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Monoclonal Antibodies
Enfortumab Vedotin for Penile Cancer
Phase 2
Recruiting
Led By Lance C. Pagliaro, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial tests a new drug to help fight penile squamous cell carcinoma that has spread or can't be removed surgically. It helps the immune system kill tumor cells by attaching to them and delivering an anticancer drug.
Who is the study for?
This trial is for adults with penile squamous cell carcinoma that has spread or can't be surgically removed. Participants may have had previous cancer treatments, must have measurable disease, and good organ function. They should not have certain other cancers, uncontrolled illnesses, severe neuropathy, active infections or hepatitis B/C, known drug allergies, or untreated brain metastases.Check my eligibility
What is being tested?
The trial tests enfortumab vedotin's effectiveness on advanced penile cancer. It's a phase II study where the drug—a monoclonal antibody linked to an anti-cancer agent—targets tumor cells by attaching to nectin-4 protein and delivering a toxin to kill them.See study design
What are the potential side effects?
Enfortumab vedotin may cause side effects like fatigue, hair loss, lowered blood counts leading to increased infection risk or bleeding problems; numbness or tingling in hands and feet; liver issues; and potential infusion-related reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I cannot have surgery for my skin cancer due to health issues or because it's too advanced, or I chose not to.
Select...
My cancer has spread to nearby lymph nodes but not to distant parts of the body, and I haven't received systemic therapy.
Select...
I am 18 years old or older.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Best response rate
Secondary outcome measures
Best response by human papillomavirus (HPV) status
Duration of Response
Incidence of adverse events
+3 moreSide effects data
From 2021 Phase 1 & 2 trial • 331 Patients • NCT0225756767%
FATIGUE
50%
ALOPECIA
50%
DECREASED APPETITE
50%
CONSTIPATION
50%
NAUSEA
50%
INSOMNIA
33%
HYPOPHOSPHATAEMIA
33%
RASH
33%
NEUTROPENIA
33%
VOMITING
33%
NIGHT SWEATS
33%
DIARRHOEA
33%
WEIGHT DECREASED
33%
HYPERGLYCAEMIA
33%
DYSPNOEA
17%
PRURITUS
17%
ARTHROPOD BITE
17%
SKIN DISCOLOURATION
17%
THROMBOCYTOPENIA
17%
HYPERTENSION
17%
PLATELET COUNT DECREASED
17%
GLAUCOMA
17%
STOMATITIS
17%
CHILLS
17%
FOLLICULITIS
17%
BONE PAIN
17%
HERPES ZOSTER
17%
INFUSION RELATED REACTION
17%
LYMPHOCYTE COUNT DECREASED
17%
HYPOMAGNESAEMIA
17%
HYPOKALAEMIA
17%
NEUROPATHY PERIPHERAL
17%
PERIPHERAL SENSORY NEUROPATHY
17%
EYE PRURITUS
17%
VISION BLURRED
17%
FLATULENCE
17%
SINUSITIS
17%
ENDOMETRIAL ADENOCARCINOMA
17%
ENDOMETRIAL CANCER
17%
ANAEMIA
17%
ABDOMINAL PAIN
17%
MUSCULAR WEAKNESS
17%
COUGH
17%
DYSPNOEA EXERTIONAL
17%
DRY SKIN
17%
MOUTH ULCERATION
17%
PALLOR
17%
EYE DISCHARGE
17%
VITAMIN D DEFICIENCY
17%
SINUS CONGESTION
17%
ATRIAL FIBRILLATION
17%
PYREXIA
17%
DIZZINESS
17%
PERIPHERAL SWELLING
17%
HODGKIN'S DISEASE
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL
Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL
Arm A (Phase II Randomization): Pola+BR in FL
Arm B (Phase II Randomization): BR in FL
Arm C (Phase II Randomization): Pola+BR in DLBCL
Arm D (Phase II Randomization): BR in DLBCL
Arm E (Phase II Expansion): Pola+BG in FL
Arm F (Phase II Expansion): Pola+BG in DLBCL
Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (Enfortumab vedotin)Experimental Treatment1 Intervention
Patients receive enfortumab vedotin IV over 30 minutes on days 1,8 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,213 Previous Clinical Trials
3,766,983 Total Patients Enrolled
Lance C. Pagliaro, M.D.Principal InvestigatorMayo Clinic in Rochester
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA granted an endorsement to treatment with Enfortumab vedotin?
"The safety of Enfortumab vedotin is rated a 2 on our scale, as there exists some evidence that it can be used safely but no data indicating its efficacy."
Answered by AI
Is there an open call for participants of this research endeavor?
"As per clinicaltrials.gov, this trial is no longer recruiting and was last updated on October 23rd of 2023. Despite this, there are 2712 other studies that currently have open enrollment for participants."
Answered by AI
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