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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

264 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-25

Study Completion Date

2026-04-12

Brief Summary

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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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Detailed Description

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Conditions

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Metastatic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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standard interval dosing

Group Type EXPERIMENTAL

Nivolumab Standard

Intervention Type 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

Intervention Type 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

extended interval dosing

Group Type EXPERIMENTAL

Nivolumab Extended

Intervention Type 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

Intervention Type DRUG

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

Interventions

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Nivolumab Standard

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

Intervention Type DRUG

Pembrolizumab Standard

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

Intervention Type DRUG

Nivolumab Extended

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

Intervention Type DRUG

Pembrolizumab Extended

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

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No