Skip to main content
TTrialFinderData
TrialFinderData is for informational purposes only and does not provide medical advice. Always talk to your doctor.

Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

A Randomized Phase II Study of Pembrolizumab and Brentuximab Vedotin Versus GDP, Followed by High Dose Chemotherapy and Autologous Stem Cell Transplantation for Relapsed/Refractory Classical Hodgkin Lymphoma

Pembrolizumab and Brentuximab Vedotin vs GDP and Stem Cell Transplant for Relapsed/Refractory Hodgkin Lymphoma (NCT05180097) is a Phase 2 interventional studying Hodgkin Lymphoma, sponsored by Canadian Cancer Trials Group. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Hodgkin Lymphoma and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 84 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Hodgkin Lymphoma subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 - 18 years of age or greater - You should be able to carry out daily activities with 0 level of ability (ECOG 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; platelet count at least 75 x 10\^9/L; blood count (hemoglobin) at least 80 g/L: Bilirubin ≤1.50 x UNL; AST and ALT ≤2.50 x UNL; Serum creatinine \<1.55 x UNL or kidney function (creatinine clearance) at least 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. Who Should NOT Join This Trial: ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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 * 18 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. Exclusion Criteria: * 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 * Participant has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis * Participant has had an allogenic tissue/solid organ transplant * Concurrent or within the previous 4 weeks of randomization, treatment with other investigational drugs or anti-cancer therapy * Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A one-week washout is permitted for palliative radiation (≤ 2 weeks of radiotherapy)

Treatments Being Tested

DRUG

Gemcitabine

1000mg/m2 IV, 30 mins D1, D8

DRUG

Dexamethasone

40mg daily PO, D1-D4

DRUG

Cisplatin

75mg/m2 IV, 1 hour, D1

DRUG

Brentuximab vedotin

1.8 mg/kg IV, 30 mins, Q21 days

DRUG

Pembrolizumab

200mg IV, 30 mins, Q 21 days

Locations (18)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Concord Repatriation General Hospital
Concord, New South Wales, Australia
Shoalhaven Cancer Care Centre
Nowra, New South Wales, Australia
Wollongong Hospital
Wollongong, New South Wales, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Austin Hospital
Heidelberg, Victoria, Australia
Sir Charles Gairdner Hospital
Perth, Western Australia, Australia
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, Canada
BCCA - Vancouver
Vancouver, British Columbia, Canada
Dr. H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, Canada
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada
London Health Sciences Centre Research Inc.
London, Ontario, Canada
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
The Jewish General Hospital
Montreal, Quebec, Canada
The Research Institute of the McGill University
Montreal, Quebec, Canada
CIUSSS de l'Estrie - Centre hospitalier
Sherbrooke, Quebec, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05180097), the sponsor (Canadian Cancer Trials Group), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05180097 clinical trial studying?

This study is being done to determine if two new drugs can shrink or eliminate classical Hodgkins lymphoma. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05180097?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05180097?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05180097. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05180097. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.