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New treatment option for Classical Hodgkin Lymphoma
Official title Study of Pembrolizumab With Bendamustine in Hodgkin Lymphoma
ClinicalTrials.gov ID: NCT04510636
What this study is testing
What is Pembrolizumab?
Pembrolizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for classical hodgkin lymphoma.
Also referred to as KEYTRUDA.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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).
You likely can't join if
- 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...
- Patient is receiving any other, non-investigational, chemotherapy, radiotherapy, small molecule, or biologic agent within 4 weeks of the first dose...
- 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...
- 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...
- Patient has received prior treatment with bendamustine, either as monotherapy or as part of a combination regimen.
See the full eligibility criteria
Who can 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.
- 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...
- 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...
- 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...
- 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.
What rules you out
- 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...
- 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)...
- 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...
- 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 \>...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.