Gynecologic cancer care: Improving clinical trial enrollment through molecular matching with targeted therapies and improving equal access to care and research for all populations

NIH Pandemic-Era Grants

Pandemic Era Grants

2024

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Principal Investigator: Floor J. Backes
Organization: OHIO STATE UNIVERSITY
Fiscal Year: 2024
Award: $132,015
Funding agency: National Cancer Institute

Project Summary/Abstract
Gynecologic Cancer remains an underfunded area of research with funding to lethality scores significantly lower
than other cancer sites. Endometrial cancer, the most common gynecologic cancer, is one of the few cancers
that has seen an increase in incidence and mortality over the recent years, with black women and minorities
disproportionally affected. Underrepresented populations often develop high risk and rare subtypes of uterine
cancers with distinct molecular profiles. Recent research has identified several molecular subtypes that can be
targeted with novel agents, however, most of these studies have low enrollment of underrepresented populations
who are most likely to have the greatest benefit.
Molecularly driven trials are critical to the progress of personalized medicine to improve survival and limit
exposure to ineffective therapy and associated toxicities. Unfortunately, these highly specialized clinical trials
are at risk of failure due to slow accrual or under-enrollment of the appropriate populations. As the national PI
for NCI/NRG-GY020 (vaginal brachytherapy +/- immunotherapy for early stage high risk mismatch repair
deficient endometrial cancer, which is a subset of endometrial cancer patients who are highly sensitive to
immunotherapy) Dr. Backes is well aware of the opportunities and challenges associated with molecularly driven
clinical trials. NCI support through the R50 mechanism will allow Dr. Backes to increase her efforts to
improve enrollment to clinical trials for all populations, both at her institution and nationally. First,
leveraging the resources of the Ohio State University Comprehensive Cancer Center (OSUCCC), Dr. Backes
will develop a comprehensive system for molecular matching to simplify and streamline the identification of
patients for trials and specialized trials for patients, which will increase accrual. Collaborative cross-disciplinary
efforts are especially important with the increasing complexity of molecularly driven clinical trials, such as NCI
ComboMatch and iMatch, and also to improve the outcomes of patients with rare tumor mutations. Secondly,
Dr. Backes will collaborate with Dr. Elektra Paskett to include gynecologic oncology on a recently opened study
“OSU Connecting Underrepresented Populations to Clinical Trials” (1U01CA274999-01). Dr. Backes and Dr.
Ashley Felix (PhD, Epidemiology) will focus on assessing barriers and implement strategies to improve access
to care and clinical trials for underrepresented populations in gynecologic oncology locally and nationally. Finally,
the opportunities afforded by this award will allow Dr. Backes to increase her time to design and support the
development of paradigm shifting clinical trials, and mentor junior investigators in this process, through
her national roles as the NRG Oncology Co-Chair for Developmental Therapeutics, member of the Uterine
Corpus Committee, New Investigator Committee, NCI Uterine Taskforce, national PI for NRG-GY020 and other
trials under development, and in additional local roles as the Disease Specific Research Group Leader, NRG
Oncology site PI for Gynecologic Oncology and Fellowship Director.

Terms: <Access to Care><Advisory Committees><Affect><Area><Award><Awareness><Body of uterus><Brachytherapy><Cancer Patient><Cancers><Clinical Trials><Collaborations><Comprehensive Cancer Center><Corpus Uteri><Curietherapy><Development><Developmental Therapeutics><Developmental Therapeutics Program><Developmental Therapy><Disease><Disorder><Doctor of Philosophy><Drug Committee><Endometrial Cancer><Endometrial Carcinoma><Endometrium Cancer><Endometrium Carcinoma><Enrollment><Epidemiology><Exposure to><Failure><Fellowship><Female Reproductive Cancer><Floor><Formulary Committee><Funding><Genetic Alteration><Genetic Change><Genetic defect><Goals><Gynecologic Cancer><Gynecologic Oncology><Gynecological Cancer><Health Services Accessibility><Immune mediated therapy><Immunologically Directed Therapy><Immunotherapy><Improve Access><Incidence><Institution><Interdisciplinary Research><Interdisciplinary Study><Investigators><MMR deficiency><Malignant Female Reproductive System Neoplasm><Malignant Gynecologic Neoplasm><Malignant Gynecologic Tumor><Malignant Neoplasm of the Uterus><Malignant Neoplasms><Malignant Tumor><Malignant Tumor of the Female Reproductive System><Malignant Tumor of the Uterus><Malignant Uterine Neoplasm><Malignant Uterine Tumor><Mentors><Minority><Mismatch Repair Deficiency><Molecular><Molecular Fingerprinting><Molecular Profiling><Multidisciplinary Collaboration><Multidisciplinary Research><Mutation><National Clinical Trials Network><Ohio><Oncology><Oncology Cancer><Patient outcome><Patient-Centered Outcomes><Patient-Focused Outcomes><Patients><Ph.D.><PhD><Pharmacy Committees><Population><Prevention trial><Process><Radiation Brachytherapy><Radioisotope Brachytherapy><Research><Research Personnel><Research Resources><Researchers><Resources><Risk><Role><Site><System><Task Forces><Therapeutics Committee><Time><Toxic effect><Toxicities><Underrepresented Groups><Underrepresented Populations><Universities><Uterine Body><Uterine Cancer><Uterus><Uterus Cancer><Vagina><Work><access to health services><access to services><access to treatment><accessibility to health services><advisory team><availability of services><black female><black women><cancer care><cancer location><cancer site><cancers that are rare><care access><clinical trial enrollment><control trial><design><designing><developmental><enroll><epidemiologic><epidemiological><ethnic minority><expression subtypes><genome mutation><gynecologic malignancy><gynecological malignancy><health service access><health services availability><high risk><immune therapeutic approach><immune therapeutic interventions><immune therapeutic regimens><immune therapeutic strategy><immune therapy><immune-based therapies><immune-based treatments><immuno therapy><improved><improved outcome><ineffective therapies><ineffective treatment><malignancy><member><molecular profile><molecular signature><molecular sub-types><molecular subsets><molecular subtypes><mortality><neoplasm/cancer><novel><patient oriented outcomes><personalization of treatment><personalized medicine><personalized therapy><personalized treatment><racial minority><rare cancer><rare malignancy><rare tumor><service availability><social role><targeted drug therapy><targeted drug treatments><targeted therapeutic><targeted therapeutic agents><targeted therapy><targeted treatment><treatment access><treatment trial><under representation of groups><under represented groups><under represented people><under represented populations><underrepresentation of groups><underrepresented people><womb>