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Clear Cell Renal CarcinomaPhase 2INMUNOSUNNCT03066427

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

A Phase 2 study testing Sunitinib in people with Clear Cell Renal Carcinoma, run by Spanish Oncology Genito-Urinary Group at 9 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Clear Cell Renal Carcinoma
What is being tested?
Sunitinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
9 sitesSpain
Study dates
10 May 2017to 22 Sep 2020
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

  • 1. Eighteen years or older on the day of consent
  • 2. Documented histological or cytological diagnosis of renal cell cancer with a clear-cell component.
  • 3. Patient must have progressed to at least one immune check point inhibitor-based therapy (antiPD1, anti-PDL1 o antiCTLA4) for the first line
  • 4. Measurable disease per RECIST 1.1 as determined by the investigator
  • 5. The subjects should not present disease that may be subsidiary of surgical treatment, radiotherapy or combined treatment with curative intent.
  • 6. 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.
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  • 7. Eastern Cooperative Oncology Group Performance Status (PS) 0-2
  • 8. Adequately controlled blood pressure (BP) with or without antihypertensive medication to maintain a BP <150/90 mmHg before the start of study treatment.
  • 9. 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).
  • 10. Adequate liver function
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 × ULN.
  • Total bilirubin ≤ 1.5 × upper limit of normal (ULN).
  • 11. Adequate kidney function: calculated creatinine clearance ≥ 30 mL/min (≥ 0.5 mL/sec) using the Cockroft-Gault equation
  • 12. Proteinuria <2+ on urine test strip
  • 13. Prothrombin Time (PT) or International Standard Ratio (INR) ≤ 1.2 x ULN.
  • 14. Life expectancy >3 months.
  • 15. Patient able to ingest study drug and meet study follow-up requirements.
  • 16. Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception
  • 17. Female subjects of childbearing potential must not be pregnant at screening.

Who cannot join

  • 1. Previous treatments with sunitinib are not permitted for the advanced or localized disease.
  • 2. Major surgery within 3 weeks of patient inclusion
  • 3. Radiation therapy or embolization within 2 weeks of first dose of sunitinib
  • 4. Previous treatment with immunosuppressive drugs such as cyclosporine, tacrolimus, azathioprine, or long-term oral glucocorticoids taken prior to (3 months) patient inclusion
  • 5. Prior high-dose chemotherapy requiring hematopoietic stem cell rescue.
  • 6. Current treatment on another clinical trial.
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  • 7. Treatment with known potent CYP3A4 inhibitors or inducers or that prolong the QT interval, within 7 days prior to the inclusion.
  • 8. Prior radiation therapy to >25% of the bone marrow.
  • 9. Uncontrolled brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease.
  • 10. 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.
  • 11. Presence of an unhealed wound or active ulcer.
  • 12. Diarrhea grade III/IV in the screening period.
  • 13. 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.
  • 14. Clinically significant cardio-cerebrovascular disease within 6 months prior to initiation of treatment.
  • 15. Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥2, atrial fibrillation of any grade that require treatment.
  • 16. Corrected QT interval (QTc) interval >500 msec.
  • 17. Active hemoptysis within 6 weeks prior to initiation of study treatment.
  • 18. Evidence of active bleeding or hemorrhagic diathesis.
  • 19. Presence of endobronchial lesions and / or lesions that infiltrate large vessels.
  • 20. Current treatment with therapeutic doses of Coumadin (low dose Coumadin up to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed).
  • 21. 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.
  • 22. Pregnancy or breastfeeding.
  • 23. Any disease that, in the opinion of the investigator, interferes with the patient's ability to participate in the clinical trial.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Spain9 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Clínic i Provincial de Barcelona

    Barcelona, 08036

  • Complejo Hospitalario Regional Reina Sofía

    Córdoba, 14004

  • ICO Duran i Reynals

    L'Hospitalet de Llobregat, Barcelona, 08908

  • Hospital Ramón Y Cajal

    Madrid, 28034

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Centro Integral Oncologico Clara Campal

    Madrid

  • MD Anderson Cancer Center Madrid

    Madrid

  • Hospital Central de Asturias

    Oviedo

Other trials in Spain

About this study

Official title: Phase II Study to Evaluate Efficacy and Safety of Sunitinib Therapy in Patients With Metastatic Renal Clear Cell Carcinoma Who Have Progressed to First-line Immunotherapy Treatment (INMUNOSUN Study)

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.

Read more

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.

Being tested
Sunitinib
Keywords
Clear Cell Renal Carcinoma, Sunitinib
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.

  • SunitinibDrug

    Also called Sutent

    Sunitinib 50 mg/d

Study groups in NCT03066427
Study groupRoleWhat they receive
SunitinibExperimentalSunitinib 50 mg/day, 4 weeks on/2weeks off
Receives: Drug: Sunitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate

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

    Measured: 12 months

Secondary outcomes (6)

  1. Progression-free survival

    Time from start of treatment to disease progression or death.

    Measured: 12 months

  2. Time to progression

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

    Measured: 12 months

  3. Duration of the response

    Time from first response to disease progression or death.

    Measured: 12 months

  4. Overall survival

    Time from start of treatment to death.

    Measured: 18 months

  5. Clinical benefit

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

    Measured: 12 months

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

    Percentage of patients with each of the adverse event per grade

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2017
  2. Study start10 May 2017
  3. Primary completion22 Sep 2020
  4. Study completion22 Sep 2020

Resources

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
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03066427
Sponsor's protocol ID
SOGUG-2016-A- IEC(REN)-10
Other IDs
2016-004011-12, 2016
Acronym
INMUNOSUN
Status last verified
Oct 2020
First submitted
23 Feb 2017
Last updated
13 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sunitinib in people with Clear Cell Renal Carcinoma, run by Spanish Oncology Genito-Urinary Group at 9 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 22 inclusion and 29 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: finished, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03066427.

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 13 Nov 2020; AzTrials last refreshed its copy on 8 Nov 2026.

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