LAPTOP: PHASE 1/2 STUDY IN BORDELINE RESECTABLE, LOCALLY ADVANCED OR METASTATIC PANCREATIC CANCER TO ASSESS SAFETY AND POTENTIAL EFFICACY OF DUAL CHECKPOINT INHIBITION IN COMBINATION WITH GEMCITABINE AND NAB-PACLITAXEL FOLLOWED BY IMMUNE-CHEMORADIATION.

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-518173-34-00

Acronym

GI 1931

Enrollment

Registered

2024-10-08

Start date

2020-06-02

Completion date

Unknown

Last updated

2024-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Borderline resectable, LAPC or mPC), locally advanced or metastatic pancreatic cancer (BRPC

Brief summary

Incidence of treatment-related AEs, SAEs, AEs leading to discontinuation, death, and laboratory abnormalities

Detailed description

Median PFS using RECIST v1.1 and PFSR at 6, 9, and 12 months, Median OS and OSR at 6 months, 1 year, and 2 years, Objective Response Rate (ORR) and median duration of response (DOR) by RECIST v1.1, Rate of downstaging to surgical resection

Interventions

DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.

DRUGAbraxane 5 mg/ml powder for dispersion for infusion.

DRUGYERVOY 5 mg/ml concentrate for solution for infusion

DRUGGEMCITABINE HYDROCHLORIDE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Incidence of treatment-related AEs, SAEs, AEs leading to discontinuation, death, and laboratory abnormalities	—

Secondary

Measure	Time frame
Median PFS using RECIST v1.1 and PFSR at 6, 9, and 12 months, Median OS and OSR at 6 months, 1 year, and 2 years, Objective Response Rate (ORR) and median duration of response (DOR) by RECIST v1.1, Rate of downstaging to surgical resection	—

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026