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NCT Number: NCT05324436

A Study of Yervoy and Opdivo Combination Therapy in Participants With Unresectable Advanced/Recurrent Malignant Pleural Mesothelioma (MPM)

The purpose of this study is to observe the safety of the combination therapy with Yervoy and Opdivo in Japanese participants for the treatment of unresectable advanced/recurrent malignant pleural mesothelioma (MPM).

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Key information

Conditions

Mesothelioma, Malignant Adenoma Disease Attributes Lung Diseases Lung Neoplasms Mesothelioma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Mesothelial Pathologic Processes Pathological Conditions, Signs and Symptoms Pleural Neoplasms Recurrence Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution

Shinjuku-ku, Tokyo, 162-0822, Japan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Initiated treatment with Yervoy and Opdivo in combination for the first time in accordance with the Japanese package insert

Exclusion criteria

  • Received combination therapy with Yervoy and Opdivo for indications other than Malignant Pleural Mesothelioma (MPM).
  • Received the Yervoy and Opdivo combination for MPM, but for an indication that is outside of the Japanese package insert.

Treatment and study plan

Primary outcomes

  1. Incidence of Adverse Events (AEs)

    Time frame: Up to 6 Months

  2. Time to onset of serious adverse events (SAEs)

    Time frame: Up to 6 Months

  3. Time to onset of AEs

    Time frame: Up to 6 Months

  4. Time to resolution of AEs

    Time frame: Up to 6 Months

  5. Time to resolution of SAEs

    Time frame: Up to 6 Months

  6. Incidence of physician seriousness assessment measured by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade - Non-serious AE

    Time frame: Up to 6 Months

  7. Incidence of physician seriousness assessment measured by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade - SAE

    Time frame: Up to 6 Months

  8. Incidence of AEs leading to interruption of treatment

    Time frame: Up to 6 Months

  9. Incidence of SAEs leading to interruption of treatment

    Time frame: Up to 6 Months

  10. Incidence of AEs leading to treatment discontinuation

    Time frame: Up to 6 Months

  11. Incidence of SAEs leading to treatment discontinuation

    Time frame: Up to 6 Months

  12. Outcome of reported AEs

    Time frame: Up to 6 Months

  13. Outcome of reported SAEs

    Time frame: Up to 6 Months

  14. Number of participants with Yervoy and Opdivo treatment related adverse events as assessed by physician causality

    Time frame: Up to 6 Months

  15. Number of participants with Yervoy and Opdivo treatment unrelated adverse events as assessed by physician causality

    Time frame: Up to 6 Months

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Special Drug Use Investigation (Survey) of Yervoy and Opdivo Combination Therapy in Patients With Unresectable Advanced/Recurrent Malignant Pleural Mesothelioma (MPM)

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 12, 2022
Registry last updated
Jan 20, 2025

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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