Evorpacept + Enfortumab Vedotin for Bladder Cancer
Recruiting in Palo Alto (17 mi)
+9 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: ALX Oncology Inc.
Must not be taking: MMAE-based ADCs, Anti-CD47
Disqualifiers: CNS metastases, Diabetes, Neuropathy, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial is testing a new treatment (ALX148) combined with another cancer drug (enfortumab vedotin) and possibly other treatments. It targets patients with urothelial carcinoma, a type of bladder cancer. ALX148 helps the immune system fight cancer, while enfortumab vedotin directly attacks the cancer cells.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the drug Enfortumab Vedotin for bladder cancer?
Enfortumab Vedotin has been shown to be effective for patients with advanced bladder cancer, with a 44% response rate in a study of 125 patients who had previously received other treatments. This drug was approved by the FDA based on this evidence, although further trials are needed to confirm its benefits.
12345What makes the drug Evorpacept + Enfortumab Vedotin unique for bladder cancer?
This drug combination is unique because Enfortumab Vedotin is an antibody-drug conjugate that targets Nectin-4, a protein found on cancer cells, and has shown effectiveness in patients who have already tried other treatments like PD-1/PD-L1 inhibitors and platinum-based chemotherapy. Evorpacept, which blocks the CD47/SIRPa pathway, may enhance the immune system's ability to attack cancer cells, potentially improving outcomes.
23456Eligibility Criteria
This trial is for adults with advanced bladder cancer that can't be removed by surgery or has spread, and who have already tried chemotherapy and immune checkpoint inhibitors. They should not have severe nerve damage, active brain metastases, previous treatment with certain drugs like enfortumab vedotin or anti-CD47/SIRPα agents, uncontrolled eye conditions, or diabetes.Inclusion Criteria
My kidney function is normal.
My bone marrow is working well.
I have been treated with a drug that boosts my immune system.
+6 more
Exclusion Criteria
I have moderate to severe nerve damage.
I have brain metastases that are causing symptoms or are not under control.
I have been treated with enfortumab vedotin or similar drugs before.
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive Evorpacept (ALX148) infusions every two weeks and Enfortumab Vedotin on Days 1, 8, and 15 of each 28-day cycle
28-day cycles
3 visits per cycle (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests Evorpacept (ALX148) in combination with Enfortumab Vedotin to see how safe they are together and how the body responds. It's an early-phase trial where all participants receive both medications to assess their combined effects on bladder cancer.
1Treatment groups
Experimental Treatment
Group I: Evorpacept (ALX148) + Enfortumab VedotinExperimental Treatment2 Interventions
Phase 1a Dose Escalation: Evorpacept (ALX148) infusions will be administered every two weeks.
Enfortumab vedotin will be administered at 1.25 mg/kg IV on Days 1, 8, and 15 of each 28-day cycle.
Enfortumab Vedotin is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Padcev for:
- Locally advanced or metastatic urothelial cancer
🇪🇺 Approved in European Union as Padcev for:
- Locally advanced or metastatic urothelial cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Chicago MedicineChicago, IL
Moffitt Cancer CenterTampa, FL
Memorial Sloan Kettering Cancer CenterNew York, NY
Massachusett's GeneralBoston, MA
More Trial Locations
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Who Is Running the Clinical Trial?
ALX Oncology Inc.Lead Sponsor
References
Enfortumab Vedotin-ejfv: A First-in-Class Anti-Nectin-4 Antibody-Drug Conjugate for the Management of Urothelial Carcinoma. [2021]To evaluate the pharmacology, pharmacokinetics, clinical efficacy, safety, dosing, cost, and clinical implications of enfortumab vedotin-ejfv (EV) in the treatment of locally advanced or metastatic urothelial carcinoma (UC).
Somatic alterations of TP53 and MDM2 associated with response to enfortumab vedotin in patients with advanced urothelial cancer. [2023]Enfortumab vedotin (EV) is an antibody-drug conjugate approved for patients with treatment-refractory advanced urothelial carcinoma (aUC), however data on biomarkers of response is lacking.
FDA Approval Summary: Enfortumab Vedotin for Locally Advanced or Metastatic Urothelial Carcinoma. [2022]On December 18, 2019, the FDA granted accelerated approval to enfortumab vedotin-ejfv (PADCEV; Astellas and Seattle Genetics) for treatment of patients with locally advanced or metastatic urothelial cancer who have previously received a programmed cell death protein 1 or programmed death ligand 1 inhibitor, and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting. Substantial evidence of effectiveness for this application is obtained from Cohort 1 of the single-arm, multicenter Study EV-201. Patients received enfortumab vedotin (EV) 1.25 mg/kg (up to a maximum dose of 125 mg) intravenously on days 1, 8, and 15 of 28-day cycles until disease progression or unacceptable toxicity. Confirmed objective response rate in the 125-patient efficacy population determined by blinded independent central review was 44% [95% confidence interval (CI), 35.1-53.2], with complete responses in 12%. Median response duration was 7.6 months (95% CI, 6.3-not estimable). Grade 3-4 adverse reactions occurred in 73% of patients. Hyperglycemia, peripheral neuropathy, ocular disorders, skin reactions, infusion site extravasations, and embryo-fetal toxicity are labeled as warnings and precautions for EV. The article summarizes the data and the FDA thought process supporting accelerated approval of EV. This approval may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
Enfortumab Vedotin: Nursing Perspectives on the Management of Adverse Events in Patients With Locally Advanced or Metastatic Urothelial Carcinoma. [2021]Many patients with locally advanced or metastatic urothelial carcinoma (mUC) need additional treatment options beyond PD-1 or PD-L1 inhibitors and platinum-based chemotherapies. Enfortumab vedotin-ejfv (EV) is an antibody-drug conjugate directed at Nectin-4 that received accelerated approval for treatment of adults with locally advanced or mUC previously treated with PD-1/PD-L1 inhibitors and platinum- containing chemotherapy in the neoadjuvant/adjuvant, locally advanced, or metastatic settings.
FDA Approves First Agent to Treat Locally Advanced, Metastatic Urothelial Cancer. [2023]The FDA approved enfortumab vedotinejfv (Padcev)-the first drug to treat adult patients with locally advanced or metastatic urothelial cancer who have received prior treatment with a programmed cell death protein 1 (PD-1)/ programmed cell death ligand 1(PD-L1) inhibitor and platinum-containing chemotherapy.
Enfortumab Vedotin Checks Urothelial Cancer. [2020]Treatment with enfortumab vedotin generated robust responses in patients with locally advanced or metastatic urothelial carcinoma. In a phase II trial of 125 patients who had previously received platinum-based chemotherapy and a PD-1 or PD-L1 checkpoint inhibitor, the overall response rate was 44%. Although nearly all patients experienced a treatment-related adverse event, most side effects were mild to moderate.