NCT05922904

PET Adapted Brentuximab Vedotin and Pembrolizumab in Combination With Doxorubicin and Dacarbazine in Classic Hodgkin Lymphoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To learn about the effects of brentuximab vedotin and pembrolizumab in combination with doxorubicin and dacarbazine when given to patients who have Stage II cHL with bulky mediastinal disease or advanced cHL (Stage III or IV) and who have not received treatment for the disease.

Detailed description

Primary Objectives: ● To assess the complete response (CR) rate at the end of therapy (EOT) with Brentuximab vedotin and pembrolizumab, doxorubicin and dacarbazine in subject with previously untreated stage II bulky mediastinal disease or advanced stage cHL. Secondary Objectives: * To assess the safety of BvP+AD * To assess the complete remission rate at interim PET (CR iPET) * To assess the overall response rate (ORR) * To assess the duration of response (DOR) * To assess the duration of complete response (DOCR) * To assess event-free survival (EFS) * To assess progression free survival (PFS) * To assess overall survival (OS)

Conditions

• Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	Brentuximab vedotin	Given by IV (vein)
DRUG	Doxorubicin Hydrochloride	Given by IV (vein)
DRUG	Pembrolizumab	Given by IV (vein)
DRUG	Dacarbazine	Given by IV (vein)

Timeline

• Start date: 2023-12-14
• Primary completion: 2027-10-30
• Completion: 2027-10-30
• First posted: 2023-06-28
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study