Personalized Neoantigen Cancer Vaccine + Pembrolizumab After Rituximab for Follicular Lymphoma

Inclusion Criteria

• •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.
• •Female patients enrolled in the study, who are not free from menses for \>2 years, post hysterectomy / oophorectomy, or surgically sterilized, must be willing to use either 2 adequate barrier methods or a barrier method plus a hormonal method of contraception to prevent pregnancy or to abstain from sexual activity throughout the study, starting with visit 1 through 4 weeks after the last dose of study therapy. Approved contraceptive methods include for example; intra uterine device, diaphragm with spermicide, cervical cap with spermicide, male condoms, or female condom with spermicide. Spermicides alone are not an acceptable method of contraception. Male participants need to agree to use an adequate method of contraception
• •Patient is agreeable to allow tumor (from peripheral blood, lymph node, or effusion) and normal tissue (from saliva) samples to be submitted for complete exome and transcriptome sequencing.
• •Ability to understand and the willingness to sign a written informed consent document.
• •Participants must meet the following criteria (in addition to the above) to be eligible to proceed to receive vaccine treatment on the study:
• •At least 7 immunizing peptides can be designed
• •Participants with known CNS involvement
• •History of allergic reactions attributed to compounds of similar chemical or biologic composition to poly-ICLC.
• •HIV-positive participants including those on combination antiretroviral therapy are ineligible because assessment of immunologic endpoints may be confounded by HIV-induced alterations in patient immune status and functio