A Phase 1 Study of CG0070 Combined with Nivolumab in Cisplatin Ineligible Patients with Muscle Invasive Bladder Cancer (MIBC)
Investigators aim to evaluate the safety and efficacy of combination neoadjuvant therapy using intravesical CG0070 and IV Nivolumab in cisplatin ineligible patients with MIBC.
To evaluate the safety of combination therapy using intravesical CG0070 and IV nivolumab according to Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).
To assess the changes in the inflammatory status of the tumors after combination therapy
Patients must have histologically confirmed MIBC (T2‐T4a, N0‐N1, M0 per American Joint Commission on Cancer [AJCC]) pure or mixed histology urothelial carcinoma. Clinical node‐ positive (N1) patients are eligible provided the lymph nodes (LNs) are within the planned surgical LN dissection template.
The initial TURBT that showed muscularis propria invasion should be within 90 days prior to beginning study therapy. Patients must have sufficient baseline tumor tissue from either initial or repeat TURBTs. The local site pathologist will be asked to estimate and record the rough approximate percentage of viable tumor in the TURBT sample (initial or repeat TURBT with highest tumor content) to document at least 20% viable tumor content prior to registration. This is to ensure adequate tissue is available to perform tumor infiltrating CD8+ T‐cell assessment.
(The actual CD8+ T cell analysis will be done by a Central Laboratory and will not be done prior to registration.)
Patients must be ineligible for cisplatin‐based chemotherapy due to any of the following:
Women who are pregnant or breastfeeding, since the effects of nivolumab and CG0070 on the fetus or breastfeeding child are unknown
Patient with local symptoms from bladder cancer, (e.g. gross hematuria, dysuria, etc.) who are deemed to be unable to complete the treatment protocol
Patients with active or prior documented autoimmune disease within the past 2 years prior to Screening or other immunosuppressive agent within 14 days of study treatment. NOTE: Patients with well controlled type 1 diabetes mellitus, vitiligo, Graves disease, Hashimoto’s disease, eczema, lichen simplex chronicus, or psoriasis not requiring systemic treatment (within the past 2 years prior to Screening) are not excluded
Patients who have concurrent upper urinary tract invasive urothelial carcinoma
Patients who have another malignancy that could interfere with the evaluation of safety or efficacy of the study drugs. Patients with a prior malignancy will be allowed without Principle Investigator approval in the following circumstances:
Not currently active and diagnosed at least 3 years prior to the date of registration
Non‐invasive diseases such as low risk cervical cancer or any cancer in situ
Localized (early stage) cancer treated with curative intent (without evidence of recurrence and intent for further therapy), and in which no chemotherapy was indicated (e.g. low/intermediate risk prostate cancer, etc.).
Patients who have received any prior immune checkpoint inhibitor (i.e. anti‐KIR, anti‐PD‐1, anti‐ PD‐L1, anti‐CTLA4 or other)
Patients who have undergone major surgery, open biopsy or significant traumatic injury or specific anti‐cancer treatment > Patients who have clinically significant cardiac diseases deemed not fit for radical cystectomy, including any of the following:
History or presence of serious uncontrolled ventricular arrhythmias
Clinically significant resting bradycardia
Any of the following within 3 months prior to starting study drug: severe/unstable angina, Congestive Heart Failure (CHF), Cerebrovascular Accident (CVA), Transient Ischemic Attack (TIA)
Uncontrolled hypertension defined by a SBP ≥ 180 mm Hg and/or DBP ≥ 100 mm Hg, with or without anti‐hypertensive medication(s)
Patients who have history of chronic active liver disease or evidence of acute or chronic Hepatitis B Virus (HBV) or Hepatitis C (HCV)
Patients who have known diagnosis of human immunodeficiency virus (HIV) infection. Testing is not required in absence of clinical suspicion
Patients who have known diagnosis of any condition that requires chronic immunosuppressive therapy which cannot be stopped for the duration of the clinical trial
Patients with any serious and/or uncontrolled concurrent medical conditions or psychiatric illness that could, in the investigator’s opinion, cause unacceptable safety risks or potentially interfere with the completion of the treatment according to the protocol
Patients who have used any live viral vaccine for prevention of infectious diseases within 4 weeks prior to study drug(s)
Patients unwilling or unable to comply with the protocol
Patients with a known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent
Patients who participate in any other therapeutic clinical trials, including those with other investigational agents not included in this trial throughout the duration of this study
Use of excluded antiviral medication that cannot be suspended at least 14 days prior and for 14 days after the
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