Pembrolizumab and Brentuximab Vedotin in Subjects With Relapsed/Refractory T-cell Lymphoma

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT05313243
Phase
PHASE2
Status
Recruiting
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Conditions

  • T-Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Brentuximab vedotin — DRUG
    Brentuximab vedotin is an antibody-drug conjugate medication used to treat relapsed or refractory Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (ALCL), a type of T cell non-Hodgkin lymphoma. It selectively targets tumor cells expressing the CD30 antigen, a defining marker of Hodgkin lymphoma and ALCL.
  • Pembrolizumab — DRUG
    Pembrolizumab is a humanized antibody used in cancer immunotherapy that treats melanoma, lung cancer, head and neck cancer, Hodgkin lymphoma, stomach cancer, cervical cancer, and certain types of breast cancer.

Study Details

This is a single arm, open label, multicenter study phase 2 study of pembrolizumab and brentuximab in subjects with relapsed/refractory CD30 positive T-cell lymphoma (including peripheral T-cell lymphoma and cutaneous T-cell lymphoma) who have received at least one prior therapy. We hypothesize that this combination is effective and will produce an overall response rate of \~55%. Pembrolizumab and brentuximab will be administered for 16 cycles in subjects with responsive disease. Pembrolizumab will be continued for an additional 19 cycles (total 35 cycles). Response assessments will occur at pre-specified intervals. For the primary endpoint the response assessment after 3 cycles will be taken into consideration. Dose adjustments for specific toxicities with either drug are detailed in the protocol. Based on statistical analysis 32 subjects will need to be accrued to evaluate for disease response based on historical control.

Key Dates

Start date
Jul 10, 2023
Status verified
May 2026
Primary completion
Apr 30, 2028
Completion
Jul 30, 2028

Study Design

Enrollment
32 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Brentuximab vedotin (brentuximab) and pembrolizumab
    All 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.

Primary Outcome Measure

The best overall response with the combination of brentuximab and pembrolizumab. [ Time Frame: 3 cycles (63 Days) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Yale Smilow Cancer HospitalNew HavenConnecticut06510
Daniel Moncayo
[email protected]
2035000834
Tarsheen Sethi, MD (PRINCIPAL_INVESTIGATOR)
Dana Farber Cancer InstituteBostonMassachusetts02115
Joanne Charles
[email protected]
857-215-2961
David Fisher, MD (SUB_INVESTIGATOR)

Find similar trials in New Haven, CT

By research site
Yale Smilow Cancer Hospital· New Haven, CTDana Farber Cancer Institute· Boston, MA

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