Clinical trial · Interventional
Comparing Dosing Intervals of Nivolumab or Pembrolizumab in Locally Advanced or Metastatic Cancers
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nivolumab Extended | Drug | Nivolumab | ALIAS |
| Nivolumab Standard | Drug | Nivolumab | ALIAS |
| Pembrolizumab Extended | Drug | Pembrolizumab | ALIAS |
| Pembrolizumab Standard | Drug | Pembrolizumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- standard interval dosing
- interventionNames
- Drug: Nivolumab Standard
- Drug: Pembrolizumab Standard
- type
- EXPERIMENTAL
- label
- extended interval dosing
- interventionNames
- Drug: Nivolumab Extended
- Drug: Pembrolizumab Extended
Primary outcomes (1)
- measure
- Noninferiority margin of extended interval dosing compared to standard dosing
- timeFrame
- 2 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available