Tumor
Conditions
Keywords
lung cancer, renal cancer, bladder cancer, skin cancer, liver cancer
Brief summary
A study evaluating the drug levels of ipilimumab alone and in combination with nivolumab applied under the skin in various tumor types
Interventions
DRUGipilimumab
Specified Dose on Specified Days
DRUGnivolumab
Specified Dose on Specified Days
DRUGENHANZE (rHuPH20)
Specified Dose on Specified Days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: * Men and women must follow methods of contraception as described in the protocol 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 * Participants with histological confirmation of Hepatocellular Cancer (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 * Histological confirmation of Renal Cell Carcinoma (RCC) * ECOG Performance Status of 0 or 1 and for RCC (Part 2 Arm B), Karnofsky performance status ≥ 70%
Exclusion criteria
\- History of allergy or hypersensitivity to study drug components Part 1 Arm A: Advanced HCC * History of hepatic encephalopathy or evidence of portal hypertension * Active coinfection with hepatitis D virus infection in participants with HBV Part 2 Arm A:Metastatic NSCLC \- Participants with known ALK translocations and EGFR mutation that are sensitive to available targeted inhibitor therapy Other inclusion/
Design outcomes
Primary
| Measure | 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) | 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 |
Secondary
| Measure | 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 |
| 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 |
Countries
Italy, New Zealand, United States
Outcome results
None listed