Clinical trial NCT06781450: Study in Patients With Relapsed/Refractory Primary Mediastinal Lymphoma Treated With Pembrolizumab or Nivolumab in Combination With Brentuximab Vedotin in a Real-life Context
Official title: Retrospective Observational Study in Patients With Relapsed / Refractory Primary Mediastinal Lymphoma Treated With Pembrolizumab or Nivolumab in Combination With Brentuximab Vedotin in a Real-life Context
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Primary Mediastinal B Cell Lymphoma
Keywords: pembrolizumab
nivolumab
brentuximab vedotin
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-01-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Primary Mediastinal B Cell Lymphoma Relapsed/Refractory treated with pembrolizumab as a single agent and nivolumab in combination with brentuximab vedotin in a real-life context with till Novembre 2021

Brief summary: Observational, Non-Interventional, Retrospective, Multicenter Study Focusing on the Efficacy and Safety of Pembrolizumab Monotherapy and Nivolumab in Combination With Brentuximab Vedotin in Clinical Practice Patients With Primary Mediastinal B Cell Lymphoma Relapsed/Refractory

Detailed description: Observational, non-interventional, retrospective, multicentre study focusing on the efficacy and safety of pembrolizumab as monotherapy and nivolumab in combination with brentuximab vedotin in daily clinical practice in patients with Primary Mediastinal B Cell Lymphoma Relapsed/Refractory. The study aims to retrospectively evaluate the efficacy in terms of overall response rate (ORR, sum of complete response rate \[CR\] and partial response rate \[PR\]) of pembrolizumab as a single agent and nivolumab in combination with brentuximab vedotin in patients with Primary Mediastinal B Cell Lymphoma Relapsed/RefractoryL treated in a real-life setting from November 2020 until November 2021.

Secondary objectives

* To assess efficacy, in terms of:
* Duration of response (DoR)
* Progression-free survival (PFS)
* Overall survival (OS)
* Disease-free survival (DFS)
* Best response rate (achieved at any time during treatment)
* To evaluate the safety and tolerability of pembrolizumab as a single agent and nivolumab in combination with brentuximab vedotin The study will include patients with Primary Mediastinal B Cell Lymphoma Relapsed/Refractory treated with pembrolizumab as a single agent and nivolumab in combination with brentuximab vedotin in a real-life setting from November 2020 until November 2021.

Eligibility criteria: Inclusion Criteria:

1. Histologically confirmed diagnosis of Primary Mediastinal B Cell Lymphoma Relapsed/Refractory patients who underwent pembrolizumab as a single agent and nivolumab in combination with brentuximab vedotin in a real-life context with till Novembre 2021
2. Age ≥ 18 years at enrollment
3. Signature of written informed consent (where applicable)

Exclusion Criteria:

1. Primary Mediastinal B Cell Lymphoma Relapsed/Refractory patients who underwent pembrolizumab as a single agent and nivolumab in combination with brentuximab vedotin in a clinical trial context.

Primary outcomes:
measure: overall response rate (ORR)
timeFrame: at the end of treatment, through study completion, an average of 2 years
Secondary outcomes:
measure: Duration of Response (DoR)
timeFrame: through study completion, an average of 2 years
measure: Progression Free Survival (PFS)
timeFrame: through study completion, an average of 2 years
measure: Overall Survival (OS)
timeFrame: through study completion, an average of 2 years
measure: Disease Free Survival (DFS)
timeFrame: through study completion, an average of 2 years
measure: Best response rate (BRR)
timeFrame: through study completion, an average of 2 years
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: through study completion, an average of 2 years
measure: Incidence of Treatment-Emergent Serious Adverse Events [Safety and Tolerability]
timeFrame: through study completion, an average of 2 years
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Azienda Ospedaliera Universitaria- POLICLINICO BARI
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero - Universitaria di Bologna
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Pier Luigi Zinzani, MD
role: PRINCIPAL_INVESTIGATOR
References: