Actively Recruiting
A Study to Investigate the Efficacy and Safety of an Infusion of IOV-4001 in Adult Participants With Unresectable or Metastatic Melanoma or Stage III or IV Non-small-cell Lung Cancer
Led by Iovance Biotherapeutics, Inc. · Updated on 2024-12-05
53
Participants Needed
10
Research Sites
253 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a study to investigate the efficacy and safety of an infusion of IOV-4001 in adult participants with unresectable or metastatic melanoma or advanced non-small-cell lung cancer (NSCLC).
CONDITIONS
Official Title
A Study to Investigate the Efficacy and Safety of an Infusion of IOV-4001 in Adult Participants With Unresectable or Metastatic Melanoma or Stage III or IV Non-small-cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of Stage IIIC, IIID, or IV unresectable or metastatic melanoma or Stage III or IV non-small-cell lung cancer
- For melanoma: progressed within 12 weeks of last anti-PD-1/PD-L1 dose and received BRAF/MEK inhibitors if BRAF mutated
- For NSCLC: received no more than 3 prior therapies and progressed within 12 weeks after last anti-PD-1/PD-L1 dose or after targeted therapy and platinum chemotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- At least one lesion that can be surgically removed
- At least one measurable lesion after lesion removal for treatment
- Adequate organ function
- Cardiac function test required
- Pulmonary function test may be required
- Willingness to use effective birth control during treatment and for 12 months after if of childbearing potential or partner of such
- Participants over 70 years may be included after discussion with medical monitor
You will not qualify if you...
- Melanoma originating from uveal/ocular sites
- Untreated or symptomatic brain metastases
- History of allogeneic organ transplant or prior cell therapy with conditioning chemotherapy in past 20 years
- Need for systemic steroid therapy equivalent to 10 mg/day prednisone or more
- Primary immunodeficiency
- Another primary cancer within the past 3 years
- Received or planned live or attenuated vaccine within 28 days before starting treatment
AI-Screening
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Trial Site Locations
Total: 10 locations
1
The Angeles Clinic and Research Institute
Los Angeles, California, United States, 90025
Actively Recruiting
2
Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
3
Orlando Health Cancer Institute
Orlando, Florida, United States, 32610
Actively Recruiting
4
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
5
The University of Kansas Cancer Center
Westwood, Kansas, United States, 66205
Actively Recruiting
6
University of Louisville
Louisville, Kentucky, United States, 40202
Actively Recruiting
7
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
8
University of Cincinnati
Cincinnati, Ohio, United States, 45219
Actively Recruiting
9
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
10
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Withdrawn
Research Team
I
Iovance Biotherapeutics Study Team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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