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
NCT ID: NCT05361174
Last Updated: 2024-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
53 participants
INTERVENTIONAL
2022-07-20
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1
Participants with unresectable or metastatic melanoma
IOV-4001
A tumor sample is resected from each participant and cultured ex-vivo to manufacture IOV-4001. After lymphodepleting chemotherapy including cyclophosphamide and fludarabine, participant is infused with IOV-4001, and followed by IL-2.
Cohort 2
Participants with Stage III or IV non-small-cell lung cancer
IOV-4001
A tumor sample is resected from each participant and cultured ex-vivo to manufacture IOV-4001. After lymphodepleting chemotherapy including cyclophosphamide and fludarabine, participant is infused with IOV-4001, and followed by IL-2.
Interventions
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IOV-4001
A tumor sample is resected from each participant and cultured ex-vivo to manufacture IOV-4001. After lymphodepleting chemotherapy including cyclophosphamide and fludarabine, participant is infused with IOV-4001, and followed by IL-2.
Eligibility Criteria
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Inclusion Criteria
2. Participants who have received the following previous therapy:
1. Cohort 1 (Melanoma): Participants who have progressed within 12 weeks of last dose of anti-PD-1/PD-L1 blocking antibody and received BRAF/MEK inhibitor in those with BRAF mutations.
2. Cohort 2 (NSCLC): Participants who should have received no more than 3 prior lines of therapy and:
* those without oncogene-driven tumors: Have progressed within 12 weeks after last dose of anti-PD-1/PD-L1 blocking antibody
* those with oncogene-driven tumors: Have progressed during/after ≥1 targeted therapy AND either:
* platinum doublet chemotherapy
* Or within 12 weeks after last dose of anti-PD-1/PD-L1 blocking antibody
3. Participants who have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Participants who is assessed as having at least one resectable lesion.
5. Participants who have at least one measurable lesion, following resection of the lesion for IOV-4001 generation.
6. Participants who have adequate organ function.
7. Cardiac function test required.
8. Pulmonary function test may be required.
9. Participants of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control during treatment and up to 12 months.
10. Participants who are \>70 years of age may be allowed to enroll after the investigator discusses with the medical monitor.
Exclusion Criteria
2. Participants who have symptomatic untreated brain metastases.
3. Participants who have had a history of allogeneic organ transplant or any form of cell therapy involving prior conditioning chemotherapy within the past 20 years.
4. Participants who require systemic steroid therapy 10 mg/day prednisone or another steroid equivalent dose.
5. Participants who have any form of primary immunodeficiency.
6. Participants who have another primary malignancy within the previous 3 years.
7. Participants who have received or will receive a live or attenuated vaccination within 28 days prior to the start of the NMA-LD.
18 Years
70 Years
ALL
No
Sponsors
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Iovance Biotherapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Iovance Biotherapeutics Study Team
Role: STUDY_DIRECTOR
Iovance Biotherapeutics
Locations
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The Angeles Clinic and Research Institute
Los Angeles, California, United States
Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Orlando Health Cancer Institute
Orlando, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
The University of Kansas Cancer Center
Westwood, Kansas, United States
University of Louisville
Louisville, Kentucky, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of Cincinnati
Cincinnati, Ohio, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Central Contacts
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Other Identifiers
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IOV-GM1-201
Identifier Type: -
Identifier Source: org_study_id