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Avelumab In Combination Regimens That Include An Immune Agonist, Epigenetic Modulator, CD20 Antagonist and/or Conventional Chemotherapy in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL) (Javelin DLBCL)

Primary Purpose

Diffuse Large B-Cell Lymphoma

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Avelumab

Utomilumab

Rituximab

Azacitidine

Bendamustine

Gemcitabine

Oxaliplatin

About this trial

This is an interventional treatment trial for Diffuse Large B-Cell Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

-Any of the following as defined by the WHO, 2016 lymphoid neoplasm classifications and histologically confirmed:

Diffuse large B-cell lymphoma (DLBCL), Not Otherwise Specified (NOS): Germinal center B-cell type (GCB), Activated B-cell type (ABC)
High-grade B-cell lymphoma (HGBCL) NOS
HGBCL with MYC and BCL2 and/or BCL6 rearrangements
T-cell histocyte-rich large B-cell lymphoma
EBV+ DLBCL, NOS
HHV8+ DLBCL, NOS

Relapsed or refractory disease following at least 2 lines (and a maximum of 4 lines) of prior rituximab containing multi-agent chemotherapy which may include an autologous stem cell transplantation unless patients are not considered suitable for intensive second-line chemotherapy or autologous stem cell transplantation. Patients who are ineligible for intensive second line chemotherapy,must have received at least one prior rituximab-containing combination chemotherapy regimen. Patients who are ineligible for intensive second line chemotherapy, must have received at least one prior rituximab-containing combination chemotherapy regimen.

Baseline measurable disease with at least 1 bi dimensional lesion with longest diameter (LDi) >1.5cm on CT scan which is FDG avid on PET scan.
A biopsy (archived or Screening/recent) will be collected at Screening.
At least 18years of age (or ≥20 years in Japan).
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.

Key Exclusion Criteria:

Active central nervous system (CNS) lymphoma.
Prior organ transplantation including prior allogeneic SCT.
Prior therapy with an anti PD 1, anti PD L1, anti PD L2, anti CD137, or anti cytotoxic T lymphocyte associated antigen 4 (CTLA 4) antibody (including ipilimumab, tremelimumab or any other antibody, or drug specifically targeting T cell co stimulatory or immune checkpoint pathways).

Sites / Locations

City of Hope
Norton Cancer Institute
Norton Diagnostic Center - Dupont
Norton Women's and Children's Hospital
Tulane Medical Center
Parexel International
University of Michigan Health System
Mayo Clinic
North Shore Hematology Oncology Associates
St. George Hospital
Monash Health
Cancer Clinical Trials Centre, Austin Health, Level 4
Genesis Care
UZ Gent
UZ Leuven
Farmacia Studi Clinici
Istituto Clinico Humanitas
Samsung Medical Center Clinical Trial Pharmacy
Samsung Medical Center
Centrum Onkologii Ziemi Lubelskiej im. Sw. Jana z Dukli
Malopolskie Centrum Medyczne S.C.
Nzoz McD Voxel Osrodek Pet-Tk-Nmr
Centrum Onkologii Ziemi Lubelskiej im. Sw. Jana z Dukli Oddzial Hematologiczny
NU-MED Centrum Diagnostyki i Terapii Onkologicznej Zamosc Sp. z o.o.
Hospital San Pedro de Alcantara
Hospital San Pedro de Alcantara
Centro de Investigación Medicina Especializada Sanitaria (CIMES)
Hospital Universitario Virgen de la Victoria
The Christie NHS Foundation Trust
The Christie Pathology Partnership

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Arm Label

Phase 1b Arm A

Phase 1b Arm B

Phase 1b Arm C

Phase 3 Arm D (selected from Phase 1b)

Phase 3 Arm E

Arm Description

avelumab/utomilumab/rituximab

avelumab/utomilumab/azacitidine

avelumab/rituximab/bendamustine

Selected regimen from Phase 1b component which may be i) avelumab/utomilumab/rituximab OR ii) avelumab/rituximab/azacitidine OR iii) avelumab/rituximab/bendamustine

Investigator's Choice of either rituximab/bendamustine or rituximab/gemcitabine/oxaliplatin

Outcomes

Primary Outcome Measures

Number of Participants With Dose Limiting Toxicities (DLT)

AEs occurring in first 4 weeks of treatment,attributable to 1 of study drugs. Hematology:1)Grade 4 neutropenia,2)Grade >=3 febrile neutropenia with single temperature of >38.3 degrees Celsius (C)/sustained temperature of >=38.0 degrees C for more than 1 hour with/without associated sepsis,3)Grade >=3 neutropenic infection,4)Grade 4 thrombocytopenia/Grade 3 thrombocytopenia with clinically significant bleeding,5)Grade 4 anemia 6)Any grade >=3 non-hematology toxicity except:transient Grade 3 flu like symptoms/fever controlled with standard medical management;transient Grade 3 fatigue,localized skin reactions/headache that resolves to Grade <=1;Grade 3 nausea,vomiting/diarrhea resolved to Grade <=1 in ˂72 hours after initiation of adequate medical management;Grade 3 skin toxicity resolved to Grade <=1 in ˂7 days;tumor flare;Single laboratory values that are out of normal range,that have no clinical correlate and resolve to Grade <=1 within 7 days with adequate medical management.

Objective Response Rate (ORR) as Assessed by Investigator Per Lugano Response Classification Criteria

ORR was defined as percentage of participants with complete response (CR) or partial response (PR), as assessed by investigator per lugano response classification criteria. CR was defined as a score of 1 (no uptake above background), 2 (uptake less than or equal to [<=] mediastinum), or 3 (uptake less than [<] mediastinum but <=liver) with or without a residual mass on PET 5-point scale (5-PS), for lymph nodes and extralymphatic sites; no new lesions; no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. PR was defined as >=50% decrease in SPD of up to six of the largest dominant lymph nodes, no increase in size of other nodes, liver, or spleen volume, a >=50% decrease in sum of products of diameters (SPD) of hepatic and splenic nodules, absence of other organ involvement, and no new sites of disease.

Secondary Outcome Measures

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Greater Than or Equal to (>=) Grade 3, As Per National Cancer Institute Common Terminology Criteria For Adverse Events (NCI-CTCAE), Version 4.03

AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per NCI-CTCAE version 4.03,severity was graded as Grade 1:asymptomatic/mild symptoms,clinical/diagnostic observations only, intervention not indicated; Grade 2:moderate, minimal, local/noninvasive intervention indicated,limiting age-appropriate instrumental activities of daily life (ADL); Grade 3:severe/medically significant but not immediately life-threatening, hospitalization/prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4:life-threatening consequence, urgent intervention indicated; Grade 5:death related to AE. TEAE was defined as events which occurred during on-treatment period beginning with first dose of study treatment through minimum (30 days + last dose of study treatment or start of new anti-cancer drug therapy). In this outcome measure participant with any TEAE of Grade 3 or above are reported.

Number of Participants With Laboratory Abnormalities As Per National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE), Version 4.03

Laboratory parameters included hematological and biochemistry: Hematological parameters included: anemia, haemoglobin increased, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased and white blood cells decreased. Biochemistry parameters included alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, cholesterol high, creatine kinase(cpk) increased, creatinine increased, gamma glutamyl transferase(ggt) increased, hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hypertriglyceridemia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia, hypophosphatemia, lipase increased,serum amylase increased.Test abnormalities were graded by NCI CTCAE version 4.03 as Grade 1=mild; Grade 2=moderate; Grade 3/Grade 4=severe/life-threatening. Number of participants with abnormalities of any grade were reported.

Number of Participants With Electrocardiogram (ECG) Abnormalities

ECG abnormalities included: 1) QT interval, QT interval corrected using Bazett's formula (QTcB) and QT interval corrected using Fridericia's formula (QTcF): increase from baseline greater than (>) 30 millisecond (ms) or 60 ms; absolute value >450 ms, >480 ms and >500 ms; 2) heart rate (HR): absolute value <=50 beats per minute (bpm) and decrease from baseline >=20 bpm; absolute value >=120 bpm and increase from baseline >=20 bpm; 3) PR interval: absolute value >=220 ms and increase from baseline >=20 ms; 4) QRS interval: absolute value >=120 ms.

Duration of Response (DOR) as Assessed by Investigator Per Lugano Response Classification Criteria

Investigator assessed DOR: was defined for participants with OR as time from first documentation of OR to time of first documentation of disease progression/death due to any cause, whichever occurred first. CR: score of 1(no uptake above background),2(uptake <=mediastinum),or 3(uptake <mediastinum but <=liver) with or without a residual mass on PET 5-PS,for lymph nodes extralymphatic sites;no new lesions;no evidence of FDG-avid disease in bone marrow. PR: >=50% decrease in SPD of up to 6 of largest dominant lymph nodes,no increase in size of other nodes,liver,spleen volume,>=50% decrease in SPD of hepatic splenic nodules,absence of other organ involvement,no new sites of disease. PD: appearance of new lesion more than 1.5 cm in any axis,at least a 50% increase from nadir in SPD/longest diameter of previous lesion/node. Data was censored on date of last adequate tumor assessment in participants with no event,started new anti-cancer therapy/had 2 or more missing assessments.

Time to Tumor Response (TTR) as Assessed by Investigator Per Lugano Response Classification Criteria

TTR was defined for participants who achieved objective response as time from randomization to first documentation of objective tumor response (CR or PR) that was subsequently confirmed. CR was defined as a score of 1 (no uptake above background), 2 (uptake <= mediastinum), or 3 (uptake <mediastinum but <=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites; no new lesions; no evidence of FDG-avid disease in bone marrow. PR was defined as >=50% decrease in SPD of up to six of the largest dominant lymph nodes, no increase in size of other nodes, liver, or spleen volume, a >=50% decrease in SPD of hepatic and splenic nodules, absence of other organ involvement, and no new sites of disease.

Disease Control Rate as Assessed by the Investigator Per Lugano Response Classification Criteria

Disease control rate was defined as percentage of participants with disease control. Disease Control (DC) was defined as the best overall response of CR, PR, or stable disease (SD). CR: score of 1 (no uptake above background), 2 (uptake <= mediastinum), or 3 (uptake less than <mediastinum but <=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites; no new lesions; no evidence of FDG-avid disease in bone marrow. PR: >=50% decrease in SPD of up to six of the largest dominant lymph nodes, no increase in size of other nodes, liver, or spleen volume, a >=50% decrease in SPD of hepatic and splenic nodules, absence of other organ involvement, and no new sites of disease. SD: <50% decrease in SDP of up to 6 dominant, measurable nodes and extranodal sites; no criteria for progressive disease met. To qualify as a best overall response of SD, at least one SD assessment must be observed >=6 weeks after start date and before disease progression.

Progression-Free Survival (PFS) as Assessed by the Investigator Per Lugano Response Classification Criteria

Investigator assessed PFS was defined as time (in months) from date of randomization to the first documentation of disease progression or death (due to any cause), whichever occurred first. PFS data was censored on the date of the last adequate tumor assessment for participants who had no an event (PD or death), for participants who start a new anti-cancer therapy prior to an event or for participants with an event after 2 or more missing or inadequate post-baseline tumor assessment. Participants without an adequate baseline or post-baseline tumor assessment were censored on the date of randomization unless death occurred on or before the time of the second planned tumor assessment in which case the death was considered as an event.

Overall Survival

Overall survival was defined as the time (in months) from the date of randomization to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan-Meier method.

Concentration Verses Time Summary of Avelumab

Number of Participants With Anti-Drug Antibodies (ADA) Against Avelumab by Never and Ever Positive Status

ADA never-positive was defined as no positive ADA results at any time point. ADA ever-positive was defined as at least one positive ADA result at any time point.

Number of Participants With Anti-Drug Antibodies (ADA) Against Rituximab by Never and Ever Positive Status

ADA never-positive was defined as no positive ADA results at any time point. ADA ever-positive was defined as at least one positive ADA result at any time point.

Number of Participants With Anti-Drug Antibodies (ADA) Against Utomilumab by Never and Ever Positive Status

ADA never-positive was defined as no positive ADA results at any time point. ADA ever-positive was defined as at least one positive ADA result at any time point.

Number of Participants With Neutralizing Antibodies (nAb) Against Avelumab by Never and Ever Positive Status

nAb never-positive was defined as no positive nAb results at any time point and nAb ever-positive was defined as at least one positive nAb result at any time point.

Number of Participants With Neutralizing Antibodies (nAb) Against Rituximab by Never and Ever Positive Status

nAb never-positive was defined as no positive nAb results at any time point and nAb ever-positive was defined as at least one positive nAb result at any time point.

Number of Participants With Neutralizing Antibodies (nAb) Against Utomilumab by Never and Ever Positive Status

nAb never-positive was defined as no positive nAb results at any time point and nAb ever-positive was defined as at least one positive nAb result at any time point.

Programmed Death Receptor-1 Ligand-1 (PD-L1) Biomarker Expression in Tumor and Immune Cells as Assessed by Immunohistochemistry (IHC) at Baseline

Percentage of Tumor and Immune Cells as Assessed by Immunohistochemistry at Baseline.

Number of Participants With Minimal Residual Disease Burden (MRD) Positive, Negative and Not Evaluable (NE) Status

Number of participants with MRD positive, negative and not evaluable status were reported in this outcome measure.

Full Information

NCT ID

NCT02951156

First Posted

October 19, 2016

Last Updated

November 20, 2020

Sponsor

Pfizer

Collaborators

EMD Serono

1. Study Identification

Unique Protocol Identification Number

NCT02951156

Brief Title

Avelumab In Combination Regimens That Include An Immune Agonist, Epigenetic Modulator, CD20 Antagonist and/or Conventional Chemotherapy in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL)

Acronym

Javelin DLBCL

Official Title

PHASE 1B/PHASE 3 MULTICENTER STUDY OF AVELUMAB (MSB0010718C) IN COMBINATION REGIMENS THAT INCLUDE AN IMMUNE AGONIST, EPIGENETIC MODULATOR, CD20 ANTAGONIST AND/OR CONVENTIONAL CHEMOTHERAPY IN PATIENTS WITH RELAPSED OR REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL) JAVELIN DLBCL

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Terminated

Why Stopped

Study was terminated due to closure of study arms following futility analysis and difficulty in enrolling participants due to evolving treatment landscape

Study Start Date

December 16, 2016 (Actual)

Primary Completion Date

December 2, 2019 (Actual)

Study Completion Date

December 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

Collaborators

EMD Serono

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Study B9991011 is a multi-center, international, randomized, open label, 2 component (Phase 1b followed by Phase 3), parallel-arm study of avelumab in combination with various agents for the treatment of Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL).

Detailed Description

The target study population of this Phase 1b/3 registrational study is patients with R/R DLBCL who have completed at least 2 (but not more than 4) lines of prior rituximab-containing multi-agent chemotherapy, and/or in whom autologous stem cell transplant (ASCT) has failed, or who are not candidates for ASCT or who are not eligible for intensive chemotherapy. Patients who are ineligible for intensive second line chemotherapy must have received at least one prior rituximab-containing combination chemotherapy regimen. The study will assess the safety, efficacy, pharmacokinetics (PK), immunogenicity of the 3 avelumab-based combination regimens tested, and collect patient reported outcome (PRO) data.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diffuse Large B-Cell Lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

29 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Phase 1b Arm A

Arm Type

Experimental

Arm Description

avelumab/utomilumab/rituximab

Arm Title

Phase 1b Arm B

Arm Type

Experimental

Arm Description

avelumab/utomilumab/azacitidine

Arm Title

Phase 1b Arm C

Arm Type

Experimental

Arm Description

avelumab/rituximab/bendamustine

Arm Title

Phase 3 Arm D (selected from Phase 1b)

Arm Type

Experimental

Arm Description

Selected regimen from Phase 1b component which may be i) avelumab/utomilumab/rituximab OR ii) avelumab/rituximab/azacitidine OR iii) avelumab/rituximab/bendamustine

Arm Title

Phase 3 Arm E

Arm Type

Active Comparator

Arm Description

Investigator's Choice of either rituximab/bendamustine or rituximab/gemcitabine/oxaliplatin

Intervention Type

Biological

Intervention Name(s)

Avelumab

Other Intervention Name(s)

MSB0010718C

Intervention Description

Investigational fully human anti-PD-L1 monoclonal antibody

Intervention Type

Biological

Intervention Name(s)

Utomilumab

Other Intervention Name(s)

PF-05082566

Intervention Description

Investigational, fully human IgG2 CD 137/4-1BB agonist

Intervention Type

Biological

Intervention Name(s)

Rituximab

Other Intervention Name(s)

Rituxan

Intervention Description

CD20-directed cytolytic antibody

Intervention Type

Other

Intervention Name(s)

Azacitidine

Other Intervention Name(s)

Vidaza

Intervention Description

Antimetabolite antineoplastic agent and demethylation agent.

Intervention Type

Drug

Intervention Name(s)

Bendamustine

Other Intervention Name(s)

Treanda

Intervention Description

Alkylating drug

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Other Intervention Name(s)

Gemzar

Intervention Description

Nucleoside analogue

Intervention Type

Drug

Intervention Name(s)

Oxaliplatin

Other Intervention Name(s)

Eloxatin

Intervention Description

Platinum-based drug

Primary Outcome Measure Information:

Title

Number of Participants With Dose Limiting Toxicities (DLT)

Description

Time Frame

Day 1 Cycle 1 up to 4 Weeks

Title

Objective Response Rate (ORR) as Assessed by Investigator Per Lugano Response Classification Criteria

Description

Time Frame

Randomization until date of PD, start of new anticancer therapy, discontinuation from study or death due to any cause, whichever occurred first (maximum up to 36 months)

Secondary Outcome Measure Information:

Title

Description

Time Frame

From first dose of study treatment up to at least 30 days after the last dose of study treatment or initiation of new anti-cancer therapy (up to 36 months)

Title

Number of Participants With Laboratory Abnormalities As Per National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE), Version 4.03

Description

Time Frame

From first dose of study treatment up to at least 30 days after the last dose of study treatment or initiation of new anti-cancer therapy (up to 36 months)

Title

Number of Participants With Electrocardiogram (ECG) Abnormalities

Description

Time Frame

From first dose of study treatment up to at least 30 days after the last dose of study treatment or initiation of new anti-cancer therapy (up to 36 months)

Title

Duration of Response (DOR) as Assessed by Investigator Per Lugano Response Classification Criteria

Description

Time Frame

First response (CR or PR) to date of PD, start of new anti-cancer therapy, discontinuation from the study, censoring date or death due to any cause, whichever occurred first (maximum up to 36 months)

Title

Time to Tumor Response (TTR) as Assessed by Investigator Per Lugano Response Classification Criteria

Description

Time Frame

From the date of randomization to the first documentation of objective response (CR or PR) (maximum up to 36 months)

Title

Disease Control Rate as Assessed by the Investigator Per Lugano Response Classification Criteria

Description

Time Frame

From the date of randomization to the first documentation of PD, study discontinuation, start of new anti-cancer therapy or death due to any cause, whichever occurred first (maximum up to 36 months)

Title

Progression-Free Survival (PFS) as Assessed by the Investigator Per Lugano Response Classification Criteria

Description

Time Frame

From the date of randomization to progression of disease, study discontinuation, censoring date or death due to any cause, whichever occurred first (up to 36 months)

Title

Overall Survival

Description

Time Frame

From the date of randomization to discontinuation from the study or death, whichever occurred first (maximum up to 36 months)

Title

Concentration Verses Time Summary of Avelumab

Time Frame

1 hour Post dose Day 2 Cycle 1, 144 hour Post dose Day 8 of Cycle 1, 0 hour Post dose Day 16 of Cycle 1, Day 1 of Cycle 4 and Cycle 6

Title

Number of Participants With Anti-Drug Antibodies (ADA) Against Avelumab by Never and Ever Positive Status

Description

ADA never-positive was defined as no positive ADA results at any time point. ADA ever-positive was defined as at least one positive ADA result at any time point.

Time Frame

Baseline: 2 hours pre-dose of first dose of avelumab, Post baseline: post first dose up to up to 30 Days after the end of treatment (maximum up to 36 months)

Title

Number of Participants With Anti-Drug Antibodies (ADA) Against Rituximab by Never and Ever Positive Status

Description

ADA never-positive was defined as no positive ADA results at any time point. ADA ever-positive was defined as at least one positive ADA result at any time point.

Time Frame

From the date of first study treatment up to 30 Days after the end of treatment (maximum up to 36 months)

Title

Number of Participants With Anti-Drug Antibodies (ADA) Against Utomilumab by Never and Ever Positive Status

Description

ADA never-positive was defined as no positive ADA results at any time point. ADA ever-positive was defined as at least one positive ADA result at any time point.

Time Frame

From the date of first study treatment up to 30 Days after the end of treatment (maximum up to 36 months)

Title

Number of Participants With Neutralizing Antibodies (nAb) Against Avelumab by Never and Ever Positive Status

Description

nAb never-positive was defined as no positive nAb results at any time point and nAb ever-positive was defined as at least one positive nAb result at any time point.

Time Frame

From the date of first study treatment up to 30 Days after the end of treatment (maximum up to 36 months)

Title

Number of Participants With Neutralizing Antibodies (nAb) Against Rituximab by Never and Ever Positive Status

Description

nAb never-positive was defined as no positive nAb results at any time point and nAb ever-positive was defined as at least one positive nAb result at any time point.

Time Frame

From the date of first study treatment up to 30 Days after the end of treatment (maximum up to 36 months)

Title

Number of Participants With Neutralizing Antibodies (nAb) Against Utomilumab by Never and Ever Positive Status

Description

nAb never-positive was defined as no positive nAb results at any time point and nAb ever-positive was defined as at least one positive nAb result at any time point.

Time Frame

From the date of first study treatment up to 30 Days after the end of treatment (maximum up to 36 months)

Title

Programmed Death Receptor-1 Ligand-1 (PD-L1) Biomarker Expression in Tumor and Immune Cells as Assessed by Immunohistochemistry (IHC) at Baseline

Description

Percentage of Tumor and Immune Cells as Assessed by Immunohistochemistry at Baseline.

Time Frame

Screening (prior to first dose of study treatment)

Title

Number of Participants With Minimal Residual Disease Burden (MRD) Positive, Negative and Not Evaluable (NE) Status

Description

Number of participants with MRD positive, negative and not evaluable status were reported in this outcome measure.

Time Frame

Baseline, Day 1 of Cycle 3, 6, 9, 12 and 18

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: -Any of the following as defined by the WHO, 2016 lymphoid neoplasm classifications and histologically confirmed: Diffuse large B-cell lymphoma (DLBCL), Not Otherwise Specified (NOS): Germinal center B-cell type (GCB), Activated B-cell type (ABC) High-grade B-cell lymphoma (HGBCL) NOS HGBCL with MYC and BCL2 and/or BCL6 rearrangements T-cell histocyte-rich large B-cell lymphoma EBV+ DLBCL, NOS HHV8+ DLBCL, NOS Relapsed or refractory disease following at least 2 lines (and a maximum of 4 lines) of prior rituximab containing multi-agent chemotherapy which may include an autologous stem cell transplantation unless patients are not considered suitable for intensive second-line chemotherapy or autologous stem cell transplantation. Patients who are ineligible for intensive second line chemotherapy,must have received at least one prior rituximab-containing combination chemotherapy regimen. Patients who are ineligible for intensive second line chemotherapy, must have received at least one prior rituximab-containing combination chemotherapy regimen. Baseline measurable disease with at least 1 bi dimensional lesion with longest diameter (LDi) >1.5cm on CT scan which is FDG avid on PET scan. A biopsy (archived or Screening/recent) will be collected at Screening. At least 18years of age (or ≥20 years in Japan). Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1. Key Exclusion Criteria: Active central nervous system (CNS) lymphoma. Prior organ transplantation including prior allogeneic SCT. Prior therapy with an anti PD 1, anti PD L1, anti PD L2, anti CD137, or anti cytotoxic T lymphocyte associated antigen 4 (CTLA 4) antibody (including ipilimumab, tremelimumab or any other antibody, or drug specifically targeting T cell co stimulatory or immune checkpoint pathways).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

City of Hope

City

Duarte

State/Province

California

ZIP/Postal Code

91010

Country

United States

Facility Name

Norton Cancer Institute

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40207

Country

United States

Facility Name

Norton Diagnostic Center - Dupont

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40207

Country

United States

Facility Name

Norton Women's and Children's Hospital

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40207

Country

United States

Facility Name

Tulane Medical Center

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70112

Country

United States

Facility Name

Parexel International

City

Billerica

State/Province

Massachusetts

ZIP/Postal Code

01821

Country

United States

Facility Name

University of Michigan Health System

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

North Shore Hematology Oncology Associates

City

East Setauket

State/Province

New York

ZIP/Postal Code

11733

Country

United States

Facility Name

St. George Hospital

City

Kogarah

State/Province

New South Wales

ZIP/Postal Code

2217

Country

Australia

Facility Name

Monash Health

City

Clayton

State/Province

Victoria

ZIP/Postal Code

3168

Country

Australia

Facility Name

Cancer Clinical Trials Centre, Austin Health, Level 4

City

Heidelberg

State/Province

Victoria

ZIP/Postal Code

3084

Country

Australia

Facility Name

Genesis Care

City

Heidelberg

State/Province

Victoria

ZIP/Postal Code

3084

Country

Australia

Facility Name

UZ Gent

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

UZ Leuven

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Farmacia Studi Clinici

City

Rozzano

State/Province

ZIP/Postal Code

20089

Country

Italy

Facility Name

Istituto Clinico Humanitas

City

Rozzano

State/Province

ZIP/Postal Code

20089

Country

Italy

Facility Name

Samsung Medical Center Clinical Trial Pharmacy

City

Seoul

ZIP/Postal Code

06351

Country

Korea, Republic of

Facility Name

Samsung Medical Center

City

Seoul

ZIP/Postal Code

06351

Country

Korea, Republic of

Facility Name

Centrum Onkologii Ziemi Lubelskiej im. Sw. Jana z Dukli

City

Lublin

State/Province

Lubelskie

ZIP/Postal Code

20-090

Country

Poland

Facility Name

Malopolskie Centrum Medyczne S.C.

City

Krakow

State/Province

Malopolskie

ZIP/Postal Code

30-510

Country

Poland

Facility Name

Nzoz McD Voxel Osrodek Pet-Tk-Nmr

City

Krakow

ZIP/Postal Code

30-006

Country

Poland

Facility Name

Centrum Onkologii Ziemi Lubelskiej im. Sw. Jana z Dukli Oddzial Hematologiczny

City

Lublin

ZIP/Postal Code

20-090

Country

Poland

Facility Name

NU-MED Centrum Diagnostyki i Terapii Onkologicznej Zamosc Sp. z o.o.

City

Zamosc

ZIP/Postal Code

22-400

Country

Poland

Facility Name

Hospital San Pedro de Alcantara

City

Caceres

ZIP/Postal Code

10003

Country

Spain

Facility Name

Hospital San Pedro de Alcantara

City

Cáceres

ZIP/Postal Code

10003

Country

Spain

Facility Name

Centro de Investigación Medicina Especializada Sanitaria (CIMES)

City

Málaga

ZIP/Postal Code

29010

Country

Spain

Facility Name

Hospital Universitario Virgen de la Victoria

City

Málaga

ZIP/Postal Code

29010

Country

Spain

Facility Name

The Christie NHS Foundation Trust

City

Manchester

ZIP/Postal Code

M20 4BX

Country

United Kingdom

Facility Name

The Christie Pathology Partnership

City

Manchester

ZIP/Postal Code

M20 4BX

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

IPD Sharing URL

https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

Citations:

PubMed Identifier

34687398

Citation

Hawkes EA, Phillips T, Budde LE, Santoro A, Saba NS, Roncolato F, Gregory GP, Verhoef G, Offner F, Quero C, Radford J, Giannopoulos K, Stevens D, Thall A, Huang B, Laird AD, Sandner R, Ansell SM. Avelumab in Combination Regimens for Relapsed/Refractory DLBCL: Results from the Phase Ib JAVELIN DLBCL Study. Target Oncol. 2021 Nov;16(6):761-771. doi: 10.1007/s11523-021-00849-8. Epub 2021 Oct 23.

Results Reference

derived

Links:

URL

https://pmiform.com/clinical-trial-info-request?StudyID=B9991011

Description

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