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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Cologne

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically proven first diagnosis of cHL

Stage I-II without risk factors

Large mediastinal mass

Extranodal involvement

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • Pembrolizumab

    Drug

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

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: PembrolizumabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Progression Free Survival

Time frame
PFS at 1 year

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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