drugset / Trial / NCT07234487

Comparison of AVD + Low-Dose Nivolumab vs. PET-Adapted BEACOPP-like in Advanced cHL

NCT07234487

Phase 2 Recruiting 178 enrolled St. Petersburg State Pavlov Medical University
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

EvaluationDrugModalityDoseRoute
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