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Trial record 4 of 69 for:    abp 798

Rituximab and Pembrolizumab in Treating Patients With Relapsed or Refractory Follicular Lymphoma or Diffuse Large B Cell Lymphoma

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ClinicalTrials.gov Identifier: NCT03401853
Recruitment Status : Recruiting
First Posted : January 17, 2018
Last Update Posted : November 12, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Washington

Brief Summary:
This phase II trial studies how well rituximab and pembrolizumab work in treating patients with follicular lymphoma or diffuse large B cell lymphoma that has come back or does not respond to treatment. Monoclonal antibodies, such as pembrolizumab and rituximab, may interfere with the ability of cancer cells to grow and spread.

Condition or disease Intervention/treatment Phase
Recurrent Diffuse Large B-Cell Lymphoma Recurrent Follicular Lymphoma Refractory Diffuse Large B-Cell Lymphoma Refractory Follicular Lymphoma Other: Laboratory Biomarker Analysis Biological: Pembrolizumab Biological: Rituximab Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. Overall response rate (ORR) of rituximab and pembrolizumab in relapsed/refractory follicular lymphoma (FL).

II. Overall response rate (ORR) of rituximab and pembrolizumab in relapsed/refractory diffuse large B cell lymphoma (DLBCL).

SECONDARY OBJECTIVES:

I. To evaluate the safety and tolerability of the combination of rituximab and pembrolizumab, and of extended pembrolizumab administered for up to 1 year.

II. To evaluate progression-free survival (PFS), and overall survival (OS) with this combination, in relapsed/refractory FL, and relapsed/refractory DLBCL.

III. To explore treatment outcomes with this combination in patients with rituximab refractory FL.

OUTLINE:

INDUCTION: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Patients also receive rituximab IV on days 1, 8, and 15 of course 1 and on day 1 of course 2. Courses repeat every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.

EXTENDED THERAPY: Patients with at least a partial response receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for up to 2 years (35 doses) in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 90 days.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 37 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Rituximab Plus Pembrolizumab (MK-3475) in Subjects With Relapsed Follicular and Diffuse Large B-Cell Lymphoma
Actual Study Start Date : March 23, 2018
Estimated Primary Completion Date : February 15, 2021
Estimated Study Completion Date : February 15, 2021


Arm Intervention/treatment
Experimental: Treatment (pembrolizumab, rituximab)

INDUCTION: Patients receive pembrolizumab IV over 30 minutes on day 1. Patients also receive rituximab IV on days 1, 8, and 15 of course 1 and on day 1 of course 2. Courses repeat every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.

EXTENDED THERAPY: Patients with at least a partial response receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for up to 2 years (35 doses) in the absence of disease progression or unacceptable toxicity.

Other: Laboratory Biomarker Analysis
Correlative studies

Biological: Pembrolizumab
Given IV
Other Names:
  • Keytruda
  • Lambrolizumab
  • MK-3475
  • SCH 900475

Biological: Rituximab
Given IV
Other Names:
  • ABP 798
  • BI 695500
  • C2B8 Monoclonal Antibody
  • Chimeric Anti-CD20 Antibody
  • CT-P10
  • IDEC-102
  • IDEC-C2B8
  • IDEC-C2B8 Monoclonal Antibody
  • MabThera
  • Monoclonal Antibody IDEC-C2B8
  • PF-05280586
  • Rituxan
  • Rituximab Biosimilar ABP 798
  • Rituximab Biosimilar BI 695500
  • Rituximab Biosimilar CT-P10
  • Rituximab Biosimilar GB241
  • Rituximab Biosimilar IBI301
  • Rituximab Biosimilar PF-05280586
  • Rituximab Biosimilar RTXM83
  • Rituximab Biosimilar SAIT101
  • RTXM83




Primary Outcome Measures :
  1. Overall response rate [ Time Frame: Up to 90 days after the last dose of pembrolizumab ]
    Will be defined as the rate of complete + partial responses using computed tomography (CT) criteria (Lugano 2014).


Secondary Outcome Measures :
  1. Incidence of serious or drug-related adverse events [ Time Frame: Up to 90 days after the last dose of pembrolizumab ]
    Evaluated by the NCI Common Terminology for Adverse Events (CTCAE), version 4.0.

  2. Progression-free survival (PFS) [ Time Frame: Up to 90 days after the last dose of pembrolizumab ]
    The Kaplan-Meier method will be used to estimate median PFS.

  3. Overall survival (OS) [ Time Frame: Up to 90 days after the last dose of pembrolizumab ]
    The Kaplan-Meier method will be used to estimate median OS.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must have relapsed/refractory DLBCL or relapsed/refractory FL

    • For DLBCL, patients must have relapsed after, declined, or considered ineligible for high-dose chemotherapy and autologous stem cell transplantation
    • For FL, in addition to relapsed/refractory disease status, patients must have received therapy with CD20 antibody-directed therapy, and must have an indication for treatment; FL eligibility also requires patients have no standard options with curative potential, nor options with more favorable risk/benefit ratio in the judgment of the investigator
  • Be willing and able to provide written informed consent/assent for the trial
  • Have measurable disease (1.5 cm or greater in the longest diameter of nodal or extranodal disease)
  • Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale
  • Within 28 days of cycle 1 day 1: Absolute neutrophil count (ANC) >= 1,000/mcL
  • Within 28 days of cycle 1 day 1: Platelets >= 75,000/mcL
  • Within 28 days of cycle 1 day 1: Hemoglobin >= 8 g/dL
  • Within 28 days of cycle 1 day 1: Serum creatinine =< 1.5 X upper limit of normal (ULN) OR measured or calculated creatinine clearance (glomerular filtration rate [GFR] can also be used in place of creatinine or creatinine clearance [CrCl]) >= 60 mL/min for subject with creatinine levels > 1.5 X institutional ULN
  • Within 28 days of cycle 1 day 1: Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
  • Within 28 days of cycle 1 day 1: Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X ULN OR =< 5 X ULN for subjects with liver involvement by lymphoma
  • Within 28 days of cycle 1 day 1: Albumin >= 2.5 mg/dL
  • Within 28 days of cycle 1 day 1: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
  • Within 28 days of cycle 1 day 1: Activated (a)PTT =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
  • 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; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
  • Female subjects of childbearing potential must be willing to use an adequate method of contraception; contraception, for the course of the study through 120 days after the last dose of study medication

    • Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
  • Male subjects of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy

    • Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject

Exclusion Criteria:

  • Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment
  • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment, except for physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency which is permitted
  • Has a known history of active TB (Bacillus tuberculosis)
  • Hypersensitivity to pembrolizumab or any of its excipients
  • Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study day 1 or who has not recovered (i.e., =< grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier
  • Prior allogeneic transplant, within the last 5 years
  • Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study day 1 or who has not recovered (i.e., =< grade 1 or at baseline) from adverse events due to a previously administered agent

    • Note: Subjects with =< grade 2 neuropathy are an exception to this criterion and may qualify for the study
    • Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy
  • Has a known additional malignancy that is progressing or requires active treatment; exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer
  • Has known active central nervous system (CNS) metastases and/or lymphomatous meningitis; subjects with previously treated brain metastases or lymphomatous meningitis may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment
  • 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 (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
  • Has known history of, or any evidence of active, non-infectious pneumonitis
  • Has an active infection requiring systemic therapy
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
  • Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment
  • Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent
  • Has a known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)
  • Has known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected)
  • Has received a live vaccine within 30 days of planned start of study therapy

    • Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed

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): NCT03401853


Locations
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United States, Washington
Fred Hutch/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Stephen D. Smith    206-288-6546    ssmith50@seattlecca.org   
Principal Investigator: Stephen D. Smith         
Sponsors and Collaborators
University of Washington
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Stephen Smith Fred Hutch/University of Washington Cancer Consortium

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Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT03401853     History of Changes
Other Study ID Numbers: 9469
NCI-2017-02361 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
9469 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: November 12, 2018
Last Verified: November 2018

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

Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Follicular
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Antibodies
Immunoglobulins
Rituximab
Antibodies, Monoclonal
Pembrolizumab
Antineoplastic Agents, Immunological
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Antirheumatic Agents