Clinical Research Details

BCG in combination with durvalumab in adult BCG-naive, high-risk NMIBC participants

Study Description

The PATAPSCO study will explore the combination of durvalumab and BCG (induction and maintenance) in BCG-naïve participants with high-risk NMIBC. This combination may thus provide the dual benefit of decreasing recurrence rates and increasing the duration of response.

Inclusion/Exclusion Criteria

Inclusion: 

1.>/=18

2.Capable of giving informed Consent

3. BCG-Naive  or >3 years

4.High-risk tumor: T1, High-grade/G3 tumor, CIS

5. TURBT  < 4 months prior

6. No radiotherapy

7. WHO group perfomance status of 0 ro 1

8.Body weight >30 kg

9. life expectancy of at least 12 wks

10. no prior immune-mediated therapy

11. Canidate for BCG treatment

12. WNL lab values

13. Non-pregnant 

Exclusion: 

1. Evidence of muscle-invasive/metastatic cancer

2. Predominantly variant histology

3. lymphovasular invasion of bladder tumor

4. immediate cystectomy is indicated

5. known BCG treatment

6. Concurrent extravesical (ie, urethra, ureter, or renal pelvis), non-muscle-invasive
transitional cell carcinoma of the urothelium.

7. involvement in the study, past or present

8. enrollment in another study

9. Treatment with immunostimulatory agents

10. Major surgical procedure within 28 days

11. allogenic organ transplantation

12. Autoimmune or inflammatory disorders

13. Uncontrolled intercurrent illness

14. History of another primary malignancy

15. History of active primary immunodeficiency

16. Active infection

17. Current or prior use of immunosuppressive medication within 14 days

18. Receipt of live attenuated vaccune with 30 days

19. Allergy to interventions

20. Antibiotics with1 week

21. PI discretion 

Open Enrollment

Contact Name: Ashley Carter
Contact Phone: (904) 244-9962
Contact Email: ashley.carter@jax.ufl.edu

Investigators