This phase II trial studies how well nogapendekin alfa (ALT-803) works in treating patients with stage III-IV ovarian, fallopian tube, or primary peritoneal cancer. Biological therapies, such as ALT-803, use substances made from living organisms that may stimulate the immune system in different ways and stop tumor cells from growing. ALT-803 is usually given as an injection under the skin (subcutaneous); however, ovarian, fallopian tube, and primary peritoneal cancers give the unique opportunity to administer drugs directly into the belly, referred to as an intraperitoneal infusion. It is not yet known if intraperitoneal infusion of ALT-803 works better than subcutaneous injection in treating patients with ovarian, fallopian tube, or primary peritoneal cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03054909.
PRIMARY OBJECTIVE:
I. To select a “winner” for future study with the intent to ensure that if one method is clearly inferior in terms of the primary endpoint of progression free survival (PFS) by 6 months of subcutaneous administration against intraperitoneal and subcutaneous administration of ALT-803.
SECONDARY OBJECTIVES:
I. To determine one and two year progression free survival (PFS).
II. To determine one and two year overall survival (OS).
III. To document ALT-803 associated toxicity when administered by intraperitoneal (IP) in this patient population.
IV. To evaluate the safety of ALT-803 when administered by IP on this schedule.
CORRELATIVE OBJECTIVES:
I. To evaluate peripheral blood and peritoneal washing lymphocyte number, phenotype and function.
II. To characterize ALT-803 immunogenicity.
III. To determine the genomic, transcriptomic, and proteomic profile of subjects’ tumors to identify gene mutations, gene amplifications, ribonucleic acid (RNA)-expression levels, and protein-expression levels.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive ALT-803 subcutaneously (SC) on days 1, 8, 15, and 22. Treatment repeats every 8 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive ALT-803 IP on days 1, 8, 15, and 22 of cycle 1 only and then SC on days 1, 8, 15, and 22 of cycles thereafter. Treatment repeats every 8 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 4 weeks and then every 3 weeks for 2 years from the start of treatment.
Lead OrganizationUniversity of Minnesota/Masonic Cancer Center
Principal InvestigatorMelissa A. Geller
