What is pembrolizumab and brentuximab vedotin studying for Hodgkin lymphoma?

Pembrolizumab and brentuximab vedotin are being studied to see if they can better shrink or eliminate classical Hodgkin lymphoma compared to standard chemotherapy. This research aims to find out if these newer drugs improve treatment outcomes for patients whose lymphoma has returned or not responded to previous therapy. The Canadian Cancer Trials Group is leading this study to evaluate these treatments.

Who may be eligible for this Hodgkin lymphoma clinical trial?

Adults aged 18 years or older with classical Hodgkin lymphoma that has relapsed or is refractory after prior chemotherapy may be eligible. Participants must have a good performance status and measurable disease, and be able to complete questionnaires in English or French. People who have had prior salvage therapy or certain health conditions may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this Hodgkin lymphoma clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel expenses and other costs may vary and are not guaranteed to be covered. Participants should consider these potential expenses when deciding to join the trial.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID05180097

Phase II Study Comparing Pembrolizumab and Brentuximab Vedotin Versus Standard GDP Therapy Followed by High-Dose Chemotherapy and Stem Cell Transplant for Relapsed or Refractory Classical Hodgkin Lymphoma

Led by Canadian Cancer Trials Group · Updated on 2026-02-02

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating treatments for people with classical Hodgkin lymphoma that has returned or did not respond to previous therapy. This phase II study compares the effects of two newer drugs, pembrolizumab and brentuximab vedotin, against the current standard salvage treatment combining gemcitabine, dexamethasone, and cisplatin GDP. The aim is to find out if the new drug combination is better or worse at shrinking or eliminating this type of lymphoma. Participants will receive either the standard GDP chemotherapy or the combination of pembrolizumab and brentuximab vedotin. The GDP treatment involves specific doses of gemcitabine and cisplatin given intravenously, plus dexamethasone tablets over several days. The experimental arm receives pembrolizumab and brentuximab vedotin intravenously every 21 days. After these treatments, participants may undergo high dose chemotherapy followed by an autologous stem cell transplant. Treatment starts within two working days of enrollment. During the study, participants will have scans and clinical evaluations to measure how well their lymphoma responds, including complete response rates assessed by PET scans. Researchers will monitor progression-free survival, event-free survival, overall survival, and the success of stem cell collection and transplantation over about 52 months. Participants will also complete quality of life and toxicity questionnaires, and side effects will be recorded. Safety monitoring includes lab tests and assessments throughout treatment and follow-up periods.

CONDITIONS

Brief Title

Pembrolizumab and Brentuximab Vedotin vs GDP and Stem Cell Transplant for Relapsed/Refractory Hodgkin Lymphoma

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

History of classical Hodgkin lymphoma confirmed by biopsy with relapsed or refractory disease after anthracycline chemotherapy
Age 18 years or older
ECOG performance status of 0 or 1
Measurable disease by clinical or radiological methods
Life expectancy greater than 90 days
Adequate blood counts and organ function as specified
Able and willing to complete quality of life questionnaires in English or French
Signed informed consent
Accessible for treatment and follow-up
Treatment to begin within 2 working days of enrollment
Agreed to use effective contraception during and for 6 months after treatment
Tumor biopsy samples available for analysis

You will not qualify if you...

Prior salvage systemic therapy for relapsed or refractory disease
History of peripheral neuropathy or breathing difficulty grade 2 or higher
Other malignancies except certain treated non-melanoma skin, bladder, cervical, breast, or prostate cancers without evidence of disease for over 3 years
Active central nervous system disease
Immunodeficiency or recent systemic steroid or immunosuppressive treatment
Active autoimmune disease requiring treatment in past 3 years or history of allogeneic transplant
Active HIV, hepatitis B or C infections, or uncontrolled systemic infections
Significant cardiovascular disease or recent heart attack
History of stroke or progressive multifocal leukoencephalopathy
Serious medical or psychiatric conditions preventing safe treatment
Recent live vaccine within 4 weeks
Pregnant or breastfeeding, or unwilling to use birth control
Prior infusion reactions to study drugs grade above 2
History of pneumonitis requiring steroids or current pneumonitis
Prior allogeneic transplant
Recent treatment with other investigational drugs or anticancer therapy
Recent radiotherapy within 2 weeks without recovery from side effects

Research Team

Annette Hay

Lois Shepherd

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Phase II Study Comparing Pembrolizumab and Brentuximab Vedotin Versus Standard GDP Therapy Followed by High-Dose Chemotherapy and Stem Cell Transplant for Relapsed or Refractory Classical Hodgkin Lymphoma

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria