Nivo40-AVD for Advanced Classic Hodgkin Lymphoma

National Medical Research Radiological Centre of the Ministry of Health of Russia

Status and phase: Enrolling; Phase 2

Conditions: Hodgkin Lymphoma, Adult

Treatments: Drug: Nivolumab; Drug: Vinblastine; Drug: Dacarbazine; Drug: Doxorubicin

Study type: Interventional

Funder types: Other

Identifiers

NCT06984146

Nivo40-AVD

Details and patient eligibility

About

The aim of the current trial is to evaluate the efficacy and safety of flat-dose nivolumab (40 mg) in combination with AVD in the management of patients with newly diagnosed advanced classic Hodgkin Lymphoma

Full description

Patients will receive 6 cycles of Nivo40-AVD with interim and EOT PET/CT scan. Interim PET/CT will not affect clinical decisions and is done as part of the study on response predictors after first line PD-1 inhibitor therapy. In patients achieving only partial metabolic response after 6 cycles (Deauville score ≥ 4) radiation therapy is allowed.

Enrollment: 54 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Newly-diagnosed histologically verified advanced stage (IIB-IV as per GHSG) classic Hodgkin lymphoma
2. No past history of autoimmune disease
3. Age > 18 years
4. Ejection fraction > 50%
5. ECOG 0-4

Exclusion criteria

1. Organ failure (e.g. creatinine > 2x ULN; ALT or AST > 5x ULN; bilirubin > 2x ULN; hemodynamic instability; respiratory failure > Grade 1)
2. Uncontrolled infection
3. Pregnancy
4. Inability to sign informed consent

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

54 participants in 1 patient group

Nivo40-AVD

Experimental group

Description:

Nivolumab 40 mg IV day 1 and 15; Doxorubicin 25 mg/m2 IV day 1 and 15; Vinblastine 6 mg/m2 IV day 1 and 15; Dacarbazine 375 mg/m2 day 1 and 15

Treatment:

Drug: Dacarbazine

Drug: Doxorubicin

Drug: Vinblastine

Drug: Nivolumab