INCMGA 0012-204: An Umbrella Study of INCMGA00012 Alone and in Combination With Other Therapies in Participants With Advanced or Metastatic Endometrial Cancer Who Have Progressed on or After Platinum-Based Chemotherapy (POD1UM-204)

Conditions

Endometrial cancer

Brief summary

Group A (INCMGA00012 monotherapy): ORR, defined as the proportion of participants having a CR or PR according to RECIST v1.1, will be determined by ICR.

Detailed description

Group A and B (INCMGA00012 monotherapy): DOR, defined as the time from the first documented objective response (CR or PR) according to RECIST v1.1 (as determined by ICR) until disease progression or death due to any cause, Group A and B (INCMGA00012 monotherapy): DCR, defined as the proportion of participants with CR, PR, or SD (as determined by ICR) as best response., Group A and B (INCMGA00012 monotherapy): PFS, defined as the time from the first dose of study treatment until disease progression (as determined by ICR) or death due to any cause., Group A and B (INCMGA00012 monotherapy): OS, defined as the time from the first dose of study treatment until death due to any cause., All other groups: • ORR, defined as the proportion of participants having a CR or PR according to RECIST v1.1 (as determined by the investigator). Safety and tolerability will be assessed by monitoring the frequency and severity of AEs and SAEs as well as laboratory test results.

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Interventions

DRUGPemazyre 4.5 mg tablets

DRUGINCAGN02385

DRUGINCAGN02390

DRUGRetifanlimab (INCMGA00012)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Group A (INCMGA00012 monotherapy): ORR, defined as the proportion of participants having a CR or PR according to RECIST v1.1, will be determined by ICR.	—

Secondary

Measure	Time frame
Group A and B (INCMGA00012 monotherapy): DOR, defined as the time from the first documented objective response (CR or PR) according to RECIST v1.1 (as determined by ICR) until disease progression or death due to any cause, Group A and B (INCMGA00012 monotherapy): DCR, defined as the proportion of participants with CR, PR, or SD (as determined by ICR) as best response., Group A and B (INCMGA00012 monotherapy): PFS, defined as the time from the first dose of study treatment until disease progression (as determined by ICR) or death due to any cause., Group A and B (INCMGA00012 monotherapy): OS, defined as the time from the first dose of study treatment until death due to any cause., All other groups: • ORR, defined as the proportion of participants having a CR or PR according to RECIST v1.1 (as determined by the investigator). Safety and tolerability will be assessed by monitoring the frequency and severity of AEs and SAEs as well as laboratory test results.	—

Measure

Time frame

Group A and B (INCMGA00012 monotherapy): DOR, defined as the time from the first documented objective response (CR or PR) according to RECIST v1.1 (as determined by ICR) until disease progression or death due to any cause, Group A and B (INCMGA00012 monotherapy): DCR, defined as the proportion of participants with CR, PR, or SD (as determined by ICR) as best response., Group A and B (INCMGA00012 monotherapy): PFS, defined as the time from the first dose of study treatment until disease progression (as determined by ICR) or death due to any cause., Group A and B (INCMGA00012 monotherapy): OS, defined as the time from the first dose of study treatment until death due to any cause., All other groups: • ORR, defined as the proportion of participants having a CR or PR according to RECIST v1.1 (as determined by the investigator). Safety and tolerability will be assessed by monitoring the frequency and severity of AEs and SAEs as well as laboratory test results.

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Countries

Belgium, France, Greece, Italy

Outcome results

None listed