Olaparib and durvalumab (MEDI4736) in patients with metastatic pancreatic cancer and DNA Damage Repair genes alterations

Conditions

Metastatic pancreatic cancer

Brief summary

Overall Response Rate (ORR) defined as the percentage of patients with an investigator-assessed complete (CR) or partial response (PR) according to Response Evaluation Criteria in Solid tumours (RECIST) v1.1.

Detailed description

PFS defined as the time from initial date of study treatment to the date of objective disease progression according to RECIST 1.1 criteria or death (due to any cause), whichever occurs first., OS defined as the time from the initial date of the study treatment to the date of death (due to any cause), with patients alive or lost to follow-up at the analysis data cut-off date censored at their last contact date., DoR defined as time from first objective response to disease progression per RECIST 1.1 criteria or death (due to any cause). For patients with response who have not progressed or died at last observation, duration of response will be censored at their last evaluable disease assessment date., DCR defined as the percentage of patients who achieve complete response, partial response or stable disease., Assessment of AEs graded by NCI CTCAE v5.0, vital signs and evaluation of laboratory parameters.

Related papers

No related papers found yet.

Interventions

DRUGOLAPARIB

DRUGDURVALUMAB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall Response Rate (ORR) defined as the percentage of patients with an investigator-assessed complete (CR) or partial response (PR) according to Response Evaluation Criteria in Solid tumours (RECIST) v1.1.	—

Secondary

Measure	Time frame
PFS defined as the time from initial date of study treatment to the date of objective disease progression according to RECIST 1.1 criteria or death (due to any cause), whichever occurs first., OS defined as the time from the initial date of the study treatment to the date of death (due to any cause), with patients alive or lost to follow-up at the analysis data cut-off date censored at their last contact date., DoR defined as time from first objective response to disease progression per RECIST 1.1 criteria or death (due to any cause). For patients with response who have not progressed or died at last observation, duration of response will be censored at their last evaluable disease assessment date., DCR defined as the percentage of patients who achieve complete response, partial response or stable disease., Assessment of AEs graded by NCI CTCAE v5.0, vital signs and evaluation of laboratory parameters.	—

Measure

Time frame

PFS defined as the time from initial date of study treatment to the date of objective disease progression according to RECIST 1.1 criteria or death (due to any cause), whichever occurs first., OS defined as the time from the initial date of the study treatment to the date of death (due to any cause), with patients alive or lost to follow-up at the analysis data cut-off date censored at their last contact date., DoR defined as time from first objective response to disease progression per RECIST 1.1 criteria or death (due to any cause). For patients with response who have not progressed or died at last observation, duration of response will be censored at their last evaluable disease assessment date., DCR defined as the percentage of patients who achieve complete response, partial response or stable disease., Assessment of AEs graded by NCI CTCAE v5.0, vital signs and evaluation of laboratory parameters.

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Countries

Spain

Outcome results

None listed