Therapy Landscape for Kidney Cancer

(ODYSSEY RCC Trial)

Not currently recruiting at 13 trial locations
SC
KW
Overseen ByKimberly Ward
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Duke University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to better understand the treatment of metastatic renal cell carcinoma (mRCC) in real-world settings in the U.S. and its impact on patients' quality of life. It focuses on individuals who have started their first or second round of treatment for mRCC within the last three months. Those who have undergone previous surgery or radiation, or who are currently not on active therapy, can also participate. The trial excludes individuals being treated for other types of cancer.

As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to the validation of a potentially effective treatment.

Why are researchers enthusiastic about this study?

Researchers are excited about this trial because it aims to build a comprehensive database that could transform how we approach treatment for renal cell carcinoma (RCC). Currently, standard treatments for RCC include targeted therapies like tyrosine kinase inhibitors and immunotherapies, which work by either blocking the signals that tumors use to grow or boosting the immune system to attack cancer cells. However, the landscape is rapidly changing, and this database will help track outcomes and effectiveness of emerging therapies. By capturing real-world data, researchers hope to better understand which treatments work best for different patient profiles, ultimately guiding personalized medicine and improving survival rates.

Who Is on the Research Team?

DG

Daniel George, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

Inclusion Criteria

Age 19 or over at time of informed consent.
Diagnosis of metastatic renal cell cancer (mRCC) with less than 6 weeks of first-line systemic therapy for mRCC.
Prior surgery and radiation therapy are permitted.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Patients undergo consent and baseline assessments, including research blood collection and processing

1 visit
1 visit (in-person)

Follow-up

Patient reported outcomes, quality of life, and medications data are obtained via follow-up phone interviews

Up to 36 months
Follow-up phone interviews every 3 months for 2 years, every 6 months thereafter

What Are the Treatments Tested in This Trial?

Find a Clinic Near You

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials
2,495
Recruited
5,912,000+

Duke Clinical Research Institute

Collaborator

Trials
69
Recruited
242,000+

Bristol-Myers Squibb

Industry Sponsor

Trials
2,731
Recruited
4,127,000+
Headquarters
New York City, USA
Known For
Oncology & Cardiovascular
Top Products
Eliquis, Opdivo, Revlimid, Orencia
Christopher Boerner profile image

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt profile image

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Exelixis

Industry Sponsor

Trials
126
Recruited
20,500+
Michael M. Morrissey profile image

Michael M. Morrissey

Exelixis

Chief Executive Officer since 2010

PhD in Chemistry from Harvard University, BSc in Chemistry from the University of Wisconsin

Vicki L. Goodman profile image

Vicki L. Goodman

Exelixis

Chief Medical Officer since 2022

MD

Merck Sharp & Dohme LLC

Industry Sponsor

Trials
4,096
Recruited
5,232,000+
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Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis profile image

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Pfizer

Industry Sponsor

Trials
4,712
Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni profile image

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

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