NCT05313243 · Yale University
Pembrolizumab and Brentuximab Vedotin in Subjects With Relapsed/Refractory T-cell Lymphoma
What this study is about
This is a single treatment group$1, open label, conducted at multiple hospitals 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.
View original scientific description
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.
Interventions
DRUG
Brentuximab vedotin
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.
DRUG
Pembrolizumab
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.
Primary outcome measures
The best overall response with the combination of brentuximab and pembrolizumab.
Time frame: 3 cycles (63 Days)
As assessed by the Lugano criteria for PTCL(16) and the global response score for CTCL(17)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Male/female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of T-cell Non-Hodgkin lymphoma (T-NHL) will be enrolled in this study. 2. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 4. Histologically confirmed T-cell Non-Hodgkin lymphoma (T-NHL), including:
- 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. Presenc
Where
- New Haven, Connecticut
- Boston, Massachusetts
Collaborators
Merck Sharp & Dohme LLC
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 11, 2026 · Source of record for eligibility and locations