New Trials in Urologic Cancers: Could Your Patient Benefit?

A number of clinical trials in nonprostate urologic cancers have opened in recent months. Maybe one of your patients could benefit from being enrolled.

Muscle-invasive bladder or upper urinary-tract cancer unable to receive cisplatin. Adult patients with muscle-invasive bladder cancer or infiltrating renal-pelvis or ureter cancer who cannot take cisplatin are sought for a phase 2 trial sponsored by the National Cancer Institute. It is investigating whether combination immunotherapy-chemotherapy prior to conventional surgery is better than surgery alone. Approximately 5 months before planned surgery, patients in the experimental arm will start to receive avelumab (Bavencio) once every 2 weeks, carboplatin once every 3 weeks, and gemcitabine twice in 3 weeks. Thus, participants will get an intravenous infusion almost weekly for 12 weeks, unless the disease progresses or the medication is too toxic. Their surgery will follow 1 to 2 months after treatment finishes. The control group will go straight to surgery. The study started recruiting on October 6 and hopes to enroll 196 participants. There are 23 trial centers across Illinois and Iowa. Pathologic complete response is the primary outcome measure. Overall survival (OS) is a secondary outcome, and quality of life (QoL) is not assessed. More details at clinicaltrials.gov

Newly diagnosed Wilms tumor. Children or adults with this type of kidney cancer scheduled for proton-beam radiation after surgery are being recruited for a phase 2 study to test the feasibility of delivering radiation to a narrow target vs the entire abdomen (the usual procedure). The goal of such “highly conformal radiation therapy” is to spare healthy organs. Participants will receive guideline-standard treatment based on their tumor stages. Those with early-stage tumors, who would not normally be slated for radiation therapy, will be controls for the patients with later-stage tumors, who will receive the targeted proton-beam radiation after surgery. The trial began recruiting for 95 participants on August 19 at the St. Jude Children’s Research Hospital in Memphis. Outcomes are abdominal growth over 10 years and, for children with stage V tumors, tumor control rate. OS and QoL are not tracked. More details at clinicaltrials.gov

Lymph-node positive urothelial bladder cancer. Adult patients with this type of cancer who are willing to undergo a transurethral bladder biopsy can join a phase 2 trial assessing whether surgery can be avoided by adding immunotherapy with durvalumab (Imfinzi), a PD-L1 inhibitor, to standard neoadjuvant chemotherapy. Participants will receive either intravenous chemotherapy or chemotherapy plus durvalumab every 2 weeks for up to 12 weeks. The patients receiving durvalumab will also get an extra dose of durvalumab 1 week before chemo starts and will stay on durvalumab after chemo, given every 4 weeks, for a further year or until relapse, whichever happens first. The study opened to 60 participants at the MD Anderson Cancer Center in Houston on October 13. Pathologic complete response rate ― ie, the proportion of patients no longer requiring surgery ― is the primary outcome; OS is a secondary outcome, and QoL will not be measured. More details at clinicaltrials.gov

Muscle-invasive bladder cancer ineligible for cisplatin. Patients with this type of cancer who are scheduled for radical cystectomy can join a phase 3 study testing the effectiveness of preoperative combinations of novel therapies vs heading straight to surgery. Participants on treatment will receive either anti-PD-L1 durvalumab plus enfortumab vedotin (Padcev), an antibody-chemotherapy conjugate recently approved for advanced urothelial cancer, or these two drugs plus the investigational checkpoint inhibitor tremelimumab. The third group will have surgery right away. Patients will receive weekly intravenous therapy for 2 of every 3 weeks for approximately 2 months, then after surgery for a further 9 months. The study opened on August 5 in California, Idaho, Nevada, New York, Texas, and Virginia. A further 222 locations are gearing up in the US and worldwide, with a total target of 830 participants. Safety and efficacy are the primary outcomes; OS over 5 years and QoL are secondary outcomes. More details at clinicaltrials.gov

Refractory advanced renal-cell carcinoma. Adults with this cancer who have progressed despite two or more treatments, including a checkpoint inhibitor, are eligible for a phase 3 trial comparing the combination of tivozanib (Fotivda) plus nivolumab (Opdivo) to treatment with tivozanib alone. Tivozanib is an oral tyrosine-kinase inhibitor that received FDA approval as monotherapy for this type of kidney cancer on March 10; this is a test of the drug as a combination. Participants will take daily tivozanib tablets 3 weeks out of 4 until first occurrence of unacceptable toxicity, disease progression, or other withdrawal criteria. Patients on the combination approach will also receive 4-weekly intravenous infusions of nivolumab for up to 2 years. The study opened on September 9 seeking 326 participants. US sites are in Louisiana, Michigan, Montana, Nevada, and Ohio. Progression-free survival is the primary outcome; OS is a secondary outcome, and QoL is not tracked. More details at clinicaltrials.gov

Unresectable and locally advanced or metastatic MET-driven papillary renal-cell carcinoma (PRCC). Patients with this type of cancer who have not received durvalumab, sunitinib (Sutent), or a MET inhibitor, or any anticancer treatment in the metastatic setting are sought for a phase 3 trial comparing the combination of savolitinib (Orpathys) plus durvalumab to monotherapy with sunitinib or durvalumab. Savolitinib is an experimental oral MET-tyrosine-kinase inhibitor under investigation for adenocarcinoma and non–small cell lung cancer as well as PRCC. In this study, participants will be treated until disease progression or they choose to leave for a maximum of approximately 3.5 years after the first person joins the trial. Treatment is either daily tablets of savolitinib plus intravenous durvalumab every 4 weeks; daily capsules of sunitinib, 4 weeks on, 2 weeks off; or intravenous durvalumab every 4 weeks. Patients who progress on durvalumab monotherapy will be offered the chance to add daily savolitinib to their treatment. The trial opened on October 28 hoping to attract 200 participants across Australia, South America, Canada, Europe, Asia, Israel, Mexico, Turkey, and Russia; US sites are in California and Illinois. Progression-free survival is the primary outcome; OS and QoL are secondary measures. More details at clinicaltrials.gov

All trial information is from the National Institutes of Health US National Library of Medicine (online at clinicaltrials.gov).

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