NCT03121677

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

Pilot Study of a Personalized Tumor Vaccine Strategy and PD-1 Blockade in Patients With Follicular Lymphoma

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Follicular Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	Personalized tumor vaccine	* Cycle 12 vaccine administration is optional * The peptides comprising the vaccine are reconstituted in up to 4 pools with 5 peptides per pool (A, B, C, and D) . At each vaccination time point, each of the up to four pools will be administered to one of the four limbs (A - Right Arm, B - Left Arm, C - Right Leg, D - Left Leg) by subcutaneous injection.
DRUG	Poly ICLC	-The personalized tumor vaccine will be co-administered with poly-ICLC.
BIOLOGICAL	Nivolumab	-Nivolumab will be administered at a dose of 240 mg intravenously
PROCEDURE	Peripheral blood draws	-Time of biopsy, during the pre-treatment check (any time before cycle 1 day 1), Cycle 1 Day 15, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 6 Day 1, Cycle 12 Day 1, Time of response, and Time of progression or relapse
PROCEDURE	Leukapheresis	* Prior to the initiation of treatment and up to five days prior to treatment on cycle 6 day 1, patients will undergo apheresis according to standard institutional procedures for non-mobilized collection. * Peripheral blood leukocytes will be cryopreserved for later assessment for the presence of T-cells that recognize tumor specific mutant antigens and immunophenotype, and the presence of other lymphocytes or regulatory populations.
BIOLOGICAL	Rituximab	-Other anti-CD20 mAb treatment can be used
PROCEDURE	Biopsy	-Biopsies on lymph node or extranodal site(s) are to be obtained at: screening (only after the patient is deemed eligible; during cycle 2 (after treatment on C2D15 and prior to treatment on C3D1); disease relapse or progression (if this occurs)

Timeline

• Start date: 2018-10-16
• Primary completion: 2020-09-24
• Completion: 2023-08-07
• First posted: 2017-04-20
• Last updated: 2023-08-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study