Back to search results

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

{ "Pembrolizumab and Brentuximab Vedotin for Relapsed/Refractory T-cell Lymphoma", "This study is testing a combination of two drugs, pembrolizumab and brentuximab vedotin, for people with T-cell lymphoma that has returned or not responded to previous treatments. Pembrolizumab is an immunotherapy that helps your body's immune system fight cancer, and brentuximab vedotin targets specific cancer cells that have a marker called CD30. Researchers want to see how many participants respond to this treatment. You may be able to join if you are at least 18 years old and have a confirmed diagnosis of T-cell lymphoma that has come back or not responded to at least one prior therapy. The study aims to enroll 32 participants.", "design": "This is a single-arm, open-label study, meaning all participants receive the same treatment and both you and the study team will know which drugs are being given. It is a Phase 2 study and plans to enroll 32 participants.", "commitments": "You will receive pembrolizumab and brentuximab vedotin for 16 cycles if your disease responds. Pembrolizumab will then continue for an additional 19 cycles, for a total of 35 cycles. Your response to treatment will be checked regularly.", "compensation": "Not stated in the trial record.", "follow_up": "Your response to treatment will be assessed after 3 cycles (63 days) for the main goal of the study. Pembrolizumab treatment can continue for up to 35 cycles.", }

Study design
Not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05313243

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Yale University
~32 participants
Updated 2026-06-11 on ClinicalTrials.gov
What's tested:Brentuximab vedotinPembrolizumab

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The best overall response with the combination of brentuximab and pembrolizumab.
Measured over 3 cycles (63 Days)

Conditions

T-Cell Lymphoma

Explore related trials

T-Cell Non-Hodgkin LymphomaTNFRSF8 Gene

NCT05313243

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Dana Farber Cancer Institute

    Boston, Massachusettsstudy coordinator listed

    Recruiting

  • Yale Smilow Cancer Hospital

    New Haven, Connecticutstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Tarsheen Sethi, MD · PRINCIPAL_INVESTIGATOR · Yale University

Who to contact

Stephanie Ladd, BS
[email protected]
954-895-0576
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Peripheral T-cell lymphoma not other specified (PTCL nos)
Angioimmunoblastic T-cell lymphoma (AITL)
Anaplastic large-cell lymphoma (ALCL)
Natural killer (NK)/T-cell lymphoma (nodal or extranodal)
Cutaneous T-cell lymphoma (CTCL), including mycosis fungoides (MF)/sezary syndrome
Transformed T-cell lymphoma
Enteropathy-associated T-cell lymphoma (EATL);
Subcutaneous panniculitis-like T-cell lymphoma (SCPTCL)
Hepatosplenic T- cell lymphomas. 5. Presence of CD30 (\>1%) by IHC on a previous biopsy sample 6. Relapsed/refractory disease having failed at least one prior systemic therapy Note: Single agent Brentuximab could have been a prior line of therapy EXCEPT those with ≥ grade 2 side effects leading to treatment discontinuation or those refractory to Brentuximab 7. For patients with peripheral T-cell lymphoma (PTCL): At least one measurable target lesion ≥1.5 cm 8. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
Not a woman of childbearing potential (WOCBP)
A woman of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test during screening within 72 hours prior to receiving first dose of protocol-indicated treatment, and must agree to follow instructions for using acceptable contraception from the time of signing consent, and at least 120 days (4 months) after her final dose of pembrolizumab. 9. A male participant must agree to use contraception during the treatment period and for at least at least 120 days (4 months) after the final dose of pembrolizumab. and refrain from donating sperm during this period. 10. Adequate organ and bone marrow function resulted ≤ 10 days prior to first dose of protocol-indicated treatment:

What this trial measures

  • 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)