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

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ClinicalTrials.gov Identifier: NCT03618550
Recruitment Status : Recruiting
First Posted : August 7, 2018
Last Update Posted : April 2, 2019
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hodgkin Lymphoma Relapsed or Refractory Hodgkin Lymphoma Drug: pembrolizumab Drug: gemcitabine Drug: vinorelbine Drug: liposomal doxorubicin Procedure: Stem cell mobilization and collection Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 39 participants
Intervention Model: Single Group Assignment
Intervention Model Description: This is a phase II study evaluating pembrolizumab plus gemcitabine, vinorelbine, liposomal doxorubicin (GVD) in transplant eligible patients with relapsed or refractory Hodgkin lymphoma following failure of 1-line of multi-agent chemotherapy.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Second-line Pembrolizumab Plus GVD for Relapsed or Refractory Hodgkin Lymphoma
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: pembrolizumab plus GVD
Patients will receive 2-4 cycles of pembrolizumab plus GVD
Drug: pembrolizumab
Age 10-17: 2mg/kg (cap at 200mg), Age ≥ 18: 200 mg (flat) ,Day 1 of each 3 week cycle IV infusion 2-4 cycles (pre-ASCT)

Drug: gemcitabine
1000mg/m^2 Days 1 and 8 of each 3 week cycle IV infusion 2-4 cycles

Drug: vinorelbine
20mg/m^2 Days 1 and 8 of each 3 week cycle IV infusion 2-4 cycles

Drug: liposomal doxorubicin
15mg/m^2 Days 1 and 8 of each 3 week cycle IV infusion 2-4 cycles

Procedure: Stem cell mobilization and collection
Stem cell mobilization and collection will be performed as per standard MSKCC guidelines after 2-4 cycles of pembrolizumab-GVD.




Primary Outcome Measures :
  1. complete response rate [ Time Frame: 2 years ]
    Response to pembrolizumab-GVD will be assessed using the RECIL criteria.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03618550


Contacts
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Contact: Alison Moskowitz, MD 212-639-4839 moskowia@mskcc.org
Contact: Heiko Schoder, MD 212-639-2079

Locations
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United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Craig Moskowitz, MD    305-243-5302      
United States, New Jersey
Memoral Sloan Kettering Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Alison Moskowitz, MD    212-639-4839      
Memoral Sloan Kettering Monmouth Recruiting
Middletown, New Jersey, United States, 07748
Contact: Alison Moskowitz, MD    212-639-4839      
United States, New York
Memorial Sloan Kettering Cancer Center @ Commack Recruiting
Commack, New York, United States, 11725
Contact: Alison Moskowitz, MD    212-639-4839      
Memoral Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: Alison Moskowitz, MD    212-639-4839      
Memorial Sloan - Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Alison Moskowitz, MD    212-639-4839      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Alison Moskowitz, MD    212-639-4839      
Contact: Heiko Schoder, MD    212-639-2079      
Principal Investigator: Alison Moskowitz, MD         
Memorial Sloan Kettering @ Rockville Recruiting
Rockville Centre, New York, United States, 11570
Contact: Alison Moskowitz, MD    212-639-4839      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Alison Moskowitz, MD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03618550     History of Changes
Other Study ID Numbers: 18-160
First Posted: August 7, 2018    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Memorial Sloan Kettering Cancer Center:
Pembrolizumab
GVD
18-160

Additional relevant MeSH terms:
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Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Gemcitabine
Doxorubicin
Pembrolizumab
Vinorelbine
Liposomal doxorubicin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents