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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility of Neovax following 4 weekly doses of rituximab assessed by the following
Secondary outcome measures
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

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
~1880
Pembrolizumab
2017
Completed Phase 2
~1950

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,072 Previous Clinical Trials
340,348 Total Patients Enrolled
Reid W Merryman, MDPrincipal InvestigatorDana-Farber Cancer Institute
1 Previous Clinical Trials
13 Total Patients Enrolled

Media Library

Pembrolizumab (PD-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03361852 — Phase 1
Follicular Lymphoma Research Study Groups: Neo Vax, NeoVax and pembrolizumab
Follicular Lymphoma Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT03361852 — Phase 1
Pembrolizumab (PD-1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03361852 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there vacancies in this experiment open to participants?

"Affirmative, clinicaltrials.gov states that this clinical trial is in the process of recruiting patients. The research was initially published on March 14th 2022 and recently updated with new information. 20 participants are needed between 1 medical centre for the study to progress further."

Answered by AI

What is the aggregate enrollment of this trial?

"Affirmative, the information on clinicaltrials.gov declares that this examination is actively enrolling patients. This research project was initially uploaded to the website on March 14th of 2022 and most recently updated around the same date. 20 volunteers are needed from a single site."

Answered by AI

What potential health hazards are associated with Neo Vax?

"Due to the limited evidence of efficacy and safety, the Power research team has given Neo Vax a score of 1 on their risk scale."

Answered by AI

What other experiments involving Neo Vax have been undertaken in the past?

"As of now, 1357 Neo Vax trials are active with 214 reaching Phase 3. Most notably, numerous medical centres in Houston, Texas are participating in the clinical trial process for this drug but there are 49950 facilities across the world conducting clinical studies on it as well."

Answered by AI

To what illnesses does Neo Vax typically offer relief?

"Neo Vax is the go-to solution for treating polyangium and can also be beneficial in addressing malignant neoplasms, unresectable melanoma, as well as microsatellite instability high."

Answered by AI
~7 spots leftby Mar 2025