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PD-1 Inhibitor

Neoantigen Vaccine + Pembrolizumab for Follicular Lymphoma

Phase 1

Waitlist Available

Led By Reid W Merryman, MD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of grade I-IIIA follicular lymphoma (pathology must be confirmed at DFCI/BWH)

Planned treatment with 4 weekly doses of rituximab

Must not have

HIV-positive participants including those on combination antiretroviral therapy

Documented transformation to diffuse large B cell lymphoma or grade 3B follicular lymphoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying a new type of FL vaccine which may be a treatment for follicular lymphoma. The agents used in this study are Rituximab, a personalized NeoAntigen vaccine, Poly-ICLC, and Pembrolizumab.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Possible side effects include allergic reactions similar to other vaccines, immune system changes due to Pembrolizumab which might cause inflammation or affect how organs work, fatigue, and infusion-related reactions from Rituximab.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lymphoma is grade I-IIIA and confirmed by DFCI/BWH.

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I am scheduled for 4 weekly doses of rituximab.

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I am 18 years old or older.

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I can do most of my daily activities without help.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am HIV-positive and may be on antiretroviral therapy.

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My lymphoma has changed into a more aggressive type.

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I have had a bone marrow or stem cell transplant.

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I am not taking any drugs that affect my immune system.

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My cancer has not improved or remains large after treatment with rituximab.

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I need regular IVIG treatments.

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I do not have an active hepatitis B or C infection.

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I do not have any unmanaged ongoing illnesses.

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My cancer has spread to my brain or spinal cord.

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I have received treatment with specific medications before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Best Objective Response

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

The proportion of participants who convert from PR to CR

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rituximab

1999

Completed Phase 4

~2990

Pembrolizumab

2017

Completed Phase 3

~3150