A Phase 1/2, multicenter, multi-cohort, open-label study of an autologous tumor-infiltrating lymphocytes (TIL) regimen with IOV-5001 in participants with previously treated advanced solid tumors
Inclusion Criteria:
Participant must be ≥ 18 years of age at the time of signing the informed consent.
Diagnosis:
NSCLC: Participant has a histologically or pathologically confirmed diagnosis of metastatic Stage IV NSCLC (squamous, nonsquamous, adenocarcinoma, large cell, or mixed histologies) without epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or ROS proto-oncogene 1 (ROS1) genomic alterations.
TNBC: Participant has a histologically or pathologically confirmed diagnosis of unresectable or Stage IV breast cancer.
CRC: Participant has a histologically or pathologically confirmed diagnosis of Stage IV CRC.
HNSCC: Participant has a histologically or pathologically confirmed diagnosis of Stage III or IV HNSCC not amenable to curative intent treatment.
Radiographic disease progression: Participant has radiographic disease progression after the most recent line of therapy.
Disease-specific criterion:
NSCLC: Radiographic disease progression occurred:
TNBC: Participant has received up to 3 prior lines of therapy. These must include at least one prior line of cytotoxic chemotherapy for unresectable or Stage IV breast cancer, regardless of ER, PR, or HER2 status at the time it was given.
CRC: Participant has received up to 3 prior lines of therapy. These must include a fluoropyrimidine, oxaliplatin, irinotecan, an anti-VEGF therapy, an anti-EGFR therapy (for RAS/rapidly accelerated fibrosarcoma [RAF] wild-type disease if the tumor originated in the left side of the colon), and an immune checkpoint inhibitor (for microsatellite instability high [MSI-H] or deficient mismatch repair [dMMR] disease.
HNSCC: Participant has received up to 3 prior lines of therapy. These must include an immune inhibitor and platinum-based chemotherapy unless platinum ineligible due to pre-existing hearing loss, Grade >= 2 tinnitus, Grade >= 2 peripheral neuropathy, or allergy to platinum.
Disease-specific criterion:
NSCLC: Participant has received up to 3 lines of prior therapy. These must include an appropriate health authority-approved targeted therapy for participants who have actionable mutations (other than EGFR, ALK, or ROS1 genomic alterations) if eligible and available.
TNBC: Participant has progressed on or is ineligible for other standard of care therapies including, but not limited to: sacituzumab govitecan, poly(ADP-ribose) polymerase (PARP) inhibitors (if breast cancer gene [BRCA]1 or BRCA2 mutated), trastuzumab deruxtecan (if HER2low), and pembrolizumab (for PD-L1 combined positive score [CPS] >= 10).
CRC: Microsatellite instability and/or mismatch repair mutational status must have been previously determined based on archival tumor biopsies.
HNSCC: Participant has documented PD-L1 status.
The participant has an ECOG performance status of 0 or 1 and an estimated life expectancy of > 6 months.
Participant is assessed as having at least one resectable lesion (or aggregate lesions) with an estimated minimum diameter of 1.5 cm (short axis) for IOV-5001 generation.
Exclusion Criteria:
Clinical.Inquiries@iovance.com844-845-4682
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