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NCT Number: NCT04295863

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

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.

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Key information

Conditions

Metastatic Cancer Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University Of Chicago Medicine Comprehensive Cancer Center, Chicago, Illinois, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Nivolumab Standard

Drug

For patients on standard schedule dosing of nivolumab, therapy will consist of 240mg IV once every 2 weeks or 480mg IV once every 4 weeks

Pembrolizumab Standard

Drug

For patients on standard schedule dosing of pembrolizumab, therapy will consist of 200mg IV once every 3 weeks or 400mg IV once every 6 weeks

Nivolumab Extended

Drug

For patients on extended interval dosing of nivolumab therapy will consist of 240mg IV once every 4 weeks or 480mg IV once every 8 weeks

Pembrolizumab Extended

Drug

For patients on extended interval dosing of pembrolizumab therapy will consist of 200mg IV once every 6 weeks

Primary outcomes

  1. Noninferiority margin of extended interval dosing compared to standard dosing

    Time frame: 2 years

    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 outcomes

  1. Compare the efficacy of extended interval and standard interval dosing

    Time frame: 2 years

    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

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Mar 5, 2020
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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