Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab for Treatment of Advanced Solid Tumors
NCT05269381 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 132
Last updated 2026-03-12
Summary
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.
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
- 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 Hepatocellular Carcinoma AJCC v8
- Stage III Lung Cancer AJCC v8
- Stage III Renal Cell Cancer 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 Hepatocellular Carcinoma AJCC v8
- Stage IV Lung Cancer AJCC v8
- Stage IV Renal Cell Cancer 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
- Breast Adenocarcinoma
- Stage III Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8
- Stage IV Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8
- Stage III Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8
- Stage IV Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8
Interventions
- DRUG
-
Given IV
- BIOLOGICAL
-
Neoantigen Peptide Vaccine
Receive personalized neoantigen vaccine SC
- BIOLOGICAL
-
Given IV
- BIOLOGICAL
-
Sargramostim
Given SC
- PROCEDURE
-
Biospecimen Collection
Undergo blood sample collection
- PROCEDURE
-
Biopsy
Undergo tissue biopsy
- PROCEDURE
-
Computed Tomography
Undergo CT
- PROCEDURE
-
Magnetic Resonance Imaging
Undergo MRI
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Yanyan Lou, MD, PhD · Mayo Clinic
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 16 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-03-31
- Primary Completion
- 2028-03-31
- Completion
- 2028-03-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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