Study on Adding Tazemetostat to Pembrolizumab for Advanced Urothelial Cancer
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT03854474
This clinical trial is exploring whether combining the drug tazemetostat with the immunotherapy drug pembrolizumab can improve treatment for patients with advanced urothelial carcinoma, a type of bladder cancer that has spread to nearby tissues or other parts of the body.
Patient Parameters
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Program Overview
This study aims to find out if adding tazemetostat to pembrolizumab can better control urothelial carcinoma that has spread. Tazemetostat may help stop cancer cells from growing by blocking certain enzymes, while pembrolizumab helps the immune system attack cancer cells. The trial will determine the best dose and assess how well this combination works compared to pembrolizumab alone.
Description
The study is divided into two phases. The first phase will determine the safest dose of tazemetostat when used with pembrolizumab. The second phase will evaluate how well this combination works in patients whose cancer has not responded to or cannot be treated with standard chemotherapy.
Participants will take tazemetostat by mouth twice a day and receive pembrolizumab through an IV every three weeks. This treatment cycle can continue for up to two years unless the cancer progresses or side effects become unacceptable. Throughout the study, participants will have regular scans and blood tests to monitor their health and the treatment's effectiveness.
After completing the treatment, participants will have follow-up visits every three months for a year to check on their health and any long-term effects of the treatment.
Eligibility Criteria
Inclusion Criteria
- Must have confirmed urothelial carcinoma, a type of bladder cancer.
- Cancer must be advanced or have spread to other parts of the body.
- Must have measurable disease based on specific medical criteria.
- Must not have received prior treatment with PD-L1 or EZH2 inhibitors.
- Must be 18 years or older.
- Must have a good performance status, meaning they can carry out daily activities with minimal assistance.
- Must have adequate blood cell counts and organ function based on recent tests.
- Women of childbearing potential and men must agree to use effective contraception during the study and for a period after the last dose.
- Must be able to understand and sign a consent form or have a representative who can do so.
- HIV-positive patients can participate if they are on effective treatment and have an undetectable viral load.
Exclusion Criteria
- Cancer that can be treated with local therapy aimed at a cure.
- Recent chemotherapy, targeted therapy, or radiation within four weeks before starting the study.
- Unresolved side effects from previous cancer treatments.
- Participation in another clinical trial or use of an investigational drug within four weeks before starting the study.
- Blood transfusions or use of certain growth factors within four weeks before starting the study.
- Current use of systemic steroids or other immunosuppressive drugs.
- Certain blood disorders or genetic abnormalities.
- Prior treatment with similar drugs to those being tested in the study.
- History of other invasive cancers within the past five years, except for certain skin or cervical cancers.
- Known brain metastases or cancer spread to the brain lining.
- Allergic reactions to similar drugs.
- Active autoimmune diseases requiring treatment in the past two years.
- History of lung inflammation requiring steroids.
- Major surgery within three weeks before starting the study.
- Use of certain medications that affect drug metabolism within 14 days before starting the study.
- Inability to take oral medication or have certain digestive issues.
- Uncontrolled illnesses or infections.
- Pregnant or breastfeeding women, or those planning to become pregnant or father children during the study.
- Known hepatitis B or C infection.
- Recent live vaccination within 30 days before starting the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Mayo Clinic Hospital in Arizona | 85054 | Phoenix | Arizona |
| Mayo Clinic in Arizona | 85259 | Scottsdale | Arizona |
| Smilow Cancer Hospital-Derby Care Center | 06418 | Derby | Connecticut |
| Smilow Cancer Hospital Care Center-Fairfield | 06824 | Fairfield | Connecticut |
| Smilow Cancer Hospital Care Center - Guilford | 06437 | Guilford | Connecticut |
| Smilow Cancer Hospital Care Center at Saint Francis | 06105 | Hartford | Connecticut |
| Smilow Cancer Center/Yale-New Haven Hospital | 06510 | New Haven | Connecticut |
| Yale University | 06520 | New Haven | Connecticut |
| Yale-New Haven Hospital North Haven Medical Center | 06473 | North Haven | Connecticut |
| Smilow Cancer Hospital-Orange Care Center | 06477 | Orange | Connecticut |
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