- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04295863
Comparing Dosing Intervals of Nivolumab or Pembrolizumab in Locally Advanced or Metastatic Cancers
April 26, 2023 updated by: University of Chicago
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
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
264
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Personalized Cancer Care Consortium
- Phone Number: 773.702.1220
- Email: PhaseIICRA@medicine.bsd.uchicago.edu
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60637
- Recruiting
- University of Chicago Medicine Comprehensive Cancer Center
-
Principal Investigator:
- Mark Ratain, MD
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53717
- Recruiting
- SSM Health Cancer Care
-
Contact:
- Terri Roberts
- Phone Number: 608-410-2769
- Email: terri.roberts@ssmhealth.com
-
Contact:
- Nicole Schultz
- Phone Number: 608-410-2774
- Email: nicole.schultz1@ssmhealth.com
-
Principal Investigator:
- Amit Sanyal, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: standard interval dosing
|
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
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
|
Experimental: extended interval dosing
|
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
For patients on extended interval dosing of pembrolizumab therapy will consist of 200mg IV once every 6 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mark Ratain, MD, University of Chicago
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 25, 2020
Primary Completion (Anticipated)
April 12, 2025
Study Completion (Anticipated)
April 12, 2025
Study Registration Dates
First Submitted
February 14, 2020
First Submitted That Met QC Criteria
March 2, 2020
First Posted (Actual)
March 5, 2020
Study Record Updates
Last Update Posted (Actual)
April 28, 2023
Last Update Submitted That Met QC Criteria
April 26, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB19-1718
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Metastatic Cancer
-
Gustave Roussy, Cancer Campus, Grand ParisCompletedGIST Metastatic Cancer | Breast Metastatic Cancer | Kidney Metastatic Cancer | Colon Metastatic Cancer | Rectal Metastatic CancerFrance
-
Orion Biotechnology Polska Sp. z o.o.Not yet recruitingMetastatic Colorectal Cancer | Metastatic Cancer | Metastatic Breast Cancer | Metastatic Urothelial Carcinoma | Metastatic Gastric Cancer | Metastatic Pancreatic Cancer
-
Albert Einstein College of MedicineTerminatedCancer | Solid Tumor | Metastatic Solid Tumor | Metastatic dMMR Solid CancerUnited States
-
Institut de Cancérologie de la LoireSaint-Louis Hospital, Paris, France; Gustave Roussy, Cancer Campus, Grand ParisWithdrawnMetastatic Colorectal Cancer | Metastatic Breast Cancer | Metastatic Head and Neck CancerFrance
-
Gottfried MayaUnknownMetastatic Lung Cancer | Metastatic Breast Cancer | Metastatic Prostate Cancer | Metastatic Gastric Cancer | Metastatic Bladder CancerIsrael
-
Advaxis, Inc.TerminatedMetastatic Melanoma | Urothelial Carcinoma | Metastatic Non-Small Cell Lung Cancer | Head and Neck Cancer Metastatic | Colon Cancer MetastaticUnited States
-
Cedars-Sinai Medical CenterRecruitingNeoplasms | Cancer | Cancer, MetastaticUnited States
-
Cota Inc.Blue Cross Blue Shield; NantHealth Inc.TerminatedPancreatic Cancer | Metastatic Lung Cancer | Metastatic Breast Cancer | Metastatic Melanoma | Metastatic Prostate Cancer | Metastatic Colon CancerUnited States
-
UNC Lineberger Comprehensive Cancer CenterHyundai Hope On WheelsRecruitingCancer | Pediatric Cancer | Survivorship | Cancer MetastaticUnited States
-
Oslo University HospitalVestre Viken Hospital Trust; University Hospital of North Norway; Ostfold Hospital... and other collaboratorsRecruitingCancer MetastaticNorway
Clinical Trials on Nivolumab Standard
-
Centre Hospitalier Universitaire de BesanconBristol-Myers Squibb; Fondation ARCActive, not recruitingAdvanced Non-small Cell Lung CancerFrance
-
Goethe UniversityActive, not recruitingMetastatic Renal Cell CarcinomaSpain, Netherlands, United Kingdom, France, Germany, Belgium, Czechia
-
Hospices Civils de LyonUnknownObesity, COVID-19 InfectionFrance
-
H. Lee Moffitt Cancer Center and Research InstituteBristol-Myers SquibbActive, not recruitingMetastatic Melanoma | Metastasis to BrainUnited States
-
Universitair Ziekenhuis BrusselNot yet recruiting
-
Bristol-Myers SquibbRecruitingMelanomaSpain, United States, Italy, Chile, Greece, Argentina
-
Brown UniversityBristol-Myers Squibb; The Miriam Hospital; Rhode Island Hospital; Women and Infants...Terminated
-
Baptist Health South FloridaBristol-Myers Squibb; NovoCure Ltd.TerminatedRecurrent GlioblastomaUnited States
-
HUYABIO International, LLC.Bristol-Myers SquibbRecruitingUnresectable or Metastatic Melanoma | Progressive Brain MetastasisSpain, United States, Italy, Japan, Belgium, France, New Zealand, Brazil, Korea, Republic of, Australia, Germany, Singapore, Czechia, Austria, South Africa, United Kingdom, Puerto Rico
-
Jason J. Luke, MDArray BioPharmaActive, not recruitingMelanoma | Renal Cell Carcinoma | Solid Tumor | Non-small Cell Lung Cancer | Head and Neck Squamous Cell CarcinomaUnited States