Study to Evaluate Safety, Pharmacokinetics and Therapeutic Activity of RO6874281 as a Combination Therapy in Participants With Unresectable Advanced and/or Metastatic Renal Cell Carcinoma (RCC)

Official Title

An Open-Label, Multi-Centre, Randomized, Dose-Escalation, Phase 1b Study to Evaluate Safety, Pharmacokinetics and Therapeutic Activity of RO6874281, in Combination With Atezolizumab ± Bevacizumab, Following Obinutuzumab Pre-Treatment, in Patients With Unresectable Advanced and/or Metastatic Renal Cell Carcinoma

Summary:

This is an open-label, multi-centre, randomized, Phase 1b, adaptive, clinical study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary therapeutic activity of RO6874281 in participants with unresectable advanced and/or metastatic RCC. The study will consist of dose-escalation part and extension part.

Trial Description

Primary Outcome:

  • Percentage of Participants with Dose-Limiting Toxicities (DLTs)
  • Maximum Tolerated Dose (MTD) of RO6874281
  • Recommended Dose of RO6874281
  • Percentage of Participants with Objective Response of Complete Response (CR) or Partial Response (PR) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1)
Secondary Outcome:
  • Serum RO6874281 Concentration
  • Area Under the Serum Concentration-Time Curve (AUC) for RO6874281
  • Maximum Observed Serum Concentration (Cmax) of RO6874281
  • Serum Atezolizumab Concentration
  • AUC of Atezolizumab
  • Cmax of Atezolizumab
  • Serum Bevacizumab Concentration
  • AUC of Bevacizumab
  • Cmax of Bevacizumab
  • Percentage of Participants with Anti-Drug Antibodies (ADA) to RO6874281
  • Absolute Lymphocytes Count in Peripheral Blood
  • Density of Lymphocytes in Tumour Samples
  • Percentage of Participants with Programmed Death-Ligand 1 (PD-L1) Status in Tumour Samples
  • Percentage of Participants with CR as Determined by the Investigator Using RECIST v1.1
  • Percentage of Participants with Disease Control as Determined by the Investigator Using RECIST v1.1
  • Duration of Response (DOR) as Determined by the Investigator Using RECIST v1.1
  • Progression-Free Survival (PFS) as Determined by the Investigator Using RECIST v1.1
  • Overall Survival (OS)

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society