Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab for Treatment of Advanced Solid Tumors

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Mayo Clinic
Study ID
NCT05269381
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Anatomic Stage III Breast Cancer AJCC v8
  • Anatomic Stage IIIA Breast Cancer AJCC v8
  • Anatomic Stage IIIB Breast Cancer AJCC v8
  • Anatomic Stage IIIC Breast Cancer AJCC v8
  • Anatomic Stage IV Breast Cancer AJCC v8
  • Breast Adenocarcinoma
  • Clinical Stage III Cutaneous Melanoma AJCC v8
  • Clinical Stage III Gastric Cancer AJCC v8
  • Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Clinical Stage III Merkel Cell Carcinoma AJCC v8
  • Clinical Stage IV Cutaneous Melanoma AJCC v8
  • Clinical Stage IV Gastric Cancer AJCC v8
  • Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Clinical Stage IV Merkel Cell Carcinoma AJCC v8
  • Clinical Stage IVA Gastric Cancer AJCC v8
  • Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Clinical Stage IVB Gastric Cancer AJCC v8
  • Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Locally Advanced Cervical Carcinoma
  • Locally Advanced Endometrial Carcinoma
  • Locally Advanced Gastric Adenocarcinoma
  • Locally Advanced Gastroesophageal Junction Adenocarcinoma
  • Locally Advanced Head and Neck Squamous Cell Carcinoma
  • Locally Advanced Hepatocellular Carcinoma
  • Locally Advanced Lung Non-Small Cell Carcinoma
  • Locally Advanced Malignant Solid Neoplasm
  • Locally Advanced Melanoma
  • Locally Advanced Merkel Cell Carcinoma
  • Locally Advanced Renal Cell Carcinoma
  • Locally Advanced Skin Squamous Cell Carcinoma
  • Locally Advanced Triple-Negative Breast Carcinoma
  • Locally Advanced Unresectable Breast Carcinoma
  • Locally Advanced Unresectable Cervical Carcinoma
  • Locally Advanced Unresectable Gastric Adenocarcinoma
  • Locally Advanced Unresectable Gastroesophageal Junction Adenocarcinoma
  • Locally Advanced Unresectable Renal Cell Carcinoma
  • Locally Advanced Urothelial Carcinoma
  • Metastatic Cervical Carcinoma
  • Metastatic Endometrial Carcinoma
  • Metastatic Gastric Adenocarcinoma
  • Metastatic Gastroesophageal Junction Adenocarcinoma
  • Metastatic Head and Neck Squamous Cell Carcinoma
  • Metastatic Hepatocellular Carcinoma
  • Metastatic Lung Non-Small Cell Carcinoma
  • Metastatic Malignant Solid Neoplasm
  • Metastatic Melanoma
  • Metastatic Merkel Cell Carcinoma
  • Metastatic Renal Cell Carcinoma
  • Metastatic Skin Squamous Cell Carcinoma
  • Metastatic Triple-Negative Breast Carcinoma
  • Metastatic Urothelial Carcinoma
  • Skin Squamous Cell Carcinoma
  • Stage III Cervical Cancer AJCC v8
  • Stage III Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8
  • Stage III Hepatocellular Carcinoma AJCC v8
  • Stage III Lung Cancer AJCC v8
  • Stage III Renal Cell Cancer AJCC v8
  • Stage III Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8
  • Stage IIIA Cervical Cancer AJCC v8
  • Stage IIIA Hepatocellular Carcinoma AJCC v8
  • Stage IIIA Lung Cancer AJCC v8
  • Stage IIIA Uterine Corpus Cancer AJCC v8
  • Stage IIIB Cervical Cancer AJCC v8
  • Stage IIIB Hepatocellular Carcinoma AJCC v8
  • Stage IIIB Lung Cancer AJCC v8
  • Stage IIIB Uterine Corpus Cancer AJCC v8
  • Stage IIIC Lung Cancer AJCC v8
  • Stage IIIC Uterine Corpus Cancer AJCC v8
  • Stage IIIC1 Uterine Corpus Cancer AJCC v8
  • Stage IIIC2 Uterine Corpus Cancer AJCC v8
  • Stage IV Cervical Cancer AJCC v8
  • Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8
  • Stage IV Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8
  • Stage IV Hepatocellular Carcinoma AJCC v8
  • Stage IV Lung Cancer AJCC v8
  • Stage IV Renal Cell Cancer AJCC v8
  • Stage IV Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8
  • Stage IVA Cervical Cancer AJCC v8
  • Stage IVA Hepatocellular Carcinoma AJCC v8
  • Stage IVA Lung Cancer AJCC v8
  • Stage IVA Uterine Corpus Cancer AJCC v8
  • Stage IVB Cervical Cancer AJCC v8
  • Stage IVB Hepatocellular Carcinoma AJCC v8
  • Stage IVB Lung Cancer AJCC v8
  • Stage IVB Uterine Corpus Cancer AJCC v8
  • Triple-Negative Breast Carcinoma
  • Unresectable Cervical Carcinoma
  • Unresectable Endometrial Carcinoma
  • Unresectable Gastric Adenocarcinoma
  • Unresectable Gastroesophageal Junction Adenocarcinoma
  • Unresectable Head and Neck Squamous Cell Carcinoma
  • Unresectable Hepatocellular Carcinoma
  • Unresectable Lung Non-Small Cell Carcinoma
  • Unresectable Malignant Solid Neoplasm
  • Unresectable Melanoma
  • Unresectable Merkel Cell Carcinoma
  • Unresectable Renal Cell Carcinoma
  • Unresectable Skin Squamous Cell Carcinoma
  • Unresectable Triple-Negative Breast Carcinoma
  • Unresectable Urothelial Carcinoma

Eligibility Criteria

Sex
ALL
Age
16 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cyclophosphamide — DRUG
    Given IV
  • Neoantigen Peptide Vaccine — BIOLOGICAL
    Receive personalized neoantigen vaccine SC
  • Pembrolizumab — BIOLOGICAL
    Given IV
  • Sargramostim — BIOLOGICAL
    Given SC
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Biopsy — PROCEDURE
    Undergo tissue biopsy
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI

Study Details

This phase I/II trial tests the safety and tolerability of an experimental personalized vaccine when given by itself and with pembrolizumab in treating patients with solid tumor cancers that have spread to other places in the body (advanced). The experimental vaccine is designed target certain proteins (neoantigens) on individuals' tumor cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving the personalized neoantigen peptide-based vaccine with pembrolizumab may be safe and effective in treating patients with advanced solid tumors.

Key Dates

Start date
Mar 31, 2022
Status verified
Mar 2026
Primary completion
Mar 31, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
132 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1(cyclophosphamide, vaccine) ** NO LONGER ENROLLING **
    NO LONGER ENROLLING Patients receive cyclophosphamide IV on day -3. Patients then receive personalized neoantigen vaccine with GM-CSF SC on days 1, 4, 8, and 15 of cycle 1 and on day 1 of cycle 2 in the absence of disease progression or unacceptable toxicity. Patients may undergo tumor biopsy throughout the study. Additionally, patients undergo blood sample collection as well as CT or MRI throughout the study.
  • Experimental: Cohort 2 (cyclophophamide, vaccine, pembrolizumab) ** NO LONGER ENROLLING **
    NO LONGER ENROLLING Patients receive cyclophosphamide IV on day -3. Patients then receive personalized neoantigen vaccine with GM-CSF SC on days 1, 4, 8, and 15 of cycle 1 and then on day 1 of cycles 2, 5, and 8. Patients also receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients may undergo tumor biopsy throughout the study. Additionally, patients undergo blood sample collection as well as CT or MRI throughout the study.
  • Experimental: Cohort 3 (cyclophosphamide, vaccine, pembrolizumab)
    Patients with TNBC receive cyclophosphamide IV on day -3. Patients then receive personalized neoantigen vaccine with GM-CSF SC on days 1, 4, 8, and 15 of cycle 1 and then on day 1 of cycles 2, 5, and 8. Patients also receive pembrolizumab IV over 30 minutes on day 1 of each cycle or as clinically indicated. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients may undergo tumor biopsy throughout the study. Additionally, patients undergo blood sample collection as well as CT or MRI throughout the study.
  • Experimental: Cohort 4 (cyclophosphamide, vaccine, pembrolizumab)
    Patients with NSCLC receive cyclophosphamide IV on day -3. Patients then receive personalized neoantigen vaccine with GM-CSF SC on days 1, 4, 8, and 15 of cycle 1 and then on day 1 of cycles 2, 5, and 8. Patients also receive pembrolizumab IV over 30 minutes on day 1 of each cycle or as clinically indicated. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients may undergo tumor biopsy throughout the study. Additionally, patients undergo blood sample collection as well as CT or MRI throughout the study.

Primary Outcome Measure

Incidence of adverse events (Phase I) [ Time Frame: Up to 2 years from first vaccine administration ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in FloridaJacksonvilleFlorida32224-9980
Clinical Trial Referral Office
[email protected]
855-776-0015
Yanyan Lou, MD, PhD (PRINCIPAL_INVESTIGATOR)

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