Using nivolumab with AVD for advanced Hodgkin lymphoma
Flat-dose Nivolumab (40 mg) in Combination With Doxorubicin, Vinblastine, and Dacarbazine (AVD) for Newly Diagnosed Advanced Classic Hodgkin Lymphoma
This study is testing if a new combination of nivolumab and AVD chemotherapy can help people with newly diagnosed advanced Hodgkin lymphoma feel better and respond well to treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Medical Research Radiological Centre of the Ministry of Health of Russia Academic / other |
| Drugs / interventions | nivolumab, radiation |
| Locations | 1 site (Moscow) |
| Trial ID | NCT06984146 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness and safety of a flat-dose nivolumab (40 mg) combined with AVD chemotherapy in patients with newly diagnosed advanced classic Hodgkin lymphoma. Participants will undergo 6 cycles of treatment, with interim and end-of-treatment PET/CT scans to assess their response. The interim scans will not influence clinical decisions but will help identify response predictors after the initial therapy. If patients show only a partial metabolic response after 6 cycles, they may receive radiation therapy as part of their treatment plan.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with newly diagnosed advanced stage classic Hodgkin lymphoma and no history of autoimmune disease.
Not a fit: Patients with organ failure, uncontrolled infections, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with advanced classic Hodgkin lymphoma.
How similar studies have performed: Other studies have shown promise with PD-1 inhibitors in treating Hodgkin lymphoma, indicating this approach may build on existing successful strategies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Moscow
- P. Hertsen Moscow Oncology Research Institute (MORI) for administrative and economic work - the branch of the FSBI "National Medical Research Radiological Centre" (NMRRC) of the Ministry of Health of the Russian Federation — Moscow, Russia (Recruiting)
Study contacts
- Study coordinator: Mobil Akhmedov, MD, PhD
- Email: mobilakhmedov@gmail.com
- Phone: 79261802399
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.