A Window of Opportunity Study of Pembrolizumab in Patients With Bladder Cancer Undergoing Radical Cystectomy

• Status: Not yet recruiting
• Trial end date: 0000-00-00
• Target enrollment: 20
• Participant gender: All

Summary

The goal of this clinical research study is to learn about the safety and efficacy of giving pembrolizumab before a cystectomy (a surgery to remove the bladder) to patients with urothelial carcinoma of the bladder.

This is an investigational study. Pembrolizumab is FDA approved and commercially available to treat many types of cancer, but not bladder cancer. It is considered investigational to use pembrolizumab to treat bladder cancer.

The study doctor can explain how the study drug is designed to work.

Up to 20 participants will be enrolled in this study. All will take part at MD Anderson.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Pembrolizumab
• Last Updated: 2017-10-23

Criteria

Inclusion Criteria:

1. Be willing and able to provide written informed consent

2. Be >/= 18 years of age

3. Have absence of metastatic disease as determined by conventional imaging studies and be considered a good surgical candidate by the treating physician.

4. Be willing to participate in the collection of blood and tissue for banking and future correlative studies

5. Have a performance status of 0 or 1 on the ECOG Performance Scale.

6. Adequate organ function: ANC >/=1,500 /mcL, Platelets >/=100,000/mcL, Hgb >/=9 g/dL or >/=5.6 mmol/L w/o transfusion within 7 days of assessment, creatinine OR calculated creatinine clearance/=60 mL/min for subject with creatinine levels >1.5 X institutional ULN, total bilibilirubin1.5 ULN AST (SGOT) and ALT (SGPT)2.5 mg/dL Coagulation International Normalized Ratio (INR) or Prothrombin Time (PT) Activated Partial Thromboplastin Time (aPTT)anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulantslong as PT or PTT is within therapeutic range of intended use of anticoagulants aCreatinine clearance should be calculated per institutional standard.

7. Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.

8. Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.

9. Male subjects of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.

Exclusion Criteria:

1. Is currently participating and receiving pembrolizumab or has participated in a study of an investigational agent and received pembrolizumab or used an investigational device within 4 weeks of the first dose of study treatment.

2. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.

3. Has a known history of active TB (Bacillus Tuberculosis).

4. Has a known history of hypersensitivity to pembrolizumab or any of its excipients.

5. Has had prior systemic anti-cancer therapy for the treatment of bladder cancer. Prior intravesical therapies, whether BCG, chemotherapy or otherwise, will remain eligible.

6. Has any other malignancy diagnosed within 2 years of screening with the exception of basal or squamous cell skin cancer, or non-invasive cancer of the cervix, or any other cancer deemed by the treating physician to be of low-risk for progression or patient morbidity during the study period.

7. Has known metastatic disease as determined by conventional staging studies

8. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.

9. Has known history of, or any evidence of active, non-infectious pneumonitis.

10. Has a clinically significant active infection requiring systemic therapy.

11. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating physician.

12. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.

13. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.

14. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).

15. Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).

16. Has received a live vaccine within 30 days of initiation of study therapy. Note:

Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.