Melanoma Clinical Trials Intelligence
Monthly Update Report for Trials Started in March 2026
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1: Summary data from new trials identified for Melanoma.
Overview
Number of Trials: 1
This trial investigates drug-drug interactions between immune checkpoint inhibitors and cytochrome P450 substrates in cancer patients initiating ICI therapy. The study aims to assess pharmacokinetic interactions using a probe cocktail approach in patients receiving single or combination ICI regimens.
Common Criteria Across Trials
Common Inclusion
- Age 18 years or older
- Diagnosed with cancer
- Initiating immune checkpoint inhibitor therapy
- Ability to provide written informed consent
Common Exclusion
- Pregnant or breastfeeding
- Body weight less than 50 kg or BMI greater than 35
- Low baseline hemoglobin (less than 10 g/dL)
- Chronic liver disease or elevated liver function tests
- Chronic kidney disease or eGFR less than 45 mL/min/1.73 m2
- Autoimmune disorders
- History of intolerance to study drugs
- Current infection requiring treatment
- Concomitant systemic immunosuppressant drugs
- Concomitant CYP/transporter probe drugs or strong inhibitors/inducers
- Inability to take oral medication
2: Extracted Trials with New Information
Trials with Special Criteria
Unique or Unusual Criteria
- NCT07389525 — Excludes patients with history of intolerance to specific probe drugs (tizanidine, bupropion, flurbiprofen, omeprazole, dextromethorphan, midazolam, rosuvastatin) used for pharmacokinetic assessment
3: Individual Trial Overviews
NCT07389525
Assessment of Drug-Drug Interactions Between Immune Checkpoint Inhibitors and Cytochrome P450 Substrates: Immune Checkpoint Inhibitor (ICI)-Drug-Drug Interaction (DDI) Study
Organization/Sponsor: Indiana University
Example patient: A 62-year-old male with metastatic melanoma, weighing 75 kg, hemoglobin 12 g/dL, normal liver and kidney function, no autoimmune disease, starting pembrolizumab monotherapy.
Phase N/A
NCT07389525
Assessment of Drug-Drug Interactions Between Immune Checkpoint Inhibitors and Cytochrome P450 Substrates: Immune Checkpoint Inhibitor (ICI)-Drug-Drug Interaction (DDI) Study
Organization/Sponsor: Indiana University
Example patient: A 62-year-old male with metastatic melanoma, weighing 75 kg, hemoglobin 12 g/dL, normal liver and kidney function, no autoimmune disease, starting pembrolizumab monotherapy.
Interventions
-
Immunotherapy: ICI Therapy
Summary: Immune checkpoint inhibitors enhance T-cell responses against cancer by blocking PD-1/PD-L1 and CTLA-4 pathways, including agents like ipilimumab, nivolumab, pembrolizumab, atezolizumab, cemiplimab, durvalumab, relatlimab, and tremelimumab. Source: Summary of Web Search.
Key Inclusion
- ≥18 years old
- Diagnosed with cancer
- Initiating therapy with immune checkpoint inhibitor
- Ability to provide written informed consent
Key Exclusion
- Actively pregnant or breastfeeding
- Body weight <50 kg or BMI >35
- Hemoglobin <10 g/dL
- Chronic liver or kidney disease
- History of autoimmune disorder
- Hypersensitivity to study drugs (tizanidine, bupropion, flurbiprofen, omeprazole, dextromethorphan, midazolam, rosuvastatin)
- Concomitant systemic immunosuppressants
- Concomitant CYP/transporter probe drugs or strong inhibitors/inducers