Clinical trial Recruiting at 10 sites Phase 2 Interventional Ages 18 and up

Testing pembrolizumab with GVD for relapsed Hodgkin lymphoma

Official title: Phase II Study of Second-line Pembrolizumab Plus GVD for Relapsed or Refractory Hodgkin Lymphoma

Run by Memorial Sloan Kettering Cancer Center · NCT03618550 · Data updated 2026-11-12

This study is testing if combining the immunotherapy drug pembrolizumab with GVD can help people with relapsed Hodgkin lymphoma feel better after their previous treatments.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment257 (estimated)
SponsorMemorial Sloan Kettering Cancer Center
Academic / other
Drugs / interventionsradiation, pembrolizumab
Locations10 sites (Duarte, California and 9 other locations)
StatusRecruiting
StartedAugust 1, 2018
Main results expectedAugust 2027
Study endsAugust 2027
Registry record updatedNovember 10, 2026
Trial IDNCT03618550 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 and older with a histologically confirmed diagnosis of classical Hodgkin lymphoma who have relapsed or refractory disease after prior chemotherapy.

Probably not a fit

Patients who have not had a prior line of chemotherapy or those with other types of lymphoma may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effects of pembrolizumab, an immunotherapy drug, in combination with GVD (gemcitabine, vinorelbine, and liposomal doxorubicin) for patients with relapsed or refractory Hodgkin lymphoma. Participants must have a confirmed diagnosis and measurable disease, having previously undergone at least one line of chemotherapy. The study aims to assess both the efficacy and safety of this treatment regimen in improving patient outcomes.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with relapsed or refractory Hodgkin lymphoma.

How similar studies have gone: Other studies have shown promising results with similar immunotherapy approaches in treating Hodgkin lymphoma, indicating potential for success.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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

  \*Lab values for eligibility should be based upon labs prior to Cycle 1 treatment of Pembro-GVD.
* 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 Criteria:

* 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.

Where it's running

  • City of Hope Cancer Center
    Duarte, California, United States
    Recruiting
  • Stanford University Medical Center
    Stanford, California, United States
    Recruiting
  • University of Miami
    Miami, Florida, United States
    Recruiting
  • Memorial Sloan Kettering Basking Ridge
    Basking Ridge, New Jersey, United States
    Recruiting
  • Memorial Sloan Kettering Monmouth
    Middletown, New Jersey, United States
    Recruiting
  • Memorial Sloan Kettering Bergen
    Montvale, New Jersey, United States
    Recruiting
Show 4 more locations
  • Memorial Sloan Kettering Cancer Center @ Commack
    Commack, New York, United States
    Recruiting
  • Memorial Sloan Kettering Westchester
    Harrison, New York, United States
    Recruiting
  • Memorial Sloan Kettering Cancer Center
    New York, New York, United States
    Recruiting
  • Memorial Sloan Kettering Nassau
    Uniondale, New York, United States
    Recruiting

Study contacts

  • Principal investigator: Alison Moskowitz, MD — Memorial Sloan Kettering Cancer Center
  • Study coordinator: Alison Moskowitz, MD
  • Email: moskowia@mskcc.org
  • Phone: 212-639-4839

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.