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PD-1 Inhibitor

Nivolumab/Poly-ICLC/Vaccine/+/- Rituximab for Follicular Lymphoma

Q: What medical purposes are the components of Nivolumab/Poly-ICLC/Vaccine/+/- Rituximab typically used for?

<p>Nivolumab/Poly-ICLC/<a href="https://www.withpower.com/clinical-trials/vaccine">Vaccine</a>/+/- Rituximab is a common intervention for polyangium, but it can also be employed to address malignant neoplasms, inoperable <a href="https://www.withpower.com/clinical-trials/melanoma">melanoma</a>, and <a href="https://www.withpower.com/clinical-trials/squamous-cell-carcinoma">squamous cell carcinoma</a>.</p>

Q: Has the FDA verified the efficacy of Nivolumab/Poly-ICLC/Vaccine/+/- Rituximab?

<p>Our team has given Nivolumab/Poly-ICLC/<a href="https://www.withpower.com/clinical-trials/vaccine">Vaccine</a>/+/- Rituximab a score of 1, as this is currently in Phase 1 trials. Thus far, there have been limited findings backing the safety and effectiveness of this treatment option.</p>

Phase 1

Waitlist Available

Led By Nancy Bartlett, M.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through 5 years after completion of treatment (approximately 111 months)

Awards & highlights

Study Summary

This trial is testing a combination of a personalized tumor vaccine with nivolumab to treat follicular lymphoma. The goal is to create a well tolerated therapy without cumulative and long-term toxicity. If this combination is successful, it may be used to treat patients with other monoclonal antibodies against CD20.

Eligible Conditions

Follicular Lymphoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through 5 years after completion of treatment (approximately 111 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through 5 years after completion of treatment (approximately 111 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and through 5 years after completion of treatment (approximately 111 months) 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 and safety of vaccine in combination with nivolumab +/1 anti-CD20 monoclonal antibody therapy as measured by the number of participants whose personal vaccines can be manufactured and delivered without unacceptable toxicity

Secondary outcome measures

Complete response (CR) rate

Duration of response

Overall response rate (ORR)

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Nivolumab/Poly-ICLC/Vaccine/+/- RituximabExperimental Treatment7 Interventions

All cycles are 4 weeks (wks), with nivolumab every 2 wks during Cycles 1-6 & every 4 wks during Cycles 7-12 & vaccine on Cycle 1 Days 1, 4, 8, 15; Cycle 2 Day 1; and then on Day 1 of Cycles 4, 6, 8, 10, 12 After 2 cycles, restaging will be performed, & patients with CR, PR, or SD will continue on nivolumab + vaccine. Patients with evidence of PD may initiate anti-CD20 mAb therapy (drug to be determined by the treating physician) weekly for 4 wks during Cycle 3, followed by a dose on Day 1 of every other cycle (Cycles 6, 8, 10, and 12). After 6 cycles, restaging will be performed again, and patients with CR, PR, or SD will continue nivolumab + vaccine. Patients with PD at that time point (but not treated with anti-CD20 mAb therapy thus far on this protocol) will initiate anti-CD20 mAb (drug to be determined by the treating physician) therapy weekly for 4 wks during Cycle 7, followed by a dose Day 1 of Cycles 10 & 12 & 2 additional doses 8 wks apart.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biopsy

2014

Completed Phase 4

~850

Poly ICLC

2014

Completed Phase 2

~270

Peripheral blood draws

2017

Completed Phase 1

~20

Nivolumab

2014

Completed Phase 3

~4750

Leukapheresis

2016

Completed Phase 2

~690

Rituximab

1999

Completed Phase 4

~1880

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,931 Previous Clinical Trials

2,299,705 Total Patients Enrolled

Nancy Bartlett, M.D.Principal InvestigatorWashington University School of Medicine

2 Previous Clinical Trials

57 Total Patients Enrolled

Frequently Asked Questions

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

What medical purposes are the components of Nivolumab/Poly-ICLC/Vaccine/+/- Rituximab typically used for?

"Nivolumab/Poly-ICLC/Vaccine/+/- Rituximab is a common intervention for polyangium, but it can also be employed to address malignant neoplasms, inoperable melanoma, and squamous cell carcinoma."

Answered by AI

Has the FDA verified the efficacy of Nivolumab/Poly-ICLC/Vaccine/+/- Rituximab?

"Our team has given Nivolumab/Poly-ICLC/Vaccine/+/- Rituximab a score of 1, as this is currently in Phase 1 trials. Thus far, there have been limited findings backing the safety and effectiveness of this treatment option."

Answered by AI

Is enrollment in the experiment still open?

"Unfortunately, this particular trial has concluded its patient recruitment phase. Initially posted on October 16th 2018 and last edited on September 28th 2022, it is no longer in need of participants. If you are looking for alternative trials to join, there are presently 1719 clinical studies actively recruiting patients with lymphoma follicular and 1112 investigations that involve Nivolumab/Poly-ICLC/Vaccine/+/- Rituximab still requiring subjects."

Answered by AI

How many participants are participating in the trial?

"Unfortunately, this clinical trial has concluded its recruitment efforts. Its initial posting was on October 16th 2018 and the last edit to it occurred a few days ago, September 28th 2022. For any other trials related to lymphoma or follicular disease that are currently recruiting patients, there are 1719 studies with Nivolumab/Poly-ICLC/Vaccine/+/- Rituximab treatments available for consideration."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Personalized Tumor Vaccine Strategy and PD-1 Blockade in Patients With Follicular Lymphoma

2018. "Personalized Tumor Vaccine Strategy and PD-1 Blockade in Patients With Follicular Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03121677.