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Classical Hodgkin LymphomaPhase 2NCT04510636

Study of Pembrolizumab With Bendamustine in Hodgkin Lymphoma

A Phase 2 study testing Pembrolizumab and Bendamustine Hydrochloride in people with Classical Hodgkin Lymphoma and Relapsed Cancer, run by University Health Network, Toronto at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pembrolizumab and Bendamustine Hydrochloride
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteCanada
Study dates
20 Dec 2021to 1 Nov 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Be willing and able to provide written informed consent for the trial and adhere to trial procedures.
  • Be age ≥18 years at the time of signing informed consent.
  • Have histologically confirmed relapsed (disease progression after most recent therapy) or refractory (failure to achieve CR or PR to most recent therapy) classical Hodgkin Lymphoma (RR HL).
  • Must have received at least standard first line chemotherapy for classical Hodgkin Lymphoma, containing an anthracycline, i.e. ABVD or BEACOPP.
  • Must have failed or declined autologous stem cell transplantation (ASCT), or not be a candidate for ASCT (as per institutional criteria).
  • May have received prior therapy with pembrolizumab (or an equivalent checkpoint inhibitor or anti-PD-L1 antibody), but not in combination with bendamustine.
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  • 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, as defined as at least one lesion that can be accurately measured in at least 2 dimensions by CT/PET scan. The minimum measurement must be >15 mm in the longest dimension or >10 mm in the short axis. Baseline FDG-PET scan must be positive (i.e. FDG-avid HL). Measurements must be done within 28 days prior to trial inclusion..
  • 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. All screening laboratory tests should be performed within 7 days of treatment initiation.
  • If FOCBP (defined as any female who has experienced menarche and who has not undergone surgical sterilization (i.e. hysterectomy or bilateral oophorectomy) and is not postmenopausal (menopause is defined as 12 months of amenorrhea in a woman over the age of 45 years in the absence of other biological or physiological causes), eligible patients must have a negative pregnancy test within 72 hours prior to the first dose of study treatment. If the urine test is positive, a serum pregnancy test will be required.
  • 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.
  • If male, and sexually active with FOCBP, must agree to use adequate contraception for the duration of treatment with study drugs and continue for 120 days after the last dose of study drug.
  • Azoospermic male, or male and FOCBP who are continuously not heterosexually active, are exempt from contraceptive requirements. However, they must still undergo pregnancy testing as described.
  • Must be available for treatment, assessment and follow-up.

Who cannot join

  • There is known severe (≥ Grade 3) hypersensitivity to pembrolizumab or bendamustine.
  • Patient receiving any other investigational agents, or on current treatment for RR HL, 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.
  • Note: Subjects who have entered the follow-up phase of an investigational trial may participate as long as it has been 4 weeks since the last dose of the previous investigational agent.
  • 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 (i.e., ≤Grade 1 or to baseline) from AEs 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).
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

John Kuruvilla, M.D. contact

416-946-2821

john.kuruvilla@uhn.ca

Canada1 site, 1 recruiting

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

    John Kuruvilla, M.D., 416-946-2821

    John Kuruvilla, M.D.

    Recruiting

Other trials in Canada

About this study

Official title: Phase 2 Study Evaluating the Safety and Efficacy of Pembrolizumab (KEytruda) in Combination With Bendamustine (TREanda) in Relapsed/Refractory Hodgkin Lymphoma

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.

Read the detailed 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.

Being tested
Pembrolizumab, Bendamustine Hydrochloride
Medical subject headings
Recurrence, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PembrolizumabDrug

    Also called KEYTRUDA

    Pembrolizumab is a intravenously administered humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2.

  • Bendamustine HydrochlorideDrug

    Also called TREANDA

    Bendamustine is a unique alkylating agent with substantial activity in hematologic malignancies.

Study groups in NCT04510636
Study groupRoleWhat they receive
Pembrolizumab and BendamustineExperimentalThe study drugs will be given in 3 week periods called cycles. Pembrolizumab is available in powder form or as a liquid for infusion. Pembrolizumab at a dose of 200 mg will be given over 30 minutes, once every cycle for up to 35 cycles (approximately 24 months). Bendamustine is available in powder form for injection. Bendamustine at a dose of 90 mg/m2 will be given over 60 minutes, on Days 1 and 2 of every cycle for up to 6 cycles.
Receives: Drug: Pembrolizumab; Drug: Bendamustine Hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response rate

    Complete response + partial response

    Measured: 5 years

  2. Complete response rate as determined by Lugano criteria

    Assessed by positron emission tomography (PET)/computed tomography (CT) scans

    Measured: 5 years

Secondary outcomes (4)

  1. Incidence of adverse events

    duration from start of study until end

    Measured: 5 years

  2. Overall survival rate

    for the duration of study

    Measured: 5 years

  3. Progression-free survival rate

    for the duration of study

    Measured: 5 years

  4. Average duration of response

    for the duration of study

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2020
  2. Study start20 Dec 2021
  3. Primary completion1 Nov 2026 (estimated)
  4. Study completion1 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04510636
Sponsor's protocol ID
KEsTREL-01
Other IDs
CAPCR 20-5231
Status last verified
Jun 2026
First submitted
9 Aug 2020
Last updated
23 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab and Bendamustine Hydrochloride in people with Classical Hodgkin Lymphoma and Relapsed Cancer, run by University Health Network, Toronto at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact John Kuruvilla, M.D. (416-946-2821, john.kuruvilla@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04510636.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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