RecruitingPhase 2interventionalRules rewrite

Phase 2: testing pembrolizumab for Hodgkin Lymphoma

This study wants to test any good and bad effects of the study drug, pembrolizumab, in combination with GVD in the treatment of Hodgkin lymphoma.

Official registry: https://clinicaltrials.gov/study/NCT03618550 · Memorial Sloan Kettering Cancer Center · enrollment listed as 257

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are pembrolizumab, gemcitabine, or vinorelbine. The registry lists allocation as randomized. This study wants to test any good and bad effects of the study drug, pembrolizumab, in combination with GVD in the treatment of Hodgkin lymphoma.

They plan to enroll about 257 people at 10 sites. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.

Official title (unrewritten)

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

Interventions: pembrolizumab, gemcitabine, vinorelbine, liposomal doxorubicin, Stem cell mobilization and collection, Involved-site radiation therapy

Primary outcome (registry wording): Complete response rate (part 1)

Who it is for (from inclusion criteria)

Ages 18 Years to any
Histologic diagnosis of classical Hodgkin's lymphoma. Primary refractory or relapsed disease proven by biopsy at enrolling institution
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

Who the registry excludes

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 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

Public study contact (from the registry)

Alison Moskowitz, MD

212-639-4839

moskowia@mskcc.org

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

10 listed

City of Hope Cancer Center — Duarte, California (recruiting)
Stanford University Medical Center — Stanford, California (recruiting)
University of Miami — Miami, Florida (recruiting)
Memorial Sloan Kettering Basking Ridge — Basking Ridge, New Jersey (recruiting)
Memorial Sloan Kettering Monmouth — Middletown, New Jersey (recruiting)
Memorial Sloan Kettering Bergen — Montvale, New Jersey (recruiting)
Memorial Sloan Kettering Cancer Center @ Commack — Commack, New York (recruiting)
Memorial Sloan Kettering Westchester — Harrison, New York (recruiting)
Memorial Sloan Kettering Cancer Center — New York, New York (recruiting)
Memorial Sloan Kettering Nassau — Uniondale, New York (recruiting)

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FAQ about this NCT record

Is NCT03618550 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT03618550?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT03618550?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary