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Brentuximab vedotin

Phase 2

Hodgkin Lymphoma | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: Aug 20, 2026

Target and mechanism

Molecular targetTUBB4B, TUBB1, TUBA3C, TUBA4A, TUBB3, TUBA1A
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment25

FDA Designations

No designations recorded

Clinical trial landscape

Brentuximab vedotin · 2 trials · 2 indications

Phase 2 2
NCT05922904PET Adapted Brentuximab Vedotin and Pembrolizumab in Combination With Doxorubicin and Dacarbazine in Classic Hodgkin LymphomaHodgkin Lymphoma
ACTIVE NOT_RECRUITING25 Analytics
NCT05313243Pembrolizumab and Brentuximab Vedotin in Subjects With Relapsed/Refractory T-cell LymphomaT-Cell Lymphoma
RECRUITING32 Analytics
PHASE2ACTIVE NOT_RECRUITING
PET Adapted Brentuximab Vedotin and Pembrolizumab in Combination With Doxorubicin and Dacarbazine in Classic Hodgkin Lymphoma
Hodgkin LymphomaUnlock trial analytics
PHASE2RECRUITING
Pembrolizumab and Brentuximab Vedotin in Subjects With Relapsed/Refractory T-cell Lymphoma
T-Cell LymphomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
through study completion; an average of 1 year.
The best overall response with the combination of brentuximab and pembrolizumab.
3 cycles (63 Days)

As assessed by the Lugano criteria for PTCL(16) and the global response score for CTCL(17)

Secondary Endpoints

Occurrence of toxicity
2 Years
Progression free survival (PFS)
2 Years
Overall survival (OS)
2 Years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part A: Pembrolizumab and Brentuximab +ADEXPERIMENTAL -
Part B: De-EscalationEXPERIMENTAL -
Part C: Standard Risk ArmEXPERIMENTAL -
Brentuximab vedotin (brentuximab) and pembrolizumabEXPERIMENTALAll subjects are scheduled to receive up to 16 cycles of combinatorial treatment with brentuximab + pembrolizumab, followed by up to 19 additional cycles of pembrolizumab monotherapy. After receiving 35 total doses of pembrolizumab (i.e. scheduled for 16 doses in the combinatorial setting and 8 doses as monotherapy), a subject's pembrolizumab treatment will be complete.

Interventions

NameTypeDescription
Brentuximab vedotinDRUGGiven by IV (vein)
Doxorubicin HydrochlorideDRUGGiven by IV (vein)
PembrolizumabDRUGGiven by IV (vein)
DacarbazineDRUGGiven by IV (vein)
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Treatment-naïve, HL subjects with Ann Arbor stage III, IV, or stage II with bulky disease (\>10 cm). 2. Histologically confirmed cHL according to the current World Health Organization Classification (nodular sclerosis, mixed cellularity, lymphocyte rich, lymphocyte depleted, ...

Countries:United States
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Frequently asked questions about Brentuximab vedotin

What is Brentuximab vedotin used for?

Brentuximab vedotin is an investigational antibody-drug conjugate being studied for the treatment of T-Cell Lymphoma and Hodgkin Lymphoma. It is currently in Phase 2 clinical development for these oncology indications. The drug is being evaluated in combination with other agents, including pembrolizumab, in clinical trials.

What does Brentuximab vedotin target?

Brentuximab vedotin is a monoclonal antibody, classified as an antibody-drug conjugate. It is designed to target CD30, a protein expressed on the surface of certain lymphoma cells. By binding to CD30, the drug delivers a cytotoxic agent directly to the cancer cells.

Who makes Brentuximab vedotin?

Brentuximab vedotin is being developed by Merck & Company, Inc., a pharmaceutical company listed on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with T-Cell Lymphoma and Hodgkin Lymphoma.

What phase is Brentuximab vedotin in?

Brentuximab vedotin is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied in active clinical trials for the treatment of T-Cell Lymphoma and Hodgkin Lymphoma.

What clinical trials is Brentuximab vedotin in?

Brentuximab vedotin is being evaluated in two Phase 2 clinical trials. NCT05313243 is studying the drug in combination with pembrolizumab in patients with relapsed or refractory T-cell lymphoma. NCT05922904 is evaluating PET-adapted brentuximab vedotin and pembrolizumab with doxorubicin and dacarbazine in classic Hodgkin lymphoma.

Is Brentuximab vedotin the same as Adcetris?

Brentuximab vedotin is the generic name for the drug also known as Adcetris. The drug is being studied under the name brentuximab vedotin in clinical trials for T-Cell Lymphoma and Hodgkin Lymphoma.