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Phase II Study of Pembrolizumab Plus GVD for Relapsed or Refractory Hodgkin Lymphoma

This study is testing the combination of pembrolizumab with GVD (gemcitabine, vinorelbine, and liposomal doxorubicin) for people with Hodgkin lymphoma that has returned or not responded to previous treatments. The main goal is to see how many people have a complete response to the treatment after two years. Researchers will also look at how many people remain free from the disease after five years. You may be able to join if you are 18 or older, have a confirmed diagnosis of classical Hodgkin lymphoma that is relapsed or refractory, and are willing to provide written consent. The study is currently recruiting participants.

Study design
This is an interventional study with a planned enrollment of 257 participants. It is a Phase II study, meaning it's evaluating the effectiveness and safety of the treatment.
What's involved
Participants will receive pembrolizumab, gemcitabine, vinorelbine, and liposomal doxorubicin through IV infusion for 2-4 cycles. After these cycles, you may undergo stem cell mobilization and collection.
Compensation
Not stated in the trial record.
Follow-up
Researchers will assess your complete response rate after 2 years and your freedom from disease after 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03618550

Phase II Study of Second- Line Pembrolizumab Plus GVD for Relapsed or Refractory Hodgkin Lymphoma

Recruiting
PHASE2Ages 18+InterventionalTreatment
Memorial Sloan Kettering Cancer Center
~257 participants
Updated 2026-08-07 on ClinicalTrials.gov
What's tested:pembrolizumabgemcitabinevinorelbineliposomal doxorubicinStem cell mobilization and collectionInvolved-site radiation therapy

At a glance

Recruiting sites
8 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Complete response rate (part 1)
Measured over 2 years
+1 more outcome measured

Conditions

Hodgkin Lymphoma
Relapsed or Refractory Hodgkin Lymphoma

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NCT03618550

Where you'd take part

This study runs at 10 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • City of Hope Cancer Center (Data Collection Only)

    Duarte, Californiastudy coordinator listed

    Not yet recruiting

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jerseystudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Bergen

    Montvale, New Jerseystudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New Yorkstudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Cancer Center @ Commack

    Commack, New Yorkstudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jerseystudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Nassau

    Uniondale, New Yorkstudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Westchester

    Harrison, New Yorkstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Alison Moskowitz, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Alison Moskowitz, MD
[email protected]
212-639-4839
Email the study team

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Eligibility criteria

Inclusion

Histologic diagnosis of classical Hodgkin's lymphoma. Primary refractory or relapsed disease proven by biopsy at enrolling institution.
Be willing and able to provide written informed consent/assent for the trial.
Be ≥ 18 years of age on day of signing informed consent.
PET scan before initiating pembro-GVD have measurable disease based on Lugano 2014 criteria
Have a performance status of 0 or 1 on the ECOG Performance Scale
Demonstrate adequate organ function as defined in table below
Demonstrate adequate organ function as defined in table below. Hematological\*
Absolute neutrophil count (ANC) ≥1000 /mcL
Platelets ≥50,000 / mcL
Hemoglobin ≥8 g/dL Renal
Serum creatinine OR ≤1.5 X upper limit of normal (ULN) OR
Measured or calculated creatinine clearance (eGFR can also be used in place of creatinine) ≥60 mL/min for subject with creatinine levels \> 1.5 X institutional ULN Hepatic\*
Serum total bilirubin ≤ 1.5 X ULN OR ≤ 3 X ULN for subjects with liver metastases
AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases Pulmonary
Hemoglobin-adjusted diffusing capacity for carbon monoxide ≥50% (If unadjusted DLCO is \>/= 50% then there is no need to calculate adjusted) Cardiac
Ejection fraction ≥45% Coagulation
International normalized ratio (INR) OR prothrombin time (PT), Activated partial thromboplastin time (aPTT): ≤ 1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants
Female subject of childbearing potential should have a negative urine or serum pregnancy within 2 weeks prior to receiving the first dose of study medication. On the day of planned treatment, if a blood pregnancy test has not been performed within the two week window, a stat pregnancy test (urine or blood) should be performed and the results reviewed before treatment is begun.
Female subjects of childbearing potential must be willing to use an adequate method of contraception (see details in section 11.4.3).
Male subjects of childbearing potential must agree to use an adequate method of contraception.(see details in section 11.4.3).
HIV-infected participants must have well-controlled HIV on ART, defined as:
Participants on ART must have a CD4+ T-cell count ≥350 cells/mm3 at the time of screening
Participants on ART must have achieved and maintained virologic suppression defined as confirmed HIV RNA level below 50 copies/mL or the LLOQ (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks before screening
It is advised that participants must not have had any AIDS-defining opportunistic infections within the past 12 months.
Participants on ART must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks before study entry (Day 1) and agree to continue ART throughout the study
Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible.

Exclusion

Known pregnancy or breast-feeding.
Breast-feeding should be discontinued prior to treatment initiation.
Medical illness unrelated to Hodgkin's Lymphoma, which, in the opinion of the attending physician and/or principal investigator, makes participation in this study inappropriate.
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.
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). 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.
Has known active HIV, Hepatitis B (e.g., Hepatitis B PCR positive) or Hepatitis C (e.g., HCV RNA \[qualitative\] is detected).
Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed.
Has a history of pneumonitis related to PD-1 blockade that required steroids.
Has an active infection requiring systemic therapy.
Has not adequately recovered from major surgery or has ongoing surgical complications
Has undergone solid organ transplant at any time, or prior allogeneic hematopoietic stem cell transplantation within the last 5 years. (Subjects who have had an allogeneic hematopoietic transplant greater than 5 years ago are eligible as long as there are no symptoms of GVHD.)
Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.

What this trial measures

  • Complete response rate (part 1)2 years

    Response to pembrolizumab-GVD will be assessed using the RECIL criteria.

  • Assess freedom from disease at 5 years (part 3)5 years

    A disease event will be defined as disease relapse after transplant or after maintenance if transplant does not occur, death, or loss to follow-up before the 5-year follow-up period ends.