Phase 2/3 Open Label Randomized Study of Telisotuzumab Adizutecan in Combination with FOLFOX Compared to Standard of Care in Subjects with First-Line Metastatic Pancreatic Ductal Adenocarcinoma - AndroMETa-PDAC-288

Conditions

Metastatic Pancreatic Ductal Adenocarcinoma; PDAC

Brief summary

Phase 2 and Phase 3: Objective response (OR) assessed by Blinded Independent CentralReview (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, Phase 3: Overall Survival

Detailed description

Phase 2 and Phase 3: Progression-Free Survival (PFS) assessed by BICR per RECIST v1.1, Phase 2 and Phase 3: Duration Of Response (DoR) Assessed by BICR per RECIST v1.1, Phase 2 and Phase 3: Clinical Benefit (CB) assessed by BICR per RECIST v1.1, Phase 2 : Overall Survival, Phase 3: Change from baseline and time to deterioration in scales/items of the EORTC QLQ-C30 and EORTC QLQ-PAN26, Phase 3: Change in Selected items of the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), Phase 3: Change in GP5 item of the Functional Assessment of Cancer Therapy-General (FACT-G), Phase 3: Change in Selected items of Patient Global Impression of Severity (PGIS)/Patient Global Impression of Change (PGIC), Phase 3: Change from baseline in European Quality of Life 5 Dimensions (EQ-5D-5L) utility index and visual analog scale (VAS)

Related papers

No related papers found yet.

Interventions

DRUGCALCIUM FOLINATE

DRUGIRINOTECAN

DRUGFLUOROURACIL

DRUGOXALIPLATIN

DRUGTelisotuzumab adizutecan

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Phase 2 and Phase 3: Objective response (OR) assessed by Blinded Independent CentralReview (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, Phase 3: Overall Survival	—

Secondary

Measure	Time frame
Phase 2 and Phase 3: Progression-Free Survival (PFS) assessed by BICR per RECIST v1.1, Phase 2 and Phase 3: Duration Of Response (DoR) Assessed by BICR per RECIST v1.1, Phase 2 and Phase 3: Clinical Benefit (CB) assessed by BICR per RECIST v1.1, Phase 2 : Overall Survival, Phase 3: Change from baseline and time to deterioration in scales/items of the EORTC QLQ-C30 and EORTC QLQ-PAN26, Phase 3: Change in Selected items of the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), Phase 3: Change in GP5 item of the Functional Assessment of Cancer Therapy-General (FACT-G), Phase 3: Change in Selected items of Patient Global Impression of Severity (PGIS)/Patient Global Impression of Change (PGIC), Phase 3: Change from baseline in European Quality of Life 5 Dimensions (EQ-5D-5L) utility index and visual analog scale (VAS)	—

Measure

Time frame

Phase 2 and Phase 3: Progression-Free Survival (PFS) assessed by BICR per RECIST v1.1, Phase 2 and Phase 3: Duration Of Response (DoR) Assessed by BICR per RECIST v1.1, Phase 2 and Phase 3: Clinical Benefit (CB) assessed by BICR per RECIST v1.1, Phase 2 : Overall Survival, Phase 3: Change from baseline and time to deterioration in scales/items of the EORTC QLQ-C30 and EORTC QLQ-PAN26, Phase 3: Change in Selected items of the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), Phase 3: Change in GP5 item of the Functional Assessment of Cancer Therapy-General (FACT-G), Phase 3: Change in Selected items of Patient Global Impression of Severity (PGIS)/Patient Global Impression of Change (PGIC), Phase 3: Change from baseline in European Quality of Life 5 Dimensions (EQ-5D-5L) utility index and visual analog scale (VAS)

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Outcome results

None listed