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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
| Vanderbilt-Ingram Cancer Center | OTHER |
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This three-arm randomized phase 2 trial will enroll advanced clear cell RCC patients (all IMDC risk groups). Patients will be randomized 2:2:1 to either Arm A (fianlimab/ cemiplimab/ ipilimumab), Arm B (fianlimab/ cemiplimab), or Arm C (standard ipilimumab/ nivolumab), respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Cemiplimab, Fianlimab, and Ipilimumab | Experimental | Cemiplimab and fianlimab will be co-administered by IV. Ipilimumab will be administered by IV. |
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| Arm B: Cemiplimab and Fianlimab | Experimental | Cemiplimab and fianlimab will be co-administered by IV. |
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| Arm C: Nivolumab and Ipilimumab | Active Comparator | Nivolumab and ipilimumab will be by IV. Nivolumab will be administered by IV after the combination. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fianlimab | Drug | Fianlimab will be co-administered by IV. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | ORR is defined as confirmed complete response (CR) + confirmed partial response (PR) and will be determined as per RECIST 1.1. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Median Progression Free Survival (PFS) | PFS is defined as the time from Day 1 of treatment to the first documented disease progression per RECIST 1.1, clinically progressive disease per investigator, or death due to any cause, whichever occurs first. | 5 years |
| 12-month Progression Free Survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brian Rini, MD | Contact | 615-936-8422 | brian.rini@vumc.org | |
| Allison Lipps | Contact | 317-634-5842 | 40 | alipps@hoosiercancer.org |
| Name | Affiliation | Role |
|---|---|---|
| Brian Rini, MD | Vanderbilt-Ingram Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt-Ingram Cancer Center | Recruiting | Nashville | Tennessee | 37232 | United States |
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| Ipilimumab | Drug | Ipilimumab will be administered by IV. |
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| Nivolumab | Drug | Nivolumab will be administered by IV. Maintenance nivolumab will then be administered by IV. |
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| Cemiplimab | Drug | Cemiplimab will co-administered by IV. |
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PFS is defined as the time from Day 1 of treatment to the first documented disease progression per RECIST 1.1, clinically progressive disease per investigator, or death due to any cause, whichever occurs first. |
| 12 months |
| 24-month Progression Free Survival (PFS) | PFS is defined as the time from Day 1 of treatment to the first documented disease progression per RECIST 1.1, clinically progressive disease per investigator, or death due to any cause, whichever occurs first. | 24 months |
| Duration of Response (DOR) | DOR is defined as the time from first documented evidence of CR or PR per RECIST 1.1 until disease progression based on RECIST 1.1 or death due to any cause, whichever occurs first. | 5 years |
| Treatment Free Survival (TFS) | TFS will be assessed based on the area between two time to event KM curves from the time of study treatment initiation to study treatment discontinuation and from study initiation to initiation of subsequent systemic anti-cancer treatment or death. Time on or off treatment with Grade 3 or greater treatment related toxicities per CTCAE v5 will be determined as the area between study initiation and toxicity start and study initiation and Grade 3 toxicity ending. | 5 years |
| Adverse Event Rates | The frequency of subjects experiencing treatment related adverse events and SAEs graded per NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) v5. | 5 years |
| Froedtert and The Medical College of Wisconsin | Recruiting | Milwaukee | Wisconsin | 53226 | United States |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000074324 | Ipilimumab |
| D000077594 | Nivolumab |
| C000627974 | cemiplimab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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