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ACTIVE NOT RECRUITING
NCT04713371
PHASE2

A Phase 2 Trial for Patients With Metastatic Solid Cancer

Sponsor: Rampart Health, L.L.C.

View on ClinicalTrials.gov

Summary

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

Official title: A Phase 2 Trial of Cryosurgical Freezing and Multiplex Immunochemotherapy in Patients With Metastatic Solid Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2021-05-19

Completion Date

2024-12

Last Updated

2024-05-09

Healthy Volunteers

No

Interventions

DRUG

Keytruda Injectable Product

Keytruda (pembrolizumab): PD-1 inhibitor antibody Injectable 50mg/mL, only 2 mL injected.

DRUG

Yervoy Injectable Product

Yervoy (ipilimumab): Anti-CTLA-4 antibody Injectable 5mg/mL, only 2 mL injected.

DRUG

Cytoxan

Injectable 250mg/m2, only 1 mL injected. Oral low dose cyclophosphamide: 50mg once daily pill for 5 days prior to first treatment, 3 days prior to 2nd and 3rd treatment.

PROCEDURE

Cryosurgical freezing (cryosurgery)

Cryosurgery, also known as cryoablation, for metastatic cancer works by freezing the cancer cells inside the tumor. Cryoablation will release intact antigens to prime the immune system.

DRUG

GM-CSF Injectable

Daily injection administered subcutaneously. 250 mcg daily injections for a total of 25 days post after each treatment.

Locations (1)

Ascension Providence Rochester Hospital

Rochester, Michigan, United States