Iovance Biotherapeutics, Inc.
Dr. Marcus Butler
Inclusion Criteria:
1. Participant has a histologically or pathologically confirmed diagnosis of Stage
IIIC, IIID, or IV unresectable or metastatic melanoma.
2. In the investigator's assessment, the participant has an Eastern Cooperative
Oncology Group (ECOG) performance status of 0 or 1 and an estimated life expectancy
of > 6 months.
3. Participant is assessed as having at least one resectable lesion (or aggregate
lesions) for lifileucel generation.
4. Participant must have at least one measurable disease as defined by RECIST 1.1
following tumor resection.
5. Participants must have adequate organ function.
6. Participants of childbearing potential or those with partners of childbearing
potential must be willing to practice an approved method of highly effective birth
control.
7. Participants who are > 70 years of age may be allowed to enroll after the
investigator discusses with the medical monitor.
Exclusion Criteria:
1. Participant has melanoma of uveal/ocular origin.
2. Participant has symptomatic untreated brain metastases.
3. Participant received more than 1 prior line of therapy.
4. Participant received prior therapy for metastatic disease
5. Participants with a BRAF V600 mutation-positive tumor received prior
adjuvant/neoadjuvant ICI therapy only
6. Participant has an active medical illness(es) that, in the opinion of the
investigator, would pose increased risks for study participation, such as systemic
infections; seizure disorders; coagulation disorders; or other active major medical
illnesses of the cardiovascular, respiratory, or immune systems.
7. Participant has any form of primary or acquired immunodeficiency (eg, SCID or AIDS).
8. Participant had another primary malignancy within the previous 3 years (except for
those that do not require treatment or were curatively treated >1 year ago, and in
the judgment of the investigator do not pose a significant risk of recurrence.)
9. Participant has a history of allogeneic cell or organ transplant.
Other protocol defined inclusion/exclusion criteria could apply.
