Klinische Studie
A Phase 2, Randomized, Double-Blind, Placebo- and Active-Comparator Controlled Clinical Study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants with High-Risk Muscle-Invasive Urothelial Carcinoma Post-Radical Resection(V940-005)Phase 2 Study of Adjuvant V940 plus Pembrolizumab Vs Placebo Plus Pembrolizumab for High-Risk Muscle-Invasive Urothelial Carcinoma Post Radical Resection
Krankheitsentität(en)
Harnblase, Harnleiter, Niere
StudientypInterventionsstudiePhase II
StudientypInterventionsstudiePhase II
Wesentliche Einschlusskriterien1. The participant must have a muscle-invasive urothelial carcinoma
originating in the lower tract (bladder, urethra) or upper tract (renal
pelvis, ureter). NOTE: UTUC enrollment will be capped at 20%.
2. Dominant histology must be urothelial carcinoma. Histology will be
confirmed locally.
- Participants with mixed histology are eligible provided the urothelial
component is ≥50%.
- Participants whose tumors contain any neuroendocrine component are
not eligible.
3. Participants must have undergone radical surgical resection (R0) for
MIUC ≤ 8 weeks prior to providing informed consent and ≤ 16 weeks
prior to randomization with no invasive cancer at the surgical margins.
Surgery must include radical cystectomy (for MIBC) or radical
nephroureterectomy (for upper tract MIUC) plus pelvic lymph node
dissection, for participants to be eligible.
4. Participants must have high-risk pathologic disease after radical surgical
resection, as per one of two definitions:
• For participants who received cisplatin-based neoadjuvant
chemotherapy: ypT2-4a and/or ypN+
• For participants who have not received cisplatin-based neoadjuvant
chemotherapy: pT3-4a and/or pN+
5. Participants who have not received cisplatin-based neoadjuvant
chemotherapy are eligible with one of following scenarios:
• Participant is cisplatin-ineligible per the following criteria:
- Creatinine Clearance (using the Cockcroft-Gault formula): < 60
mL/min and >30 mL/min
- CTCAE v5.0 Grade 2 or higher audiometric hearing loss
- CTCAE v5.0, Grade 2 or higher peripheral neuropathy
- ECOG Performance Status ≥ 2
• Participant is cisplatin-eligible but refuses adjuvant cisplatin-based
chemotherapy offered as an off-study treatment option by the
investigator
Wesentliche Ausschlusskriterien1. Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2
agent, or with an agent directed to another stimulatory or coinhibitory T�cell receptor (eg, CTLA-4, OX-40, CD137). Exception includes participants who received anti-PD-1 or PD-L1 therapy for NMIBC with recurrence >12 months from completion of therapy.
2. Received prior systemic anticancer therapy including investigational
agents in the adjuvant setting after radical surgery.
3. Received a live or live-attenuated vaccine within 30 days before the first
dose of study intervention. Administration of killed vaccines are allowed.
4. Received therapy with hematopoietic growth factor such as G-CSF or
GM-CSF within 14 days prior to randomization.
5. Has received an investigational agent or has used an investigational
device within 4 weeks prior to study intervention administration.
Statusrekrutierend
Ansprechpartner & KontaktCaritas-Krankenhaus St. Josef RegensburgUrologieStudienzentrale0941 7823506uro-studienzentrum(at)csj.de