Patients

Crestone For Patients

 

What is CRESTONE?

CRESTONE, or Clinical study of REsponse to Seribantumab in TumOrs with NEuregulin 1 (NRG1) fusions, is a clinical trial opportunity for patients with advanced solid tumors who have not responded, or are no longer responding to standard treatment, and whose tumor has tested positive for the NRG1 fusion.

Eligibility

Who is Eligible?

If you can answer “yes” to all of the statements below, you may qualify for the CRESTONE trial. We recommend that you discuss your clinical trial options with your physician.

  • I am 18 years of age or older
  • I am not currently pregnant, and do not plan to become pregnant soon
  • I have an advanced solid tumor
  • My cancer is no longer responding to standard anti-cancer treatment, or there is no standard treatment that is available
  • I have had a genomic or molecular test performed on my tumor, and the test result shows that my tumor has an NRG1 gene fusion

What if I’m not sure if I meet every eligibility criteria for CRESTONE?

As long as your tumor has an NRG1 gene fusion, you may be eligible to receive seribantumab on an investigational basis. We encourage you to talk to your physician about your clinical trial options and reach out to us with any questions at medicalaffairs@elevationoncology.com or +1 716-371-1125.

How do I find out if my tumor has an NRG1 fusion?

Today, the only way to know for sure if your tumor has an NRG1 fusion is to have your tumor genomically tested.

There are multiple types of tests available today for detecting gene fusions, but some are more sensitive than others. The most sensitive method of detecting an NRG1 gene fusion currently is by getting an RNA-based Next Generation Sequencing (NGS) test that looks at your tumor’s RNA instead of its DNA.

If you have been diagnosed with a solid tumor, we encourage you use the resources below to learn more, and to talk to your physician about your genomic testing options.

FAQ

Frequently Asked Questions about CRESTONE

How do I get enrolled in CRESTONE?

If you have not yet had your tumor tested for an NRG1 gene fusion, talk to your physician today about available testing options.

If your tumor has tested positive for an NRG1 fusion and you and your physician determine that the CRESTONE study may be the right path forward in your treatment journey, the next step is to find a participating study site near you.

Active sites are listed below in the “Participating CRESTONE study sites” section, and at www.clinicaltrials.gov (NCT04383210). Our team is also available to help identify the best study site for you. Contact us at medicalaffairs@elevationoncology.com or +1 (716) 371-1125, and we will return your message within 48 hours.

What should I expect once I am enrolled in CRESTONE?

Clinical trials like CRESTONE offer access to experimental medicines that may help you and other patients in the future. Because a clinical trial is a rigorously controlled study, you can expect a comprehensive treatment plan with clear milestones and follow-up. Clinical trials are reviewed and approved by study sites to ensure quality of care.

Your physician and the investigators at the clinical trial site will give you a full description of what to expect while you participate in CRESTONE. At any time, feel free to contact us at medicalaffairs@elevationoncology.com or +1 (716) 371-1125 and our medical team will answer any questions that you have.

What does it cost to participate in CRESTONE?

Your cancer treatment on CRESTONE is provided free of charge to you. In addition, we are committed to assisting our patients with travel and lodging costs. While travel is often necessary, we believe participation in the CRESTONE study should not be a financial burden.  Please contact us at medicalaffairs@elevationoncology.com or +1 (716) 371-1125 for specific details and our team will be happy to answer any specific questions that you may have.

Am I guaranteed to receive seribantumab on CRESTONE?

Yes, the CRESTONE study is designed so that all patients will receive the investigational drug seribantumab. No patients on CRESTONE will receive a placebo.

How is seribantumab given?

Seribantumab is an intravenous (IV) medication that is administered in a hospital, out-patient infusion center based upon the clinical trial site’s facilities and capabilities. Your physician will explain to you the frequency and duration of each administration that you can expect throughout the clinical trial.

Learn More

Patient resources

The following downloadable resources are available to help you and your loved ones learn more about the CRESTONE study. These resources may also be helpful to share with your doctor at your next appointment:

CRESTONE for Patients
NRG1 fusions – The science behind the CRESTONE study
Genomic testing for NRG1 fusions

To learn more about genomic testing for cancer and how it can help your doctor better tailor your treatment plan for you, the following resources may be a good place to start:

Genomic testing for cancer
Patient-Doctor discussion guide

Find a Location

Participating CRESTONE study sites

The CRESTONE study is open and enrolling patients at the US clinical sites listed below. Most of the clinical sites are part of a larger network, and all questions and/or referrals should be directed to the primary contact at the main operations center.

We are actively opening new sites across the US and will update this list regularly. If you do not yet see a clinical site open near you and would like to learn more about the CRESTONE study, please contact us directly at medicalaffairs@elevationoncology.com or +1 (716) 371-1125. We look forward to hearing from you, and will return your message within 48 hours.

Clinical Trial Site City State Status
University of Alabama at Birmingham Birmingham AL Open and Enrolling
Honor Health Scottsdale AZ Open and Enrolling
Compassionate Cancer Care Fountain Valley CA Open and Enrolling
Pacific Shores Medical Group Huntington Beach CA Open and Enrolling
Cedars Sinai Los Angeles CA Open and Enrolling
University of California – Irvine Medical Center Orange CA Open and Enrolling
University of Colorado Denver CO Open and Enrolling
Georgetown University Washington DC Open and Enrollling
Medical Oncology Hematology Consultants Newark DE Open and Enrollling
Advent Health Orlando FL Open and Enrolling
Moffit Cancer Center Tampa FL Open and Enrolling
University Cancer & Blood Center Athens GA Open and Enrolling
Hawaii Cancer Care, Inc. Honolulu HI Open and Enrolling
Robert H. Lurie Comprehensive Cancer Center of Northwestern University Chicago IL Open and Enrolling
Massachusetts General Hospital (MGH) Boston MA Open and Enrolling
Henry Ford Detroit MI Open and Enrolling
Metro Minnesota CCOP St. Louis Park MN Open and Enrolling
Washington University at St. Louis St. Louis MO Open and Enrolling
Levine Cancer Center Charlotte NC Open and Enrolling
Nebraska Methodist Hospital Omaha NE Open and Enrolling
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center New York NY Open and Enrolling
Montefiore Bronx NY Open and Enrolling
Ohio State University Columbus OH Open and Enrolling
Oregon Health and Science University Portland OR Open and Enrolling
The Pennsylvania State University (Penn State) Milton S. Hershey Medical Center Hershey PA Open and Enrolling
Fox Chase Cancer Center Philadelphia PA Open and Enrolling
Sarah Cannon Research Institute (SCRI) Nashville TN Open and Enrolling
MD Anderson Cancer Center Houston TX Open and Enrolling
Utah Cancer Specialists Salt Lake City UT Open and Enrolling
VA Cancer Specialists Fairfax VA Open and Enrolling
Northwest Medical Specialists Tacoma WA Open and Enrolling
University of Wisconsin Madison WI Open and Enrolling
The Kinghorn Cancer Centre Darlinghurst, NSW AUS Open and Enrolling
Peter MacCallum Cancer Centre Melbourne, VIC AUS Open and Enrolling
William Osler Health System Brampton, ON CAN Open and Enrolling
British Columbia Cancer Agency Vancouver, BC CAN Open and Enrolling

Getting Started in the Trial

Talk with your physician about tumor testing and clinical trials

If you are interested in getting your tumor tested and learning about investigational therapies that may be uniquely targeted to your tumor, please talk to your physician. We encourage all patients to consider genomic testing for their tumor to make sure you have all of the information available before choosing a treatment path.

Your physician can help determine if participating in a clinical trial may be an option for the treatment of your cancer. Your decision to participate in a clinical trial is voluntary and should only be made after all your questions have been answered and you feel comfortable making a well-informed decision.

We are also here to help and provide the information necessary to make an informed decision. You can always contact our medical staff at medicalaffairs@elevationoncology.com or +1 (716) 371-1125. Send us a message, and we’ll get back to you within 48 hours.