Personalized Neoantigen Cancer Vaccine + Pembrolizumab After Rituximab for Follicular Lymphoma

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT03361852
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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
  • Neo Vax — BIOLOGICAL
    Neo Vax is an experimental "viral mimic" and an activator of immunity.
  • Pembrolizumab — DRUG
    Pembrolizumab is a monoclonal antibody that targets PD-1. It is a type of immunotherapy

Study Details

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

Key Dates

First listed
Dec 5, 2017
Start date
Mar 14, 2022
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Dec 26, 2033

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Neo Vax
    * 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
  • Experimental: NeoVax and pembrolizumab
    * 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

Primary Outcome Measure

Feasibility of Neovax following 4 weekly doses of rituximab assessed by the following [ Time Frame: 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer InstituteBostonMassachusetts02115-

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Dana Farber Cancer Institute· Boston, MA

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