Purpose

This phase II trial studies the effect of adding pembrolizumab to gemcitabine in treating patients with non-muscle invasive bladder cancer whose cancer does not respond to Bacillus Calmette-Guerin (BCG) treatment. Chemotherapy drugs, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the patient's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Adding pembrolizumab to gemcitabine may delay the return of BCG-unresponsive bladder cancer for longer period compared to gemcitabine alone.

Category

IRB Number
20200056HU
NCT Number
NCT04164082
Open to Enrollment
Yes
Sponsor
National Cancer Institute (NCI) -



Study Contact

Principal Investigator
Chethan Ramamurthy

Regulatory Point of Contact
Frances Crawford
(210) 450-5037
crawfordf1@uthscsa.edu

Regulatory Point of Contact
Sonia Creighton
(210) 450-1366
creighton@uthscsa.edu

Regulatory Point of Contact
Patricia Devore
(210) 450-1233
devore@uthscsa.edu

Regulatory Point of Contact
Myrna Montenegro
(210) 450-5954
montenegro@uthscsa.edu

Regulatory Point of Contact
Courtney Nichols
(210) 450-1794
nicholsc2@uthscsa.edu

Regulatory Point of Contact
Chethan Ramamurthy
(210) 450-1667
ramamurthyc@uthscsa.edu

Regulatory Point of Contact
Mailbox Ctrc Regulatory Affairs
regaffapp@uthscsa.edu

Regulatory Point of Contact
Regulatory Staff
regaffstaff@uthscsa.edu

Regulatory Point of Contact
Kathleen Rodriguez
(210) 450-1365
rodriguezk3@uthscsa.edu

Regulatory Point of Contact
Benjamin Schleif
(210) 450-1366
schleifb@uthscsa.edu

Regulatory Point of Contact
Morgan Seekatz
(210) 450-1133
seekatz@uthscsa.edu



Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

    Exclusion Criteria


      Study Design

      Phase
      Phase 2
      Study Type
      Interventional
      Allocation
      N/A
      Intervention Model
      Single Group Assignment
      Primary Purpose
      Treatment
      Masking
      None (Open Label)
      Condition
    1. Bladder Urothelial Carcinoma In Situ
    2. Infiltrating Bladder Mixed Carcinoma
    3. Stage 0a Bladder Cancer AJCC v8
    4. Stage 0is Bladder Cancer AJCC v8
    5. Stage I Bladder Cancer AJCC v8

      6. Arm Groups

      ArmDescriptionIntervention
      Experimental

      Treatment (pembrolizumab, gemcitabine hydrochloride)

      		INDUCTION: Patients receive pembrolizumab IV over 25-40 minutes on day 1 of cycles 1-4. Patients also receive gemcitabine hydrochloride intravesically on days 1, 8 and 15 of cycles 1 and 2. Treatment repeats every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Beginning cycle 5, patients with no evidence of disease after induction receive pembrolizumab IV over 25-40 minutes and gemcitabine intravesically on day 1. Treatment repeats every 3 weeks for 12 cycles in the absence of disease progression or unacceptable toxicity.
    6. Drug: Gemcitabine Hydrochloride

      Given intravesically

      Other names:

      • dFdCyd
      • Difluorodeoxycytidine Hydrochloride
      • FF 10832
      • FF-10832
      • FF10832
      • Gemcitabine HCI
      • Gemzar
      • LY-188011
      • LY188011

    7. Biological: Pembrolizumab

      Given IV

      Other names:

      • Keytruda
      • Lambrolizumab
      • MK-3475
      • SCH 900475

      8.