Study CP-MGD019-03 is an open-label study of lorigerlimab in participants with platinum-resistant ovarian cancer (PROC) or clear cell gynecologic cancer (CCGC). Approximately 60 participants will be enrolled. The study will assess the efficacy and safety of lorigerlimab in participants with PROC or CCGC. Participants will receive lorigerlimab by intravenous (IV) infusion on Day 1 of every 21-day treatment cycle. Treatment cycles will continue until progression of cancer, unacceptable side effects, withdrawal of consent by the participant, or the study ends. Participants will be monitored closely for side effects by physical exam and routine laboratory tests every cycle. Tumor status will be checked approximately every 9 weeks for the first year, then every 12 weeks for the duration of treatment. Participants will have a safety followup performed within 30 days after treatment discontinuation. Participants who discontinue study treatment for reasons other than progression of cancer, will continue CA-125 and tumor assessments every 12 weeks. Participants who discontinue study treatment for progression of cancer will enter the 6-month survival follow up portion of the study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Bispecific DART protein binding PD-1 and CTLA-4
UCLA
Los Angeles, California, United States
RECRUITINGOchsner MD Anderson Cancer Center
New Orleans, Louisiana, United States
RECRUITINGSTART Midwest
Grand Rapids, Michigan, United States
RECRUITINGWest Penn Allegheny Health
Pittsburgh, Pennsylvania, United States
RECRUITINGMays Clinic
Houston, Texas, United States
RECRUITINGSTART San Antonio
San Antonio, Texas, United States
RECRUITINGWisconsin Institute Medical Research- UW Cancer Connect
Madison, Wisconsin, United States
RECRUITINGPrincess Margaret Cancer Center
Toronto, Ontario, Canada
RECRUITINGMcGill University
Montreal, Quebec, Canada
RECRUITINGNational Cancer Center
Goyang-si, Gyeonggi-do, South Korea
RECRUITING...and 6 more locations
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria as determined by the investigator
The ORR, is defined as the percentage of patients in the response evaluable population who achieve a best overall response of complete response (CR) or partial response (PR), per RECIST, version 1.1 criteria. CR is defined as disappearance of all target and non-target lesions. PR is defined as at least a 30% decrease from baseline in the sum of diameters of target lesions.
Time frame: Throughout the study up to approximately 2 years
Number of participants with adverse event (AEs), serious AEs (SAEs), and AEs leading to study treatment discontinuation.
Time frame: Throughout the study, up to approximately 2 years
Median duration of response (DoR) per RECIST 1.1 criteria
The DoR will be calculated per RECIST v1.1 criteria, as determined by the investigator, from the date of initial tumor response (CR or PR) to the date of first documented progressive disease (PD) or death from any cause, whichever occurs first.
Time frame: Throughout the study, up to approximately 2.5 years
Median progression free survival (PFS) per RECIST 1.1 criteria
PFS is defined as the time from the first dose of study treatment to the date of documented PD or death from any cause, whichever occurs first.
Time frame: Throughout the study, up to 2.5 years
Percent change from baseline in tumor size
Tumor size is defined as the sum of diameters of the target lesions.
Time frame: Throughout the study, up to 2.5 years
Best percent change from baseline in tumor size
Tumor size is defined as the sum of diameters of the target lesions.
Time frame: Throughout the study, up to 2.5 years
Disease control rate (DCR)
DCR, per RECIST v1.1 criteria, as determined by the investigator, is defined as the proportion of participants in the response evaluable population who achieve a CR, PR or stable disease for at least 3 months.
Time frame: Throughout the study, up to 2.5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.