Health TrialsbyHealthPanel

Study of Pembrolizumab With Bendamustine in Hodgkin Lymphoma

ConditionsClassical Hodgkin LymphomaRelapsed CancerRefractory Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Pembrolizumab

    Drug

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

  • Bendamustine Hydrochloride

    Drug

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

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Pembrolizumab and BendamustineExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Overall response rate

Complete response + partial response

Time frame
5 years
2

Complete response rate as determined by Lugano criteria

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

Time frame
5 years

Secondary outcomes

1

Incidence of adverse events

duration from start of study until end

Time frame
5 years
2

Overall survival rate

for the duration of study

Time frame
5 years
3

Progression-free survival rate

for the duration of study

Time frame
5 years
4

Average duration of response

for the duration of study

Time frame
5 years

Other outcomes

Sponsors and contacts

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

University Health Network, Toronto

Lead sponsor

Source ClinicalTrials.gov
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