OncoMatch/Clinical Trials/NCT03618550
Phase II Study of Second- Line Pembrolizumab Plus GVD for Relapsed or Refractory Hodgkin Lymphoma
Is NCT03618550 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including pembrolizumab and gemcitabine for hodgkin lymphoma.
Treatment: pembrolizumab · gemcitabine · vinorelbine · liposomal doxorubicin — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Hodgkin Lymphoma
Disease stage
Required: Stage I, II, III
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: multi-agent chemotherapy
Relapse or refractory disease following 1 line of multi-agent chemotherapy (not including pembro-GVD)
Cannot have received: radiotherapy
Exception: must be >2 weeks prior to start of study treatment and recovered from all radiation-related toxicities
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.
Cannot have received: allogeneic hematopoietic stem cell transplantation
Exception: allowed if >5 years ago and no symptoms of GVHD
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.)
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥1000 /mcL; Platelets ≥50,000 / mcL; Hemoglobin ≥8 g/dL
Kidney function
Serum creatinine ≤1.5 X ULN OR measured/calculated creatinine clearance (eGFR can also be used) ≥60 mL/min for subjects with creatinine >1.5 X ULN
Liver function
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
Cardiac function
Ejection fraction ≥45%
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 ≤1.5 X ULN OR measured/calculated creatinine clearance (eGFR can also be used) ≥60 mL/min for subjects with creatinine >1.5 X 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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Miami · Miami, Florida
- Memorial Sloan Kettering Basking Ridge · Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth · Middletown, New Jersey
- Memorial Sloan Kettering Bergen · Montvale, New Jersey
- Memorial Sloan Kettering Cancer Center @ Commack · Commack, New York
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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