Actively Recruiting
A Study Evaluating the Safety, Efficacy, and Pharmacokinetics (PK) of EVOLVE104 in Participants With Advanced Urothelial and Squamous Cell Carcinomas
Led by EvolveImmune United, Inc · Updated on 2026-04-13
160
Participants Needed
9
Research Sites
271 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this study is to evaluate the safety and effectiveness of EVOLVE104 in participants with advanced urothelial and squamous cell carcinomas who have previously taken standard treatment options, have declined or have been ineligible for treatment with these medications. Participants with advanced or metastatic cancer who meet all eligibility criteria may be eligible to participate in the study.
CONDITIONS
Official Title
A Study Evaluating the Safety, Efficacy, and Pharmacokinetics (PK) of EVOLVE104 in Participants With Advanced Urothelial and Squamous Cell Carcinomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have locally advanced or metastatic bladder cancer, squamous cell carcinoma of the lung, esophagus, skin, or anogenital area
- Have documented disease progression during or after standard treatment
- Cancer must be measurable by CT scan or MRI
- Eastern Cooperative Oncology Group (ECOG) performance status of 1 or less
- Anticipated life expectancy of at least 3 months
- Adequate organ function confirmed by blood tests
- Able to provide a fresh or archival tumor biopsy
- Agree to use contraception during the study and for 120 days after last dose, except for post-menopausal or surgically sterile women
You will not qualify if you...
- Eligible for treatment with targeted agents known to be beneficial
- Persistent significant toxicities from prior cancer treatments
- Brain metastases unless treated and stable
- Previous severe or life-threatening immune reactions to treatments
- Significant medical conditions including:
- History of serious heart disease
- Severe esophageal disease like rupture or severe erosive esophagitis
- Active inflammation or ulcerations in the eye
- History of cirrhosis or significant portal hypertension
- Uncontrolled or serious infections
- Certain other cancers within the past 3 years
- Recent arterial thrombosis, stroke, or transient ischemic attack within 6 months
- Active or uncontrolled HIV, hepatitis B or C infections
- Autoimmune or other conditions needing long-term immune suppression
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
2
Yale University Cancer Center
New Haven, Connecticut, United States, 06511
Actively Recruiting
3
The Winship Cancer Institute Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
4
START Midwest
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
5
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
6
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
7
SCRI
Nashville, Tennessee, United States, 37203
Actively Recruiting
8
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
9
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
E
Evolve Study Team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
12
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