# Dana‐Farber/Harvard Cancer Center Experimental Therapeutics Clinical Trials Network Site (DF/HCC ETCTN Site)

> **NIH NIH UM1** · DANA-FARBER CANCER INST · 2020 · $6,942,412

## Abstract

PROJECT SUMMARY/ABSTRACT
The NCI-designated Dana-Farber/Harvard Cancer Center (DF/HCC) includes the Dana-Farber Cancer Institute
(DFCI)/Brigham and Women's Hospital (BWH), Massachusetts General Hospital (MGH) and the Beth Israel
Deaconess Medical Center (BIDMC), which together comprise a Lead Academic Organization (LAO) in the
integrated NCI Experimental Therapeutics Clinical Trials Network (ETCTN). Under the auspices of a UM1
Cooperative Agreement, the DF/HCC LAO has participated in 15 NCI-CTEP project teams, with leadership
roles on 6 teams, led 20 ETCTN trials and participated in 43 studies, with an average of 102 enrollments per
year over the last 5 years. Our LAO utilizes a multiple PD/PI structure and includes (1) a core of translational
investigators with expertise in biomarker development for signal transduction, cell cycle, DNA repair and
immuno-oncology agents, as well as proficiency in liquid biopsy analyses, computational biology and beside-
to-bench cell line, organoid and PDX model development; (2) investigators who conduct Phase 1 and basket
studies, as well as eight lead disease-focused investigators who work with DF/HCC Program and SPORE
leaders to conduct disease-specific ETCTN trials; (3) representatives of DF/HCC interventional radiology,
research pathology and biostatistics; and (4) leaders who direct regulatory oversight, a robust mentoring
program for early career clinical and translational investigators and outreach activities designed to increase the
enrollment of underserved populations in ETCTN trials. Through continued participation in NCI Project Teams
and the leveraging of DF/HCC translational science, DF/HCC investigators will develop letters of intent and
statistically rigorous protocols utilizing CTEP IND agents as monotherapies or in rational combinations that will
be efficiently conducted and reported in collaboration with other ETCTN sites. Additionally, our investigators
will accrue to ETCTN studies led by other LAOs with the overall goal of at least 30% network participation and
100 enrollments per year. Investigators will utilize both DF/HCC cores and NCI central laboratories to
incorporate validated integral and integrated biomarker assays and exploratory biomarkers in trial designs that
examine proof-of-principle evidence of therapeutic activity in selected patient populations, proof-of-mechanism
evidence of target engagement, as well as signatures of response, pathway adaptation and resistance. The
DF/HCC LAO will maintain extensive commitments to the training of early career investigators in
developmental therapeutics and to strategic initiatives expected to increase the diversity of the population
enrolled to ETCTN trials.

## Key facts

- **NIH application ID:** 9933180
- **Project number:** 2UM1CA186709-06
- **Recipient organization:** DANA-FARBER CANCER INST
- **Principal Investigator:** KEITH T FLAHERTY
- **Activity code:** UM1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $6,942,412
- **Award type:** 2
- **Project period:** 2014-03-13 → 2023-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9933180

## Citation

> US National Institutes of Health, RePORTER application 9933180, Dana‐Farber/Harvard Cancer Center Experimental Therapeutics Clinical Trials Network Site (DF/HCC ETCTN Site) (2UM1CA186709-06). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/9933180. Licensed CC0.

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