Personalized Neoantigen Cancer Vaccine + Pembrolizumab After Rituximab for Follicular Lymphoma

NCT03361852 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 17-353
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is studying a novel type of FL vaccine as a possible treatment for follicular lymphoma (FL). The agents involved in this study are:

• Rituximab
• Personalized NeoAntigen vaccine
• Poly-ICLC
• Pembrolizumab

Conditions

Follicular Lymphoma

Keywords

Follicular Lymphoma

Outcome Measures

Primary Outcomes (1)

• Feasibility of Neovax following 4 weekly doses of rituximab assessed by the following

  The proportion of all enrolled patients for whom sequencing and analysis leads to identification of at least 7 actionable peptides to initiate vaccine production and, of the patients who generate at least 7 actionable peptides, the proportion for whom the time from sample collection to vaccine availability is less than 12 weeks.

  2 years

Secondary Outcomes (5)

• The proportion of participants who achieve an IFN-γ T cell response to one or more of the peptide pools

  2 years

• The proportion of participants who convert from PR to CR

  2 years

• The proportion of participants who convert from SD to PR/CR

  2 years

• Best Objective Response

  2 years

• To describe the safety and tolerability of NeoVax following 4 weekly doses of rituximab in patient with previously untreated follicular lymphoma

  2 years

Study Arms (2)

Neo Vax

EXPERIMENTAL

* Neo Vax is injected into up to 4 different anatomic site. * NeoVax may be administered within +/- 1 day of the scheduled administration date for days 4 and 8, * Within +/-3 days of the scheduled administration date for days 15 and 22 * Within +/-7 days of days 78 and 134. * Participants will receive Rituximab weekly x 4 weeks per institutional standard

Drug: Rituximab; Biological: Neo Vax

NeoVax and pembrolizumab

EXPERIMENTAL

* Neo Vax is injected into up to 4 different anatomic site. * NeoVax may be administered within +/- 1 day of the scheduled administration date for days 4 and 8, * Within +/-3 days of the scheduled administration date for days 15 and 22 * Within +/-7 days of days 78 and 134. * Patients will receive pembrolizumab every 3 weeks starting on day 78 * Participants will receive Rituximab weekly x 4 weeks per institutional standard

Drug: Rituximab; Biological: Neo Vax; Drug: Pembrolizumab

Interventions

Neo Vax BIOLOGICAL

Neo Vax is an experimental "viral mimic" and an activator of immunity.

Neo Vax; NeoVax and pembrolizumab

Pembrolizumab DRUG

Pembrolizumab is a monoclonal antibody that targets PD-1. It is a type of immunotherapy

NeoVax and pembrolizumab

Rituximab DRUG

Rituximab is classified as a monoclonal antibody. It works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells

Also known as: Rituxan

Neo Vax; NeoVax and pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of grade I-IIIA follicular lymphoma (pathology must be confirmed at DFCI/BWH)
• Planned treatment with 4 weekly doses of rituximab.
• No prior systemic therapy for follicular lymphoma; prior radiation with palliative or curative intent is allowed if radiation occurred more than 3 months prior to study entry
• Patient must have measurable disease by Cheson criteria
• Age ≥ 18 years.
• ECOG performance status \< 2.
• Participants must have normal organ and marrow function as defined below:
• Hemoglobin \> 9 gm/dl (ESAs or transfusion are not allowed) \[greater than 8 gm/dl if there is lymphoma involvement of the bone marrow\]
• ANC \> 1000 (greater than 750 if there is lymphoma involvement of the bone marrow)
• Platelet count \>100,000 (greater than 50,000 if there is lymphoma involvement of the bone marrow\]
• International normalized ratio (INR) or prothrombin time (PT) or activated partial thromboplastin time (aPTT) \< 1.5 x ULN unless subject is on anticoagulation as long as PT or aPTT is within intended therapeutic range of anticoagulant used
• AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal (\< 5 x ULN if there are hepatic metastases)
• Creatinine \< 1.5 x ULN or measured or calculated creatinine clearance (GFR can also be used in place of creatinine clearance) \> 30 ml/min for subject with creatinine \> 1.5 x institutional ULN
• total bilirubin less than institutional 1.5 x ULN (or a direct bilirubin \< ULN if total bilirubin is \>1.5 x ULN)
• The effects of NeoVax and poly-ICLC on the developing human fetus are unknown. For this reason, women of childbearing potential (WOCBP) must have a negative pregnancy test (serum) before entry onto the trial and within 7 days prior to start of study vaccination.

You may not qualify if:

• Achieved a CR, PR, or SD with no residual mass greater than 5 cm per Lugano criteria following single agent rituximab per
• Recovered from all AEs due to rituximab to ≤Grade 1 or baseline. Participants with ≤Grade 2 neuropathy may be eligible. Note: If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment
• Prior systemic therapy for follicular lymphoma with the exception of 4 weekly doses of rituximab as proscribed per protocol
• Radiation with palliative or curative intent within 90 days of study screening
• Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
• Participants who are receiving any other investigational agents.
• Previous bone marrow or stem cell transplant
• Concomitant therapy with immunosuppressive or immunomodulatory agents; chronic use of systemic corticosteroids at doses of 10 mg of prednisone (or equivalent) for indications other than treatment of follicular lymphoma is acceptable. Use of higher doses of corticosteroids after initial registration is acceptable if tapered to 10 mg of prednisone (or equivalent) or les at least 7 days prior to NeoVax administration so long as the corticosteroids were not administered for follicular lymphoma.
• Use of a non-oncology vaccine therapy for prevention of infectious diseases within 2 weeks prior to any NeoVax administration.
• History of severe allergic reactions attributed to any vaccine therapy for the prevention of infectious diseases.
• Active, known, or suspected autoimmune disease or immunosuppressive conditions with the exception of vitiligo, type 1 diabetes, residual autoimmune-related hypothyroidism requiring hormone replacement, or psoriasis not requiring systemic treatment.
• Progressive disease or stable disease with residual tumor mass \> 5 cm by CT scan (measured as long axis) following 4 weekly doses of rituximab (for treatment phase only).
• Any documented transformation to diffuse large B cell lymphoma or grade 3Bfollicular lymphoma.
• Currently requiring chronic intravenous immunoglobulin G (IVIG)
• Active infection with hepatitis B or C (see Study Calendar in Section 10 for screening assays).

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

Rituximab; pembrolizumab

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Reid W Merryman, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: All patients will receive 4 weekly doses of rituximab. Afterwards, will receive either NeoVax alone (first 5 patients) or NeoVax in combination with pembrolizumab (5 patients)

Study Record Dates

• First Submitted: November 29, 2017
• First Posted: December 5, 2017
• Study Start: March 14, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 26, 2033
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)