Study on Botensilimab for Treating Metastatic Pancreatic Cancer

Sponsor: Agenus Inc.

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05630183

Provider View

This clinical trial is testing whether adding botensilimab to standard chemotherapy can improve treatment outcomes for patients with metastatic pancreatic cancer. Participants will be divided into two groups: one receiving only chemotherapy and the other receiving both botensilimab and chemotherapy.

Patient Parameters

Program Overview

The aim of this study is to determine if combining botensilimab with standard chemotherapy drugs can better treat metastatic pancreatic cancer compared to chemotherapy alone. Participants will be split into two groups: one will receive only chemotherapy, while the other will receive both botensilimab and chemotherapy. The study will be conducted in two parts. The first part will focus on determining the safe dose of botensilimab, and the second part will assess its effectiveness.

Description

This clinical trial will take place at multiple centers and will involve two parts. In the first part, researchers will determine the safe dose of botensilimab when combined with chemotherapy drugs nab-paclitaxel and gemcitabine. In the second part, participants will be randomly assigned to receive either the combination of botensilimab and chemotherapy or chemotherapy alone. The study will be open-label, meaning both the participants and researchers will know which treatment is being administered.

Eligibility Criteria

Inclusion Criteria

  • Confirmed diagnosis of pancreatic ductal adenocarcinoma.
  • Cancer has progressed after treatment with FOLFIRINOX for metastatic disease.
  • Good overall health with a performance status of 0 or 1.
  • Life expectancy of at least 3 months.
  • Cancer that can be measured on scans.
  • Mild or no existing nerve damage.
  • Acceptable blood clotting levels, unless on blood thinners approved by the doctor.
  • Proper organ function.
  • Women of childbearing age must have a negative pregnancy test before starting the study.
  • Men with female partners of childbearing age must use effective birth control during the study.

Exclusion Criteria

  • More than one previous treatment for metastatic cancer.
  • Cancer spread to the brain.
  • Another active cancer requiring treatment or a history of cancer within the last 2 years, except for certain skin cancers or non-invasive cancers.
  • Uncontrolled health issues, including significant heart disease.
  • Active infections needing IV treatment within 2 weeks before starting the study.
  • Major surgery within 4 weeks before joining the study.
  • Previous treatment with immune checkpoint inhibitors.
  • Fluid buildup in the abdomen that is hard to treat.
  • Recent or current bowel blockage.
  • Serious digestive disorders.
  • Recent treatment with certain drugs, including chemotherapy, antibodies, or investigational drugs.
  • Recent COVID-19 infection or vaccination.
  • Allergies to study drugs.
  • Lung diseases that could interfere with treatment.
  • History of organ transplant.
  • Mental health or substance abuse issues affecting study participation.
  • Recent use of high-dose steroids or immunosuppressive drugs.
  • Active or recent autoimmune diseases needing treatment.
  • Pregnant or breastfeeding.
  • Uncontrolled HIV infection.
  • Active hepatitis B or C infection.
  • Dependence on IV nutrition.
  • Severe diarrhea despite treatment.
  • Active or latent tuberculosis.
  • Any condition that might interfere with the study or its results.
  • Inability or unwillingness to follow study procedures.

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