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| ID | Type | Description | Link |
|---|---|---|---|
| IRB00465956 | Other Identifier | Johns Hopkins Medicine Internal Review Board |
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| Name | Class |
|---|---|
| Agenus Inc. | INDUSTRY |
| Lustgarten Foundation | OTHER |
| Oncovir, Inc. | INDUSTRY |
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The purpose of this study is to determine the optimal dose of AGEN2373 that is safe when given in combination with balstilimab and Pancreatic GVAX Whole Cell Vaccine and evaluate the safety and clinical activity of balstilimab and AGEN2373 in combination with GVAX (Arm 1) or mKRASvax (Arm 2) in surgically resectable pancreatic adenocarcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 - AGEN2373/Balstilimab/Cyclophosphamide/GVAX | Experimental |
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| Arm 2 - AGEN2373/Balstilimab/mKRASvax (1.8mg total peptides +0.5mg each poly-ICLC) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AGEN2373 | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Dose Limiting Toxicities in Phase I participants | Phase I participants will be evaluated for dose limiting toxicities (DLTs) during the first 14 day cycle and 14 days post-operatively for the purpose of determining the recommended phase II dose of AGEN2373 when given concurrently with balstilimab and cancer vaccination. | 1 month |
| Number of participants experiencing Grade 3 or Higher 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 |
| Number of participants who form Intratumoral tertiary lymphoid structures (TLS) | Number of participants who form at least one tertiary lymphoid structure (TLS) following one cycle of study drugs. The presence of at least 50 CD20+ B cells and 50 CD3+ T cells in a ≥50 µM area of surgical tissue is considered "positive" for TLS. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic overall response rate (pORR) | Number of participants who have a pathologic response to the first dose of study drug as determined using surgically resected tissue and the College of American Pathologists (CAP) scoring system. A pathologic response is defined as CAP grade of 0-2. Possible CAP grades include grade 0: Complete Response/ No viable residual tumor; grade 1: Marked Response/ minimal residual cancer with single cells or small groups of cancer cells; grade 2: Moderate Response/ residual cancer outgrown by fibrosis; and grade 3: Poor or No response/ extensive residual cancer. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Colleen Apostol, RN | Contact | 410-614-3644 | GIClinicalTrials@jhmi.edu |
| Name | Affiliation | Role |
|---|---|---|
| Eric Christenson, MD | SKCCC • Johns Hopkins Medical Institution | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Sidney Kimmel Comprehensive Cancer Center | Recruiting | Baltimore | Maryland | 21287 | United States |
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| Balstilimab | Drug |
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| Cyclophosphamide | Drug |
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| GVAX | Drug |
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| AGEN2373 (RP2D) | Drug |
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| Balstilimab | Drug |
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| mKRASvax | Drug |
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| evaluated at time of surgery, approximately 2 weeks from first dose of study drug |
| CD3+CD8+CD137+ T cell density in Tumor Tissue | Number of CD3+CD8+CD137+ T cells found in resected surgical tissue by Immunohistochemistry (IHC). | evaluated at time of surgery, approximately 2 weeks from first dose of study drug |
| Change in peripheral interferon-gamma (IFNγ) producing mutant KRAS-specific T cells | Percent change in the number of IFNγ producing T cells at Cycle 2 Day 14 when compared with baseline. Number of IFNγ T cells will be assessed by ELISPOT. | 13 weeks |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C000720935 | balstilimab |
| D003520 | Cyclophosphamide |
| C019531 | poly ICLC |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
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