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A study evaluating the drug levels of ipilimumab alone and in combination with nivolumab applied under the skin in various tumor types
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 Arm A: mM, mUC, HCC | Experimental | metastatic Melanoma (mM), metastatic Urothelial Carcinoma (mUC), and advanced Heptocellular Carcinoma (HCC) |
|
| Part 1: Arm B: mM | Experimental | metastatic Melanoma (mM) |
|
| Part 2: Arm A: NSCLC | Experimental | metastatic non small cell lung cancer (NSCLC) |
|
| Part 2: Arm B: RCC | Experimental | advanced or metastatic renal cell carcinoma (RCC) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ipilimumab | Drug | Specified Dose on Specified Days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1 Arm A: Average concentration of ipilimumab (Cavg21d) | Day 21 | |
| Part 1 Arm A: Area under the concentration in ipilimumab AUC(0-21d) | Day 21 | |
| Part 1 Arm A: Maximum observed serum concentration of ipilimumab (Cmax) | Up to 21 days | |
| Part 1 Arm A: Observed concentration of ipilimumab at 21 days post dose (C21d) | Day 21 | |
| Part 1 Arm A: Time of maximum observed concentration in ipilimumab (Tmax) | Up to 21 days | |
| Part 2 Arm A: Average concentration in ipilimumab (Cavg42d) | Day 42 | |
| Part 2 Arm A: Area under the concentration in ipilimumab AUC(0-42d) | Day 42 | |
| Part 2 Arm A: Maximum observed serum Concentration of Ipilimumab (Cmax) | Up to 42 days | |
| Part 2 Arm A: Observed concentration in ipilimumab (C42d) | Day 42 | |
| Part 2 Arm A: Time of maximum observed concentration in ipilimumab (Tmax) | Up to 42 days | |
| Part 2 Arm B: Average concentration of Ipilimumab at 21 days post dose (Cavg21d) |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1 Arm B: Average concentration of ipilimumab without rHuPH20 (Cavg21d) | Day 21 | |
| Part 1 Arm B: Area under the concentration in ipilimumab without rHuPH20 AUC(0-21d) | Day 21 | |
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria:
Part 1 Arms A and B: Metastatic Melanoma
- Previously untreated, histologically confirmed stage IV melanoma, as per American Joint Committee on Cancer (AJCC) staging system v.8.0
Part 1 Arm A:Advanced/mUC - Participants with histologically or cytologically confirmed urothelial carcinoma.
Part 1 Arm A: Advanced HCC
Part 2 Arm A: Metastatic NSCLC
- Participants with histologically confirmed stage IV or recurrent Non Small Cell Lung Cancer (NSCLC)
Part 2 Arm B: Advanced or Metastatic RCC
Exclusion Criteria:
- History of allergy or hypersensitivity to study drug components
Part 1 Arm A: Advanced HCC
Part 2 Arm A:Metastatic NSCLC
- Participants with known ALK translocations and EGFR mutation that are sensitive to available targeted inhibitor therapy
Other inclusion/exclusion criteria apply.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0020 | Hartford | Connecticut | 06106 | United States | ||
| Local Institution - 0013 |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
| FDA Safety Alerts and Recalls |
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|
| nivolumab | Drug | Specified Dose on Specified Days |
|
|
| ENHANZE (rHuPH20) | Drug | Specified Dose on Specified Days |
|
| nivolumab | Drug | Specified Dose on Specified Days |
|
|
| Day 21 |
| Part 2 Arm B: Area Under the Concentration in Ipilimumab AUC(0-21d) | Day 21 |
| Part 2 Arm B: Maximum observed serum Concentration in Ipilimumab (Cmax) | Up to 21 days |
| Part 2 Arm B: Observed concentration of ipilimumab at 21 days post dose (C21d) | Day 21 |
| Part 2 Arm B: Time of maximum observed concentration in Ipilimumab (Tmax) | Up to 21 days |
| Part 1 Arm B: Maximum observed serum concentration of ipilimumab without rHuPH20 (Cmax) |
| Up to 21 days |
| Part 1 Arm B: Observed concentration of ipilimumab without rHuPH20 at 21 days post dose (C21d) | Day 21 |
| Part 1 Arm B: Time of maximum observed concentration in ipilimumab without rHuPH20 (Tmax) | Up to 21 days |
| Incidence of adverse events (AE's) | Up to 2.5 years |
| Incidence of serious adverse events (SAEs) | Up to 5 years |
| Incidence of AE's leading to discontinuation | Up to 2.5 years |
| Incidence of death | Up to 2.5 years |
| Incidence of laboratory abnormalities | Up to 2.5 years |
| Instance of Anaphylactic occurring within 2 days of study drug administration | Up to 2.5 years |
| Instance of hypersensitivity occurring within 2 days of study drug administration | Up to 2.5 years |
| Incidence of hypersensitivity occurring within 2 days of study drug administration | Up to 2.5 years |
| Incidence of infusion reactions occurring within 2 days of study drug administration | Up to 2.5 years |
| Incidence of injection occurring within 2 days of study drug administration | Up to 2.5 years |
| Percentage of participants who develop anti-ipilimumab antibodies | Up to 2.5 years |
| Percentage of participants who develop anti-nivolumab antibodies | Up to 2.5 years |
| Percentage of participants who have developed neutralizing antibodies | Up to 2.5 years |
| Fort Wayne |
| Indiana |
| 46804 |
| United States |
| Istituto Nazionale Tumori IRCCS Fondazione Pascale-s.c. melanoma, immunoterapia oncologica e terapie | Naples | 80131 | Italy |
| Humanitas-U.O di Oncologia medica ed Ematologia | Rozzano | 20089 | Italy |
| ospedale le scotte-U.O.C. Immunoterapia Oncologica | Siena | 53100 | Italy |
| Local Institution - 0010 | Auckland | 1023 | New Zealand |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D008175 | Lung Neoplasms |
| D007680 | Kidney Neoplasms |
| D001749 | Urinary Bladder Neoplasms |
| D012878 | Skin Neoplasms |
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| D000074324 | Ipilimumab |
| D000077594 | Nivolumab |
| 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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