Status:
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
Lead Sponsor:
Iovance Biotherapeutics, Inc.
Conditions:
Unresectable Melanoma
Metastatic Melanoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
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).
Detailed Description
This study is the first-in-human study of IOV-4001, a genetically modified autologous tumor- infiltrating lymphocytes (TIL) product. IOV-4001 is expected to have antitumor activity through its capacit...
Eligibility Criteria
Inclusion
- Participants must have a confirmed diagnosis of Stage IIIC, IIID, or IV unresectable or 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 last dose of anti-PD-1/PD-L1 blocking antibody and received BRAF/MEK inhibitor in those with BRAF mutations.
- 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
- Participants who have an Eastern Cooperative Oncology Group (ECOG) performance status 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 the lesion 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 childbearing potential must be willing to practice an approved method of highly effective birth control during treatment and up to 12 months.
- Participants who are \>70 years of age may be allowed to enroll after the investigator discusses with the medical monitor.
Exclusion
- 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 of cell therapy involving prior conditioning chemotherapy within the past 20 years.
- Participants who require systemic steroid therapy 10 mg/day prednisone or another steroid 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 vaccination within 28 days prior to the start of the NMA-LD.
Key Trial Info
Start Date :
July 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT05361174
Start Date
July 20 2022
End Date
June 1 2027
Last Update
December 5 2024
Active Locations (10)
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1
The Angeles Clinic and Research Institute
Los Angeles, California, United States, 90025
2
Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
3
Orlando Health Cancer Institute
Orlando, Florida, United States, 32610
4
Moffitt Cancer Center
Tampa, Florida, United States, 33612