US company stis about to start a clinical trial for Patients With Metastatic Solid Cancer

Rampart Health, L.L.C is starting a new clinical trial of A Phase 2 Trial for Patients With Metastatic Solid Cancer.

This study seeks to estimate the potential efficacy of the study treatment, as well as the occurrence of adverse events.

Cryosurgical freezing (limited to 1.5 cm diameter single freeze within the cancer (up to two cancer sites selected and treated)) will release intact antigens to prime the immune system. The study treatment immunotherapeutic drugs (PD-1 inhibitor monoclonal antibody nivolumab or pembrolizumab and anti-CTLA-4 monoclonal antibody ipilimumab, and low-dose cyclophosphamide) will then be sequentially injected directly into each of the treated cancer sites immediately following cryosurgical freezing.

The clinical trial will start in January 2021 and will continue throughout December 2023.

Among the inclusion criteria are:

  • Have a performance status of 0-3 on the ECOG Performance Scale.
  • Have a life expectancy of 6 months or more as determined by treating physician.
  • Have exhausted all other standard therapies; Have failed available therapy or are not a candidate for, or refuse available therapy (i.e. concerned with high adverse events rate in available therapy or outcome worse than disease); or failure of prior chemotherapy.
  • Histologically-documented solid cancer. All subjects must submit their primary tumor or metastatic pathology specimens and laboratory and imaging reports to Rampart Health where they will be centrally reviewed. Central Rampart Health pathologic review is not required for screening but rather for confirmation of diagnosis and histologic subtype of cancer. Local pathologic review is sufficient for eligibility determination.

The full list can be viewed at the link below.

The contacts and locations are the Vincere Cancer Center, Scottsdale, Arizona, United States.

For more details: https://ichgcp.net/clinical-trials-registry/NCT04713371

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