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Diffuse Large B Cell LymphomaEarly Phase 1NCT03311958

Molecular Monitoring With Circulating Tumor DNA and Nivolumab Maintenance

A Early Phase 1 study testing Nivolumab, IV, 240 mg in people with Diffuse Large B Cell Lymphoma, run by Fox Chase Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diffuse Large B Cell Lymphoma
What is being tested?
Nivolumab, IV, 240 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
15 May 2018to 26 Jan 2024
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have a tissue diagnosis of diffuse large B cell lymphoma, with a negative PET/CT scan performed within 28 days of study enrollment, with one of the following clinical features: high risk IPI, ABC-subtype DLBCL, Double hit/ triple hit DLBCL, Ki67>90%, or MYC translocation.
  • Patients can have any number of prior therapies and any amount of time period from the last therapy as long as they have complete response as seen in PET/CT at the time of enrolment.
  • Patients with prior salvage chemo-immunotherapy, radiation therapy, autologous transplantation are included
  • Prior radiation therapy must be completed at least 2 weeks prior to study enrollment
  • Autologous transplant must have been done 100 days prior to the study enrollment
  • Age > 18 years.
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  • ECOG performance status ≤ 2
  • Life expectancy of at least 3 months
  • A formalin fixed tissue block or equivalent of 24 slides of the tumor sample for analyses by Adaptive Sequenta and NeoGenomics must be available for analysis.
  • Patients must be off cancer-directed therapy for at least 3 weeks (2 weeks for oral agents prior to day 1 of the study
  • Patients must have suitable organ and marrow function as defined below
  • Absolute neutrophil count > 500/mm3
  • Platelets > 20,000/mm3
  • Total bilirubin < 2.5 times the ULN
  • AST/ALT (SGOT/SGPT) < 2 times institutional normal limits
  • Creatinine ≤1.5 times normal institutional limits OR
  • Creatinine clearance > 40 ml/min for patients
  • Ability to understand and willingness to sign a written informed consent and HIPAA consent document
  • WOCBP and sexually active, non-sterile men must be willing to use acceptable method of contraception. WOCBP must agree to not get pregnant and sexually active, non-sterile men must agree not to impregnate a woman for at least 18 weeks after the last dose of nivolumab

Who cannot join

  • Patients with second malignancies (except monoclonal B cells of undetermined significance, antecendant indolent non Hodgkin lymphoma, non-melanomatous skin cancers, papillary thyroid carcinomas, ductal carcinoma in-situ, superficial bladder cancer, prostate cancer or in situ cervical cancers) are excluded unless a complete remission was achieved at least 3 years prior to enrollment and no additional therapy is required or anticipated to be required during the treatment.
  • Subjects with active autoimmune disease or a syndrome that requires systemic corticosteroids
  • Subjects who received non-oncology vaccine therapies for prevention of infectious disease within 4 weeks of study drug administration.
  • Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 agent
  • Any contraindication to therapy with nivolumab
  • Prior allogeneic transplantation
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  • Known hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Patients with documented cure from HCV infection will be included
  • Known uncontrolled human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS). Patients with documented controlled HIV infection (CD4 > 200 and undetectable viral load) will be included.
  • Any condition requiring systemic treatment with corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days prior to first dose of study drug. Inhaled or topical steroids and adrenal replacement steroid doses > 10 mg daily prednisone or equivalent are permitted in the absence of active autoimmune disease.
  • History of anaphylactic reaction to monoclonal antibody therapy
  • Poor psychiatric risk
  • Patients receiving other investigational agents
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant or breast feeding. Refer to section 4.4 for further details

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

Other trials in United States

About this study

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

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.

Read the detailed description

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.
Being tested
Nivolumab, IV, 240 mg
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nivolumab, IV, 240 mgDrug

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

Study groups in NCT03311958
Study groupRoleWhat they receive
NivolumabExperimentalNot described
Receives: Drug: Nivolumab, IV, 240 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of the rate of conversion from positive to negative ctDNA in nivolumab treated patients

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

    Measured: 2 years

  2. Evaluation of the rate of conversion from positive to negative ctDNA in nivolumab treated patients

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

    Measured: 2 years

Secondary outcomes (4)

  1. To evaluate adverse events in patients on nivolumab as maintenance drug in post-induction, post-salvage and post-autologous transplant setting

    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

    Measured: 2 years

  2. Relapse free survival (RFS-ctDNA) for nivolumab treated patients

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

    Measured: 2 years

  3. Proportion of patients who are able to convert from ctDNA positive to ctDNA negative after nivolumab treatment

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

    Measured: 2 years

  4. To compare the ctDNA results of Clonoseq and Neolabs platform

    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

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2017
  2. Study start15 May 2018
  3. Primary completion26 Jan 2024
  4. Study completion26 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
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
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03311958
Sponsor's protocol ID
HM-110
Status last verified
Apr 2025
First submitted
5 Oct 2017
Last updated
6 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Nivolumab, IV, 240 mg in people with Diffuse Large B Cell Lymphoma, run by Fox Chase Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of the rate of conversion from positive to negative ctDNA in nivolumab treated patients (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03311958.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.

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