264 Participants Needed

Extended vs Standard Dosing for Immunotherapy in Cancer

Recruiting at 1 trial location
PC
Overseen ByPersonalized Cancer Care Consortium
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: University of Chicago
Must be taking: Nivolumab, Pembrolizumab
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

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

MR

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

I am 18 years old or older.
My doctor recommends nivolumab or pembrolizumab for my advanced cancer.
Measurable disease per RECIST criteria

Exclusion Criteria

I am not planning to receive both ipilimumab and nivolumab for my treatment.
My treatment plan includes ipilimumab with nivolumab or pembrolizumab.
I have received treatments like immune checkpoint inhibitors or experimental antibody therapy before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either standard interval dosing or extended interval dosing of nivolumab or pembrolizumab

2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Nivolumab
  • Pembrolizumab
Trial OverviewThe study tests if nivolumab and pembrolizumab can be given less frequently than the current standard without affecting drug levels in the blood. Patients will receive either extended interval dosing or standard dosing of these medications.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: standard interval dosingExperimental Treatment2 Interventions
Group II: extended interval dosingExperimental Treatment2 Interventions

Nivolumab is already approved in United States, European Union, Canada, Switzerland for the following indications:

🇺🇸
Approved in United States as Opdivo for:
  • 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
🇪🇺
Approved in European Union as Opdivo for:
  • 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
🇨🇦
Approved in Canada as Opdivo for:
  • 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
🇨🇭
Approved in Switzerland as Opdivo for:
  • 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

Trials
1,086
Recruited
844,000+

Findings from Research

Nivolumab and pembrolizumab are FDA-approved monoclonal antibodies that target PD-1, helping to enhance T cell activity against cancer by blocking the PD-1/PD-L1 interaction, which allows cancer cells to escape immune detection.
Both drugs have shown efficacy across multiple cancer types, including melanoma and non-small cell lung cancer, and are considered interchangeable options for treating these conditions, which may help manage the rising costs of cancer therapies.
Nivolumab and pembrolizumab: Monoclonal antibodies against programmed cell death-1 (PD-1) that are interchangeable.Prasad, V., Kaestner, V.[2022]
In a phase II trial involving 15 patients with resectable non-small cell lung cancer (NSCLC), neoadjuvant treatment with pembrolizumab showed a major pathologic response in 27% of patients, indicating promising antitumor activity before surgery.
The treatment was found to be feasible and safe, with only 33% of patients experiencing moderate adverse events, and no postoperative mortality, suggesting that pembrolizumab does not compromise surgical outcomes.
Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience.Eichhorn, F., Klotz, LV., Kriegsmann, M., et al.[2022]
The REFINE-Lung study (NCT05085028) is a UK multicentre phase 3 trial that aims to optimize the dosing frequency of pembrolizumab, an anti-PD-1 therapy, for patients with advanced non-small-cell lung cancer, addressing concerns about overtreatment and its associated costs and side effects.
This study employs a novel multi-arm multi-stage response over continuous interventions (MAMS-ROCI) design, which allows for more efficient exploration of multiple dosing strategies compared to traditional trial designs, potentially leading to significant improvements in patient care and treatment optimization across various cancers.
REFINE-Lung implements a novel multi-arm randomised trial design to address possible immunotherapy overtreatment.Ghorani, E., Quartagno, M., Blackhall, F., et al.[2023]

References

Nivolumab and pembrolizumab: Monoclonal antibodies against programmed cell death-1 (PD-1) that are interchangeable. [2022]
Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience. [2022]
REFINE-Lung implements a novel multi-arm randomised trial design to address possible immunotherapy overtreatment. [2023]
Pembrolizumab Exposure-Response Assessments Challenged by Association of Cancer Cachexia and Catabolic Clearance. [2019]
FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma. [2021]
Recurrent and atypical immune checkpoint inhibitor-induced pneumonitis. [2023]
FDA Approval Summary: Pembrolizumab for the Treatment of Patients with Unresectable or Metastatic Melanoma. [2022]
A real-world study on the safety of the extended dosing schedule for nivolumab and pembrolizumab in patients with solid tumors. [2022]
A Phamacoeconomic Analysis of Personalized Dosing vs Fixed Dosing of Pembrolizumab in Firstline PD-L1-Positive Non-Small Cell Lung Cancer. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Standard-Dose Pembrolizumab Plus Alternate-Dose Ipilimumab in Advanced Melanoma: KEYNOTE-029 Cohort 1C, a Phase 2 Randomized Study of Two Dosing Schedules. [2023]
Utilization and toxicity patterns of 2-weekly (Q2W) versus 4-weekly (Q4W) nivolumab for treatment of adjuvant and metastatic melanoma at BC cancer. [2023]