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

NCT05180097 | Recruiting Phase 2 DMC

• 1 other identifier: HD11
• Study Type: interventional
• Target: 84
• Locations: 2 countries
• Sites: 18

Brief Summary

This study is being done to determine if two new drugs can shrink or eliminate classical Hodgkins lymphoma.

Conditions

Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

• Complete response rate by PET Deauville criteria (score 1-3) of pembrolizumab and brentuximab vedotin compared to standard GDP (gemcitabine, dexamethasone, cisplatin) given as salvage therapy

  52 months

Secondary Outcomes (12)

• Progression-free survival

  52 months

• Event-free survival

  52 months

• Overall survival

  52 months

• Successful stem cell collection rate

  52 months

• Transplantation rate

  52 months

Study Arms (2)

GDP

ACTIVE COMPARATOR

Drug: Gemcitabine; Drug: Dexamethasone; Drug: Cisplatin

Brentuximab vedotin + Pembrolizumab

ACTIVE COMPARATOR

Drug: Brentuximab vedotin; Drug: Pembrolizumab

Interventions

Gemcitabine DRUG

1000mg/m2 IV, 30 mins D1, D8

GDP

Dexamethasone DRUG

40mg daily PO, D1-D4

GDP

Cisplatin DRUG

75mg/m2 IV, 1 hour, D1

GDP

Brentuximab vedotin DRUG

1.8 mg/kg IV, 30 mins, Q21 days

Brentuximab vedotin + Pembrolizumab

Pembrolizumab DRUG

200mg IV, 30 mins, Q 21 days

Brentuximab vedotin + Pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of classic Hodgkin lymphoma by histopathology and now have relapsed or refractory disease after anthracycline-containing chemotherapy and eligible for high dose chemotherapy and autologous stem cell transplant
• years of age or greater
• ECOG performance status 0-1
• Clinically and/or radiologically measurable disease as per the Lugano 2014 classification
• Life expectancy \> 90 days
• Absolute neutrophils ≥1.0 x 10\^9/L; Platelets ≥75 x 10\^9/L; Hemoglobin ≥80 g/L: Bilirubin ≤1.50 x UNL; AST and ALT ≤2.50 x UNL; Serum creatinine \<1.55 x UNL or Creatinine clearance ≥30 mL/min
• Participant is able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaires and/or health utility in either English or French
• Participant consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each participant must sign a consent form prior to enrollment in the trial to document their willingness to participate.
• Participants must be accessible for treatment and follow-up.
• In accordance with CCTG policy, protocol treatment is to begin within 2 working days of participant enrollment
• Women/men of childbearing potential must have agreed to use a highly effective contraceptive method during the study plus approximately 6 months after treatment completion
• All patients must have a tumour block from their primary diagnostic biopsy and relapse/refractory biopsy if available and the centre/pathologist must have agreed to release the block or recently cut slides for correlative analysis if the participant has consented. If the primary diagnostic biopsy is not accessible, the original pathology report should be submitted for review and a biopsy from the relapse/refractory disease must be submitted.

You may not qualify if:

• Participants who have received prior salvage systemic therapy for their relapsed or refractory disease.
• History of peripheral neuropathy or dyspnea ≥ grade 2
• Participants with a history of other malignancies except: adequately treated non-melanoma skin cancer and superficial bladder cancer, curatively treated in-situ cancer of the cervix or breast, or localized excised prostate cancer, other solid tumours curatively treated with no evidence of disease for \> 3 years
• History of active CNS disease
• Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (at doses more than 10 mg prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first and any dose of trial treatment
• Has active autoimmune disease that has required systemic treatment in the past 3 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs) or history of allogeneic transplantation. Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
• Known history of human immunodeficiency virus (HIV), active Hepatitis C Virus infection, active Hepatitis B Virus infection or any uncontrolled active systemic infection requiring intravenous (IV) antibiotics. Participants that are Hepatitis B core antibody positive are eligible if they are HBV DNA negative and are concurrently treated with anti-viral therapy. Participants with a past history of hepatitis C who have eradicated the virus are eligible
• Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, angina, or myocardial infarction within 6 months of screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification
• Documented history of cerebral vascular event (stroke or transient ischemic attack)
• History of progressive multifocal leukoencephalopathy (PML).
• Any serious active disease or co-morbid medical condition, including psychiatric illness, judged by the local investigator to preclude safe administration of the planned protocol treatment or required follow-up
• Any other serious intercurrent illness, life-threatening condition, organ system dysfunction, or medical condition judged by the local investigator to compromise the subject's safety (for example): active, uncontrolled bacterial, fungal or viral infection; clinically significant cardiac dysfunction or cardiovascular disease
• Participants who have been vaccinated with live, attenuated vaccines within 4 weeks of enrollment
• Pregnant or lactating females, or women/men of childbearing potential not willing to use an adequate method of birth control for the duration of the study through 6 months after the last dose of trial treatment
• Participants are not eligible if they have had a prior infusion reaction to the study drugs or their components \> grade 2

Sponsors & Collaborators

• Canadian Cancer Trials Group: lead
• Merck Sharp & Dohme LLC: collaborator
• Pfizer: collaborator
• Australasian Leukaemia and Lymphoma Group: collaborator

Study Sites (18)

Concord Repatriation General Hospital

Concord, New South Wales, 2139, Australia

RECRUITING

Shoalhaven Cancer Care Centre

Nowra, New South Wales, 2541, Australia

RECRUITING

Wollongong Hospital

Wollongong, New South Wales, 2500, Australia

RECRUITING

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

RECRUITING

Austin Hospital

Heidelberg, Victoria, 3084, Australia

RECRUITING

Sir Charles Gairdner Hospital

Perth, Western Australia, 6009, Australia

RECRUITING

Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta, T2N 5G2, Canada

RECRUITING

BCCA - Vancouver

Vancouver, British Columbia, V5Z 4E6, Canada

RECRUITING

Dr. H. Bliss Murphy Cancer Centre

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

RECRUITING

QEII Health Sciences Centre

Halifax, Nova Scotia, B3H 1V7, Canada

RECRUITING

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, L8V 5C2, Canada

RECRUITING

London Health Sciences Centre Research Inc.

London, Ontario, N6A 5W9, Canada

RECRUITING

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

University Health Network

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

The Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

RECRUITING

The Research Institute of the McGill University

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

CIUSSS de l'Estrie - Centre hospitalier

Sherbrooke, Quebec, J1H 5N4, Canada

RECRUITING

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

RECRUITING

MeSH Terms

Conditions

Hodgkin Disease

Interventions

Gemcitabine; Dexamethasone; Cisplatin; Brentuximab Vedotin; pembrolizumab

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Study Officials

• Kerry Savage

  BCCA-Vancouver Cancer Centre

  STUDY CHAIR

• John Kuruvilla

  University Health Network, Princess Margaret Hospital

  STUDY CHAIR

Central Study Contacts

Annette Hay

CONTACT

613-533-6430; ahay@ctg.queensu.ca

Lois Shepherd

CONTACT

613-533-6430; lshepherd@ctg.queensu.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2021
• First Posted: January 6, 2022
• Study Start: November 1, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 2, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (6); CA (12)