Trial Summary
What is the purpose of this trial?
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
Eligibility Criteria
This trial is for adults with grade I-IIIA follicular lymphoma who haven't had systemic therapy except rituximab. They must have measurable disease, normal organ/marrow function, and be willing to provide tissue samples for research. Women of childbearing potential and men must agree to use contraception.Inclusion Criteria
Ability to understand and sign a written informed consent document
Patient must have measurable disease by Cheson criteria
I agree to provide samples of my tumor and normal tissues for testing.
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Exclusion Criteria
Underlying medical, psychiatric, or social conditions compromising study administration or AE assessment
I am HIV-positive and may be on antiretroviral therapy.
Active autoimmune disease or immunosuppressive conditions
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Treatment Details
Interventions
- Pembrolizumab (PD-1 Inhibitor)
- Personalized NeoAntigen vaccine (Cancer Vaccine)
- Rituximab (Monoclonal Antibodies)
Trial OverviewThe study tests a new vaccine (NeoVax) alongside Pembrolizumab after initial treatment with Rituximab in patients with follicular lymphoma. The goal is to see if this combination can improve outcomes compared to current treatments.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: NeoVax and pembrolizumabExperimental Treatment3 Interventions
* 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
Group II: Neo VaxExperimental Treatment2 Interventions
* 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
Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:
🇺🇸 Approved in United States as KEYTRUDA for:
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
🇪🇺 Approved in European Union as KEYTRUDA for:
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
🇬🇧 Approved in United Kingdom as KEYTRUDA for:
- Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Dana Farber Cancer InstituteBoston, MA
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Who Is Running the Clinical Trial?
Dana-Farber Cancer InstituteLead Sponsor