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

NCT05740501 | Completed

• 2 other identifiers: 17-002103NCI-2023-00069
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Non-Small Cell Carcinoma; Melanoma

Outcome Measures

Primary Outcomes (7)

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

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

  Up to 1 year

• Measurement of patient samples for pembrolizumab

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

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

• Measurement of patient samples for nivolumab

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

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

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

  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.

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

• Correlation of steady-state concentrations of nivolumab correlate with clinical efficacy

  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.

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

• Clinical efficacy

  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.

  After 6 months (24 weeks or more) of treatment

• Presence of auto-immune side effects

  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.

  Through study completion, an average of 1 month

Study Arms (1)

Observational (biospecimen collection, chart review)

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

Procedure: Biospecimen Collection; Other: Electronic Health Record Review; Other: Questionnaire Administration

Interventions

Biospecimen Collection PROCEDURE

Undergo collection of blood samples

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Observational (biospecimen collection, chart review)

Electronic Health Record Review OTHER

Medical records are reviewed

Observational (biospecimen collection, chart review)

Questionnaire Administration OTHER

Ancillary studies

Observational (biospecimen collection, chart review)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with melanoma or non-small cell lung cancer who are taking monoclonal antibody therapy at Mayo Clinic Cancer Center

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Melanoma

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Paul J Jannetto

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 3, 2023
• First Posted: February 23, 2023
• Study Start: April 26, 2017
• Primary Completion: January 3, 2020
• Study Completion: January 3, 2020
• Last Updated: August 4, 2023

Record last verified: 2023-08

Locations

US (1)