Is NCT06104618 recruiting in Phoenix, AZ?

Yes, NCT06104618 is currently recruiting participants at its Phoenix, AZ location. This penile cancer clinical trial is actively enrolling qualified participants.

How do I join the penile cancer clinical trial in Phoenix?

To join this clinical trial in Phoenix, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Phoenix clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Penile Cancer Clinical Trial in Phoenix, AZ

About This Penile Cancer Study in Phoenix

This phase II trial tests how well enfortumab vedotin works for treating patients with squamous cell carcinoma of the penis that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Enfortumab vedotin is a monoclonal antibody, enfortumab, linked to an anticancer drug called vedotin. It works by helping the immune system to slow or stop the growth of tumor cells. Enfortumab attaches to a protein called nectin-4 on tumor cells in a targeted way and de

Sponsor: Mayo Clinic

Who Can Participate

Inclusion Criteria

Age ≥ 18 years

Histological confirmation of squamous cell carcinoma of the penis (PSCC): NOTE: Biopsy confirmation of at least one site of metastasis is encouraged but not required.

At least one site of metastatic or unresectable PSCC. NOTE: Prior therapy is not required for patients whose treatment is considered palliative (for example, presence of distant metastasis). NOTE: Patients who are potentially curable (any T, N1 - N3, M0) must have had tumor progression after standard chemotherapy, radiotherapy, or surgery, or be unable to receive such treatment. Eligible stages include:

Any T, N1 (i.e., a palpable mobile unilateral inguinal lymph node), M0 OR

Any T, N2 (i.e., palpable mobile multiple or bilateral inguinal lymph nodes), M0 OR

Any T, N3 (i.e., fixed inguinal nodal mass or any pelvic lymphadenopathy), M0 OR

Any T, any N, M1

Patients with clinical N1, M0 mPSCC at protocol entry must be ineligible for surgery because of comorbidities or clinical T4 disease, or have refused surgery

Patients with clinical N1 - N3, M0, and no prior systemic therapy must be:

Unable to receive neoadjuvant (paclitaxel + ifosfamide + cisplatin) TIP because of comorbidities or refused TIP; AND

Unable to receive radiotherapy with curative intent, or refused radiotherapy

Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

Prior therapy is allowed. Patients may be treatment-naïve or have had any number of prior anti-cancer treatments

Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

Hemoglobin ≥ 9.0 g/dL obtained ≤15 days prior to registration

Absolute neutrophil count (ANC) ≥ 1000/mm\^3 obtained ≤ 15 days prior to registration

Platelet count ≥ 100,000/mm\^3 obtained ≤ 15 days prior to registration

Total bilirubin ≤ 1.5 x upper limit of normal (ULN) or ≤ 3 x ULN for patients with Gilbert's disease obtained ≤ 15 days prior to registration

Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 2.5 x ULN obtained ≤ 15 days prior to registration

Glomerular filtration rate (GFR) or calculated creatinine clearance ≥ 30 ml/min as estimated using the Cockcroft-Gault formula or as measured by 24-hour urine collection obtained ≤ 15 days prior to registration

Provide written informed consent

Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)

Exclusion Criteria

Pure verrucous carcinoma of the penis

Non-squamous malignancy of the penis

Squamous carcinoma of the urethra

Preexisting sensory or motor neuropathy ≥ grade 2

Active central nervous system (CNS) metastases. Exception: Treated CNS metastases are allowed if all of the following are true:

CNS metastases are clinically stable for ≥ 6 weeks prior to registration

If needed, steroid dose is stable and ≤ 20 mg/day of prednisone or equivalent for ≥ 2 weeks prior to registration

Baseline imaging shows no evidence of new or enlarged brain metastasis

No leptomeningeal disease

History of uncontrolled diabetes mellitus ≤ 3 months prior to registration NOTE: Uncontrolled diabetes is defined as hemoglobin A1c (HbA1c) ≥ 8.0% or HbA1c 7.0-7.9% with associated diabetes symptoms (polyuria or polydipsia) that are not otherwise explained

Failure to recover from any of the following therapies prior to registration:

Major surgery

Radiotherapy, chemotherapy, biologics, investigational agents, and/or antitumor treatment with immunotherapy

Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive

Uncontrolled intercurrent illness including, but not limited to:

Ongoing or active infection requiring systemic treatment

History of cerebral vascular event (stroke or transient ischemic attack)

Myocardial infarction or symptomatic congestive heart failure (New York Heart Association \[NYHA\] Class III-IV) ≤ 6 months prior to registration

Unstable angina pectoris

Cardiac arrhythmia

Or psychiatric illness/social situations that would limit compliance with study requirements (e.g., history of substance abuse)

Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm

Currently receiving systemic antimicrobial treatment for viral, bacterial or fungal infection. NOTE: Routine antimicrobial prophylaxis is allowed

Known active hepatitis B (e.g., hepatitis B surface antigen \[HBsAg\] reactive) or active hepatitis C (e.g., hepatitis C virus \[HCV\] ribonucleic acid (RNA) \[qualitative\] is detected)

Known active keratitis or corneal ulcerations. NOTE: Superficial punctate keratitis is allowed if the disorder is being adequately treated

Known hypersensitivity to enfortumab vedotin or to any excipient contained in the drug formulation of enfortumab vedotin (including histidine, trehalose dihydrate and polysorbate 20) OR subject has known hypersensitivity to biopharmaceutical produced in Chinese hamster ovary cells

Other active malignancy ≤ 2 years prior to registration. EXCEPTIONS: Locally curable cancers that have been apparently cured such as basal or squamous cell skin cancer, non-muscle-invasive bladder cancer, or carcinoma in situ of the breast or low risk Gleason 6 prostate cancer.

History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias

Patients who are sexually active and unwilling to use effective contraception (if they are not already surgically sterile)

Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens

Chemotherapy-naïve patients who are potentially curable (any T, N1 - N3, M0) in the absence of any condition that precludes cisplatin-based chemotherapy, such as low GFR, peripheral neuropathy, hearing impairment, or psychosocial considerations

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Phoenix?

Yes, this clinical trial (NCT06104618) has an active research site in Phoenix, AZ that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Penile Cancer Treatment Options in Phoenix, AZ

If you're searching for penile cancer treatment options in Phoenix, AZ, this clinical trial (NCT06104618) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Phoenix research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced penile cancer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all penile cancer clinical trials near you to find additional studies recruiting in your area.

Penile Cancer Clinical Trial in Phoenix, AZ

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No-Cost Care

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