MedTrace Logo

A Phase 2 Trial for Patients With Metastatic Solid Cancer

NCT04713371 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-05-09

No results posted yet for this study

Summary

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

Conditions

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.

Sponsors & Collaborators

  • Rampart Health, L.L.C.

    lead INDUSTRY

Principal Investigators

  • David G Bostwick, M.D., M.B.A. · Rampart Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-19
Primary Completion
2024-12-31
Completion
2024-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04713371 on ClinicalTrials.gov