# Cancer Immunotherapy Trials Network Central Operations and Statistical Center

> **NIH NIH UM1** · FRED HUTCHINSON CANCER RESEARCH CENTER · 2020 · $2,878,060

## Abstract

Project Summary
The Cancer Immunotherapy Trials Network (CITN) came about from discussions at the 2007 NCI
Immunotherapy Agent Workshop, in which high-priority agents were identified that showed the potential to
benefit patients with cancer—but that were not yet broadly available for investigator-initiated trials (IITs). Since
2007, a sea change has occurred in the field of cancer immunotherapy, resulting from the success of anti-PD1
and anti-PD-L1. However, most of the priority agents identified in the NCI Workshop are still not broadly
available for academic IITs.
Since the original award in 2011, the CITN focused on testing these high-priority agents, including 5 of the top
8 ranked agents that hit targets critical for optimal immune responses. CITN trials are among the few academic
IITs of these agents, and each trial has defined biologic and therapeutic principles. Two trials have led to
changes in clinical practice. The abbreviated Specific Aims for the CITN are as follows:
Aim 1: (a) to continue to conduct innovative early phase multicenter immunotherapy trials for adult cancers
using high-priority immunomodulatory agents; (b) to form a Pediatric CITN (PedCITN) to conduct innovative
early phase multicenter immunotherapy trials for pediatric cancers using high-priority immunomodulatory
agents; (c) to provide leadership, infrastructure, and statistical support for the conduct of these clinical trials;
(d) to continue to access high-priority agents central to immune responses and not broadly available for IITs
Aim 2: to coordinate studies with Cancer Immune Monitoring and Analysis Center (CIMAC) and other labs for
specimen analysis (immune monitoring, biomarker credentialing) of adult and pediatric patients on CITN trials
Scientific Goals of the CITN
1. Continue trials with T cell and natural killer cell activator and growth factor IL-15, homeostatic T cell growth
 factor IL-7, dendritic cell activator anti-CD40, dendritic cell growth factor Flt3L, and IDO inhibitor ± anti-PD1
2. Continue trials with anti-PD1 for orphan and ultra-orphan indications, including pediatric cancers
3. Conduct biopsy-intense trials to identify actionable causes of anti-PD1 failure and linked to therapeutic
 administration of potential rescue agents
4. Conduct trials to assess therapies that eliminate or activate the myeloid, monocytes/macrophage, and/or
 myeloid-derived suppressor cells that reside within most cancers
5. Conduct multicenter Phase I and early Phase II immunotherapy trials for pediatric patients with cancer
The results will inform future trial designs and improve the understanding of these high-priority agents. CITN
trials are designed to identify paths to regulatory approval and will likely change standard practice or spur
confirmatory pivotal trials by NCI cooperative groups and industry for adult and pediatric cancers.

## Key facts

- **NIH application ID:** 10018807
- **Project number:** 5UM1CA154967-10
- **Recipient organization:** FRED HUTCHINSON CANCER RESEARCH CENTER
- **Principal Investigator:** NANCY ELLEN DAVIDSON
- **Activity code:** UM1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $2,878,060
- **Award type:** 5
- **Project period:** 2010-09-22 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10018807

## Citation

> US National Institutes of Health, RePORTER application 10018807, Cancer Immunotherapy Trials Network Central Operations and Statistical Center (5UM1CA154967-10). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10018807. Licensed CC0.

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