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Thank you for participating in the BOND-003, NCT04452591 Phase 3, Global (US, Japan, South Korea, Taiwan, Australia, Canada) study.

Here we provide the resources you need as a site participating in the study. If you cannot find what you need, or have questions please reach out to the CG Oncology team

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In this study, cretostimogene grenadenorepvec (CG0070) is being investigated as a monotherapy for the treatment of BCG-unresponsive, Non-Muscle Invasive Bladder Cancer (NMIBC). In patients with high-risk NMIBC (CIS with or without Ta/T1, Ta or T1) who do not respond to BCG intravesical therapy (standard of care).

For more information on CG Oncology
go to www.cgoncology.com

For more information on cretostimogene grenadenorepvec and other studies sponsored by CGOncologyplease go to www.cgoncology.com/science/

Protocol

In this study, cretostimogene grenadenorepvec (CG0070) is being investigated as a monotherapy for the treatment of BCG-unresponsive, Non-Muscle Invasive Bladder Cancer (NMIBC). In patients with high-risk NMIBC (CIS with or without Ta/T1, Ta or T1) who do not respond to BCG intravesical therapy (standard of care).

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Newsletters

CURRENT BOND-003 NEWSLETTER
5th Edition (January 2023)
PREVIOUS BOND-003 NEWSLETTER
4th Edition (December 2022)
3rd Edition (November 2022)
2nd Edition (October 2022)

1st Edition (September 2022)

FAQ’s

Can we schedule a virtual demonstration?
Yes! If your institution has onsite restrictions, we are happy to set up a virtual instillation demonstration for you and your team.
Can you train the newest members of our team?
Yes! If you have new members on your study team, please let us know and we will be glad to set up a refresher training for new and established members of your team.
Can we do an onsite booster visit?
Yes! Someone from CG Oncology can come to you and we can conduct an in-person booster visit. Let us know if this is your preference and we will coordinate a time that works for you and the team.
What’s the difference between a booster visit and monitoring?
Monitoring visits are conducted by your CRA and are required at scheduled intervals if the site has enrolled patients. Booster visits are conducted by the medical team and are more like strategy sessions between CG Oncology and the site study team.
If patient has a recent cystoscopy on file, is one still required prior to study enrollment?
If performed within 8 weeks prior to day 1, the procedure does not need to be repeated as part of screening, as long as documentation of proper performance and outcome are demonstrated.
How soon after TURBT can treatment begin?
CG0070 treatment cannot begin until at least 14 days after the most recent TURBT or biopsy, unless discussed with the medical team at CG Oncology.
Do patients need to have their qualifying BCG course completed within 12 months of study entry?
No. Adequate BCG history does not need to be within the last 12 months. It could have been longer than 12 months ago, but a diagnosis of NMIBC with CIS +/- TaHG or T1 must be documented within 12 months of the last qualifying dose of BCG.
Can patients on study get Covid-19 vaccines and boosters?
Yes. Patients on trial can get their Covid-19 vaccines but we recommend a 7-day window between the vaccine and their treatment with CG0070.
If there is no evidence of disease on a local pathology report during one of the on-study timepoints, do I still need to send in all blocks of tissue to Q2?
Yes! If the local pathology report states that tissue was taken, or a specimen was received for each block, Q2 will need all tissue slides/blocks even if it is benign on the local report, to confirm absence or presence of disease.
If a patient is hospitalized during the study period, should the hospitalization be documented as a serious adverse event (SAE)?
No. Hospitalization is an action taken to treat the event and should not be reported as a SAE. Instead, the AE or SAE leading to hospitalization should be reported.

Hints and Tips

• Syringe-to-syringe prep for CG0070 is now available on Prep Worksheet V6. Check it out!
• Use central results to complete the Response Assessment Worksheet.
• Don’t forget to link all medications to the appropriate forms in the EDC
• Please be sure to follow up on your vendor queries within 5 business days. Reach out to your CRA if you need assistance.
• The barcoded Q2 envelope must be used for local pathology and urine cytology reports, even when shipped separately from the sample.
• Don’t forget to schedule your patients for their End-of-Study Visit 30-60 days after their final dose of CG0070 or their final assessment visit
• CG0070 and DDM cannot be thawed and re-frozen. Please ensure that proper storage temperatures are maintained and logged at all times. As a reminder, 24-hour temperature monitoring is required for any freezers containing CG0070 and DDM. Please contact your CRA with questions
• If a patient is referred to a practice for consideration into the BOND-003 study, CG Oncology will require that the BOND-003 site perform a cystoscopy, at minimum. If advanced disease is suspected, a TURBT will be requested. Please reach out to your CRA or the medical team at CG Oncology with any questions.
• THE BIG 3 Reminder: When pre-screening patients, consider the Big 3 as a starting point.
1. Pathology diagnosis of high grade NMIBC (CIS, TaHG, or T1) that leads to treatment with BCG.
2. A documented history of adequate BCG treatment (5+2 minimum) within a 12-month time frame.
3. Pathology diagnosis of CIS +/- TaHG or T1 within 12 months of last qualifying BCG dose
• Patient cystoscopies may be performed utilizing “white” light, “blue” light, or narrowband imaging, but the same technique that was used for screening must be used for all disease assessments throughout the study
• Q2 Reminders:
Tissue: If multiple biopsies are taken from one patient during one time point, the site should send in all applicable tissue to Q2 Solutions as follows under one accession number/kit:
Screening: All tissue deemed non-benign by local review should be shipped for central review. This includes CIS, Ta, and/or T1
On study: All tissue collected during response assessment timepoints, or during additional disease work ups, regardless of presence of disease, should be shipped for central review (Week 13, Week 25, Week 37, Week 49, Week 61, Week 73, Week 85, Week 97, and any additional disease work up)
Cytology: The barcoded envelope must be used when sending local cytology reports to Q2
Send the local cytology report to Q2 in the provided barcoded envelope once local lab review has been completed.
If the local report is shipped separately from the Q2 urine sample, include a photocopy of the requisition form in the shipment.
The barcoded envelope must be used, even when the local report is shipped separately, for proper accessioning
• “Response assessment checkpoints include cystoscopies, cytologies, mappings, and scans with the potential of suspicious findings. Scheduling these appointments 2 weeks ahead of time allows the central lab enough time to process the samples. It’s important to communicate with the monitor so that they can reach out to the central lab for potential delays or to help answer any questions that arise.” Allan Guidos, GU Team Lead at Mayo Clinic, Phoenix, AZ
• Reminder: High-quality resection/fulgration of all Ta, T1, and CIS is required prior to day 1 treatment. Additionally, T1 disease resection must have biopsy evaluation of the prior resection site 2-8 weeks prior to initial study treatment. Patients with T1 disease at any timepoint after trial entry will come off trial.
• Please ensure that everyone on the study team understands the difference between an adverse event (AE) and a serious adverse event (SAE). If you feel you would benefit from additional training or guidance, reach out to your CRA to set up a training session, or refer to the Safety Reporting section of the BOND-003 protocol.
• When reporting a serious adverse event (SAE):
Avoid reporting multiple medical problems or a combination of symptoms.
The SAE term should be a medical event, such as a diagnosis, rather than a symptom.
If there are multiple concurrent medical events, identify the most clinically significant event and report that one as the SAE. This would be the event requiring hospitalization or urgent intervention.

Publications and Presentations

Phase 2 CG 00700 Safety and Efficacy Study Interim results: Overall 6-month CR was 47% and patients with pure T1 showed a CR at 6 months (pdf)

UROLOGIC ONCOLOGY 2017

BOND-003, Phase 3 CG0070 monotherapy pivotal trial in BCG-unresponsive NMIBC

ABSTRACTS and POSTERS
ASCO GU 2022
MEETING ABSTRACT

BOND-003, Phase 3 CG0070 monotherapy pivotal trial in BCG-unresponsive NMIBC (pdf)

SITC 2021
POSTER

BOND-003, Phase 3 CG0070 monotherapy pivotal trial in BCG-unresponsive NMIBC (pdf)

SUO 2020
POSTER

Enrollment

Total enrolled

Total Number of Patients Needed

February 2023 last updated enrollment numbers

Arizona Institute of Urology
5670 N. Professional Park Drive
Tucson, AZ 85704
Number of enrolled patients: 2

Carolina Urologic Research Center
823 82nd Parkway, Suite B
Myrtle Beach, SC 29572
Number of enrolled patients: 3

Chesapeake Urology
7580 Buckingham Blvd., Suite 110
Hanover, MD 21076
Number of enrolled patients: 3

Duke University
30 Duke Medicine Circle
Durham, NC 27710
Number of enrolled patients: 3

Emory University
1365 Clifton Road NE, Suite B1400
Atlanta, GA 30322
Number of enrolled patients: 3

Lady of Lords
169 Riverside Dr
Bingamton, NY 13905
Number of enrolled patients: 0

Mayo Clinic Arizona
5777 E. Mayo Blvd.
Phoenix, AZ 85054
Number of enrolled patients: 8

Mayo Jacksonville
4500 San Pablo Road
Jacksonville, FL 32224
Number of enrolled patients: 3

MedStar Georgetown
106 Irving Street Northwest
Washington, DC 20020
Number of enrolled patients: 0

Moffitt Cancer Center
12902 USF Magnolia Drive
Tampa, FL 33612
Number of enrolled patients: 6

Montefiore Medical Center
1250 Waters Place, Tower 2
Bronx, NY 10461
Number of enrolled patients: 0

Spokane Urology
1401 East Trent Ave., Ste 200
Spokane, WA 99202
Number of enrolled patients: 1

University of California – Irvine
333 City Blvd. West, Suite 2100, Department of Urology
Irvine, CA 92868
Number of enrolled patients: 5

Urology Centers of Alabama
3485 Independence Drive
Homewood, AL 35209
Number of enrolled patients: 0

University of Colorado
1665 Aurora Ct 1st Floor
Aurora, CO 80045
Number of enrolled patients: 2

University of Kansas Cancer Center
3901 Rainbow Boulevard
Fairway, KS 66160
Number of enrolled patients: 2

University of Pennsylvania
3400 Civic Center Boulevard, 3rd Floor, West Pavilion, Division of Urology
Philadelphia, PA 19104
Number of enrolled patients: 0

University of Toledo
Precision Oncology Research, RHC, Room 1503, 3000 Arlington Ave
Toledo, OH 43614-2598
Number of enrolled patients: 3

Vanderbilt
1161 21st Ave, South
Tennessee, Tennessee 37232-2765
Number of enrolled patients: 0

Wake Forest Baptist Comprehensive Cancer Center
Medical Center Boulevard
Winston-Salem, NC 27157
Number of enrolled patients: 0

Patients Enrolled by Country:

Australia: 3

Canada: 0

Japan: 11

South Korea: 15

Taiwan: 5

United States: 44

Who to contact at CG Oncology

 

Please include your assigned CRA in all communications.
Medical Support:

Dr. Andy Danisk
406-861-7672
andy.darilek@CGoncology.com

Recruitment support:

Gigi Palomera
615-549-4430
Gigi.palomera@CGOncology.com

JoAnn Horn
949-346-5997
JoAnn.Horn@CGOncology.com

Operational support:

Melody Keel
813 810 7161
Melody.Keel@CGOncology.com

CRA’s:
Gayleen Eichensehr

Site: University of Toledo
Location: Toledo, OH

Site: Urology Centers of Alabama
Location: Homewood, AL

Site: University of Kansas Cancer Center
Location: Fairway, KS

Site: Mayo Clinic Arizona
Location: Phoenix, AZ

Site: Arizona Institute of Urology
Location: Tucson, AZ

Site: University of Colorado
Location: Aurora, CO

Site: MedStar Georgetown
Location: Washington, DC

Site: Spokane Urology
Location: Spokane, WA

Phone: (775) 843-3779
Email: gayleen.eichensehr@cgoncology.com

Ian Barrow

Site: University of Pennsylvania
Location: Philadelphia, PA

Site: New Jersey Urology
Location: Edison, NJ

Site: Montefiore Medical Center
Location: Bronx, NY

Site: Mayo Clinic Jacksonville
Location: Tennessee

Site: MedStar Georgetown
Location: Washington, DC

Site: Our Lady of Lourdes Hospital
Location: Binghamton, NY

Site: Chesapeake Urology
Location: Hanover, MD

Office: 301-868-4860
Phone: 301-806-8746
Email: ian.barrow@cgoncology.com

Marnie Cobb

Site: Carolina Urologic Research Center
Location: Myrtle Beach, SC

Site: Prisma Health
Location: Greenville, SC

Site: Emory University
Location: Atlanta, GA

Site: Duke University
Location: Durham, NC

Site: Wake Forest Baptist Comprehensive Cancer Center
Location: Winston-Salem, NC

Phone: (605)-929-2819
Email: marnie.cobb@cgoncology.com

David Gibson

Site: University of California- Irvine
Location: Orange, CA

Phone: +1 (510) 427 7873
Email: david.gibson@catalystcr.com

Tad Cresswell

Site: Moffit Cancer Center
Location: Tampa, FL

Phone: (412) 933-8936
Email: tad.cresswell@cgoncology.com

Information on BCG and the F.D.A.

FDA Guidance on BCG – Unresponsive NMIBC De-Risks Development & Regulatory Pathway to BLA Approval

“Single-arm trials with complete response rate as primary endpoint in the
context of duration of response may be appropriate for a full approval”
– 2018 FDA Guidance from BCG Unresponsive NMIBC

FDA industry guidance

Information About BCG shortage

BCAN patient tools

The Bladder Cancer Advocacy Network (BCAN) provides many tools that you and your patients may find useful. BCAN gives bladder cancer patients and caregivers the resources and support they need to cope with the disease. BCAN can send healthcare professionals printed copies of some of their materials. BCAN contact: https://bcan.org/about-bcan/contact-us/

Find Support

Click here

Bladder Cancer Basics Handbook

Click here

Advancing Research

Click here