Extended vs Standard Dosing for Immunotherapy in Cancer
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the drug Nivolumab and Pembrolizumab in cancer treatment?
Nivolumab and Pembrolizumab are effective in treating several types of cancer, including melanoma and non-small cell lung cancer, by helping the immune system recognize and attack cancer cells. They have been approved by the FDA for these uses, showing significant tumor response rates and prolonged response durations in patients.12345
Is immunotherapy with drugs like Nivolumab and Pembrolizumab generally safe for humans?
Immunotherapy drugs like Nivolumab (Opdivo) and Pembrolizumab (Keytruda) have been approved for several cancers and are generally considered safe, but they can cause side effects. Common side effects include fatigue, cough, and nausea, while more serious immune-related side effects can include lung inflammation (pneumonitis) and thyroid issues.12567
How is the drug Nivolumab and Pembrolizumab unique compared to other cancer treatments?
Nivolumab and Pembrolizumab are unique because they are immune checkpoint inhibitors that can be administered with extended dosing intervals, allowing for less frequent hospital visits while maintaining effectiveness. This extended dosing schedule is particularly novel as it offers more convenience for patients without compromising safety or efficacy.5891011
Research Team
Mark Ratain, MD
Principal Investigator
University of Chicago
Eligibility Criteria
This trial is for adults with measurable, advanced or metastatic cancer who are candidates for nivolumab or pembrolizumab treatment. It's not open to those who've had immune checkpoint inhibitors before, or plan to combine these drugs with ipilimumab or other anti-CTLA4 antibodies.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either standard interval dosing or extended interval dosing of nivolumab or pembrolizumab
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Nivolumab
- Pembrolizumab
Nivolumab is already approved in United States, European Union, Canada, Switzerland for the following indications:
- Advanced or metastatic gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Hepatocellular carcinoma
- Esophageal squamous cell carcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Chicago
Lead Sponsor