapy. If results of these studies were positive, the therapeutic algorithm would be modified so that the remaining drugs would have to be repositioned within the therapeutic decision scheme.

Sunitinib has previously demonstrated its benefit in patients who had failed to prior treatment with cytokines, so it is likely to continue to be effective in patients who have become resistant to treatment with new drugs based on immune checkpoint blockade.

This phase II study is developed to evaluate the activity of sunitinib after treatment with immunotherapy-based regimens that are currently being developed within phase III clinical trials.

02

Conditions studied

  • Clear Cell Renal Carcinoma

Keywords

  • Clear Cell Renal Carcinoma
  • Sunitinib
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 23 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Spanish Oncology Genito-Urinary Group is the lead sponsor of 30 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

    1. Eighteen years or older on the day of consent
    1. Documented histological or cytological diagnosis of renal cell cancer with a clear-cell component.
    1. Patient must have progressed to at least one immune check point inhibitor-based therapy (antiPD1, anti-PDL1 o antiCTLA4) for the first line
    1. Measurable disease per RECIST 1.1 as determined by the investigator
    1. The subjects should not present disease that may be subsidiary of surgical treatment, radiotherapy or combined treatment with curative intent.
    1. Recovery of toxicities related to any prior treatments to ≤ Grade 1 CTCAE v.4.03, unless adverse event(s) are clinically nonsignificant and/or stable on supportive therapy.
    1. Eastern Cooperative Oncology Group Performance Status (PS) 0-2
    1. Adequately controlled blood pressure (BP) with or without antihypertensive medication to maintain a BP \<150/90 mmHg before the start of study treatment.
    1. Adequate marrow function

      • Absolute neutrophil count (ANC) ≥ 1500/mm3 (≥ 1.5 GI/L).
      • Platelets ≥ 100,000/mm3 (≥ 100 GI/L).
      • Hemoglobin ≥ 9 g/dL (≥ 5,6 mmol/L).
    1. Adequate liver function

      • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2.5 × ULN.
      • Total bilirubin ≤ 1.5 × upper limit of normal (ULN).
    1. Adequate kidney function: calculated creatinine clearance ≥ 30 mL/min (≥ 0.5 mL/sec) using the Cockroft-Gault equation
    1. Proteinuria \<2+ on urine test strip
    1. Prothrombin Time (PT) or International Standard Ratio (INR) ≤ 1.2 x ULN.
    1. Life expectancy >3 months.
    1. Patient able to ingest study drug and meet study follow-up requirements.
    1. Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception
    1. Female subjects of childbearing potential must not be pregnant at screening.

Exclusion criteria

Exclusion Criteria:

    1. Previous treatments with sunitinib are not permitted for the advanced or localized disease.
    1. Major surgery within 3 weeks of patient inclusion
    1. Radiation therapy or embolization within 2 weeks of first dose of sunitinib
    1. Previous treatment with immunosuppressive drugs such as cyclosporine, tacrolimus, azathioprine, or long-term oral glucocorticoids taken prior to (3 months) patient inclusion
    1. Prior high-dose chemotherapy requiring hematopoietic stem cell rescue.
    1. Current treatment on another clinical trial.
    1. Treatment with known potent CYP3A4 inhibitors or inducers or that prolong the QT interval, within 7 days prior to the inclusion.
    1. Prior radiation therapy to >25% of the bone marrow.
    1. Uncontrolled brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease.
    1. Any gastrointestinal malabsorption disorder or any other condition that, in the opinion of the investigator, may affect the absorption of sunitinib or increase the risk of bleeding or perforation.
    1. Presence of an unhealed wound or active ulcer.
    1. Diarrhea grade III/IV in the screening period.
    1. Diagnosis of any second malignancy within the last 3 years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.
    1. Clinically significant cardio-cerebrovascular disease within 6 months prior to initiation of treatment.
    1. Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥2, atrial fibrillation of any grade that require treatment.
    1. Corrected QT interval (QTc) interval >500 msec.
    1. Active hemoptysis within 6 weeks prior to initiation of study treatment.
    1. Evidence of active bleeding or hemorrhagic diathesis.
    1. Presence of endobronchial lesions and / or lesions that infiltrate large vessels.
    1. Current treatment with therapeutic doses of Coumadin (low dose Coumadin up to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed).
    1. Other clinically significant alterations:

      • Known human immunodeficiency virus (HIV) infection.
      • Presence of an uncontrolled active infection.
      • Presence of uncontrolled or symptomatic hypothyroidism.
      • Moderate-severe liver disease (Child Pugh B-C).
      • Requirement for hemodialysis or peritoneal dialysis.
      • History of solid organ transplantation.
    1. Pregnancy or breastfeeding.
    1. Any disease that, in the opinion of the investigator, interferes with the patient's ability to participate in the clinical trial.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
23 participants (actual)

Study arms

  • Experimental
    Sunitinib

    Sunitinib 50 mg/day, 4 weeks on/2weeks off

    Drug: Sunitinib

Interventions

  • DrugSunitinib

    Sunitinib 50 mg/d

    Also known as: Sutent

06

What researchers measure

Primary outcomes

  1. Objective response rate

    Percentage of patients with documented response according RECIST 1.1 criteria (complete response + partial response)

    Time frame: 12 months

Secondary outcomes

  1. Progression-free survival

    Time from start of treatment to disease progression or death.

    Time frame: 12 months

  2. Time to progression

    Time from start of treatment to disease progression or death due to the illness

    Time frame: 12 months

  3. Duration of the response

    Time from first response to disease progression or death.

    Time frame: 12 months

  4. Overall survival

    Time from start of treatment to death.

    Time frame: 18 months

  5. Clinical benefit

    Percentage of patients with documented response or disease stabilization according RECIST 1.1 criteria

    Time frame: 12 months

  6. Number of individual events (hematologic events and not hematologic events)

    Percentage of patients with each of the adverse event per grade

    Time frame: 12 months

07

Study locations

9 sites
  • ICO Duran i Reynals
    L'Hospitalet de Llobregat, Barcelona 08908, Spain
  • Hospital Universitari Vall d'Hebron
    Barcelona, 08035, Spain
  • Hospital Clínic i Provincial de Barcelona
    Barcelona, 08036, Spain
  • Complejo Hospitalario Regional Reina Sofía
    Córdoba, 14004, Spain
  • Hospital Ramón Y Cajal
    Madrid, 28034, Spain
  • Hospital Universitario 12 de Octubre
    Madrid, 28041, Spain
  • Centro Integral Oncologico Clara Campal
    Madrid, Spain
  • MD Anderson Cancer Center Madrid
    Madrid, Spain
  • Hospital Central de Asturias
    Oviedo, Spain
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03066427
Lead sponsor
Spanish Oncology Genito-Urinary Group
Collaborators
Pfizer, Apices Soluciones S.L.
Responsible party
Sponsor
First posted
Feb 28, 2017
Start date
May 10, 2017
Primary completion
Sep 22, 2020
Completion
Sep 22, 2020
Last update
Nov 13, 2020

Study contacts

Enrique Grande, MD
study chair · MD Anderson Cancer Center Madrid
Cristina Suárez, MD
principal investigator · Hospital Vall d'Hebron
Xavier García del Muro, MD
principal investigator · Hestia Duran i Reynals
Oscar Reig, MD
principal investigator · Hospital Clínic i Provincial de Barcelona
María J Méndez, MD
principal investigator · Complejo Hospitalario Regional Reina Sofia
Daniel Castellano, MD
principal investigator · Hospital Universitario 12 de Octubre
Teresa Alonso, MD
principal investigator · Hospital Universitario Ramon y Cajal

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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