Clinical Trials Logo

Clinical Trial Summary

This phase I trial studies the safety of personalized neo-antigen peptide vaccine in treating patients with stage IIIC-IV melanoma or hormone receptor positive Her2 negative breast cancer that has spread to other places in the body (metastatic) or does not respond to treatment (refractory). Personalized neo-antigen peptide vaccine is a product combines multiple patient specific neo-antigens. Given personalized neo-antigen peptide vaccine together with Th1 polarizing adjuvant poly ICLC may induce a polyclonal, poly-epitope, cytolytic T cell immunity against the patient's tumor.


Clinical Trial Description

OUTLINE: Patients receive poly ICLC intramuscularly (IM) once weekly in weeks when no vaccine is given. Beginning 2 weeks after starting poly ICLC, patients receive personalized neo-antigen peptide vaccine IM once every 4 weeks and nivolumab every 2 or 4 weeks. Treatment continuous for 25 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive nivolumab every 2 or 4 weeks for up to 12 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 24, 36, and 48 weeks. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05098210
Study type Interventional
Source Fred Hutchinson Cancer Center
Contact FHCC Intake
Phone 206-606-1024
Email hutchdoc@fredhutch.org
Status Recruiting
Phase Phase 1
Start date June 9, 2022
Completion date November 1, 2025

See also
  Status Clinical Trial Phase
Suspended NCT05673200 - Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer Phase 1
Active, not recruiting NCT03218826 - PI3Kbeta Inhibitor AZD8186 and Docetaxel in Treating Patients Advanced Solid Tumors With PTEN or PIK3CB Mutations That Are Metastatic or Cannot Be Removed by Surgery Phase 1
Recruiting NCT04521764 - A Vaccine (MV-s-NAP) for the Treatment of Patients With Invasive Metastatic Breast Cancer Phase 1
Recruiting NCT03723928 - S1703 Serum Tumor Marker Directed Disease Monitoring in Patients With Hormone Receptor Positive Her2 Negative Metastatic Breast Cancer N/A
Suspended NCT03737695 - Clinical Information and Biospecimen Collection From Patients With Recurrent or Stage IV Breast Cancer
Active, not recruiting NCT04316117 - Using FDG-PET/CT to Assess Response of Bone-Dominant Metastatic Breast Cancer, FEATURE Study Phase 2
Not yet recruiting NCT04529044 - 177Lu-DOTATATE for the Treatment of Stage IV or Recurrent Breast Cancer Phase 2
Recruiting NCT04862585 - Safely Stopping Pre-medications in Patients With Breast Cancer Who Are Receiving Paclitaxel Phase 2/Phase 3
Completed NCT00338728 - Letrozole and Imatinib Mesylate in Treating Postmenopausal Participants With Estrogen or Progesterone Positive Metastatic Breast Cancer Phase 2
Withdrawn NCT05967286 - Olaparib and Alpelisib for Treatment of Metastatic Breast Cancer, A ComboMATCH Treatment Trial Phase 2
Recruiting NCT04673448 - Niraparib and TSR-042 for the Treatment of BRCA-Mutated Unresectable or Metastatic Breast, Pancreas, Ovary, Fallopian Tube, or Primary Peritoneal Cancer Phase 1
Active, not recruiting NCT05081492 - CF33-hNIS-antiPDL1 for the Treatment of Metastatic Triple Negative Breast Cancer Phase 1
Recruiting NCT05318469 - Ivermectin and Balstilimab for the Treatment of Metastatic Triple Negative Breast Cancer Phase 1/Phase 2
Not yet recruiting NCT05539365 - Dendritic Cell-Based Treatment Plus Immunotherapy for the Treatment of Metastatic or Unresectable Triple Negative Breast Cancer Phase 2
Terminated NCT05198843 - Testing an Omega-3 Fatty Acid-Based Anti-Cancer Therapy for Patients With Triple-Negative Inflammatory Breast Cancer That Has Spread to Other Parts of the Body Phase 1/Phase 2
Active, not recruiting NCT04514484 - Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and HIV Phase 1
Recruiting NCT05751668 - Finding an Effective Dose of GM1 to Reduce or Prevent Neuropathy (Numbness or Weakness) Due to Treatment With Paclitaxel (Phase II) Phase 2
Suspended NCT04906369 - Optimizing Treatment of Stage IV Breast Cancer Through Real-Time Disease Monitoring
Completed NCT03291938 - IACS-010759 in Advanced Cancers Phase 1
Recruiting NCT04314401 - National Cancer Institute "Cancer Moonshot Biobank"