Actively Recruiting
Phase II Study of Second- Line Pembrolizumab Plus GVD for Relapsed or Refractory Hodgkin Lymphoma
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-04-16
257
Participants Needed
10
Research Sites
417 weeks
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to test any good and bad effects of the study drug, pembrolizumab, in combination with GVD in the treatment of Hodgkin lymphoma.
CONDITIONS
Official Title
Phase II Study of Second- Line Pembrolizumab Plus GVD for Relapsed or Refractory Hodgkin Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologic diagnosis of classical Hodgkin's lymphoma with biopsy-proven relapsed or primary refractory disease
- Stage I-III Hodgkin lymphoma (part 3)
- Relapse or refractory disease after 1 line of multi-agent chemotherapy (excluding pembrolizumab-GVD)
- Eligible for high-dose therapy and autologous stem cell transplant (ASCT)
- Achieved complete response (Deauville 3 or better) after 2 cycles of pembrolizumab-GVD
- Willing and able to provide informed consent or assent
- At least 18 years old at consent
- Measurable disease by Lugano 2014 criteria
- ECOG performance status of 0 or 1
- Adequate organ function including:
- Absolute neutrophil count ≥1000 /mcL
- Platelets ≥50,000 /mcL
- Hemoglobin ≥8 g/dL
- Serum creatinine ≤1.5 x ULN or creatinine clearance ≥60 mL/min if creatinine >1.5 x ULN
- Total bilirubin ≤1.5 x ULN or ≤3 x ULN if liver metastases
- AST and ALT ≤2.5 x ULN or ≤5 x ULN if liver metastases
- Hemoglobin-adjusted DLCO ≥50%
- Ejection fraction ≥45%
- INR or PT, aPTT ≤1.5 x ULN unless on anticoagulants within therapeutic range
- Negative pregnancy test within 2 weeks before first dose for females of childbearing potential
- Use of effective contraception for females and males of childbearing potential
- For HIV-infected participants: well-controlled HIV on ART, CD4+ count ≥350 cells/mm3, viral suppression for at least 12 weeks, no recent AIDS-defining infections, stable ART regimen
- Recovery to ≤Grade 1 or baseline from adverse events of prior therapies; endocrine-related AEs treated with hormone replacement or ≤Grade 2 neuropathy allowed
You will not qualify if you...
- More than 1 prior treatment for Hodgkin lymphoma (combined modality counts as 1)
- Known pregnancy or breastfeeding (breastfeeding must stop before treatment)
- Medical illnesses unrelated to Hodgkin lymphoma that make participation unsafe
- Prior radiotherapy within 2 weeks before study treatment start without recovery from toxicities
- Active central nervous system metastases or carcinomatous meningitis
- Active autoimmune disease requiring systemic treatment in past 2 years (replacement therapy excluded)
- Active HIV, Hepatitis B, or Hepatitis C infection
- Live vaccine within 30 days before first dose (killed vaccines allowed)
- History of pneumonitis requiring steroids or current pneumonitis
- Active infection needing systemic therapy
- Not recovered from major surgery or ongoing surgical complications
- Solid organ transplant at any time or allogeneic hematopoietic stem cell transplant within last 5 years (except >5 years without graft-versus-host disease)
- Conditions or abnormalities that could interfere with study participation or results
- Psychiatric or substance abuse disorders interfering with cooperation
AI-Screening
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Trial Site Locations
Total: 10 locations
1
City of Hope Cancer Center (Data Collection Only)
Duarte, California, United States, 91010
Not Yet Recruiting
2
Stanford University Medical Center
Stanford, California, United States, 94305-5408
Not Yet Recruiting
3
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
4
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
5
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States, 07748
Actively Recruiting
6
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States, 07645
Actively Recruiting
7
Memorial Sloan Kettering Cancer Center @ Commack
Commack, New York, United States, 11725
Actively Recruiting
8
Memorial Sloan Kettering Westchester
Harrison, New York, United States, 10604
Actively Recruiting
9
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
10
Memorial Sloan Kettering Nassau
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
A
Alison Moskowitz, MD
CONTACT
H
Heiko Schoder, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
6
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