RECURRENT CERVICAL CANCER TRIALS Flashcards
Study #: IOVANCE
A Phase 2, Multicenter Study to Evaluate the Efficacy and Safety Using Autologous Tumor Infiltrating Lymphocytes (LN-145) in Patients with Recurrent, Metastatic or Persistent Cervical Carcinoma
Schema:
Cyclophosphamide IV (60 mg/kg x 2 doses) and fludarabine IV (25 mg/m2 x 5 doses), followed by the infusion of autologous TIL (LN-145) and administration of IL-2 (600,000 IU/kg) 6 doses, as tolerated.
Cohort 2: LN-145 monotherapy
Prior Therapies:
Cohort 1: (CLOSED)
Cohort 2: – LN-145 monotherapy in patients previously treated with an anti-programmed cell death protein-1 (PD-1) or anti-programmed death-ligand 1 (PD-L1) checkpoint inhibitor:
Cohort 3: (CLOSED)
Measureable Disease:
Must have at least 1 (1.5cm) lesion that is resectable for TIL generation
Following resection for TIL generation, must have a remaining measurable target lesion as defined by RECIST 1.1.
Inclusion:
•Any prior therapy must be discontinued at least 28 days prior to tumor resection.
•ECOG 0 or 1
•Cohort 1 and Cohort 2: Progression during or following at least one, but
no more than three, prior systemic chemotherapeutic treatments for
recurrent, metastatic, or persistent cervical carcinoma
•Cohort 3: Must have not received any therapies other than prior chemoradiation or surgery for loco-regional disease
Exclusion:
•No systemic steriods
• Hypersensitivity to antibiotics of the aminoglycoside group (ie, streptomycin, gentamicin)
• Active systemic infections, coagulation disorders or other active major medical illnesses
• Primary malignancy within the previous 3 years
•Cohort 1 and Cohort 3: prior treatment with
immunotherapy
•Cohort 2: Grade ≥ 2 diarrhea or colitis as a result of PD-1/PD-L1 checkpoint inhibitor(s)
•Cohort 2: Immunotherapy-related endocrinopathies stable
for at least 6
•Cohort 3: no autoimmune
or inflammatory disorders (including pneumonitis, inflammatory bowel
disease, diverticulitis [exception
diverticulosis], Lupus, sarcoidosis syndrome, or Wegener syndrome,Graves’ disease, rheumatoid arthritis, hypophysitis, uveitis, etc.])
