A Randomized, Double-Blind, Phase 3 Study of Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma (DAWN-303)
Summary
The purpose of this study is to evaluate the efficacy and safety of standard chemotherapy with or without INCB161734 in participants with metastatic pancreatic ductal adenocarcinoma (PDAC).
Arms & interventions
- DrugINCB161734
Oral; tablet
- DrugPlacebo
Oral; tablet
- DrugInvestigator's choice of chemotherapy
The investigator will select the chemotherapy in accordance with the protocol-defined requirements. The possible choices as defined by the protocol:
Outcome measures
Primary
Overall Survival (OS)
Defined as the time from the date of randomization to the date of death due to any cause.
Time frame: Up to approximately 3 years
Progression-free survival (PFS) by BICR
Defined as the time from the date of randomization to the date of the first documented progression as determined by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death due to any cause.
Time frame: Up to approximately 2 years
Objective Response by BICR
Defined as complete response (CR) or partial response (PR) as determined by BICR per RECIST v1.1.
Time frame: Up to approximately 2 years
Secondary
Duration of Response (DOR) by BICR
Time frame: Up to approximately 2 years
Disease control by BICR
Time frame: Up to approximately 2 years
Progression-Free Survival (PFS) by investigator assessment
Time frame: Up to approximately 2 years
Objective response by investigator assessment
Time frame: Up to approximately 2 years
DOR by investigator assessment
Time frame: Up to approximately 2 years
Disease control by investigator assessment
Time frame: Up to approximately 2 years
Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to approximately 2 years and 30 days
TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatment
Time frame: Up to approximately 2 years and 30 days
Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-Core 30 (C30) at each postbaseline visit
Time frame: Up to approximately 2 years
Change from baseline in EORTC QLQ-PAN26 score at each postbaseline visit
Time frame: Up to approximately 2 years
Change from baseline in EQ-5D-5L score at each postbaseline visit
Time frame: Up to approximately 2 years
Eligibility criteria
Study locations (68)
Investigative Site US058
Birmingham, Alabama, 35233
Investigative Site US016
Anchorage, Alaska, 99508
Investigative Site US026
Chandler, Arizona, 85224
Investigative Site US045
Tucson, Arizona, 85719
Investigative Site US051
Duarte, California, 91010
Investigative Site US048
Fountain Valley, California, 92708
Investigative Site US049
Irvine, California, 92612
Investigative Site US054
La Jolla, California, 92093
Investigative Site US027
Los Angeles, California, 90027
Investigative Site US036
Los Angeles, California, 90033
Investigative Site US034
San Francisco, California, 94143
Investigative Site US001
Santa Monica, California, 90404
Investigative Site US071
Denver, Colorado, 80218
Investigative Site US013
Washington D.C., District of Columbia, 20007
Investigative Site US046
Washington D.C., District of Columbia, 20016
Investigative Site US072
Fort Myers, Florida, 33901
Investigative Site US075
Miami, Florida, 33136
Investigative Site US074
St. Petersburg, Florida, 33701-4553
Investigative Site US073
West Palm Beach, Florida, 33401
Investigative Site US023
Atlanta, Georgia, 30322
Investigative Site US079
Chicago, Illinois, 60637
Investigative Site US030
Evanston, Illinois, 60201
Investigative Site US005
Naperville, Illinois, 60540
Investigative Site US009
Springfield, Illinois, 62702
Investigative Site US021
Indianapolis, Indiana, 46250
Investigative Site US007
New Orleans, Louisiana, 70121
Investigative Site US022
Boston, Massachusetts, 02215
Investigative Site US006
Ann Arbor, Michigan, 48109
Investigative Site US010
Detroit, Michigan, 48201
Investigative Site US078
Grand Rapids, Michigan, 49546
Investigative Site US012
Ypsilanti, Michigan, 48197
Investigative Site US066
Maple Grove, Minnesota, 55369
Investigative Site US047
Hattiesburg, Mississippi, 39401
Investigative Site US077
Hackensack, New Jersey, 07601
Investigative Site US017
Morristown, New Jersey, 07960
Investigative Site US059
Lake Success, New York, 11042
Investigative Site US031
New York, New York, 10016
Investigative Site US041
New York, New York, 10029
Investigative Site US004
New York, New York, 10032
Investigative Site US003
New York, New York, 10065
Investigative Site US029
The Bronx, New York, 10461
Investigative Site US035
Chapel Hill, North Carolina, 27514
Investigative Site US050
Cleveland, Ohio, 44106
Investigative Site US020
Cleveland, Ohio, 44195
Investigative Site US033
Columbus, Ohio, 43210
Investigative Site US042
Portland, Oregon, 97239
Investigative Site US008
Philadelphia, Pennsylvania, 19104
Investigative Site US043
Philadelphia, Pennsylvania, 19107
Investigative Site US056
Pittsburgh, Pennsylvania, 15212
Investigative Site US082
Charleston, South Carolina, 29425
Investigative Site US055
Sioux Falls, South Dakota, 57105
Investigative Site US039
Nashville, Tennessee, 37203
Investigative Site US060
Nashville, Tennessee, 37203
Investigative Site US070
Nashville, Tennessee, 37232
Investigative Site US067
Dallas, Texas, 75246
Investigative Site US062
Denison, Texas, 75020
Investigative Site US011
Houston, Texas, 77030
Investigative Site US018
Houston, Texas, 77030
Investigative Site US080
San Antonio, Texas, 78229
Investigative Site US063
San Antonio, Texas, 78240
Investigative Site US053
Salt Lake City, Utah, 84112
Investigative Site US076
Charlottesville, Virginia, 22903
Investigative Site US057
Fairfax, Virginia, 22031
Investigative Site US065
Fairfax, Virginia, 22031
Investigative Site US064
Salem, Virginia, 24153
Investigative Site US081
Olympia, Washington, 98506
Investigative Site US032
Seattle, Washington, 98122
Investigative Site US044
Madison, Wisconsin, 53792