Actively Recruiting
Study of Pembrolizumab With Bendamustine in Hodgkin Lymphoma
Led by University Health Network, Toronto · Updated on 2024-03-22
37
Participants Needed
1
Research Sites
232 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of Pembrolizumab With Bendamustine in Hodgkin Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent and follow trial procedures
- Histologically confirmed relapsed or refractory classical Hodgkin Lymphoma
- Received at least standard first-line chemotherapy containing an anthracycline
- Failed or declined autologous stem cell transplantation (ASCT), or not a candidate for ASCT
- May have had prior pembrolizumab or equivalent checkpoint inhibitor but not combined with bendamustine
- May have had prior autologous stem cell transplant, at least 100 days post-transplant with resolved adverse events and no immunosuppression
- Measurable or evaluable disease
- Eastern Cooperative Group (ECOG) performance status 0-1
- Estimated life expectancy greater than 90 days
- Adequate organ and bone marrow function
- Negative pregnancy test within 72 hours before first study treatment dose for females of child-bearing potential
- Willing to use adequate contraception during treatment and for 120 days after last dose
- Available for treatment, assessment, and follow-up
You will not qualify if you...
- Known severe (grade 3 or higher) allergy to pembrolizumab or bendamustine
- Receiving other investigational agents or participated in investigational studies within 4 weeks before treatment
- Receiving other chemotherapy, radiotherapy, small molecule, or biologic treatments within 4 weeks before treatment or not recovered from prior treatment adverse events
- Prior monoclonal antibody treatment within 4 weeks before treatment or unresolved adverse events from earlier treatments
- Received pembrolizumab or similar checkpoint inhibitors with disease progression during or within 3 months after therapy without intervening systemic treatment
- Prior treatment with bendamustine alone or in combination
- Prior allogeneic hematopoietic stem cell transplant
- Concurrent active malignancy except treated non-melanoma skin cancer or cervical carcinoma in situ, disease-free and off treatment for over 3 years
- Known active central nervous system or meningeal disease
- Active or past autoimmune disease requiring treatment within past 2 years
- Receiving systemic steroids over 10 mg/day prednisone or equivalent for 7 days before study treatment
- Uncontrolled illnesses such as active infection, severe heart failure, unstable angina, arrhythmia, or uncontrolled graft-versus-host disease
- History of steroid-treated pneumonitis or active pneumonitis
- Pregnant, nursing, or planning pregnancy during the study and 120 days after last dose
- Known HIV, active tuberculosis, or active hepatitis B or C
- Received live vaccine within 30 days before study drugs
- Eligible for stem cell transplant but declined it
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
Research Team
J
John Kuruvilla, M.D.
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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