Clinical Trials /

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

NCT03618550

Description:

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.

Related Conditions:
  • Classical Hodgkin Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Phase II Study of Second- Line Pembrolizumab Plus GVD for Relapsed or Refractory Hodgkin Lymphoma
  • Official Title: Phase II Study of Second-line Pembrolizumab Plus GVD for Relapsed or Refractory Hodgkin Lymphoma

Clinical Trial IDs

  • ORG STUDY ID: 18-160
  • NCT ID: NCT03618550

Conditions

  • Hodgkin Lymphoma
  • Relapsed or Refractory Hodgkin Lymphoma

Interventions

DrugSynonymsArms
pembrolizumabpembrolizumab plus GVD
gemcitabinepembrolizumab plus GVD
vinorelbinepembrolizumab plus GVD
liposomal doxorubicinpembrolizumab plus GVD

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
pembrolizumab plus GVDExperimentalPatients will receive 2-4 cycles of pembrolizumab plus GVD
  • pembrolizumab
  • gemcitabine
  • vinorelbine
  • liposomal doxorubicin

Eligibility Criteria

        Inclusion Criteria:

          -  Histologic diagnosis classical Hodgkin's lymphoma.

          -  Primary refractory or relapsed disease proven by excisional or core needle biopsy at
             enrolling institution.

          -  Relapse or refractory disease following 1 line of multi-agent chemotherapy.

          -  Be willing and able to provide written informed consent/assent for the trial.

          -  Be ≥ 10 years of age on day of signing informed consent.

          -  Have measurable disease based on RECIL26

          -  Have a performance status of 0 or 1 on the ECOG Performance Scale.

          -  Demonstrate adequate organ function as defined in table below.

          -  Absolute neutrophil count (ANC) ≥1000 /mcL

          -  Platelets ≥50,000 / mcL

          -  Hemoglobin ≥8 g/dL

          -  Serum creatinine OR ≤1.5 X upper limit of normal (ULN) OR

          -  Measured or calculateda creatinine clearance (GFR can also be used in place of
             creatinine or CrCl) ≥60 mL/min for subject with creatinine levels > 1.5 X
             institutional ULN

          -  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

          -  Hemoglobin-adjusted diffusing capacity for carbon monoxide ≥50%

          -  Ejection fraction ≥45%

          -  Female subject of childbearing potential should have a negative urine or serum
             pregnancy within 72 hours prior to receiving the first dose of study medication.

          -  Female subjects of childbearing potential must be willing to use an adequate method of
             contraception

          -  Male subjects of childbearing potential must agree to use an adequate method of
             contraception.

        Exclusion Criteria:

          -  Received more than 1 prior treatment (combined modality therapy represents 1
             treatment) for Hodgkin Lymphoma

          -  Known pregnancy or breast-feeding.

          -  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 (eg., 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 within 30 days prior to the first dose of study drug.
             Examples of live vaccines include, but are not limited to, the following: measles,
             mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus
             Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection
             are generally killed virus vaccines and are allowed; however, intranasal influenza
             vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.

          -  Has a history of (non-infectious) pneumonitis that required steroids or has current
             pneumonitis.

          -  Has an active infection requiring systemic therapy.

          -  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.)
      
Maximum Eligible Age:N/A
Minimum Eligible Age:10 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:complete response rate
Time Frame:2 years
Safety Issue:
Description:Response to pembrolizumab-GVD will be assessed using the RECIL criteria.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Memorial Sloan Kettering Cancer Center

Trial Keywords

  • Pembrolizumab
  • GVD
  • 18-160

Last Updated

April 25, 2019