A Phase I/II, Open-label, One-arm, Single-center Study to Evaluate the Safety and Efficacy of the PLENA Regimen in Subjects With Unresectable Pancreatic Cancer or Biliary Tract Cancer

Chinese PLA General Hospital1 site in 1 country65 target enrollmentApril 12, 2022

Overview

Brief Summary

Immunotherapy of cancer based on PD-1/PD-L1 blockade has prompted a revolution in cancer clinical management, albeit as yet immunotherapy-based treatment approaches in pancreatic cancer and biliary tract cancer (BTC) remain to have proven value, highlights the urgency for designing novel therapeutic strategies to combat these deadly diseases. The immunomodulatory effect of lenvatinib (Lenvatinib is an oral multi-kinase inhibitor) on tumor microenvironments may contribute to antitumor activity of immune checkpoint blockade. This one-arm, phase I/II study is designed to assess the safety and efficacy of the combined regimen of Durvalumab (anti-PD-L1 antibody), Lenvatinib and Paclitaxel albumin (nab-paclitaxel).

Registry

clinicaltrials.gov

Start Date

April 12, 2022

End Date

April 30, 2024

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Chinese PLA General Hospital

Responsible Party

Principal Investigator

Han weidong

Principal Investigator

Chinese PLA General Hospital

Eligibility Criteria

Inclusion Criteria

•1.Subjects must have histologically proven unresectable pancreatic cancer or biliary tract cancer 2.18 to 75 years old. 3.Life expectancy of at least 6 months. 4.Eastern Cooperative Oncology Group performance status 0-
•5.Subjects must have at least one measurable lesion ≥ 1 cm as defined by response criteria.
•6.Subjects with Anti-PD-1/L1 antibody treatment history are eligible which must be disease progression.
•7.Adequate organ function. 8.Participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study drug.

Exclusion Criteria

•Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications.
•Serious uncontrolled medical disorders or active infections, pulmonary infection especially.
•Prior organ allograft.
•Women who are pregnant or breastfeeding.
•Women with a positive pregnancy test on enrollment or prior to investigational product administration.
•Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.

Arms & Interventions

PLENA regimen

Subject received PLENA regimen every 3 weeks until achieving a second assessable complete response or up to a maximum of 8 cycles. Treatment continued until progressive disease or intolerable toxicity, or withdrawal of consent.

Intervention: Durvalumab

PLENA regimen

Subject received PLENA regimen every 3 weeks until achieving a second assessable complete response or up to a maximum of 8 cycles. Treatment continued until progressive disease or intolerable toxicity, or withdrawal of consent.

Intervention: Lenvatinib

PLENA regimen

Subject received PLENA regimen every 3 weeks until achieving a second assessable complete response or up to a maximum of 8 cycles. Treatment continued until progressive disease or intolerable toxicity, or withdrawal of consent.

Intervention: Nab paclitaxel

Outcomes

Primary Outcomes

Number of Subjects with treatment-related adverse events (AEs)

Time Frame: 6 months

Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0. AEs were considered to be treatment-related if they had started or worsened within the interval from first study drug administration until the follow-up visit.

Object response rate (ORR)

Time Frame: 12 months

ORR is defined as the proportion of subjects who achieved a partial response (PR) or complete response (CR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.