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)
Overview
- Phase
- Phase 2
- Intervention
- Sunitinib
- Conditions
- Clear Cell Renal Carcinoma
- Sponsor
- Spanish Oncology Genito-Urinary Group
- Enrollment
- 23
- Locations
- 9
- Primary Endpoint
- Objective response rate
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Eighteen years or older on the day of consent
- •Documented histological or cytological diagnosis of renal cell cancer with a clear-cell component.
- •Patient must have progressed to at least one immune check point inhibitor-based therapy (antiPD1, anti-PDL1 o antiCTLA4) for the first line
- •Measurable disease per RECIST 1.1 as determined by the investigator
- •The subjects should not present disease that may be subsidiary of surgical treatment, radiotherapy or combined treatment with curative intent.
- •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.
- •Eastern Cooperative Oncology Group Performance Status (PS) 0-2
- •Adequately controlled blood pressure (BP) with or without antihypertensive medication to maintain a BP \<150/90 mmHg before the start of study treatment.
- •Adequate marrow function
- •Absolute neutrophil count (ANC) ≥ 1500/mm3 (≥ 1.5 GI/L).
Exclusion Criteria
- •Previous treatments with sunitinib are not permitted for the advanced or localized disease.
- •Major surgery within 3 weeks of patient inclusion
- •Radiation therapy or embolization within 2 weeks of first dose of sunitinib
- •Previous treatment with immunosuppressive drugs such as cyclosporine, tacrolimus, azathioprine, or long-term oral glucocorticoids taken prior to (3 months) patient inclusion
- •Prior high-dose chemotherapy requiring hematopoietic stem cell rescue.
- •Current treatment on another clinical trial.
- •Treatment with known potent CYP3A4 inhibitors or inducers or that prolong the QT interval, within 7 days prior to the inclusion.
- •Prior radiation therapy to \>25% of the bone marrow.
- •Uncontrolled brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease.
- •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.
Arms & Interventions
Sunitinib
Sunitinib 50 mg/day, 4 weeks on/2weeks off
Intervention: Sunitinib
Outcomes
Primary Outcomes
Objective response rate
Time Frame: 12 months
Percentage of patients with documented response according RECIST 1.1 criteria (complete response + partial response)
Secondary Outcomes
- Progression-free survival(12 months)
- Time to progression(12 months)
- Duration of the response(12 months)
- Overall survival(18 months)
- Clinical benefit(12 months)
- Number of individual events (hematologic events and not hematologic events)(12 months)