# Multi-omic liquid biopsy assessment in NCI trials: evaluating ctDNA, extravesicle RNA, and outcomes with immunotherapy in patient with colorectal and anal cancers

> **NIH NIH R50** · UNIVERSITY OF TX MD ANDERSON CAN CTR · 2024 · $181,640

## Abstract

My long term goal as a clinical scientist at MD Anderson Cancer Center is to lead clinical trials that improve
survival for patients with gastrointestinal malignancies, particularly colorectal and anal cancer. To accomplish
this, I have integrated novel testing techniques and promising immunotherapy combinations into the design of
NCI-supported clinical trials. I am the overall Principal Investigator for the NRG-GI005 phase II/III trial evaluating
circulating tumor DNA (ctDNA) as a predictive biomarker for adjuvant chemotherapy benefit in patients with stage
IIA colon cancer. NRG-GI005 is the first NCI-supported trial for any solid tumor type to incorporate ctDNA as an
integral biomarker for treatment assignment as part of a clinical trial design. Planned analysis of optional blood
collected on this study will compare head-to-head different methodologies for detecting minimal residual disease
(MRD) performed on the same samples and provide missing insights into optimal ctDNA assay selection needed
for future NCI trials evaluating ctDNA as a surrogate for the presence of MRD. I have also written and led, as
overall PI, two immunotherapy trials across NCTN (SWOG S2107) and ETCTN (NCI 9673) sites. Promising
clinical activity for the triple therapy of encorafenib, cetuximab, and nivolumab for patients with microsatellite
stable BRAFV600E metastatic colorectal cancer from a pilot trial at MD Anderson were applied for the
subsequent SWOG S2107 randomized phase II trial, now activated across the NCTN. The ETCTN-sponsored
NCI 9673 trial demonstrated antitumor activity of nivolumab metastatic anal cancer and led to this treatment as
a recommended option on the NCCN Guidelines for anal cancer.
As an R50 funded clinical scientist, I propose to combine these clinical trial leadership experiences and expand
on the role of blood-based biomarkers to generate novel combination immunotherapy trials. I have utilized
extravesicle RNA (evRNA) isolated from plasma to characterize changes in RNA signatures associated with
treatment response to encorafenib, cetuximab, and nivolumab in patients with BRAFV600E metastatic colorectal
cancer. With R50 protected effort, I will expand plasma evRNA analysis in evaluating response using samples
collected from SWOG S2107, with >90% yield from patients enrolled thus far. During the funding period, I also
propose to develop my leadership institutionally in my role as SWOG PI for the NCTN LAPS grant Executive
Committee, where I will expand enrollment at new affiliate sites for MD Anderson, prioritizing SWOG/NCTN trials
first, which we also anticipate will improve underrepresented minority enrollment and address health disparities
on NCI trials conducted under MD Anderson umbrage. If successful, these efforts collectively could serve as
justification to expand the utility of liquid biopsy beyond ctDNA, with the goal of applying translational studies to
identify effective therapeutic strategies for all patients with gastrointestinal ...

## Key facts

- **NIH application ID:** 10942040
- **Project number:** 1R50CA285403-01A1
- **Recipient organization:** UNIVERSITY OF TX MD ANDERSON CAN CTR
- **Principal Investigator:** VAN K MORRIS
- **Activity code:** R50 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $181,640
- **Award type:** 1
- **Project period:** 2024-09-12 → 2029-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10942040

## Citation

> US National Institutes of Health, RePORTER application 10942040, Multi-omic liquid biopsy assessment in NCI trials: evaluating ctDNA, extravesicle RNA, and outcomes with immunotherapy in patient with colorectal and anal cancers (1R50CA285403-01A1). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10942040. Licensed CC0.

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