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

January 28, 2025 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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

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

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Bari, Italy, 70124
      • Bologna, Italy, 40138
        • Recruiting
        • IRCCS Azienda Ospedaliero - Universitaria di Bologna
        • Contact:
          • Pier Luigi Zinzani, MD
        • Contact:
        • Contact:
      • Milano, Italy, 20133

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall response rate (ORR)
Time Frame: 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
at the end of treatment, through study completion, an average of 2 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

  • Principal Investigator: Pier Luigi Zinzani, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 23, 2022

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

December 3, 2024

First Submitted That Met QC Criteria

January 13, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 28, 2025

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRIMICI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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