Study on Intismeran Autogene and BCG for Treating Bladder Cancer
Sponsor: Merck Sharp & Dohme LLC
ClinicalTrials ID:NCT06833073
This clinical trial is exploring a new treatment option for people with high-risk non-muscle invasive bladder cancer (HR NMIBC) by adding a study drug, intismeran autogene, to the standard treatment with BCG. The study aims to see if this combination can better control the cancer compared to BCG alone.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
Researchers are testing a new approach to treat high-risk non-muscle invasive bladder cancer (HR NMIBC), which is a type of bladder cancer that hasn't spread to the muscle but has a high chance of worsening or returning. The standard treatment involves removing the tumor and using a therapy called BCG to help the immune system fight the cancer. However, BCG doesn't work for everyone. This study is investigating whether adding a new treatment, intismeran autogene, can improve outcomes by helping the immune system target the cancer more effectively. The study will compare how well patients do with the combination of intismeran autogene and BCG versus BCG alone, and also look at the effects of intismeran autogene by itself.
Eligibility Criteria
Inclusion Criteria
- Recently had a procedure to remove bladder tumors within the last 12 weeks, showing high-risk non-muscle invasive bladder cancer.
BCG Arms:
- Have high-risk non-muscle invasive bladder cancer.
- Have never received BCG or received it more than 2 years ago with no cancer return during that time.
Intismeran Autogene Monotherapy Arm:
- Have a specific type of bladder cancer (CIS) with or without other non-muscle invasive cancer.
- Cannot or choose not to receive certain bladder treatments.
- Have never received BCG or did not complete the full BCG treatment and had cancer return within 2 years.
- If HIV-positive, must have well-controlled HIV on medication.
Exclusion Criteria
- Have or had advanced or spreading bladder cancer.
- Have bladder cancer outside the bladder that returned in the last 2 years, with some exceptions.
- Have another cancer that is getting worse or needed treatment in the last 3 years.
- Had a heart attack in the last 6 months.
- Received any cancer treatment or experimental drugs in the last 4 weeks.
- Previously treated with a cancer vaccine.
- Have immune system issues or are on long-term steroid treatment.
- Have an active autoimmune disease needing treatment in the last 2 years.
- Cannot have certain imaging tests due to allergies or other reasons.
BCG Arms:
- Have active tuberculosis.
- Have a known history of HIV infection.
Intismeran Autogene Monotherapy Arm:
- HIV-positive individuals with a history of certain diseases like Kaposi's sarcoma.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Michael G Oefelein Clinical Trials ( Site 0138) | 93301 | Bakersfield | California |
| Los Alamitos Hematology Oncology Medical Group ( Site 0141) | 90720 | Los Alamitos | California |
| Genesis Healthcare-Torrance ( Site 0140) | 90503 | Torrance | California |
| Genesis Research LLC ( Site 0118) | 90505 | Torrance | California |
| Urological Research Network ( Site 0133) | 33016 | Hialeah | Florida |
| University of Missouri Health Care ( Site 0126) | 65212 | Columbia | Missouri |
| NHO Revive Research Institute, LLC ( Site 0137) | 68506 | Lincoln | Nebraska |
| OHSU Knight Cancer Institute - South Waterfront ( Site 0110) | 97239 | Portland | Oregon |
| Urology Austin, PLLC ( Site 0109) | 78759 | Austin | Texas |
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