Nivolumab and AVD in Early-stage Unfavorable Classical Hodgkin Lymphoma

• Status: Active, not recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the trial is to improve first-line treatment for early unfavorable cHL by introduction of the anti-PD-1 antibody Nivolumab with a truncated standard chemotherapy (AVD).

The primary objective is to show efficacy of the two experimental treatment strategies. Secondary objectives are to further evaluate efficacy, show safety and feasibility and perform correlative studies.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Cologne
• Treatments: Antibodies, Monoclonal; Dacarbazine; Doxorubicin; Liposomal doxorubicin; Nivolumab; Vinblastine

Criteria

Inclusion Criteria:

• Histologically proven classical HL

• First diagnosis, no previous treatment

• Age: 18-60 years

• Stage I, IIA with risk factors a-d, IIB with RF c-d:

1. large mediastinal mass

2. extranodal lesions

3. elevated ESR

4. ≥ 3 nodal areas confirmed by central review.

Exclusion Criteria:

• Composite lymphoma or nodular lymphocyte- predominant Hodgkin lymphoma (NLPHL)

• History of other malignancy ≤ 5 years

• Prior chemotherapy or radiation therapy

• Concurrent disease precluding protocol treatment

• Pregnancy, lactation

• Non-compliance