Phase 2 Study for Patients with Metastatic Solid Cancer

Sponsor: Rampart Health, L.L.C.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04713371

Provider View

This clinical trial is exploring a new treatment approach for patients with metastatic solid cancer, focusing on its effectiveness and potential side effects.

Patient Parameters

Program Overview

The study is testing a new treatment method that involves freezing a small part of the cancer to help the immune system recognize and attack it. After freezing, special drugs are injected directly into the cancer to boost the immune response. These drugs include PD-1 inhibitors like nivolumab or pembrolizumab, and an anti-CTLA-4 antibody called ipilimumab, along with low-dose cyclophosphamide. The goal is to stimulate the body's immune system to fight the cancer more effectively, potentially leading to a significant anti-cancer response with fewer side effects than traditional treatments.

Description

This trial involves a new treatment method called AbscopalRx5001, which combines cryosurgery and immunotherapy to treat metastatic solid cancer. Cryosurgery involves freezing a small part of the cancer to release antigens that help the immune system recognize the cancer. After freezing, drugs are injected directly into the cancer to enhance the immune response. These drugs include PD-1 inhibitors (nivolumab or pembrolizumab), an anti-CTLA-4 antibody (ipilimumab), and low-dose cyclophosphamide. The treatment aims to activate the immune system to attack cancer cells locally and throughout the body, potentially leading to a systemic anti-cancer response. The study also uses GM-CSF injections to prolong the immune response. This approach is expected to have fewer side effects than traditional systemic therapies.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older and able to provide written consent.
  • Have a performance status score of 0-3, indicating varying levels of activity.
  • Have a life expectancy of at least 6 months.
  • Have tried all standard treatments without success or are not candidates for them.
  • Have a confirmed diagnosis of solid cancer with measurable disease.
  • Must have at least one cancer site that is 1 cm or larger.
  • Agree to use effective contraception during the study and for 120 days after the last treatment.
  • Must have acceptable initial lab values, including blood counts and organ function.
  • Women of childbearing potential must test negative for pregnancy before treatment.
  • No major medical or psychological issues that could complicate participation.

Exclusion Criteria

  • Currently participating in another study or have recently used investigational treatments.
  • Have only bone metastasis as the site of disease.
  • Have a diagnosis of immunodeficiency or are on immunosuppressive therapy.
  • Have a performance status score of 4-5, indicating severe disability.
  • Have a history of active tuberculosis.
  • Have allergies to the study drugs or their components.
  • Have had recent chemotherapy or radiation therapy without recovery from side effects.
  • Have significant heart disease or recent heart events.
  • Have another progressing cancer that requires treatment.
  • Have high-risk metastatic lesions for procedure-related complications.
  • Have active autoimmune diseases requiring treatment in the past 2 years.
  • Have a history of non-infectious lung inflammation.
  • Have active infections requiring treatment.
  • Have conditions that could interfere with the study or its results.
  • Have psychiatric or substance abuse issues affecting participation.
  • Are pregnant or planning to have children during the study.
  • Have a history of HIV or active hepatitis B or C.
  • Have received a live vaccine recently.
  • Unable to understand or consent to the study requirements.
  • Have allergies to cyclophosphamide or GM-CSF.

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