Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma, Large B-Cell, Diffuse

Lymphoma

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Lymphosarcoma

Antineoplastic Agents

All Drugs and Chemicals

Pidilizumab

Antineoplastic Agents, Immunological

Patients receive pidilizumab IV over approximately 5 hours on day 1. Treatment repeats every 42 days for 3 courses in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis

Jane Winter, MD

The purpose of this study is to evaluate pidilizumab and its effect, bad and/or good, on the immune system in relation to its ability to fight cancer cells. Many cancers can be brought to a phase called complete remission (no cancer is found) but have a chance that they may come back. Researchers are working to improve therapy and to find new drugs that lower the chance of disease coming back. This study uses a drug called pidilizumab. The drug targets our immune system. It can change how our immune system finds cancer cells. The drug may kill any remaining cancer cells that we cannot see with computed tomography (CT) scans. The drug, pidilizumab, is being studied in other cancers.

PRIMARY OBJECTIVES:

I. To estimate the rate of response, whereby either cluster of differentiation (CD)4+CD25+programmed death 1 ligand 1 (PD-L1)+ T lymphocytes or CD4+CD62L+CD127+ T lymphocytes has an "increase" following administration of pidilizumab in patients with diffuse large B-cell lymphoma (DLBCL) that have completed induction chemotherapy.

SECONDARY OBJECTIVES:

I. To determine the toxicity and tolerability of pidilizumab therapy following induction chemotherapy.

II. To estimate the progression free survival (PFS) at 2 years. III. To estimate the overall survival (OS) at 2 years. IV. To estimate time to second line chemotherapy (TSLC) at 2 years.

TERTIARY OBJECTIVES:

I. To characterize programmed death 1 (PD-1) pathway specific expression markers from the diagnostic biopsy specimens.

II. To characterize serum biomarkers of immune and inflammatory response during treatment with pidilizumab.

III. To characterize levels of soluble PD-L1 related to treatment with pidilizumab.

OUTLINE:

Patients receive pidilizumab intravenously (IV) over approximately 5 hours on day 1. Treatment repeats every 42 days for 3 courses in the absence of disease progression or unacceptable toxicity.

After completion of treatment, patients are followed up at 30 days and then every 3 months for 2 years.

Pidilizumab in Treating Patients With Stage III-IV Diffuse Large B-Cell Lymphoma Following First Remission

Phase II Study of Pidilizumab (MDV9300) in Patients With Diffuse Large B-Cell Lymphoma Following First Remission

Peripheral blood obtained at day 1 and day 127 will be analyzed and levels will be compared to evaluate for a change (increase/decrease) following treatment with pidilizumab.

Peripheral blood will be tested for serum levels of TNF-α, IFN-γ, IL-2, IL- 7, IL-9, and galectin-1. Levels will be compared from specified time points through treatment.

Tissue sample slides from the diagnostic biopsy will be evaluated by immunohistochemistry for expression of PD-1 and PD-L1. Presence/absence (binary) of PD-1 and PD-L1 will be correlated with response to pidilizumab and clinical outcomes.

Response will be defined as the proportion of CD4+CD25+PD-L1+ T lymphocytes and CD4+CD62L+CD127+ T lymphocytes responders. Responders are defined as either a) a 50% increase or b) a half standard deviation increase in lymphocyte subsets. Lymphocyte subsets will be evaluated by flow cytometry on peripheral blood obtained at specified time points through the treatment period.

Adverse events (AEs) were graded according to the National Cancer Institute's Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0. In general, AEs are graded according to the following:

Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE

To estimate the overall survival (OS) at 2 years

To estimate the progression free survival (PFS) at 2 years. PFS will be defined as time from study enrollment until the first occurrence of disease relapse, progression, re-initiation of cytotoxic chemotherapy, or death due to disease, or until last contact if the patient did not experience any of these.

To estimate time to second line chemotherapy (TSLC) at 2 years

Gateway for Cancer Research

National Cancer Institute (NCI)

Northwestern University

Principal Investigator

The study was designed to collect adverse events at the following timepoints: Start of treatment, and at days 22, 43, 85, 127 and every 3 months for up to 2 years. Due to early termination of the study, AEs for all patients were collected throughout treatment and up until the point of termination of the study.

Patients receive pidilizumab IV over approximately 5 hours on day 1. Treatment repeats every 42 days for 3 courses in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Pidilizumab: Given IV

Treatment (Pidilizumab)

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Study terminated early due to manufacturer decision to discontinue pidilizumab. As a result insufficient data was collected to be analyzed.

Winter, Jane MD

Response to Pidilizumab

Grade 1

Grade 2

Grade 3

Grade 4

Grade 5

This is only based of of 4 patients that received treatment of pidilizumab. Study terminated early due to manufacturer decision to discontinue pidilizumab.

The Frequency and Severity of Toxicity - Number of Grade 1, 2, 3, 4, and 5, Adverse Events Experienced During Treatment of Pidilizumab Defined by NCI CTCAE v 4.03.

Overall Survival (OS)

Progression Free Survival (PFS)

Relapsed Disease

Time to Second Line Chemotherapy (TSLC)

Change in Soluble PD-L1 Levels

Levels of Serum Biomarkers of Immune and Inflammatory Response

PD-1 and PD-L1 Pathway Specific Expression Markers

Completed Treatment

Followed for Survival for 2 Years

Heart and Blood Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Antibodies

Antibodies, Monoclonal

Lenalidomide

Immunoglobulins

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

Patients receive lenalidomide PO daily on days 1-21 and pidilizumab IV over 1-2 hours on day 3. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

lenalidomide

pidilizumab

pharmacological study

laboratory biomarker analysis

Yvonne Efebera

This phase I/II trial studies the side effects and best dose of lenalidomide and pidilizumab and to see how well they work in treating patients with multiple myeloma that has come back (relapsed) or has not responded to treatment (refractory). Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as pidilizumab, can block cancer growth by blocking the ability of cancer to grow and spread. Giving lenalidomide with pidilizumab may work better in treating relapsed or refractory multiple myeloma.

PRIMARY OBJECTIVES:

I. To determine the maximum tolerated dose (MTD), safety and efficacy of CT-011 (pidilizumab) in combination with lenalidomide (Revlimid) and assess efficacy in terms of overall response rate in patients with relapse/refractory multiple myeloma (MM).

OUTLINE: This is a phase I, dose-escalation study followed by a phase II study but this phase did not move forward.

Patients receive lenalidomide orally (PO) daily on days 1-21 and pidilizumab intravenously (IV) over 2 hours on day 3. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days.

Lenalidomide and Pidilizumab in Treating Patients With Relapsed or Refractory Multiple Myeloma

Phase I/II Study of Lenalidomide in Combination With Anti-PD-1 Monoclonal Antibody CT-011 in Patients With Relapsed/Refractory Multiple Myeloma

Extensive immunomonitoring of T and NK cell subsets at baseline and upon completion of each 28-d cycle of therapy will be conducted.

The proportion of responses (partial and complete) will be calculated out of all eligible patients who receive any treatment in that disease group who are included in the phase II assessment. Assuming the number of responses is binomially distributed, 95% binomial confidence intervals will also be calculated for the estimate of the proportion of responses.

OS will be evaluated using the methods of Kaplan-Meier.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pidilizumab in Treating Patients With Stage III-IV Diffuse Large B-Cell Lymphoma Following First Remission	NCT02530125	Stage III Diffu... Stage IV Diffus...	Laboratory Biom... Pidilizumab	18 Years -	Northwestern University
Lenalidomide and Pidilizumab in Treating Patients With Relapsed or Refractory Multiple Myeloma	NCT02077959	Multiple Myelom...	lenalidomide pidilizumab pharmacological... laboratory biom...	18 Years -	Ohio State University Comprehensive Cancer Center
Pidilizumab in Treating Patients With Stage III-IV Diffuse Large B-Cell Lymphoma Following First Remission	NCT02530125	Stage III Diffu... Stage IV Diffus...	Laboratory Biom... Pidilizumab	18 Years -	Northwestern University

Spots Global Cancer Trial Database for pidilizumab

Every month we try and update this database with for pidilizumab cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for pidilizumab

Every month we try and update this database with for pidilizumab cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for pidilizumab cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.