What is pembrolizumab and brentuximab vedotin studying for T-cell lymphoma?

This trial is evaluating how well the combination of pembrolizumab and brentuximab vedotin works for adults with relapsed or refractory CD30 positive T-cell lymphoma. Researchers aim to see if this treatment can improve response rates in patients who have had previous therapies. The study is sponsored by Yale University.

Who may be eligible for this T-cell lymphoma clinical trial?

Adults aged 18 or older with a confirmed diagnosis of CD30 positive T-cell lymphoma who have had at least one prior treatment may be eligible. Participants should have good overall health with an ECOG status of 0 or 1, and women should not be pregnant or breastfeeding. Please review eligibility criteria for more details.

Is there any cost to participate in this T-cell lymphoma clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel expenses and other costs related to participation may not be covered and can vary. Participants should plan accordingly.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID05313243

Study of Pembrolizumab and Brentuximab Vedotin for Adults with Relapsed or Refractory CD30 Positive T-cell Lymphoma Evaluating Treatment Response

Led by Yale University · Updated on 2026-06-11

Participants Needed

Research Sites

13 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying a combination of pembrolizumab and brentuximab vedotin in adults with relapsed or refractory CD30 positive T-cell lymphoma, including peripheral and cutaneous types. This phase 2, open-label, single-arm, multicenter study aims to evaluate the overall response rate of this treatment in patients who have previously received at least one therapy. T-cell lymphomas are aggressive with limited effective options, and this study addresses the need for improved treatments by testing this novel drug combination. Participants will receive up to 16 cycles of combined treatment with pembrolizumab and brentuximab vedotin. If their disease responds, pembrolizumab alone will continue for an additional 19 cycles, totaling up to 35 cycles. The drugs are given according to set schedules, and dose adjustments may be made for specific side effects. Response to treatment will be assessed at regular intervals, with the primary outcome based on response after the first 3 cycles. During the study, participants will undergo various assessments including response evaluations, toxicity monitoring, and survival follow-up over two years. Researchers will collect data on disease progression, treatment failure, duration of response, and overall survival. Safety is closely monitored throughout the treatment and follow-up periods. Participants are involved in frequent visits for treatment administration and evaluations over the course of the study until treatment completion or disease progression.

CONDITIONS

Brief Title

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

How This Trial Compares With Other Options

This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.

Factors	Brentuximab vedotin and pembrolizumab (study treatment)	Systemic therapy per guideline/physician's choice
What it is	The investigational treatment is a combination of brentuximab vedotin (an anti-CD30 antibody–drug conjugate) and pembrolizumab (an anti-PD-1 checkpoint inhibitor), given together to adults with relapsed or refractory CD30-positive T-cell lymphomas.	Standard care includes guideline-supported systemic therapies, such as single-agent chemotherapy or targeted therapies, chosen at the physician’s discretion for adults with relapsed or refractory CD30-positive T-cell lymphomas.
Role in study	This was the only active treatment given to all eligible participants in the trial.	These therapies represent the recommended care options outside of trial enrollment, and were not studied as a control arm in this trial.
Primary use	Being studied for the treatment of relapsed or refractory CD30-positive T-cell lymphoma after at least one prior regimen.	Used as standard-of-care therapy for people with relapsed or refractory CD30-positive T-cell lymphomas who are not in clinical trials.
How it is given	Participants received both brentuximab vedotin and pembrolizumab as intravenous infusions, with dosing and schedule as defined in the study protocol.	Standard systemic therapies are administered as intravenous infusions or oral agents, depending on the regimen chosen by the treating physician.
Evidence status	Clinical evidence for this combination in relapsed or refractory CD30-positive T-cell lymphomas is currently based on ongoing investigation in a single-arm study; published outcomes are not yet established.	Guideline-aligned systemic therapies—including brentuximab vedotin monotherapy, methotrexate, and bexarotene—have established clinical trial evidence supporting their use in similar populations.
Important limitations	The combination is being studied in a single-group, non-randomized design, so direct comparison with standard therapies is limited. No mature results from this combination in this population are published yet.	Efficacy and tolerability of standard therapies vary between regimens and patient subtypes. Limited options exist after multiple prior therapies, and outcomes remain suboptimal for some subtypes.

Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Adults aged 18 years or older with confirmed T-cell Non-Hodgkin lymphoma
Written informed consent provided
ECOG performance status of 0 or 1
Diagnosis includes peripheral T-cell lymphoma subtypes, cutaneous T-cell lymphoma, and related forms
CD30 expression over 1% on previous biopsy
Relapsed or refractory disease after at least one prior systemic therapy
Measurable target lesion of at least 1.5 cm for peripheral T-cell lymphoma
Women must not be pregnant or breastfeeding and agree to contraception if of childbearing potential
Men must agree to use contraception and avoid sperm donation during treatment and for 4 months after
Adequate organ and bone marrow function within 10 days before treatment start

You will not qualify if you...

Prior treatment with anti-PD-1, anti-PD-L1, or similar immune checkpoint inhibitors
Diagnosis of adult T-cell leukemia/lymphoma
Recent anti-cancer therapy within 4 weeks before study treatment (exceptions apply)
Pregnant or breastfeeding women or positive pregnancy test at screening
Radiotherapy within 2 weeks before treatment
History or current pneumonitis/interstitial lung disease requiring steroids
Live vaccine within 30 days before treatment
Current participation in another investigational study within 4 weeks
Immunodeficiency, chronic steroid use above 10 mg prednisone daily, or recent immunosuppressive therapy
Active autoimmune disease requiring systemic treatment in the past year
Uncontrolled infection needing systemic therapy
Active myocarditis or severe heart failure
Active or untreated brain metastases
Recent malignancies except certain skin or cervical cancers
Severe hypersensitivity to pembrolizumab or its components
Known HIV, active Hepatitis B or C infection
Conditions or lab abnormalities interfering with study participation
Significant liver disease or current substance abuse
Active tuberculosis
Recent allogeneic stem cell transplant or active graft vs. host disease
Grade 2 or higher peripheral neuropathy

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 35 cycles total

Participants receive up to 16 cycles of combined pembrolizumab and brentuximab vedotin, followed by up to 19 additional cycles of pembrolizumab alone if the disease responds.

Regular visits for treatment and response assessments

Follow-up

Duration - Up to 2 years

Researchers monitor participants for toxicity, progression-free survival, overall survival, and other outcomes for up to 2 years after treatment.

Periodic visits as scheduled