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

ConditionT-Cell Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.

Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

Peripheral T-cell lymphoma not other specified (PTCL nos)

Disqualifiers

Prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).

Patients with adult T-cell leukemia/ lymphoma (ATLL)

Has received prior systemic anti-cancer therapy including investigational agents ≤ 4 weeks prior to first dose of study treatment on Cycle 1, Day 1. Could consider shorter interval for kinase inhibitors or other short half-life drugs.

Pregnant or breast-feeding females. A WOCBP who has a positive urine pregnancy test at screening. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. In the event that 72 hours have elapsed between the screening pregnancy test and the first dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative in order for subject to start receiving study medication.

Trial design

Design model

Single group

Treatments tested in this trial

  • Brentuximab vedotin

    Drug

    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.

  • Pembrolizumab

    Drug

    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.

Treatment groups

32 Participants
are divided into 1 treatment group
Group A: Brentuximab vedotin (brentuximab) and pembrolizumabExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

The best overall response with the combination of brentuximab and pembrolizumab.

As assessed by the Lugano criteria for PTCL(16) and the global response score for CTCL(17)

Time frame
3 cycles (63 Days)

Secondary outcomes

1

Occurrence of toxicity

As assessed by using the NCI Common Terminology Criteria for Adverse Events version 5 (CTCAE v5) for grading

Time frame
2 Years
2

Progression free survival (PFS)

Defined as the time from enrollment to earliest of progression, death or follow-up

Time frame
2 Years
3

Overall survival (OS)

Defined as the time from enrollment to death or last follow-up

Time frame
2 Years
4

Time to treatment failure

Defined as interval from initiation of chemotherapy to premature discontinuation for any reason.

Time frame
2 Years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yale University

Lead sponsor

Merck Sharp & Dohme LLC

Collaborator

Source ClinicalTrials.gov
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