Klinische Studie
A Phase III Randomized, Open-Label, Multicenter Study to Determine the Efficacy and Safety of Durvalumab in Combination with Tremelimumab and Enfortumab Vedotin or Durvalumab in Combination with Enfortumab Vedotin for Perioperative Treatment in Patients Ineligible for Cisplatin Undergoing Radical Cystectomy for Muscle Invasive Bladder Cancer(VOLGA)Efficacy & Safety of Durvalumab +/- Tremelimumab & Enfortumab Vedotin for Perioperative Treatment in Cisplatin Ineligible Patients Undergoing Radical Cystectomy for Muscle Invasive Bladder Cancer
Krankheitsentität(en)
Harnblase, Harnleiter, Niere
StudientypInterventionsstudiePhase III
StudientypInterventionsstudiePhase III
Wesentliche Einschlusskriterien1. Histologically or cytologically documented muscle-invasive TCC of the bladder with
clinical stage of T2-4aN0-N1M0 (AJCC Cancer Staging Manual, 8th Edition).
Transitional and mixed transitional/non-transitional/variant cell histologies are
accepted
2. Medically fit for cystectomy and able to receive neoadjuvant therapy
3. ECOG performance status of 0 to 2 with no deterioration over the previous 2 weeks prior
to baseline or day of first dosing.
4. Provision of the most recent tissue sample from MIBC to assess the PD-L1
status/expression prior to randomization.
5. Cisplatin-ineligible
Wesentliche Ausschlusskriterien1. Evidence of multiple lymph node (N2+) or metastatic TCC/UC, extravesical TCC/UC
that invades the pelvic and/or abdominal wall for bladder cancer (T4b), or primary
non-bladder (ie, ureter, urethral, or renal pelvis) TCC/UC of the urothelium.
2. Nephroureterectomy required per investigator at the time of randomization for tumor of
the mid ureter, renal pelvis, or collecting system.
3. Ureterectomy required if a ureteral tumor is present proximal to common iliacs in
addition to planned cystectomy.
4. History of allogeneic organ transplantation that requires use of immunosuppressive
agents. Participants with a history of allogenic stem cell transplantation are also excluded.
5. Active or prior documented autoimmune or inflammatory disorders (including
inflammatory bowel disease [eg, colitis or Crohn’s disease], diverticulitis [with the
exception of diverticulosis], autoimmune pneumonitis, autoimmune myocarditis, systemic
lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with
polyangiitis, Graves’ disease, rheumatoid arthritis, hypophysitis, uveitis, etc]).
Statusrekrutierend
Ansprechpartner & KontaktCaritas-Krankenhaus St. Josef RegensburgUrologieStudienzentrale0941 7823506uro-studienzentrum(at)csj.de