Study of Intratumoral G100 With Or Without Pembrolizumab or Rituximab In Participants With Follicular Non-Hodgkin's Lymphoma (MK-3475-174/IMDZ-G142)

Conditions

• Follicular Low Grade Non-Hodgkin's Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• G100 — DRUG
  GLA is a fully synthetic toll-like receptor-4 (TLR4) agonist
• Pembrolizumab — DRUG
  PD-1 Inhibitor
• Rituximab — DRUG
  Rituximab (anti-CD20 antibody)

Study Details

This is a Phase 1/2 open label trial of G100 in participants with low grade Non-Hodgkin's Lymphoma (NHL). G100 is composed of glucopranosyl lipid A in a stable emulsion and is a potent TLR4 (toll-like receptor-4) agonist. G100 will be administered by direct injection (intratumorally) into tumors of low grade NHL with or without standard low dose radiation therapy. Preclinical models and clinical studies in other cancers such as Merkel cell carcinoma have demonstrated that G100 administered in this manner can alter the tumor microenvironment, activate dendritic cells, T cells and other immune cells and induce systemic anti-tumor immune responses. In this trial, the safety, immunogenicity, and preliminary clinical efficacy of G100 will be examined alone or with pembrolizumab.

Key Dates

Start date

Feb 3, 2016

Status verified

Aug 2020

Primary completion

Aug 1, 2019

Completion

Aug 1, 2019

Study Design

Enrollment

52 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Part 1: Local Radiation + G100 5μg/tumor
  Part 1: Local radiation and G100 \[glucopyranosyl lipid A stable emulsion, GLA-SE\] at 5μg/tumor administered intratumorally (IT) into accessible tumors for up to 8 weeks.
• Experimental: Part 1: Local Radiation + G100 10μg/tumor
  Part 1: Local radiation and G100 at 10μg/tumor administered IT into accessible tumors for up to 8 weeks.
• Experimental: Part 2: Local Radiation + G100 10μg/tumor
  Part 2: Local radiation and G100 at 10μg/tumor administered IT into accessible tumors for up to 8 weeks.
• Experimental: Part 2: Local Radiation + G100 10μg/tumor+Pembrolizumab 200mg
  Part 2: Local radiation and G100 at 10μg/tumor administered IT into accessible tumors for up to 8 weeks; pembrolizumab 200mg intravenously (IV) administered every 3 weeks (Q3W) IV for up to 2 years.
• Experimental: Part 2: Local Radiation, G100 20 μg/tumor in Large Tumors
  Part 2: Local radiation and G100 at 20 μg/tumor administered IT into accessible large tumors \[injectable lymphoma mass(es) ≥ 4 cm in total size\] for up to 8 weeks.
• Experimental: Part 3: Local Radiation + G100 20μg/tumor
  Part 3: Local radiation and G100 at 20μg/tumor administered IT into accessible tumors for up to 8 weeks.
• Experimental: Part 4: G100 20μg/tumor and pembrolizumab 200mg
  Part 4: G100 at 20μg/tumor administered IT into accessible tumors for up to 8 weeks and pembrolizumab 200mg IV and administered Q3W for up to 2 years.
• Experimental: Part 5: G100 + Rituximab 375mg/m^2
  Part 5: G100 at 20, 40, 60, or 80μg/tumor administered IT for up to 6 weeks and rituximab administered as an IV infusion at 375mg/m\^2 on Day 0 and then QW for up to 3 weeks.

Primary Outcome Measure

Number of Participants With an Adverse Event (AE) [ Time Frame: Up to approximately 42 months ]