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NCT Number: NCT05740501

Pharmacokinetic Profiling of Pembrolizumab and Nivolumab in Patients With Melanoma and/or Non-Small Cell Lung Cancer

This early phase I study collects blood samples and monitors the levels of pembrolizumab and nivolumab as they move through the body in patients with melanoma and/or non-small cell lung cancer. Pembrolizumab and nivolumab are a monoclonal antibodies that may interfere with the ability of cancer cells to grow and spread. Studying samples of blood in the laboratory from patients receiving pembrolizumab and nivolumab may help doctors learn more about the effects of pembrolizumab and nivolumab on cells. It may also help doctors understand how well patients respond to treatment. Information from this study may be used in the future to guide physicians to make dosage adjustments based on serum concentrations of drug to minimize adverse side effects and maximize the effect of the drug.

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Key information

Conditions

Lung Non-Small Cell Carcinoma Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

PRIMARY OBJECTIVE:

I. To perform a steady-state PK study on patients who are taking monoclonal antibody therapy (25 patients starting pembrolizumab and 25 patients starting nivolumab for melanoma or non-small cell lung cancer).

II. Develop and validate a liquid chromatography tandem mass spectrometry (LC-MS/MS) assay to measure pembrolizumab and nivolumab in serum.

III. Measure patient samples for pembrolizumab/nivolumab at various clinical time points.

IV. Use the pharmacokinetic data (drug concentrations) to determine the area under the curve (AUC), maximum observed serum concentration (Cmax), clearance, half-life (t1/2), and trough steady-state drug concentrations.

V. Compare the data to the clinical efficacy (defined using Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 criteria)1, as well as, presence of auto-immune side effects using multiple variable regression modeling in Statistical Analysis System (SAS) version (v)9.4 or other statistical software.

OUTLINE:

Patients undergo collection of blood samples and have medical records reviewed on study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults who are at steady-state and taking monoclonal antibody therapy with pembrolizumab or nivolumab for melanoma or non-small cell lung cancer. Steady-state for pembrolizumab is week 21 or later and for nivolumab is week 14 or later from the initial infusion

Exclusion criteria

  • Patients not taking pembrolizumab or nivolumab or taking pembrolizumab or nivolumab for other indications (not melanoma or non-small cell lung cancer).

Treatment and study plan

Biospecimen Collection

Procedure

Undergo collection of blood samples

Other names: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Electronic Health Record Review

Other

Medical records are reviewed

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Development and validation of a laboratory developed test (LDT) using liquid chromatography tandem mass spectrometry to measure pemborlizumab and nivolumab.

    Time frame: Up to 1 year

    Verify the accuracy, precision, linearity, sensitivity and specificity of a mass spectrometry assay for pembrolizumab and nivolumab in serum

  2. Measurement of patient samples for pembrolizumab

    Time frame: Through study completion at several time points, an average of 3 weeks after taking pembrolizumab for at least 21 weeks.

    Using a validated LDT liquid chromatography tandem mass spectrometry assay measure the concentration of pembrolizumab in serum.

  3. Measurement of patient samples for nivolumab

    Time frame: Through study completion at several time points, an average of 1 month after taking nivolumab for at least 14 weeks

    Using a validated LDT liquid chromatography tandem mass spectrometry assay measure the concentration of nivolumab in serum.

  4. Correlation of steady-state concentrations of pembrolizumab correlate with clinical efficacy and/or toxicity

    Time frame: Through study completion, an average of 3 weeks after taking pembrolizumab for at least 21 weeks.

    Will assess if therapeutic drug monitoring correlates with efficacy and/or toxicity of pembrolizumab. Concentrations in serum will be determined using a LDT mass spectrometry assay.

  5. Correlation of steady-state concentrations of nivolumab correlate with clinical efficacy

    Time frame: Through study completion, an average of 1 month after taking nivolumab for at least 14 weeks

    Will assess if therapeutic drug monitoring correlates with efficacy and/or toxicity of nivolumab. Concentrations in serum will be determined using a LDT mass spectrometry assay.

  6. Clinical efficacy

    Time frame: After 6 months (24 weeks or more) of treatment

    Tumor response will be determined using Response Evaluation Criteria in Solid Tumors1.1 criteria. Clinical efficacy defined as achieving an objective response (complete response or partial response) versus stable disease, or disease progression.

  7. Presence of auto-immune side effects

    Time frame: Through study completion, an average of 1 month

    Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse events, version 4.0. Investigators will indicate if it was potentially immune related (i.e. grade 3-4 adverse events such as pneumonitis, diarrhea/colitis, hypophysitis/adrenal insufficiency, hyper/hypothyroidism, autoimmune hepatitis, severe skin reactions, nephritis/kidney failure, uveitis, myositis) in combination with other basic laboratory tests that are routinely monitored. Will use multiple variable regression modeling in Statistical Analysis System version 9.4 or other statistical software.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Pharmacokinetic Profiling of Pembrolizumab (Keytruda&Amp;Reg;) and Nivolumab (Opdiva&Amp;Reg;) in Patients With Melanoma and/or Non-Small Cell Lung Cancer: Clinical Validation of a Mass Spectrometry-based Assay

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Feb 23, 2023
Registry last updated
Aug 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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