drugset / Trial / NCT07234487
Comparison of AVD + Low-Dose Nivolumab vs. PET-Adapted BEACOPP-like in Advanced cHL
RandomizedParallel-groupOpen-labelTreatment
Summary
Patients in this prospective multicenter phase II study will be randomized between two first-line therapy strategies for advanced stages of cHL. In the Nivo-AVD cohort, patients will receive 2 cycles of nivolumab monotherapy followed by a switch to Nivo-AVD combination therapy (total of 6 cycles); in the Standard cohort, patients will receive therapy according to current clinical guidelines in Russian Federation for first-line therapy of cHL, which include starting first-line therapy with 2 cycles of BEACOPP-like regimens and, after assessing response after 2 courses, switching to A(B)VD or continuing with BEACOPP-like regimens
Timeline
- Start
- 2024-10-14
- Primary completion
- 2029-10
- Completion
- 2030-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dacarbazine | Small molecule | 375 mg/m2 | — |
| Subject | Doxorubicin | Other / unclassified | 25 mg/m2 | — |
| Subject | Nivolumab | Monoclonal antibody | 40 mg | — |
| Subject | Vinblastine | Small molecule | 6 mg/m2 | — |