Combination Therapy for Patients with Localized Pancreatic Cancer

Sponsor: Gulam Manji

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06048484

Provider View

This clinical trial is exploring a new treatment approach that combines standard radiation therapy with drugs designed to boost the immune system and target cancer cells in patients with localized pancreatic cancer. The study aims to determine if this combination is safe and effective in enhancing the body's response to the tumor before surgery.

Patient Parameters

Program Overview

The study is testing a combination of standard radiation therapy with drugs that help the immune system fight cancer cells. It also includes drugs that block pathways the tumor uses to hide from the immune system. The goal is to see if these treatments, given before surgery, are safe and can improve the immune response against pancreatic cancer.

Description

This study aims to combine standard radiation therapy with drugs that stimulate the immune system to fight cancer cells. It also includes drugs that block pathways the tumor uses to evade the immune system. The main goal is to find out if the treatment with zimberelimab (an antibody targeting PD-1) and stereotactic body radiation therapy (SBRT), alone or with quemliclustat (blocks CD73) and etrumadenant (blocks A2a/b), is safe and can enhance the immune response against the tumor.

The study has two stages. In Stage 1, participants will receive 5 days of SBRT and take zimberelimab, quemliclustat, and etrumadenant for 7 weeks before surgery. If this is safe, the study moves to Stage 2. In Stage 2, participants will be randomly assigned to one of three groups: zimberelimab alone, zimberelimab with quemliclustat, or zimberelimab with quemliclustat and etrumadenant, all for 7 weeks before surgery.

Eligibility Criteria

Inclusion Criteria

  • Confirmed diagnosis of pancreatic ductal adenocarcinoma (PDAC) by a pathologist.
  • Completed 8 cycles of a specific chemotherapy regimen (mFOLFIRINOX), with some flexibility in the last cycles if needed.
  • Cancer that can be surgically removed and is suitable for the operation.
  • Eligible for stereotactic body radiation therapy (SBRT).
  • Measurable disease according to specific criteria.
  • No previous surgery, systemic therapy, or radiotherapy for PDAC, except for mFOLFIRINOX.
  • Good overall health with a performance status of 0 or 1.
  • Aged 18 years or older.
  • Adequate blood and organ function based on recent lab tests.

Exclusion Criteria

  • Previous treatment with certain immune therapies.
  • Currently receiving other experimental treatments.
  • Taking other cancer-fighting drugs (except hormonal therapy).
  • Uncontrolled fluid buildup around the lungs, heart, or abdomen.
  • Uncontrolled high calcium levels in the blood.
  • Active or past autoimmune diseases or immune deficiencies, with some exceptions.
  • History of certain lung diseases or active lung inflammation.
  • Positive HIV test.
  • Active hepatitis B or C infections.
  • Significant liver disease.
  • Active tuberculosis.
  • Difficulty swallowing or absorbing medications.
  • Pregnant or breastfeeding women.
  • Allergies to specific chemotherapy drugs.
  • History of Gilbert's disease or specific genetic conditions.
  • Inflammatory bowel disease or severe diarrhea.
  • Active or past celiac disease.
  • Psychiatric or substance abuse issues that could affect participation.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.