An Open-label, Phase I/II Study of PLENA Regimen in Patients With Unresectable Pancreatic Cancer or BTC

NCT05327582 | Unknown Phase 1 DMC

• 1 other identifier: CHN-PLAGH-BT-070
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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).

Conditions

Pancreatic Cancer; Biliary Tract Cancer

Keywords

unresectable; anti-PD-L1 antibody; lenvatinib; nab-paclitaxel

Outcome Measures

Primary Outcomes (2)

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

  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.

  6 months

• Object response rate (ORR)

  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.

  12 months

Secondary Outcomes (4)

• Disease control rate (DCR)

  12 months

• Progression-free survival (PFS)

  12 months

• Overall survival (OS)

  24 months

• Number of participants with laboratory test abnormalities

  12 months

Study Arms (1)

PLENA regimen

EXPERIMENTAL

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.

Drug: Durvalumab; Drug: Lenvatinib; Drug: Nab paclitaxel

Interventions

Durvalumab DRUG

Administered intravenously, 1000 mg on day 1 in a 3-week cycle

PLENA regimen

Lenvatinib DRUG

Administered orally, 8mg/d once daily in a 3-week cycle

PLENA regimen

Nab paclitaxel DRUG

Administered intravenously, 180-220 mg/m2 on day1 in a 3-week cycle

PLENA regimen

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 0-2. 5.Subjects must have at least one measurable lesion ≥ 1 cm as defined by response criteria.
• Subjects with Anti-PD-1/L1 antibody treatment history are eligible which must be disease progression.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Biotherapeutic Department of Chinese PLA General Hospital

Beijing, Beijing Municipality, 100083, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms; Biliary Tract Neoplasms

Interventions

durvalumab; lenvatinib; Taxes

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Biliary Tract Diseases

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations

Study Officials

• Weidong Han, Dr

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weidong Han

CONTACT

+861066937463; hanwdrsw@sina.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: April 14, 2022
• Study Start: April 12, 2022
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2024
• Last Updated: April 14, 2022

Record last verified: 2022-04

Locations

CN (1)