Study in Patients with Relapsed/refractory Primary Mediastinal Lymphoma Treated with Pembrolizumab or Nivolumab in Combination with Brentuximab Vedotin in a Real-life Context

Recruiting

• Conditions: Primary Mediastinal B Cell Lymphoma

• Registration Number: NCT06781450
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

Study Timeline

• Study Start: 2022-04-23
• Status Verified: 2024-10
• Study First Submitted: 2024-12-03
• Study First Submitted QC: 2025-01-13
• Study First Posted: 2025-01-17
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-30
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
overall response rate (ORR)	at the end of treatment, through study completion, an average of 2 years	The study aims to retrospectively evaluate the efficacy in terms of overall response rate (ORR, the sum of complete response \[CR\] and partial response \[PR\] rate) of pembrolizumab as a single agent and nivolumab in combination with brentuximab vedotin in patients with Primary Mediastinal B Cell Lymphoma Relapsed/Refractory treated in a real-life setting from November 2020 through November 2021

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	through study completion, an average of 2 years	Overall Survival (OS)
Disease Free Survival (DFS)	through study completion, an average of 2 years	Disease Free Survival (DFS)
Incidence of Treatment-Emergent Serious Adverse Events [Safety and Tolerability]	through study completion, an average of 2 years	safety and tolerability of pembrolizumab as a single agent and nivolumab in combination with brentuximab vedotin
Duration of Response (DoR)	through study completion, an average of 2 years	Duration of Response (DoR)
Progression Free Survival (PFS)	through study completion, an average of 2 years	Progression Free Survival (PFS)
Best response rate (BRR)	through study completion, an average of 2 years	Best response rate (BRR)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	through study completion, an average of 2 years	safety and tolerability of pembrolizumab as a single agent and nivolumab in combination with brentuximab vedotin

Trial Locations

Locations (3)

Azienda Ospedaliera Universitaria- POLICLINICO BARI; 🇮🇹 Bari, Italy

IRCCS Azienda Ospedaliero - Universitaria di Bologna; 🇮🇹 Bologna, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori; 🇮🇹 Milano, Italy