Clinical trial NCT05324436: A Study of Yervoy and Opdivo Combination Therapy in Participants With Unresectable Advanced/Recurrent Malignant Pleural Mesothelioma (MPM)
Official title: Special Drug Use Investigation (Survey) of Yervoy and Opdivo Combination Therapy in Patients With Unresectable Advanced/Recurrent Malignant Pleural Mesothelioma (MPM)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mesothelioma, Malignant
Keywords: Malignant pleural mesothelioma (MPM)
Opdivo
Yervoy
Unrectable
Advanced/recurrent
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2022-04-12
Enrollment: 75
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will consist of participants with unresectable advanced/recurrent Malignant Pleural Mesothelioma (MPM) who will start the combination therapy for the first time under daily routine practice in Japan.

Brief summary: 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Adverse Events (AEs)
timeFrame: Up to 6 Months
measure: Time to onset of serious adverse events (SAEs)
timeFrame: Up to 6 Months
measure: Time to onset of AEs
timeFrame: Up to 6 Months
measure: Time to resolution of AEs
timeFrame: Up to 6 Months
measure: Time to resolution of SAEs
timeFrame: Up to 6 Months
measure: Incidence of physician seriousness assessment measured by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade - Non-serious AE
timeFrame: Up to 6 Months
measure: Incidence of physician seriousness assessment measured by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade - SAE
timeFrame: Up to 6 Months
measure: Incidence of AEs leading to interruption of treatment
timeFrame: Up to 6 Months
measure: Incidence of SAEs leading to interruption of treatment
timeFrame: Up to 6 Months
measure: Incidence of AEs leading to treatment discontinuation
timeFrame: Up to 6 Months
measure: Incidence of SAEs leading to treatment discontinuation
timeFrame: Up to 6 Months
measure: Outcome of reported AEs
timeFrame: Up to 6 Months
measure: Outcome of reported SAEs
timeFrame: Up to 6 Months
measure: Number of participants with Yervoy and Opdivo treatment related adverse events as assessed by physician causality
timeFrame: Up to 6 Months
measure: Number of participants with Yervoy and Opdivo treatment unrelated adverse events as assessed by physician causality
timeFrame: Up to 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Shinjuku-ku
country: Japan
facility: Local Institution
state: Tokyo
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: