Clinical Trials /

Comparing Dosing Intervals of Nivolumab or Pembrolizumab in Locally Advanced or Metastatic Cancers

NCT04295863

Description:

A randomized research study of drugs nivolumab and pembrolizumab in patients with locally advanced or metastatic cancers. Based on data from earlier studies it appears that the drugs can be given less often then the currently approved schedule. This trial will compare drug levels from the blood from standard interval dosing levels versus taking the drugs less often.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Not yet recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Comparing Dosing Intervals of Nivolumab or Pembrolizumab in Locally Advanced or Metastatic Cancers
  • Official Title: A Randomized Study Investigating the Pharmacokinetics of Standard Interval Dosing Compared to Extended Interval Dosing of Nivolumab or Pembrolizumab in Locally Advanced or Metastatic Cancers

Clinical Trial IDs

  • ORG STUDY ID: IRB19-1718
  • NCT ID: NCT04295863

Conditions

  • Metastatic Cancer

Interventions

DrugSynonymsArms
Nivolumab Standardstandard interval dosing
Pembrolizumab Standardstandard interval dosing
Nivolumab Extendedextended interval dosing
Pembrolizumab Extendedextended interval dosing

Purpose

A randomized research study of drugs nivolumab and pembrolizumab in patients with locally advanced or metastatic cancers. Based on data from earlier studies it appears that the drugs can be given less often then the currently approved schedule. This trial will compare drug levels from the blood from standard interval dosing levels versus taking the drugs less often.

Trial Arms

NameTypeDescriptionInterventions
standard interval dosingExperimental
  • Nivolumab Standard
  • Pembrolizumab Standard
extended interval dosingExperimental
  • Nivolumab Extended
  • Pembrolizumab Extended

Eligibility Criteria

        Inclusion Criteria:

          -  Patients with locally advandced or metastatic cancer whose physician has determined
             they are candidates for treatment with nivolumab or pembrolizumab

          -  18 years old or older

          -  Measurable disease per RECIST criteria

        Exclusion Criteria:

          -  Patients who have previously received immune checkpoint inhibitors or investigational
             monoclonal antibody therapy.

          -  Patients whose treatment plan is to receive ipilimumab or other anti-CTLA4 monoclonal
             antibody in combination with either nivolumab or pembrolizumab.

               -  Ipilimumab and nivolumab combination are not eligible for this trial.

               -  (Note: Patients whose planned treatment is the combination of anti-PD-1 and
                  tyrosine kinase inhibitor such as pembrolizumab-axitinib or the combination of
                  traditional cytotoxic chemotherapy and anti-PD-1 are eligible)
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Noninferiority margin of extended interval dosing compared to standard dosing
Time Frame:2 years
Safety Issue:
Description:To assess the noninferiority of pharmacokinetic success, defined as drug trough levels above the target concentration of 1.5 µg/mL. Evaluable patients will be categorized as success or failure for this primary objective.

Secondary Outcome Measures

Measure:Compare the efficacy of extended interval and standard interval dosing
Time Frame:2 years
Safety Issue:
Description:To compare the correlation of extended interval and standard interval dosing, as based on a combination of time-to-treatment discontinuation (TTD) and overall survival (OS). This secondary analysis will include all patients who received at least one dose

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:University of Chicago

Last Updated

March 2, 2020