KEY TAKEAWAYS
- The RACE IT trial is a prospective, single-arm, multicenter, phase II trial.
- The trial’s primary aim is to evaluate the feasibility of neoadjuvant radioimmunotherapy in patients with locally advanced, muscle-invasive bladder cancer.
- The method involves treating patients with Nivolumab 240mg i.v. q2w for 4 cycles, starting one week before radiotherapy of the pelvis with max. 50.4 Gy.
- The trial outcome will be measured in terms of safety and efficacy. The main inclusion criteria are locally advanced urothelial bladder cancer in patients eligible for radical cystectomy.
- A pre-planned safety interim analysis with a temporary inclusion pause was successfully performed after the inclusion of 11 patients.
Poor outcomes are expected for patients undergoing radical surgery for locally advanced bladder cancer (cT3/4 cN0/N+ cM0). Overall survival at 5 years was < 35% when perioperative combination chemotherapy was added to surgery alone. Agents like Nivolumab, part of the anti-PD1/PDL1 class of immunotherapies, are effective against metastatic bladder cancer, prompting their approval by the FDA and EMA. Recent research on neoadjuvant immunotherapy for muscle-invasive bladder cancer has shown encouraging early results (PURE-01, ABACUS, NABUCCO). Radiation and immunotherapy have been hypothesized to work effectively in preclinical and early clinical trials. Researchers devised this trial to determine whether neoadjuvant radioimmunotherapy is feasible, safe, and effective for patients with locally advanced, muscle-invasive bladder cancer.
Patients are given Nivolumab 240 mg intravenously (i.v.) in this prospective, single-arm, multicenter, phase II trial. Every other week for four cycles, beginning a week before pelvic radiation therapy with a maximum dose. 50.4 Gy. One year of postoperative follow-up is performed after radio-immunotherapy and a radical cystectomy with standard pelvic lymphadenectomy are performed. Patients with locally advanced urothelial bladder cancer (cT3/4 cN0/N+ cM0) are candidates for radical cystectomy but are either not candidates for or refuse neoadjuvant cisplatin-based chemotherapy are the primary population of interest. Primary exclusions include metastatic disease, either locally or in distant sites, prior chemotherapy, pelvic radiation, autoimmune disease, or gastrointestinal disorders associated with a high risk of perforation or fistula. The trial still accepts participants as of 02/2019, when it enrolled 15 of the 33 total; after including 11 patients, the researchers paused enrollment temporarily to conduct an interim safety analysis.
Source: https://oncologypro.esmo.org/meeting-resources/esmo-virtual-congress-2020/race-it-a-prospective-single-arm-multicenter-phase-ii-trial-to-assess-safety-and-efficacy-of-preoperative-radiation-therapy-before-radical-cyst
Clinical Trial:https://clinicaltrials.gov/ct2/show/NCT03529890
S.C. Schmid, F. Beckert, F. Koll, C. Rödel, A.K. Seitz, P. Maisch, A. Sauter, H. Kübler, M. Flentje, S.E. Combs, K. Schiller, J. Gschwend, M. Retz/RACE IT: A prospective, single arm, multicenter, phase II-trial to assess safety and efficacy of preoperative radiation therapy before radical cystectomy combined with immunotherapy in locally advanced urothelial carcinoma of the bladder (AB 65/18)| OncologyPRO. (n.d.). Oncologypro.esmo.org. Retrieved March 30, 2023, from https://oncologypro.esmo.org/meeting-resources/esmo-virtual-congress-2020/ Annals of Oncology (2020) 31 (suppl_4): S550-S550. 10.1016/annonc/annonc274
