Status:
COMPLETED
Molecular Monitoring With Circulating Tumor DNA and Nivolumab Maintenance
Lead Sponsor:
Fox Chase Cancer Center
Conditions:
Diffuse Large B Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief 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....
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 relap...
Eligibility Criteria
Inclusion
- 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.
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
May 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 26 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03311958
Start Date
May 15 2018
End Date
January 26 2024
Last Update
April 6 2025
Active Locations (1)
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1
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111