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 (Jun 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
Treatments studied
Immunotherapy
Chemotherapy
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 →Frequently asked questions
Is NCT03618550 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior radiotherapy, allogeneic hematopoietic stem cell transplantation disqualifies patients from enrollment.
What disease stage is eligible?
Stage I or II or III is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages