Enfortumab Vedotin With Radiation for Locally Advanced Bladder Cancer (CONSOLIDATE)

NCT06434350 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 2024-0071NCI-2024-04592
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

To learn if the combination of enfortumab vedotin plus radiation therapy could help to control the disease.

Conditions

Advanced Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• Safety and adverse events (AEs)

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.0

  Through study completion; an average of 1 year.

Study Arms (1)

Enfortumab Vedotin with Radiation

EXPERIMENTAL

Particpants will receive enfortumab vedotin by vein over about 1-2 hours on Days 1 and 8 of every 28-day cycle. Two dose levels of enfortumab vedotin will be tested. The dose of enfortumab vedotin participants receive will depend on when the participant join the study. Participants will also receive radiation therapy 5 times a week (Monday through Friday) for about 4-5 weeks.

Drug: Enfortumab Vedotin; Radiation: Radiation Therapy

Interventions

Radiation Therapy RADIATION

Given by Radiation Therapy

Enfortumab Vedotin with Radiation

Enfortumab Vedotin DRUG

Given by IV

Enfortumab Vedotin with Radiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically confirmed diagnosis of urothelial carcinoma of the bladder including patients with T4N0 and T1-4N2-3 disease. Participants with mixed urothelial carcinoma of bladder will also be included.
• Be ≥ 18 years of age on the day of signing informed consent.
• ECOG performance status 0-2. NOTE: If participants is unable to walk due to paralysis, but is mobile in a wheelchair, participants is ambulatory for the purpose of assessing their performance status.
• The participant has the following baseline laboratory data:
• Hemoglobin ≥ 9 g/dL
• Platelet count ≥ 100 x 109 g/dL
• Creatinine clearance (CrCl) ≥ 30 mL/min as estimated per institutional standards (glomerular filtration rate \[GFR\] can also be used instead of CrCl)
• Absolute neutrophil count (ANC) ≥ 1500/mm3
• Male participants must consistently use highly effective methods of birth control starting at screening and continue throughout study period and for at least 6 months after radiation completion
• \. Candidate for definitive local therapy to active disease per the discretion of the treating physicians.

You may not qualify if:

• Has a diagnosis of active scleroderma, lupus, ulcerative colitis, or other rheumatologic disease which in the opinion of the treating radiation oncologist precludes safe radiation therapy.
• Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial as determined by the treating physician and/or member of the study team.
• Distant metastatic disease beyond lymph node metastases, which by the discretion of the treating physician cannot be treated definitively in a radiation field
• Has history of prior pelvic radiation therapy
• Has ongoing clinically significant toxicity (Grade 2 or higher with exception of alopecia) associated with prior systemic therapy
• History of uncontrolled diabetes mellitus within 3 months of enrollment. Uncontrolled diabetes is defined as hemoglobin A1c (HbA1c) ≥ 8% or HbA1c between 7 and \< 8% with associated diabetes symptoms (polyuria or polydipsia) that are not otherwise explained.
• Has estimated life expectancy of less than 12 weeks
• Has preexisting sensory or motor neuropathy Grade ≥ 2
• Participants receiving ongoing systemic intravenous antimicrobial treatment for active infection at time of randomization
• Participants have a known history of hepatitis B (defined as HBsAg reactive) or known active hepatitis C virus (defined as HCV RNA \[qualitative\] is detected) infection. No testing for hepatitis B and hepatitis C is required unless mandated by local health authority.
• Has a known history of human immunodeficiency virus (HIV) infection. Testing is not required unless mandated by the local health authority.
• Has conditions requiring high doses of steroids (\>10 mg/day of prednisone or equivalent) or other immunosuppressive medications are excluded. Inhaled or topical steroids are permitted in the absence of active autoimmune disease. Physiologic replacement doses of corticosteroids are permitted for participants with adrenal insufficiency.
• Has a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
• Has received a prior allogeneic stem cell or solid organ transplant.
• \. Is pregnant or expecting to conceive within the projected duration of the trial at the screening visit.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center

MeSH Terms

Interventions

enfortumab vedotin; Radiotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Comron Hassanzadeh, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Comron Hassanzadeh, MD

CONTACT

(713) 657-9802; cjhassanzadeh@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: May 30, 2024
• Study Start: October 10, 2024
• Primary Completion (Estimated): September 24, 2027
• Study Completion (Estimated): September 24, 2027
• Last Updated: March 2, 2026

Record last verified: 2026-02

Locations

US (1)