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Clinical Trial 20711

Cancer Type: Genitourinary
Study Type: Treatment
NCT#: NCT04387461

Phase: Phase II
Principal Investigator:

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Study Title

A Phase 2, Single Arm Study of CG0070 Combined with Pembrolizumab in Patients with Non Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG)


To evaluate the activity of intravesical administration of CG0070 and intravenous administration of Pembrolizumab in patients with tissue pathology-confirmed non-muscular invasive bladder cancer (NMIBC) who have Bacillus-Calmette-Guerin (BCG) unresponsive disease with carcinoma in situ (CIS) with or without Ta/T1 papillary disease.


Primary: Evaluate the complete response rate at 12 months of CG0070 combined with pembrolizumab in patients with BCG unresponsive CIS with or without concomitant high-grade Ta or T1 papillary disease





CG0070 (); DDM (); Pembrolizumab (Keytruda)

Inclusion Criteria


  • 18 years of age or older
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  • Pathologically confirmed (WHO grading system employed for tumor grading) CIS unresponsive to prior BCG therapy. Patients with CIS unresponsive to BCG are those unlikely to benefit from and who will not be receiving further IVE BCG. There is no maximum limit to the amount of prior BCG past treatment but maintenance BCG should be administered on a schedule consistent with standard induction-maintenance protocols (e.g., BCG weekly x 6 then weekly x 3 weeks administered at Months 3, 6, 12, 18, 24, and 36). The definition of BCG unresponsive CIS will also require the following: (a) Relapsed or persistent CIS (with or without HG Ta or T1) within 12 months of the completion (last dose) of adequate BCG treatment. (b) Pathological confirmation of BCG unresponsive CIS within 10 weeks of study enrollment. (c) CIS specimen must be predominantly urothelial (transitional cell) and have less than 50% variant (e.g., sarcomatoid, squamous etc. component) histology.
  • No maximum limit to the amount of BCG administered but maintenance BCG should be administered on a schedule consistent with the SWOG 8507 regimen
  • Any disease-free interval of 2 years or more from the last dose of adequate BCG must be assumed to be a new primary tumor with prior BCG treatments not counted towards qualification for the study
  • Have all Ta and/or T1 disease resected and all CIS resected or fulgurated, as feasible, prior to study treatment (e.g., prior to Day 1 treatment) NOTE: T1 disease resection site must have biopsy evaluation of the prior resection site 2–8 weeks prior to initial study treatment
  • Received prior adequate BCG therapy as defined as at least one of the following (5+2 minimum exposure; all 7 qualifying doses must be greater than or equal to one thrid of full dose BCG)
  • At least 5 of 6 doses of an initial induction course (adequate induction) plus at least 2 of 3 doses of maintenance therapy, OR At least 5 of 6 doses of an initial induction course (adequate induction) plus at least 2 of 5 doses of a second induction course
  • NOTE: Past qualifying “adequate BCG” must be clearly documented including dates of BCG treatment and pathological recurrence or persistence within 12 months of last dose of BCG. As above, any disease-free interval of 2 years or more following adequate BCG course should be re-assessed and treated as a second primary urothelial carcinoma. Please contact the Sponsor if there are questions.
  • Ineligble (or medically unfit) to receive radical cystectomy or refusal of radical cystectomy based on Investigator assessment
  • Demonstrate adequate organ function, as defined per protocol
  • Willing to use barrier contraception, as outlined in Section 13.F during sexual activity, starting with Day 1 for up to 6 weeks after each dose of CG0070
  • Meet the following regarding criteria to prevent pregnancy: Male patients able to father children must agree to use highly effective contraception method during the treatment period and for at least 120 days after the last dose of CG0070 and pembrolizumab. Female patients are eligible to participate if not pregnant, not breast feeding, and at least one of the following condition applies: Not woman of childbearing potential or A woman of childbearing potential who agrees to follow the contraception guidance during the treatment period and for at least 150 days after the last dose of CG0070 and pembrolizumab.
  • Patients must be willing to comply with study mandated cystoscopies, urine cytology, urograms, biopsies, and other procedures (including TURBT or other resection for all Ta/T1 disease). Patients who withdraw consent for these procedures will be withdrawn from the trial.

  • Exclusion Criteria

  • Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor
  • Current or past history of muscle invasive (T2 or higher stage) or locally advanced (T3/T4, any N) or metastatic bladder cancer
  • Urothelial carcinoma in the upper genitourinary tract (kidneys, renal collecting systems, ureters) or prostatic urethra (including CIS of the urethra) within 24 months of enrollment
  • Has received systemic anti-cancer therapy, including investigational agents, within 4 weeks of Day 1
  • Has received prior systemic treatment, radiation therapy, or surgery for bladder cancer other than TURBT or bladder biopsies
  • Has any of the following within the 6 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, cerebrovascular accident, pulmonary embolus, uncontrolled hypertension or uncontrolled congestive heart failure.
  • Has used excluded anti-viral medication (e.g., interferon/peg-interferon, ribavirin, etc.) within 14 days of Day 1 and that cannot be suspended throughout for at least 14 days prior to and after the each treatment with CG0070.
  • Has had prior treatment with any human adenovirus serotype 5 based therapy (e.g., Ad-interferon or Instildrin)
  • Requires use of anti-platelet or anti-coagulant therapy that cannot be safely suspended for per protocol biopsies and other procedures as per standard of care
  • Has signifncant immunodeficiency due to underlying illness (e.g., known HIV/AIDS)
  • Has received systemic immunosuppressive medication including high-dose corticosteroids (e.g., systemic corticosteroids >10 mg prednisone or equivalent), within 28 days prior to Day 1.
  • Has had an allogenic tissue/solid organ transplant
  • Has a known history of Hepatitis B (defined as HBsAg reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection
  • Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation to non-CNS disease
  • Other exclusions apply

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