Nivolumab and AVD in Early-stage Unfavorable Classical Hodgkin Lymphoma (NIVAHL)

University of Cologne

Status and phase: Completed; Phase 2

Conditions: Classical Hodgkin Lymphoma

Treatments: Drug: Adriamycin; Drug: Vinblastine; Drug: Dacarbazine; Drug: Nivolumab

Study type: Interventional

Funder types: Other

Identifiers

NCT03004833

Uni-Koeln-2854

Details and patient eligibility

About

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.

Enrollment: 110 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Arm A

Experimental group

Description:

4 Cycles of Nivolumab plus AVD followed by IF-RT (30 Gy)

Treatment:

Drug: Nivolumab

Drug: Dacarbazine

Drug: Vinblastine

Drug: Adriamycin

Arm B

Experimental group

Description:

4 Cycles of Nivolumab, followed by 2 cycles of Nivolumab plus AVD, followed by 2 Cycles of AVD followed by IF-RT (30 Gy)

Treatment:

Drug: Nivolumab

Drug: Dacarbazine

Drug: Vinblastine

Drug: Adriamycin