Trial of Immunotherapy with Avelumab and Pepinemab as Second Line Treatment for Patients with Metastatic Pancreatic Cancer

Sponsor: Vaccinex Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05102721

Provider View

This clinical trial is testing a new combination of immunotherapy drugs, Avelumab and Pepinemab, for patients with metastatic pancreatic cancer that has worsened after initial chemotherapy. The study aims to determine if this treatment is safe and effective.

Patient Parameters

Program Overview

This study is exploring a new treatment for metastatic pancreatic cancer using two immunotherapy drugs, Avelumab and Pepinemab. The trial is divided into two phases. The first phase will focus on the safety and tolerability of the treatment, while the second phase will assess how well the treatment works in shrinking tumors. Pancreatic cancer is a challenging disease with limited treatment options, especially after the first line of chemotherapy fails. This study aims to find a more effective second-line treatment with fewer side effects than traditional chemotherapy.

Description

Pancreatic cancer is a serious disease with a high mortality rate, often because it is diagnosed at an advanced stage and tends to return even after surgery. Current treatments, like chemotherapy, have limited success, especially after the first round of treatment. This trial is testing a new approach using immunotherapy drugs Avelumab and Pepinemab, which may help the immune system better fight the cancer.

The trial is conducted in two parts. In the first part, researchers will determine the safest dose of the drug combination by testing it on a small group of patients. If the treatment shows promise, the study will expand to include more patients to see how well it works in reducing tumors.

The study will monitor patients for side effects and measure the treatment's effectiveness using specific criteria. If the treatment shows a significant response in shrinking tumors, it may offer a new option for patients with metastatic pancreatic cancer who have not responded to other treatments.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must have confirmed metastatic pancreatic cancer.
  • Must have measurable disease that can be tracked by scans.
  • Must have received and not responded to first-line chemotherapy treatments like 5FU or Gemcitabine.
  • Must have a life expectancy of at least 3 months.
  • Must have normal blood and organ function.
  • Must not be on blood thinners unless within normal limits.
  • Must be in good general health with a performance status of 0, 1, or 2.
  • Must agree to provide tissue samples for research.
  • Women must have a negative pregnancy test and agree to use contraception.
  • Men must agree to use contraception if their partner is of childbearing potential.

Exclusion Criteria

  • Have a different type of pancreatic cancer.
  • Have had another cancer within the last 3 years, except for certain skin or cervical cancers.
  • Have received certain investigational treatments.
  • Have allergies to similar drugs.
  • Have uncontrolled health issues like heart problems or infections.
  • Have an autoimmune disease requiring treatment.
  • Have had an organ transplant.
  • Have lung disease or a history of severe lung inflammation.
  • Have received a live vaccine recently.
  • Have active Hepatitis B or C.
  • Are pregnant or breastfeeding.
  • Have ongoing side effects from previous cancer treatments.
  • Have had major surgery or investigational drugs recently.
  • Have substance abuse issues.
  • Have had a prior organ or bone marrow transplant.
  • Cannot comply with study requirements.

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