Skip to main content
OpenTrials
Recruiting

NCT Number: 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

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Primary Mediastinal B Cell Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Azienda Ospedaliero - Universitaria di Bologna, Bologna, Italy

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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
  • Age ≥ 18 years at enrollment
  • Signature of written informed consent (where applicable)

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Duration of Response (DoR)

    Time frame: through study completion, an average of 2 years

    Duration of Response (DoR)

  2. Progression Free Survival (PFS)

    Time frame: through study completion, an average of 2 years

    Progression Free Survival (PFS)

  3. Overall Survival (OS)

    Time frame: through study completion, an average of 2 years

    Overall Survival (OS)

  4. Disease Free Survival (DFS)

    Time frame: through study completion, an average of 2 years

    Disease Free Survival (DFS)

  5. Best response rate (BRR)

    Time frame: through study completion, an average of 2 years

    Best response rate (BRR)

  6. 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

  7. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Cinzia Pellegrini, MD

CONTACT

[email protected]

+390512143680

Pier Luigi Zinzani, MD

CONTACT

[email protected]

+390512144042

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study 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

Acronym: PRIMICI

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jan 17, 2025
Registry last updated
Jan 30, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.