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Study to Evaluate the Safety and Efficacy of Treatment With NLM-001 and Standard Chemotherapy Plus Zalifrelimab in Patients With Advanced Pancreatic Cancer

NCT04827953 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2024-12-30

No results posted yet for this study

Summary

In order to improve the survival rates and decrease progression of pancreatic advanced cancer, this study aims to evaluate the first line treatment approved for this disease (gemcitabine plus nab-paclitaxel) in combination with two experimental drugs, an inhibitor of the signaling pathway of Hedgehog and an immunotherapy drug able of blocking the CTLA-4 receptor.

Conditions

Interventions

DRUG

Gemcitabine

Gemcitabine 1000 mg/m2 IV on days 1, 8 and 15 (conventional chemotherapy).

DRUG

Nab paclitaxel

Nab-Paclitaxel 125 mg/m2 IV on days 1, 8 and 15 (conventional chemotherapy).

DRUG

NLM-001

NLM-001 will be administered three cycles consecutively followed by two rest cycles.

DRUG

Zalifrelimab

Zalifrelimab administration each 6 weeks.

Sponsors & Collaborators

  • Apices Soluciones S.L.

    collaborator INDUSTRY

  • Agenus Inc.

    collaborator INDUSTRY

  • Nelum Corp

    lead INDUSTRY

Principal Investigators

  • Teresa Macarulla, MD · Hospital Vall d'Hebron

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2025-04-30
Completion
2025-04-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04827953 on ClinicalTrials.gov