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An open label, single-arm, phase 2 study of perioperative sacituzumab govitecan in combination with zimberelimab and domvanalimab for patients with muscle invasive bladder cancer ineligible for cisplatin-based chemotherapy. (PeRioperative Immunotherapy combined with Sacituzumab govitecan in Muscle invasive blAdder cancer)
EU CTIS ID: 2023-504420-26-00
What this study is testing
To evaluate the efficacy measured as pathologic complete response (pCR) rates of the combo Sacituzumab govitecan (SG) + Zimberelimab (AB 122) (ZIM) + Domvanalimab (AB 154) (DOM) in the perioperative setting in patients with MIBC who are either unfit for platinum-based chemotherapy or unwilling to receive that therapy.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Willing and able to provide written informed consent.
- Adequate coagulation (Prothrombin Time [PT]) or International Normalized Ratio [INR] and Activated Partial Thromboplastin Time [aPTT]) ≤ 1.5xULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants.
- Negative pregnancy test within 3 days of Day 1 Cycle 1 for female patients of childbearing potential.
- Male patients and female patients of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception as described in annex 5
- Ability to comply with the study procedures and requirements and restrictions in this protocol
- Age ≥ 18 years.
You likely can't join if
- Concurrent enrollment in another interventional clinical trial, unless in a follow-up period or it is an observational study.
- Met any of the following criteria for cardiac disease: a. Myocardial infarction or unstable angina pectoris within 6 months of enrollment. b. History of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring antiarrhythmic medications (except for atrial fibrillation that is well controlled with antiarrhythmic medication). c. History of QT interval prolongation.
- Patient currently on dialysis.
- Gastrointestinal perforation within 6 months of enrollment.
- Patients who have organ allografts
- Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.
See the full eligibility criteria
Who can join
- Willing and able to provide written informed consent.
- Adequate coagulation (Prothrombin Time [PT]) or International Normalized Ratio [INR] and Activated Partial Thromboplastin Time [aPTT]) ≤ 1.5xULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants.
- Negative pregnancy test within 3 days of Day 1 Cycle 1 for female patients of childbearing potential.
- Male patients and female patients of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception as described in annex 5
- Ability to comply with the study procedures and requirements and restrictions in this protocol
- Age ≥ 18 years.
- Muscle invasive urothelial carcinoma of the bladder stage cT2-T4cN0- 1cM0. Patients with other histological subtypes [i.e. squamous, adenocarcinoma, etc] can also be included
- Fit and planned for cystectomy (according to local guidelines)
- Refusal of neoadjuvant cisplatin-based chemotherapy or patients in whom neoadjuvant cisplatin-based therapy is not appropriate. (This will be determined by the investigator and not solely based in Galsky Criteria)
- Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens (blocks preferred) or at least 15 unstained slides, with an associated pathology report, for testing at the study sponsor site. Patients with fewer than 15 unstained slides available at baseline (but no fewer than 10) may be eligible following discussion with the PI of the study.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
- Adequate hematologic and end-organ function tests defined by the following: a. WBC ≥ 2.0x109 /L, b. Neutrophils ≥1.5x109 /L, c. Platelets ≥100 x109 /L, d. Hemoglobin ≥ 10 g/dL, e. Creatinine clearance ≥ 30 mL/min as assessed by the CockcroftGault (https://www.mdcalc.com/calc/43/creatinine-clearance-cockcroftgault-equation) f. AST ≤ 2.5 x ULN, g. ALT ≤2.5 x ULN, h. Bilirubin ≤1.5 X ULN.
What rules you out
- Concurrent enrollment in another interventional clinical trial, unless in a follow-up period or it is an observational study.
- Met any of the following criteria for cardiac disease: a. Myocardial infarction or unstable angina pectoris within 6 months of enrollment. b. History of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring antiarrhythmic medications (except for atrial fibrillation that is well controlled with antiarrhythmic medication). c. History of QT interval prolongation.
- Patient currently on dialysis.
- Gastrointestinal perforation within 6 months of enrollment.
- Patients who have organ allografts
- Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.
- Known allergy or hypersensitivity to study drugs formulations.
- Patients who have invasive catheters that under the investigator criteria might put the patient at risk of developing severe complications due to neutropenia [i.e. percutaneous nephrostomy
- Females who are pregnant, lactating, or intend to become pregnant during their participation in the study.
- 2. Having received previous anticancer therapy
- Underlying medical conditions that might make the administration of study drugs hazardous or that might obscure the interpretation of adverse events
- Patient receiving treatment with inhibitors or inducers of UGT1A1 at the time of enrollment.
- Patient receiving treatment with high dose systemic corticosteroids (>10 mg of prednisone or its equivalent) within 2 weeks of C1D1.
- Patients who have received a vaccination within 30 days prior to inclusion (examples include, but are not limited to, intranasal influenza vaccines, typhoid [oral] vaccines, and Bacillus Calmette-Guerin [BCG]). Patients are allowed to receive the COVID-19 vaccine to reduce the risk and complications of COVID-19 infection. The study visits should continue as planned if vaccination occurs while the patient is on the study.
- Malignancy, other than bladder cancer, in the previous 2 years. Patients with low-risk prostate cancer (defined as Stage T1/T2a, Gleason score ≤ 6, and PSA ≤ 10 ng/mL) appropriately treated or that are treatment-naive and undergoing active surveillance are eligible. Also, noninvasive malignancies such as cervical carcinoma in situ, nonmelanomatous carcinoma of the skin, or ductal carcinoma in situ of the breast, that have undergone potentially curative therapy are not excluded.
- Major surgical procedure within 4 weeks prior to enrollment or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis or treatment of its bladder cancer
- Severe infection within 4 weeks prior to enrollment in the study including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.