Phase II Trial of Anti-PD-1 Antibody Treatment and Radiotherapy in Early-stage Favorable Classic Hodgkin Lymphoma (PREFer)

University of Cologne

Status and phase: Not yet enrolling; Phase 2

Conditions: Classical Hodgkin Lymphoma

Treatments: Drug: Pembrolizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT06916416

2024-520138-31-00 (EU Trial (CTIS) Number)

Uni-Koeln-5450

Details and patient eligibility

About

By the implementation of the anti-PD-1 antibody pembrolizumab and given its possible synergy with RT, the aim of the present trial is to develop a chemotherapy-free first-line treatment for patients with newly diagnosed early-stage favorable cHL.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically proven first diagnosis of cHL

• Stage I-II without risk factors

  • Large mediastinal mass
  • Extranodal involvement
  • Elevated erythrocyte sedimentation rate (ESR)
  • Involvement of ≥ 3 nodal areas

Exclusion criteria

• Central nervous system lymphoma, nodular lymphocyte-predominant Hodgkin lymphoma or composite lymphoma,
• Prior cHL-directed treatment
• Prior chemotherapy, RT or allogeneic stem cell/solid organ transplant
• Prior or concurrent disease precluding protocol treatment (for details see section 4.2)
• Pregnancy or breastfeeding
• Non-compliance

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Pembrolizumab

Experimental group

Description:

All patients will receive 6 doses of 200mg Pembrolizumab iv as single agent every three weeks followed by 20Gy radiotherapy

Treatment:

Drug: Pembrolizumab