Evaluating pembrolizumab and nivolumab treatments for relapsed primary mediastinal lymphoma
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
This study is testing how well two different treatments, pembrolizumab alone and nivolumab with brentuximab vedotin, work for people with relapsed primary mediastinal lymphoma.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Drugs / interventions | pembrolizumab, nivolumab, brentuximab |
| Locations | 3 sites (Bologna, Bologna and 2 other locations) |
| Trial ID | NCT06781450 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on the efficacy and safety of pembrolizumab as a standalone treatment and nivolumab combined with brentuximab vedotin in patients with relapsed or refractory primary mediastinal B cell lymphoma. It is a retrospective, multicenter analysis that evaluates treatment outcomes in a real-life clinical setting from November 2020 to November 2021. The study aims to assess overall response rates, duration of response, progression-free survival, overall survival, and safety profiles of the treatments administered.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a histologically confirmed diagnosis of relapsed or refractory primary mediastinal B cell lymphoma who have received the specified treatments.
Not a fit: Patients who have participated in clinical trials for pembrolizumab or nivolumab in combination with brentuximab vedotin will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into effective treatment options for patients with relapsed or refractory primary mediastinal lymphoma.
How similar studies have performed: While this study is observational and retrospective, similar approaches have shown promise in evaluating treatment efficacy in real-world settings.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bologna, Bologna and 2 other locations
- IRCCS Azienda Ospedaliero - Universitaria di Bologna — Bologna, Bologna, Italy (Recruiting)
- Azienda Ospedaliera Universitaria- POLICLINICO BARI — Bari, Italy (Recruiting)
- Fondazione IRCCS Istituto Nazionale dei Tumori — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Pier Luigi Zinzani, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Pier Luigi Zinzani, MD
- Email: pierluigi.zinzani@unibo.it
- Phone: +390512144042
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.