Meeting
2018 Gastrointestinal Cancers Symposium
HALO 110-101: A phase Ib, randomized, open-label study of PEGPH20 (pegvorhyaluronidase alfa) in combination with cisplatin (CIS) + gemcitabine (GEM) (PEGCISGEM) or atezolizumab and CIS + GEM (PEGCISGEMATEZO) in hyaluronan-high subjects with locally advanced or metastatic cholangiocarcinoma and gallbladder cancer.
Authors
Mitesh J. Borad
Mayo Clinic, Scottsdale, AZ
Mitesh J. Borad , Rachna T. Shroff , Ghassan K. Abou-Alfa , J. Randolph Hecht , Andrea J. Bullock , Paul S. Ritch , Dimitrios Chondros , Mann Muhsin , Do-Youn Oh
Organizations
Mayo Clinic, Scottsdale, AZ, University of Texas MD Anderson Cancer Center, Houston, TX, Memorial Sloan Kettering Cancer Center, New York, NY, UCLA David Geffen School of Medicine, Los Angeles, CA, Beth Israel Deaconess Medical Center, Boston, MA, Froedtert & the Medical College of Wisconsin, Milwaukee, WI, Halozyme Therapeutics, Inc., San Francisco, CA, Halozyme Therapeutics, Inc., San Diego, CA, Seoul National University Hospital, Seoul, Korea, Republic of (South)
Research Funding
Pharmaceutical/Biotech Company
Background: Cholangiocarcinoma (CCA) is treated with CIS and GEM (CISGEM), but prognosis is poor. Hyaluronan (HA) accumulation in solid tumors may impede drug and immune cell access. PEGPH20 targets tumors that accumulate HA (HA-high). This study (NCT03267940) plans to enroll 70 subjects to evaluate the safety and activity of PEGPH20 + programmed cell death-ligand 1 (PD-L1) agent atezolizumab, (PEGCISGEMATEZO), & PEGPH20 + CISGEM (PEGCISGEM) in HA-high subjects with CCA and gallbladder cancer. Study will comprise initial run-in and expansion portions. Primary endpoints include incidence of AEs and other laboratory/safety parameters and ORR (RECIST v1.1). Secondary endpoints include PK parameters; DOR, DCR, PFS, and ORR (RECIST v1.1 and immune-modified RECIST); and OS and OS by PD-L1 expression. Methods: ~6 HA-high subjects will be enrolled in PEGCISGEM arm run-in portion and undergo at ≥1 cycle; subsequently, 6 HA-high subjects will enter the PEGCISGEMATEZO arm. Treatment period will be 21-day cycles. In the expansion portion, ~50 HA-high subjects will be enrolled and randomized in a 2:2:1 ratio into PEGCISGEMATEZO, PEGCISGEM, and CISGEM arms. PEGPH20 is planned to be administered at 3.0 μg/kg on Days 1, 8 and 15 of all cycles in both portions. ATEZO will be administered at 1200 mg 1–3 hours after PEGPH20 on Day 1 of each 21-day cycle in the PEGCISGEMATEZO arm in both portions. In the PEGCISGEM & PEGCISGEMATEZO arms, dosing schedule for CISGEM is the same during both portions, with administration of 25 mg/m2 CIS and 1000 mg/m2 GEM on Days 2 and 9 of each cycle. In CISGEM control arm (expansion only), dosing schedule will be on Days 1 and 8 of each cycle. Treatment will continue until death, withdrawal of consent, disease progression, or unacceptable toxicity. Tumor response will be evaluated using RECIST v1.1. AEs will be graded per NCI CTCAE v4.03. Tumor samples will be tested retrospectively for PD-L1 expression. Safety data will be periodically monitored by an independent data monitoring committee. Clinical trial information: NCT03267940
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Abstract Details
Session Type
Trials in Progress Poster Session
Session Title
Trials in Progress Poster Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract
Track
Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract
Sub Track
Multidisciplinary Treatment
Clinical Trial Registration Number
NCT03267940
Citation
J Clin Oncol 36, 2018 (suppl 4S; abstr TPS543)
DOI
10.1200/JCO.2018.36.4_suppl.TPS543
Abstract #
TPS543
Poster Bd #
Q19
Abstract Disclosures
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