IPINIVO - A Pharmacodynamics study of Nivolumab in Combination with Ipilimumab in Patients with Advanced or Metastatic Solid Tumours’

ABSTRACT: Interventions: Approximately 21 eligible patients with advanced or metastatic solid tumors will be enrolled into two cohorts. In the first cohort, nine (9) subjects will receive 1mg/kg of ipilimumab every 6 weeks and Nivolumab 3mg/kg every 2 weeks until disease progression or discontinuation due to toxicity or a maximum of 12 weeks. The second cohort of twelve (12) subjects will receive 0.3mg/kg of ipilimumab every 6 weeks and Nivolumab 3mg/kg dosed every 2 weeks until disease progression or discontinuation due to toxicity or a maximum of 12 weeks. Chort 1 and Cohort 2 will not be enrolled concurrently. Cohort 2 shall proceed after review of all Cohort 1 Day 8 data to identify if the study end point has been met. Nivolumab & Ipilimumab are administered intravenously in clinic at the study sites under the review of study doctors and nurses to ensure this is correctly administered and to review for any adverse reaction. When administered in combination Nivolumab is infused first followed by Ipilimumab on the same day. Primary outcome(s): To evaluate the change in Ki-67 expression in CD4+ peripheral blood T-cells as a pharmacodynamic biomarker for the effect of nivolumab in combination with ipilimumab on peripheral T-cells.[Change in Ki-67 expression from baseline in CD4+ peripheral blood T-cells at Cycle 1, Day 4 and Day 8 and from baseline to the end of the first 6-week cycle.] Study Design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Type of endpoint: Pharmacodynamics

DISEASE(S): Cancer-hodgkin's,Cancer-brain,Cancer-bladder,Cancer-kidney,Cancer-prostate,Cancer-malignant Melanoma,Cancer-bowel-back Passage (rectum) Or Large Bowel (colon),Cancer-other Cancer Types,Cancer-head And Neck,Advanced Or Metastatic Solid Tumours,Cancer-lung-non Small Cell

PROVIDER: 2465826 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR