Clinical Trials Logo

Clinical Trial Summary

This trial will evaluate the addition of cytoreductive stereotactic body radiation therapy (SBRT) to standard of care combination ipilimumab and nivolumab (I/N) versus I/N alone for the treatment of metastatic kidney cancer.


Clinical Trial Description

This is a multi-centre, open label, phase II randomized clinical trial evaluating SBRT as upfront cytoreductive therapy to the primary renal mass along with combination I/N therapy in patients with intermediate/poor risk mRCC who are not candidates for cytoreductive nephrectomy. Eligible and consenting, newly diagnosed and histologically confirmed intermediate/poor risk mRCC patients based on IMDC criteria with primary disease in-situ will be randomized in a 2:1 fashion to either induction I/N followed by SBRT prior to the second cycle (experimental arm) versus I/N alone (standard arm). Patients will be stratified based on IMDC criteria (intermediate 1-2 versus poor 3-6). - Standard Arm: induction ipilimumab 1 mg/kg combined with nivolumab 3 mg/kg (I/N) every 3 weeks for cycles 1-4 followed by maintenance treatment with nivolumab 240mg every 2 weeks or 480mg every 4 weeks until disease progression (as determined by RECIST 1.1), intolerance, or patient/physician decision to stop treatment. - Experimental Arm: induction ipilimumab 1 mg/kg combined with nivolumab 3 mg/kg (I/N) every 3 weeks for one cycle, followed by SBRT to the primary disease in-situ, prior to cycle 2-4 of I/N. Patients randomized to SBRT will undergo radiation planning during the first cycle of I/N to their primary kidney mass, and then the radiation will be delivered between cycles 1 and 2 to a dose of 30-40 Gy in 5 fractions every other day over 1.5 weeks. Approximately one week following completion of SBRT, patients will start cycle 2 of I/N as per standard of care. The total time elapsed between the start of cycle 1 and 2 of I/N should be no more than 6 weeks. After completion of up to four cycles of I/N, patients will proceed to standard of care maintenance treatment with nivolumab 240mg every 2 weeks or 480mg every 4 weeks until disease progression (as determined by RECIST 1.1), intolerance, or patient/physician decision to stop treatment. During treatment (standard and experimental arm) participants will be assessed for radiation toxicity and the occurrence of adverse events. Following treatment, participants will be assessed at a clinic visit every 3 months, for a period of 1 year. Progression free survival will be assessed by CT scan (chest; abdomen and pelvis), which is performed after the final I/N treatment and every 3 months as per standard of care. Participants will be followed for one additional year, seen at 18 and 24 months to assess survival. The planned sample size is 78 study participants. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04090710
Study type Interventional
Source Ontario Clinical Oncology Group (OCOG)
Contact
Status Active, not recruiting
Phase Phase 2
Start date January 29, 2020
Completion date March 31, 2025

See also
  Status Clinical Trial Phase
Completed NCT00930033 - Clinical Trial to Assess the Importance of Nephrectomy Phase 3
Recruiting NCT05863351 - Focused Radiation Versus Systemic Therapy for Kidney Cancer Patients With Limited Metastasis, SOAR Study Phase 3
Not yet recruiting NCT06284564 - A Phase II Study Bolstering Outcomes by Optimizing Immunotherapy Strategies With Evolocumab and Nivolumab in Patients With Metastatic Renal Cell Carcinoma (BOOST-RCC) Phase 2
Completed NCT00414765 - Aldesleukin in Participants With Metastatic Renal Cell Carcinoma or Metastatic Melanoma Phase 4
Active, not recruiting NCT03149822 - Study of Pembrolizumab and Cabozantinib in Patients With Metastatic Renal Cell Carcinoma Phase 1/Phase 2
Recruiting NCT03647878 - Study of Cabozantinib as Monotherapy or in Combination With Nivolumab in Patients With Advanced or Metastatic Renal Cell Carcinoma Under Real-life Clinical Setting in 1st Line Treatment.
Completed NCT01517243 - Phase II Study of Alternating Sunitinib and Temsirolimus Phase 2
Withdrawn NCT03927248 - PAC-1 for Treatment of Refractory, Metastatic Kidney Cancer Phase 1/Phase 2
Terminated NCT02122003 - Second Line Sorafenib After Pazopanib in Patients With RCC Phase 2
Completed NCT01182142 - Study of Capecitabine in Metastatic Non-clear Cell Renal Cell Carcinoma (RCC) Patients Phase 2
Completed NCT00630409 - Phase II Clinical Trial of Gemcitabine and Doxil® for Metastatic Renal Cell Carcinoma Phase 2
Recruiting NCT04140526 - Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC Phase 1/Phase 2
Completed NCT04076787 - Clinical Outcomes for Patients With Renal Cell Carcinoma Who Received First-Line Sunitinib
Active, not recruiting NCT04467021 - Cancer and Blood Pressure Management, CARISMA Study N/A
Recruiting NCT05119335 - A Study of NKT2152, a HIF2α Inhibitor, in Patients With Advanced Clear Cell Renal Cell Carcinoma Phase 1/Phase 2
Completed NCT02282579 - Spanish Retrospective Study to Evaluate the Efficacy and Safety of Targeted Therapies After Pazopanib as First-line Therapy
Completed NCT01731158 - Sequential Therapy in Metastatic Renal Cell Carinoma Phase 2
Terminated NCT02071641 - Phase II Study of Sunitinib Rechallenge in Patients With Metastatic Renal Cell Carcinoma Phase 2
Terminated NCT01342627 - Sorafenib in Elderly Patients With Metastatic Renal Cell Carcinoma Phase 2
Active, not recruiting NCT01274273 - Study of Interleukin-2, Interferon-alpha and Bevacizumab in Metastatic Kidney Cancer Phase 2