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| ID | Type | Description | Link |
|---|---|---|---|
| IRB00270405 | Other Identifier | Johns Hopkins Medicine Internal Review Board | |
| 5P50CA062924 | U.S. NIH Grant/Contract | View source |
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Study never started
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| Name | Class |
|---|---|
| Incyte Corporation | INDUSTRY |
| National Cancer Institute (NCI) | NIH |
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Phase 1 study evaluating feasibility, safety, and immune response to a personalized neoantigen vaccine combined with retifanlimab for MMR-p mCRC and mPDAC patients with measurable disease following first-line FOLFIRINOX/FOLFOXIRI (FFX).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoantigen Vaccine with Poly-ICLC adjuvant and Retifanlimab | Experimental | All participants receive this intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neoantigen Vaccine with Poly-ICLC adjuvant | Drug | Neoantigen Vaccine with Poly-ICLC adjuvant will be administered on days 1, 8, 15 and 22. 2 to 5 subcutaneous injections will be administered in the upper thighs, arms and/or back. Drug: 0.3 mg per peptide vaccine + 0.5mg Poly-ICLC |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients who receive at least one dose of personalized neoantigen vaccine | Percentage of patients that receive at least one dose of personalized neoantigen vaccine in the maintenance setting among the total number of patients who achieved disease response (eligible for vaccine generation). | 9 months |
| Number of participants experiencing study drug-related toxicities | Number of participants experiencing study drug-related adverse events Grade 3 or higher as defined by CTCAE v5.0. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) per RECIST 1.1 | ORR is defined as the number of patients who are administered at least 1 dose of personalized neoantigen vaccine achieving a complete response (CR) or partial response (PR) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) at any time during the study. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nilofer Azad, MD | SKCCC at the Johns Hopkins Medical Institution | Principal Investigator |
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| Retifanlimab | Drug | 500 mg will be administered as a 30 minute IV. Infusion (-5 min/+15min) on Day 1 of each 28 day cycle every 4 weeks. |
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| 2 years |
| Objective Response Rate (ORR) per iRECIST | ORR is defined as the number of patients who are administered at least 1 dose of personalized neoantigen vaccine achieving a complete response (iCR) or partial response (iPR) based on the Response Evaluation Criteria in Solid Tumors (Immune-related RECIST (iRECIST) at any time during the study. iCR = disappearance of all target lesions, iPR is =>30% decrease in sum of diameters of target lesions, progressive disease (iPD) is >20% increase in sum of diameters of target lesions, stable disease (iSD) is <30% decrease or <20% increase in sum of diameters of target lesions. | 2 years |
| Disease Control Rate (DCR) | DCR is defined as the number of patients achieving a complete response (CR) or partial response (PR) and stable disease (SD) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) at 2 months post first vaccination. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. | 2 months |
| Disease Control Rate (DCR) | DCR is defined as the number of patients achieving a complete response (CR) or partial response (PR) and stable disease (SD) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) at 6 months post first vaccination. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. | 6 months |
| Disease Control Rate (DCR) | DCR is defined as the number of patients achieving a complete response (CR) or partial response (PR) and stable disease (SD) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) at 12 months post first vaccination. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. | 12 months |
| Progression-free Survival (PFS) per RECIST 1.1 | PFS is defined as the number of months from the date of first personalized vaccine dose to disease progression (progressive disease [PD] or relapse from complete response [CR] as assessed using RECIST 1.1 criteria) or death due to any cause. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is >20% increase in sum of diameters of target lesions, Stable Disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. | 4 years |
| Progression-free Survival (PFS) per iRECIST | PFS is defined as the number of months from the date of first personalized vaccine dose to disease progression (progressive disease [iPD] or relapse from complete response [iCR] as assessed using RECIST 1.1 criteria) or death due to any cause. Per iRECIST (iPFS) criteria, iCR = disappearance of all target lesions, Partial Response (iPR) is =>30% decrease in sum of diameters of target lesions, Progressive Disease (iPD) is >20% increase in sum of diameters of target lesions, Stable Disease (iSD) is <30% decrease or <20% increase in sum of diameters of target lesions. | 4 years |
| Overall Survival (OS) | OS will be measured as the number of months from date of first personalized vaccine dose until death or end of follow-up (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). Estimation based on the Kaplan-Meier curve. | 4 years |
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C019531 | poly ICLC |
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