Trial · NCT05269381
Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab for Treatment of Advanced Solid Tumors
NCT05269381, Phase 1, Phase 2, Recruiting, Mayo Clinic
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab for Treatment of Advanced Solid Tumors. Trials, record NCT05269381. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05269381
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab for Treatment of Advanced Solid Tumors
- NCT number
- NCT05269381
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 138 participants, estimated
- Lead sponsor
- Mayo Clinic
- 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, Invasive Breast Lobular Carcinoma
- Interventions
- Cyclophosphamide, Neoantigen Peptide Vaccine, Pembrolizumab, Sargramostim, Biospecimen Collection, Biopsy, Computed Tomography, Magnetic Resonance Imaging
- First posted
- 2022-03-08
- Last updated
- 2026-08-20
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximally tolerated dose (MTD) (Phase I, Cohort 1, Cohort 2, and Pilot Cohort 5) | Up to 2 years | MTD is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients (at least 2 of a maximum of 6 new patients). A total of 6 patients treated at the MTD will be sufficient to identify common toxicities at the MTD. For instance, those toxicities with an incidence of at least 25% will be observed with a probability of at least 82% (1-(1-0.25). |
| Primary | Dose Limiting Toxicity (DLT) (Phase I, Cohort 1, Cohort 2, and Pilot Cohort 5) | Up to 2 years | DLT are defined to be adverse event (AE) occurring from day -3 through day 35 that is possibly, probably, or definitely related to neoantigen peptide vaccine with/without pembrolizumab and fulfills any of the following criteria using the National Cancer Institute's Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), version (v) 5.0 |
| Primary | Incidence of adverse events (Phase I, Cohort 1, Cohort 2, and Pilot Cohort 5) | Up to 2 years from first vaccine administration | The number and severity (grade) of all treatment related adverse events (AEs) will be tabulated and summarized. Non-hematologic AEs will be evaluated via the ordinal CTCAE v5.0 standard AE grading. Hematologic toxicity measures of thrombocytopenia, neutropenia, and leukopenia will be assessed using continuous variables as the outcome measures (primarily nadir) as well as categorization via CTCAE v5.0 standard AE grading. Both all grade and grade 3 and above AEs will be described and summarized in a similar fashion. Overall AE incidences as well as AE profiles by dose level and patient will be explored and summarized. Frequency distributions, graphical techniques and other descriptive measures will form the basis of these analyses. |
| Primary | Event free survival (EFS) (Phase II Cohort 3) | Up to 2 years | EFS is defined as the length of time after primary treatment for a cancer ends until occurrence of complications or events that the treatment was intended to prevent or delay. |
| Primary | Disease-free survival (DFS) (Phase II Cohort 4) | Up to 2 years | DFS is defined as the length of time after primary treatment for a cancer ends until any signs or symptoms of that cancer recur. |
| Secondary | Immunogenicity response rate (Phase I, Cohort 1, Cohort 2, and Pilot Cohort 5) | Within 24 weeks | Will be defined as number of patients who have ≥ 20% of neoantigens formulated into vaccine with at least 3-folds of value increase at any timepoint within 24 weeks, divided by total number of evaluable patients. Evaluable patients are defined as patients who are properly registered and received at least one dose of vaccine. |
| Secondary | Incidence of adverse events (Phase II) | Up to 2 years | Will be assessed using CTCAE v5.0. Defined as the proportion of patients experienced at least one grade 3, grade 4, or grade 5 of each type of AE during the protocol defined treatment. The binary endpoints will be estimated, in each cohort (or by dose level. Dose intensity and number of cycles will be summarized by mean, standard deviation, median, Q1, Q3, and range, in each cohort. The maximum grade for each type of adverse events that are possibly, probably, or definitely related to study treatments will be recorded for each patient. The frequency tables will be reviewed to determine the patterns. |
| Secondary | Immunogenicity response rate (Phase II) | Within 24 weeks | Will be defined as number of patients who have ≥ 20% of neoantigens formulated into vaccine with at least 3-folds of value increase at any timepoint within 24 weeks, divided by total number of evaluable patients. Evaluable patients are defined as patients who are properly registered and received at least one dose of vaccine. |
| Other | Objective response rate (Phase I and Pilot Cohort 5) | Within 12 weeks | Will be defined as number of patients who achieve complete response or partial response per Response Evaluation Criteria in Solid Tumors criteria version 1.1, confirmed based on at least two consecutive evaluations with 6 weeks apart or at the next re-staging computed tomography scan determined by treating physician, divided by total number of evaluable patients. |
| Other | Persistence Immunogenicity response rate (Phase I and Phase II) | Within 24 weeks from baseline | Will be defined as number of patients who have as at least 3-folds of value increase of any neoantigen from baseline at 12 months among neoantigens that had been detected with at least 3-folds of value increase within 24 weeks from baseline, divided by total number of evaluable patients. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA015083 | Mayo Clinic Comprehensive Cancer Center Support Grant | WILLMAN, CHERYL LYNN | MAYO CLINIC ROCHESTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05269381
GET https://conductscience.org/api/trials/v1/NCT05269381/registered