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

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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