Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, Large B-Cell, Diffuse

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Antineoplastic Agents

All Drugs and Chemicals

Nivolumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Patients would be given an infusion of 240 mg nivolumab over 30 min

Nivolumab, IV, 240 mg

Shazia Nakhoda, MD

Patients suffering from diffuse large B-cell lymphoma (DLBCL) who relapse within 12 months of chemotherapy usually undergo salvage therapies, followed by autologous transplant with a low success rate. These treatments for relapse have significant toxicities and may not be tolerated well by the patients. These patients need an effective means of identifying relapse at an early time point to be treated effectively. Detection of circulating tumor DNA (ctDNA) has been reported to be a sensitive and more specific method to detect relapse at an early stage compared to PET/ CT scans. Purpose of this trial is to monitor patients who have undergone successful chemotherapy for the presence of ctDNA. Patients who test positive for ctDNA would be treated with Nivolumab for a period of 2 years to avoid complete relapse.

Primary Objective:

To determine if nivolumab administration, as a maintenance strategy in DLBCL patients with high risk of relapse, can convert positive ctDNA to negative ctDNA and/or result in relapse free survival (RFS-ctDNA) of 9 months or longer after positive ctDNA was documented.

Secondary Objectives:

1. To evaluate safety of nivolumab as maintenance drug in post-induction, post-salvage and post-autologous transplant setting
2. Relapse free survival (RFS-ctDNA) for nivolumab treated patients
3. Proportion of patients who are able to convert from ctDNA positive to ctDNA negative after nivolumab treatment
4. To validate NeoLabs assay platform by comparing the results to Clonoseq platform.

Regular testing of DLBCL patients who have successfully undergone chemotherapy and are negative for ctDNA. Treatment of patients who become positive for ctDNA with Nivolumab

Molecular Monitoring With Circulating Tumor DNA and Nivolumab Maintenance

Molecular Monitoring With Circulating Tumor DNA and Nivolumab Maintenance: A Pilot Study in Diffuse Large B-Cell Lymphoma

Regular monitoring of ctDNA positive patients on nivolumab until they become ctDNA negative

Regular testing of ctDNA in positive patients on nivoluman until clinical relapse

Safety evaluated by the frequency and grade of adverse events, as defined by NCI CTCAE 4.03 criteria, for patients treated with nivolumab, such as, uveitis, abnormal lab report or intercurrent illness

RFS will be calculated from the day of nivolumab administration until clinical disease

Number of patients who are ctDNA positive and treated with nivolumab, turn ctDNA negative

The results obtained from the two platforms will be compared for the feasibility of NeoLabs platform for detecting any change in ctDNA numbers in blood

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Molecular Monitoring With Circulating Tumor DNA and Nivolumab Maintenance	NCT03311958	Diffuse Large B...	Nivolumab, IV, ...	18 Years -	Fox Chase Cancer Center
Molecular Monitoring With Circulating Tumor DNA and Nivolumab Maintenance	NCT03311958	Diffuse Large B...	Nivolumab, IV, ...	18 Years -	Fox Chase Cancer Center
Molecular Monitoring With Circulating Tumor DNA and Nivolumab Maintenance	NCT03311958	Diffuse Large B...	Nivolumab, IV, ...	18 Years -	Fox Chase Cancer Center

Spots Global Cancer Trial Database for nivolumab, iv, 240 mg