MLN0128 and MLN0128 + MLN1117 Compared With Everolimus in the Treatment of Adults With Advanced or Metastatic Clear-Cell Renal Cell Carcinoma

Official Title

A Phase 2, Open-label Study to Evaluate the Efficacy and Safety of Single-Agent MLN0128 and the Combination of MLN0128+MLN1117 Compared With Everolimus in the Treatment of Adult Patients With Advanced or Metastatic Clear-Cell Renal Cell Carcinoma That Has Progressed on Vascular Endothelial Growth Factor-Targeted Therapy


This study will evaluate the efficacy and safety of single-agent MLN0128 and the combination of MLN0128 + MLN1117 compared with everolimus in the treatment of participants with metastatic clear-cell renal cell carcinoma (mccRCC) that have progressed on vascular endothelial growth factor (VEGF)-targeted therapy.

Trial Description

Primary Outcome:

  • Progression-Free survival (PFS)
Secondary Outcome:
  • Percentage of Participants with Treatment-Emergent Adverse Events (TEAEs)
  • Overall survival (OS)
  • Time-to-progression (TTP)
  • Objective Response Rate (ORR)
  • Clinical Benefit Rate (CBR)
The drugs being tested in this study are called MLN0128 and MLN1117. MLN0128 and MLN1117 are being tested to treat people who have mccRCC. This study will assess the efficacy and safety of MLN0128 and MLN1117 as well as how it is processed by the body in participants with advanced or mccRCC. The study will enroll approximately 189 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the three treatment groups:
  • Everolimus 10 mg once daily (QD)
  • MLN0128 30 mg once weekly (QW)
  • MLN0128 4 mg + MLN1117 200 mg QD x 3 days per week All participants will be asked to take the study drug at the same time on each scheduled day. This multi-centre trial will be conducted worldwide. The overall time to participate in this study is 2 years after last participant is randomized, or when the last participant discontinues study treatment (approximately 3 years). Participants will make multiple visits to the clinic including a follow-up visit 30 to 40 days after receiving their last dose of study drug or prior to start of subsequent anticancer therapy for safety assessment. Participants will then be followed for Progression Free and Overall Survival.

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Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society