Study of Pembrolizumab With Bendamustine in Hodgkin Lymphoma

  • STATUS
    Recruiting
  • End date
    Jun 1, 2026
  • participants needed
    37
  • sponsor
    University Health Network, Toronto
Updated on 22 March 2022

Summary

This is a phase 2 open-label study to test the safety and effectiveness of combining pembrolizumab and bendamustine in patients with relapsed (cancer that has come back or started getting worse) or refractory (cancer that is not responding or has stopped responding to treatment) Hodgkin lymphoma.

Description

Pembrolizumab and bendamustine will be explored as a safe and effective treatment for these patients.

Although current treatment options are available for patients in the relapsed state, once these therapies fail or are not tolerated, treatment options are quite limited.

Pembrolizumab and bendamustine have both shown activity when used as a single agent as treatment for Hodgkin Lymphoma. Their side effect profiles also do not overlap, which makes them ideal to combine, with an intent to increase the amount and duration of complete responses while limiting the toxicities experienced by patients.

Details
Condition Classical Hodgkin Lymphoma, Relapsed Cancer, Refractory Cancer
Treatment Pembrolizumab, bendamustine hydrochloride
Clinical Study IdentifierNCT04510636
SponsorUniversity Health Network, Toronto
Last Modified on22 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Be willing and able to provide written informed consent for the trial and adhere to trial procedures
Have histologically confirmed relapsed (disease progression after most recent therapy) or refractory (failure to achieve complete response [CR] or partial response [PR] to most recent therapy) classical Hodgkin Lymphoma)
Must have received at least standard first line chemotherapy for classical Hodgkin Lymphoma, containing an anthracycline
Must have failed or declined autologous stem cell transplantation (ASCT), or not be a candidate for ASCT
May have received prior therapy with pembrolizumab (or an equivalent checkpoint inhibitor or anti-PD-L1 antibody), but not in combination with bendamustine
May have received a prior autologous stem cell transplant but must be at least ≥100 days post-auto-transplant, and all transplant- related adverse events must have resolved to a grade 1 or less, and patients are not on immunosuppression, and meet all other eligibility criteria
Must have measurable or evaluable disease
Must have Eastern Cooperative Group (ECOG) performance status 0-1
Must have an estimated life expectancy of greater than 90 days
Demonstrate adequate organ and bone marrow function
If female of child-bearing potential, must have a negative pregnancy test within 72 hours prior to the first dose of study treatment
All participants must be willing to use adequate contraception for the duration of treatment with study drugs and continue for 120 days after the last dose of study drug
Must be available for treatment, assessment and follow-up

Exclusion Criteria

There is known severe (≥ Grade 3) hypersensitivity to pembrolizumab or bendamustine
Patient receiving any other investigational agents, or has participated in a study of an investigational agent and has received study therapy or used an investigational device within 4 weeks of the first dose of treatment
Patient is receiving any other, non-investigational, chemotherapy, radiotherapy, small molecule, or biologic agent within 4 weeks of the first dose of treatment, or who has not recovered from adverse events due to a previously administered agent
Patient has had a prior monoclonal antibody within 4 weeks prior to first dose of therapy in the study, or who has not recovered from adverse events due to agents administered more than 4 weeks earlier
Patient has received pembrolizumab, or another anti-PD1, or anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4, or anti-OX-40 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways, with disease progression whilst on therapy, or within 3 months of completion of this line of therapy, without intervening systemic therapy (including chemotherapy, antibody drug conjugates or other targeted agents)
Patient has received prior treatment with bendamustine, either as monotherapy or as part of a combination regimen
Patient has undergone prior allogeneic hematopoietic stem cell transplant
Patient has another concurrent active malignancy (excluding non-melanoma skin cancer or carcinoma in situ of the cervix that has undergone potentially curative therapy), and must be disease-free and off treatment for > 3 years
Patient has known active central nervous system or meningeal disease
Patients with active or past documented autoimmune disease that has required treatment in the past 2 years
Patient is receiving systemic steroid therapy at a dose of > 10 mg/day of prednisone (or equivalent) for 7 days prior to day 1 of study treatment
Has an uncontrolled co-existing illness, including but not limited to: ongoing or active infection requiring systemic therapy; systemic congestive heart failure Class III or IV by NYHA criteria; unstable angina pectoris or cardiac arrhythmia; in patients status post allogeneic transplantation uncontrolled GVHD
Patient has a history of (non-infectious) pneumonitis that has required steroid treatment, or concurrent active pneumonitis
Patient is pregnant, or nursing, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of pembrolizumab and/or bendamustine
Has a known history of Human Immunodeficiency Virus (HIV), active tuberculosis (TB, Mycobacterium tuberculosis), or active hepatitis B or hepatitis C
Patient has received a live vaccine within 30 days prior to first dose of study drugs
Patient is eligible for autologous or allogeneic stem cell transplant, unless patient has declined this, therefore rendering themselves ineligible for stem cell transplantation
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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