Study on Combination Treatment with Chemokine Inhibitor, Immunotherapy, and Chemotherapy for Pancreatic Cancer

Sponsor: Gulam Manji

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04543071

Provider View

This clinical trial is testing a new combination of treatments for pancreatic cancer, including standard chemotherapy, an immunotherapy drug, and a new medication that may enhance the effects of immunotherapy. The study aims to see if this combination can shrink tumors, extend patients' lives, and is safe to use.

Patient Parameters

Program Overview

The study is exploring a new treatment approach for pancreatic cancer using a combination of drugs: cemiplimab (an immunotherapy), motixafortide (a new drug that may boost immunotherapy), and standard chemotherapy drugs gemcitabine and nab-paclitaxel. The goal is to see if this combination can effectively reduce tumor size, improve survival rates, and ensure safety for patients. Cemiplimab is approved for skin cancer but not yet for pancreatic cancer, and motixafortide is being tested with this specific combination for the first time.

Description

Pancreatic adenocarcinoma is a challenging type of cancer with limited treatment progress. This Phase 2 study involves patients with newly diagnosed metastatic pancreatic cancer. The study will test the effectiveness of a new drug combination, including motixafortide, cemiplimab, and standard chemotherapy drugs gemcitabine and nab-paclitaxel. Participants will first receive motixafortide alone for five days, followed by a combination of motixafortide twice a week, cemiplimab every three weeks, and chemotherapy. The study aims to compare the response rates to historical data and assess the safety and effectiveness of this treatment.

Eligibility Criteria

Inclusion Criteria

  • Confirmed diagnosis of metastatic pancreatic adenocarcinoma.
  • Cancer must be confirmed by a pathologist before starting the study treatment.
  • Must not have endocrine or acinar pancreatic carcinoma.
  • Good overall health with an ECOG performance status of 0 or 1.
  • Aged 18 years or older.
  • Adequate blood and organ function based on specific test results.
  • Must have measurable disease and a tumor that can be biopsied.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception.
  • Men must agree to use effective birth control methods with partners.
  • Must provide written informed consent and be willing to follow study requirements.
  • Must have undergone testing for blood clots and be on stable anticoagulation if needed.

Exclusion Criteria

  • No prior systemic therapy, radiation, or surgery for pancreatic cancer.
  • No current use of other investigational drugs.
  • No unresolved side effects from previous cancer treatments, except for hair loss and mild nerve damage.
  • No uncontrolled fluid buildup around the lungs, heart, or abdomen.
  • No history of brain or central nervous system cancer spread.
  • No uncontrolled high calcium levels in the blood.
  • No recent major surgery or significant injury.
  • No active or history of autoimmune diseases, except for certain controlled conditions.
  • No lung diseases like pulmonary fibrosis or pneumonitis.
  • No active infections like HIV, hepatitis B, or hepatitis C.
  • No significant heart disease or recent heart events.
  • No history of other cancers within the past two years, except for certain low-risk cancers.
  • No recent live vaccinations.
  • No severe allergic reactions to study drugs.
  • No recent use of immunosuppressive medications, except for certain low-dose steroids.
  • Not pregnant or breastfeeding.
  • No other conditions that may interfere with the study or pose a high risk to the patient.

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