A Study of the Experimental Combination of Mogamulizumab and Pembrolizumab For Relapsed or Refractory Lymphomas

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"Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!"
Age: 18 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: Relapsed and Refractory Lymphoma, Lymphoma, Relapsed Lymphoma, Refractory Lymphoma
Type: Other study, Phase [/1/,/ /2/]
Target:
10 Participants
Investigator:
Description
This study will compare pembrolizumab alone to the combination mogamulizumab plus pembrolizumab. Adding mogamulizumab to pembrolizumab could shrink your cancer. It could also cause side effects.

We hope to learn if this combination is better, the same, or worse than pembrolizumab alone.

The combination mentioned above is not approved by the FDA to treat any kind of cancer.

Mogamulizumab is an experimental drug that is not currently FDA-approved.

Pembrolizumab has already been FDA-approved to treat many cancer types.
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

Inclusion criteria:

  • For phase 1 dose-escalation: patients must have histologically confirmed relapsed or refractory lymphoma for which standard curative or palliative measures do not exist or are no longer effective; this includes non-Hodgkin and Hodgkin lymphomas
  • For phase 2: patients must have histologically confirmed diffuse large B-cell lymphoma; all subtypes of diffuse large B-cell lymphoma are eligible, including high-grade B-cell lymphoma and diffuse large B-cell lymphoma (DLBCL) that has transformed from a prior indolent B-cell non-Hodgkin lymphoma
  • Patients must have measurable disease per 2014 Lugano Classification Criteria which is defined as at least one nodal lesion measuring > 1.5 cm in greatest diameter or at least one extranodal lesion measuring > 1.0 cm in greatest diameter
  • For phase 2: patients and received at least 2 prior lines of therapy and must have previously received or been deemed ineligible for autologous stem cell transplantation
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
  • Absolute neutrophil count >= 1,500/mcL (if neutropenia is related to bone marrow involvement with lymphoma, the absolute neutrophil count must be >= 1,000/mcL)
  • Platelets >= 75,000/mcL (if thrombocytopenia is related to bone marrow involvement with lymphoma, the platelet count must be >= 50,000/mcL)
  • Hemoglobin >= 9 g/dL (if anemia is related to bone marrow involvement with lymphoma, the hemoglobin must be >= 8 g/dL)
  • Total bilirubin within normal institutional limits of < 3X the upper limit of normal in patients with Gilbert's disease
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5x institutional upper limit of normal
  • Creatinine =< 1.5x institutional upper limit of normal OR measured or calculated creatinine clearance if creatinine > 1.5x upper limit of normal (ULN) then creatinine clearance >= 40 mL/min/1.73 m^2 as calculated by Cockcroft and Gault equation
  • Life expectancy of greater than 3 months
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of MK-3475 (pembrolizumab) in combination with KW-0761 (mogamulizumab) administration
  • Submit adequate archival tissue specimen from a biopsy performed after progression of disease on most recent therapy OR subject is willing to undergo a new core or excisional biopsy to obtain evaluable tumor tissue sample for immunohistochemical assessment and sequencing for B2M loss; repeat samples may be required if adequate tissue is not provided
  • Ability to understand and the willingness to sign a written informed consent document
  • Subjects with prior history of chemotherapy-induced or radiation-induced pulmonary toxicity require confirmation of diffuse capacity of the lung for carbon monoxide (DLCO) over 60% (adjusted for hemoglobin) by a pulmonary function test prior to study enrollment

Exclusion criteria:

  • Patients who have had previous systemic anti-cancer therapy within 3 weeks of registration or those who have not recovered from adverse events due to agents administered previously
  • Note: Patients are considered enrolled on the study after protocol registration and not after signing consent
  • Patients who are receiving any other concurrent investigational agents
  • Patient is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment; the use of physiologic doses of corticosteroids may be approved after consultation with the study principal investigator (PI); topical or inhaled corticosteroids are allowed
  • Has a known additional malignancy that is progressing or requires active treatment; exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cervical cancer
  • Patients with known cerebral or meningeal involvement by lymphoma should be excluded from this clinical trial
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to MK-3475 (pembrolizumab) or KW-0761 (mogamulizumab)
  • Subject with active autoimmune disease; subjects with vitiligo, eczema, alopecia, type I diabetes mellitus, psoriasis not requiring systemic treatment, or endocrine deficiencies (such as hypothyroidism) managed with replacement hormones, including physiologic corticosteroid replacement therapy are eligible
  • Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator
  • Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
  • Prior allogeneic stem cell transplant (SCT)
  • Patients who are planning to receive allogeneic SCT in the future
  • Autologous SCT =< 90 days prior to first dose of study drug
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, interstitial lung disease or active, non-infectious pneumonitis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with MK-3475
  • Patients are excluded from this study if pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 180 days after the last dose of trial treatment
  • Patients with human immunodeficiency virus (HIV) are excluded if they have a detectable viral load, are not on a stable antiretroviral regimen, have a decreased CD4+ T-cell count (< 500), or require prophylactic antibiotics for the prevention of opportunistic infections
  • Has known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active hepatitis C virus (defined as HCV ribonucleic acid [RNA] [qualitative] is detected) infection
  • Note: No testing for hepatitis B and hepatitis C is required unless mandated by local health authority
  • Has a known history of active tuberculosis (TB)
  • Patients with significant cardiac disease (e.g., New York Heart Association [NYHA] class III-IV congestive heart failure, unstable angina, recent myocardial infarction within the last 6 months, etc.)
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will not be paid to take part in this research study.
Resources
Schedule
Study duration and period
You will be in the study until your disease gets worse or the side effects become too severe. You will receive a maximum of 2 years of treatment.
Recruitment period
From Oct. 2, 2018
Location
UC Davis Comprehensive Cancer Center
4501 X Street
Sacramento, CA 95817
Contact
Christina Romo
Research Topic
Conditions:
  • Diffuse Large B-Cell Lymphoma
  • Recurrent Hodgkin Lymphoma
  • Recurrent Non-Hodgkin Lymphoma
  • Refractory Hodgkin Lymphoma
  • Refractory Non-Hodgkin Lymphoma

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


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