NCT03121677

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

Terminated Phase 1 Last updated 14 August 2023

What this trial tests

Phase 1 trial testing Personalized tumor vaccine in Follicular Lymphoma in 4 participants. Terminated before completion.

Timeline

16 October 2018

Primary endpoint
24 September 2020

7 August 2023

Quick facts

Lead sponsor	Washington University School of Medicine
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	4
Start date	16 October 2018
Primary completion	24 September 2020
Estimated completion	7 August 2023
Sites	1 location across United States

Drugs / interventions tested

• Personalized tumor vaccine
• Poly ICLC
• Nivolumab (nivolumab) — full drug profile →
• Peripheral blood draws
• Leukapheresis — full drug profile →
• Rituximab — full drug profile →
• Biopsy

Conditions studied

• Follicular Lymphoma — all drugs for Follicular Lymphoma →

Sponsor

Washington University School of Medicine

Who can join

18 and older, any sex, with Follicular Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Follicular lymphoma (FL) has a number of effective standard of care therapies; however, FL is not currently considered curable. Therefore, designing well tolerated therapies without cumulative and long-term toxicity is critical. This is a pilot safety and feasibility study that combines a personalized tumor vaccine with nivolumab for the treatment of FL. Patients who demonstrate progression on this study may be treated with rituximab (or another monoclonal antibody against CD20) in addition to vaccine therapy with nivolumab at the discretion of treating physician if clinically indicated.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Immune checkpoint blockade and CAR-T cell therapy in hematologic malignancies.
   Wang H, Kaur G, Sankin AI, Chen F, et al · · 2019 · cited 138× · PMID 31186046 · DOI 10.1186/s13045-019-0746-1
2. Neoantigen prediction and computational perspectives towards clinical benefit: recommendations from the ESMO Precision Medicine Working Group.
   De Mattos-Arruda L, Vazquez M, Finotello F, Lepore R, et al · · 2020 · cited 126× · PMID 32610166 · DOI 10.1016/j.annonc.2020.05.008
3. Trial watch: Peptide-based vaccines in anticancer therapy.
   Bezu L, Kepp O, Cerrato G, Pol J, et al · · 2018 · cited 114× · PMID 30524907 · DOI 10.1080/2162402x.2018.1511506
4. Personalized neoantigen vaccination with synthetic long peptides: recent advances and future perspectives.
   Chen X, Yang J, Wang L, Liu B. · · 2020 · cited 69× · PMID 32483434 · DOI 10.7150/thno.38742
5. Immune checkpoint inhibitors in lymphoma: challenges and opportunities.
   Hatic H, Sampat D, Goyal G. · · 2021 · cited 50× · PMID 34277837 · DOI 10.21037/atm-20-6833
6. Pathogen Molecular Pattern Receptor Agonists: Treating Cancer by Mimicking Infection.
   Aleynick M, Svensson-Arvelund J, Flowers CR, Marabelle A, et al · · 2019 · cited 45× · PMID 31123052 · DOI 10.1158/1078-0432.ccr-18-1800
7. Cancer vaccines: translation from mice to human clinical trials.
   Maeng H, Terabe M, Berzofsky JA. · · 2018 · cited 40× · PMID 29554495 · DOI 10.1016/j.coi.2018.03.001
8. Novel and emerging therapies for B cell lymphoma.
   Ayyappan S, Maddocks K. · · 2019 · cited 37× · PMID 31345247 · DOI 10.1186/s13045-019-0752-3