Actively Recruiting
Pembrolizumab and Brentuximab Vedotin in Subjects With Relapsed/Refractory T-cell Lymphoma
Led by Yale University · Updated on 2025-03-20
32
Participants Needed
2
Research Sites
263 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
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.
CONDITIONS
Official Title
Pembrolizumab and Brentuximab Vedotin in Subjects With Relapsed/Refractory T-cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older with histologically confirmed T-cell Non-Hodgkin lymphoma
- Written informed consent provided by participant or legally acceptable representative
- ECOG performance status of 0 or 1
- Diagnosis includes subtypes such as PTCL NOS, AITL, ALCL, NK/T-cell lymphoma, CTCL (including mycosis fungoides/sezary syndrome), transformed T-cell lymphoma, EATL, SCPTCL, or hepatosplenic T-cell lymphomas
- CD30 expression greater than 1% by immunohistochemistry on previous biopsy
- Relapsed or refractory disease after at least one prior systemic therapy; prior single agent brentuximab allowed unless discontinued due to grade 2 or higher side effects or refractory
- For PTCL patients, presence of at least one measurable target lesion 1.5 cm or larger
- Female participants must not be pregnant or breastfeeding and either not be women of childbearing potential or have a negative pregnancy test within 72 hours before treatment and agree to use acceptable contraception during and for 4 months after treatment
- Male participants must agree to use contraception during treatment and for 4 months after and avoid sperm donation
- Adequate organ and bone marrow function within 10 days prior to starting treatment
You will not qualify if you...
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2 agents, or other T-cell receptor stimulatory or co-inhibitory agents
- Diagnosis of adult T-cell leukemia/lymphoma (ATLL)
- Systemic anti-cancer therapy or investigational agents within 4 weeks prior to starting study treatment (with exceptions for stable use of bexarotene or vorinostat in CTCL)
- Pregnant or breastfeeding females, or positive pregnancy test during screening
- Radiotherapy within 2 weeks prior to study treatment start unless palliative with at least 1-week washout
- History or current pneumonitis/interstitial lung disease requiring steroids
- Receipt of live vaccines within 30 days prior to first dose
- Participation in another investigational study within 4 weeks prior to first dose
- Immunodeficiency or recent use of systemic steroids over 10 mg prednisone equivalent or other immunosuppressive therapy within 7 days
- Active autoimmune disease requiring systemic treatment within past year
- Active uncontrolled infection requiring systemic therapy
- Active myocarditis or severe heart failure (NYHA III-IV)
- Active CNS metastases or carcinomatous meningitis unless stable and off steroids
- Recent malignancies within 1 year except certain skin or cervical/breast carcinoma in situ
- Known severe hypersensitivity to pembrolizumab or its excipients
- Known HIV, active Hepatitis B or C infection
- Conditions or therapies that may interfere with study participation or safety
- Significant liver disease, alcohol abuse, or cirrhosis
- Psychiatric or substance abuse disorders interfering with trial cooperation
- Known active tuberculosis
- Prior allogeneic stem cell transplant within last 5 years or active graft vs. host disease
- Grade 2 or higher peripheral neuropathy
AI-Screening
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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
Research Team
S
Stephanie Ladd, BS
CONTACT
J
Julie Holub
CONTACT
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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