Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID05313243

Phase 2 Study of Pembrolizumab and Brentuximab Vedotin in Subjects With Relapsed/Refractory CD30 Positive T-cell Lymphoma

Led by Yale University · Updated on 2025-03-20

32

Participants Needed

2

Research Sites

13 weeks

Total Duration

On this page

Sponsors

Y

Yale University

Lead Sponsor

M

Merck Sharp & Dohme LLC

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the 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, multicenter study aims to assess the overall response rate of this treatment in patients who have received at least one prior therapy. The study addresses the need for improved therapies in these aggressive lymphomas, which often have poor outcomes and limited options after relapse. Participants will receive up to 16 cycles of combined brentuximab and pembrolizumab treatment, followed by up to 19 additional cycles of pembrolizumab alone, totaling 35 cycles. Dose adjustments for specific side effects are detailed in the protocol. Response to treatment will be assessed at specific intervals, with the primary outcome measured after 3 cycles (63 days). During the study, participants will undergo regular evaluations to monitor treatment response and side effects. Assessments include clinical examinations, laboratory tests, and imaging to track disease status. The primary measure is the best overall response to the combination treatment after 3 cycles. Secondary outcomes such as toxicity, progression-free survival, overall survival, and duration of response will be followed for up to 2 years, with ongoing safety monitoring throughout the study.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female participants aged 18 years or older at informed consent
  • Histologically confirmed diagnosis of T-cell Non-Hodgkin lymphoma including PTCL nos, AITL, ALCL, NK/T-cell lymphoma, CTCL, transformed T-cell lymphoma, EATL, SCPTCL, or hepatosplenic T-cell lymphoma
  • Presence of CD30 expression greater than 1% by immunohistochemistry on a previous biopsy
  • Relapsed or refractory disease after at least one prior systemic therapy (some prior Brentuximab use allowed with restrictions)
  • At least one measurable target lesion 1.5 cm or larger for patients with peripheral T-cell lymphoma
  • ECOG performance status of 0 or 1
  • Female participants must not be pregnant or breastfeeding and meet contraception requirements if of childbearing potential
  • Male participants must agree to use contraception during treatment and for 120 days after last dose
  • Adequate organ and bone marrow function within 10 days prior to first treatment
Not Eligible

You will not qualify if you...

  • Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or other T-cell receptor targeted agents
  • Diagnosis of adult T-cell leukemia/lymphoma
  • Systemic anti-cancer therapy within 4 weeks before first study dose (shorter intervals for some drugs allowed)
  • Pregnant or breastfeeding females or positive pregnancy test at screening
  • Radiotherapy within 2 weeks before treatment start unless recovery criteria met
  • History or current pneumonitis or interstitial lung disease requiring steroids
  • Live vaccine within 30 days before first dose
  • Participation in investigational studies within 4 weeks before treatment
  • Immunodeficiency, chronic systemic steroid use above 10 mg prednisone equivalent, or immunosuppressive therapy within 7 days before treatment
  • Active autoimmune disease requiring systemic treatment within the past year
  • Active uncontrolled infection requiring systemic therapy
  • Active myocarditis or severe heart failure (NYHA class III-IV)
  • Active central nervous system metastases or carcinomatous meningitis
  • History of other malignancies unless disease-free for at least 1 year with exceptions
  • Severe hypersensitivity to pembrolizumab or its components
  • Known HIV, active Hepatitis B or C infection
  • Conditions interfering with study participation or results as judged by the investigator
  • Significant liver disease including alcohol abuse or cirrhosis
  • Psychiatric or substance abuse disorders interfering with trial cooperation
  • Known active tuberculosis
  • Prior allogeneic stem cell transplant within 5 years or active graft vs. host disease
  • Grade 2 or higher peripheral neuropathy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for screening and enrollment

Treatment

Duration - Until completion of up to 35 total pembrolizumab doses

Participants receive up to 16 cycles of combined treatment with brentuximab and pembrolizumab, followed by up to 19 additional cycles of pembrolizumab alone.

Visits scheduled for each treatment cycle up to 35 doses

Trial Site Locations

Total: 2 locations

1

Yale Smilow Cancer Hospital

New Haven, Connecticut, United States, 06510

Actively Recruiting

2

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02115

Actively Recruiting

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Research Team

S

Stephanie Ladd, BS

J

Julie Holub

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Frequently Asked Questions

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Published Research Related To This Trial

Brentuximab vedotin or physician's choice in CD30-positive cutaneous T-cell lymphoma (ALCANZA): an international, open-label, randomised, phase 3, multicentre trial.

H Miles Prince, Youn H Kim, Steven M Horwitz...

https://pubmed.ncbi.nlm.nih.gov/28600132

Clinical end points and response criteria in mycosis fungoides and Sézary syndrome: a consensus statement of the International Society for Cutaneous Lymphomas, the United States Cutaneous Lymphoma Consortium, and the Cutaneous Lymphoma Task Force of the European Organisation for Research and Treatment of Cancer.

Elise A Olsen, Sean Whittaker, Youn H Kim...

https://pubmed.ncbi.nlm.nih.gov/21576639

Circulating Tfh1 (cTfh1) cell numbers and PD1 expression are elevated in low-grade B-cell non-Hodgkin's lymphoma and cTfh gene expression is perturbed in marginal zone lymphoma.

Elliot T Byford, Matthew Carr, Eleni Ladikou...

https://pubmed.ncbi.nlm.nih.gov/29293620