Phase
Condition
Metastatic Melanoma
Melanoma
Treatment
IOV-4001
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants must have a confirmed diagnosis of Stage IIIC, IIID, or IV unresectableor metastatic melanoma or Stage III or IV NSCLC.
Participants who have received the following previous therapy:
Cohort 1 (Melanoma): Participants who have progressed within 12 weeks of lastdose of anti-PD-1/PD-L1 blocking antibody and received BRAF/MEK inhibitor inthose with BRAF mutations.
Cohort 2 (NSCLC): Participants who should have received no more than 3 priorlines of therapy and:
- those without oncogene-driven tumors: Have progressed within 12 weeksafter last dose of anti-PD-1/PD-L1 blocking antibody
- those with oncogene-driven tumors: Have progressed during/after ≥1targeted therapy AND either:
- platinum doublet chemotherapy
- Or within 12 weeks after last dose of anti-PD-1/PD-L1 blockingantibody
Participants who have an Eastern Cooperative Oncology Group (ECOG) performancestatus of 0 or 1.
Participants who is assessed as having at least one resectable lesion.
Participants who have at least one measurable lesion, following resection of thelesion for IOV-4001 generation.
Participants who have adequate organ function.
Cardiac function test required.
Pulmonary function test may be required.
Participants of childbearing potential or those with partners of childbearingpotential must be willing to practice an approved method of highly effective birthcontrol during treatment and up to 12 months.
Participants who are >70 years of age may be allowed to enroll after theinvestigator discusses with the medical monitor.
Exclusion
Exclusion Criteria:
Participants who have melanoma of uveal/ocular origin.
Participants who have symptomatic untreated brain metastases.
Participants who have had a history of allogeneic organ transplant or any form ofcell therapy involving prior conditioning chemotherapy within the past 20 years.
Participants who require systemic steroid therapy 10 mg/day prednisone or anothersteroid equivalent dose.
Participants who have any form of primary immunodeficiency.
Participants who have another primary malignancy within the previous 3 years.
Participants who have received or will receive a live or attenuated vaccinationwithin 28 days prior to the start of the NMA-LD.
Study Design
Study Description
Connect with a study center
The Angeles Clinic and Research Institute
Los Angeles, California 90025
United StatesActive - Recruiting
Sylvester Comprehensive Cancer Center
Miami, Florida 33136
United StatesActive - Recruiting
Orlando Health Cancer Institute
Orlando, Florida 32610
United StatesActive - Recruiting
Moffitt Cancer Center
Tampa, Florida 33612
United StatesActive - Recruiting
The University of Kansas Cancer Center
Westwood, Kansas 66205
United StatesActive - Recruiting
University of Louisville
Louisville, Kentucky 40202
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United StatesActive - Recruiting
University of Cincinnati
Cincinnati, Ohio 45219
United StatesActive - Recruiting
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania 15232
United StatesActive - Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United StatesSite Not Available
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