CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 9 enrolled
Drug / intervention
Ipilimumab +2 morebiological
Likely dose
Ipilimumab 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02254772
NCT02254772Phase 2Completed
CompareCT.gov

A Phase I/II Study of Intratumoral Injection of SD-101, an Immunostimulatory CpG, and Intratumoral Injection of Ipilimumab, an Anti-CTLA4 Monoclonal Antibody, in Combination With Local Radiation in Low-Grade B-Cell Lymphomas

Robert Lowsky·interventional·Posted Oct 2, 2014·Updated Nov 27, 2019

In Brief

A Phase 2 clinical trial evaluating Ipilimumab, SD-101, and 1 other intervention for Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue and 6 related conditions. Completed, enrolled 9 participants across 1 site.

Detailed Summary

This phase 1-2 trial studies the side effects and best dose of ipilimumab in combination with toll-like receptor 9 (TLR9) agonist SD-101 and radiation therapy in treating patients with recurrent low-grade B-cell lymphoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsExtranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Nodal Marginal Zone B-cell Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Small Lymphocytic Lymphoma, Splenic Marginal Zone Lymphoma
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 2, 2014
Enrollment StartSep 1, 2014
Primary CompletionNov 10, 2016
Study CompletionJan 26, 2017
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 11.8 years ago

Interventions

Ipilimumabbiological

A dose of 10 mg in cohort 1 or 25mg in cohort 2 via intratumoral injection on day 2, week 1.

SD-101drug

Started on day 2 week 1, then once every week x 4 successive weeks for a total of 5 injections.

Radiation therapyradiation

Undergo low-dose radiation therapy to 1 site of disease