A study evaluating the drug levels of ipilimumab alone and in combination with nivolumab applied under the skin in various tumor types
| Overal Status | Start Date | Phase | Study Type |
|---|---|---|---|
| Recruiting | June 22, 2020 | Phase 1/Phase 2 | Interventional |
Primary Outcome 1 - Measure: Part 1 Arm A: Average concentration of ipilimumab (Cavg21d)
Primary Outcome 1 - Time Frame: Day 21
Primary Outcome 2 - Measure: Part 1 Arm A: Area under the concentration in ipilimumab AUC(0-21d)
Primary Outcome 2 - Time Frame: Day 21
Primary Outcome 3 - Measure: Part 1 Arm A: Maximum observed serum concentration of ipilimumab (Cmax)
Primary Outcome 3 - Time Frame: Up to 21 days
Primary Outcome 4 - Measure: Part 1 Arm A: Observed concentration of ipilimumab at 21 days post dose (C21d)
Primary Outcome 4 - Time Frame: Day 21
Primary Outcome 5 - Measure: Part 1 Arm A: Time of maximum observed concentration in ipilimumab (Tmax)
Primary Outcome 5 - Time Frame: Up to 21 days
Primary Outcome 6 - Measure: Part 2 Arm A: Average concentration in ipilimumab (Cavg42d)
Primary Outcome 6 - Time Frame: Day 42
Primary Outcome 7 - Measure: Part 2 Arm A: Area under the concentration in ipilimumab AUC(0-42d)
Primary Outcome 7 - Time Frame: Day 42
Primary Outcome 8 - Measure: Part 2 Arm A: Maximum observed serum Concentration of Ipilimumab (Cmax)
Primary Outcome 8 - Time Frame: Up to 42 days
Primary Outcome 9 - Measure: Part 2 Arm A: Observed concentration in ipilimumab (C42d)
Primary Outcome 9 - Time Frame: Day 42
Primary Outcome 10 - Measure: Part 2 Arm A: Time of maximum observed concentration in ipilimumab (Tmax)
Primary Outcome 10 - Time Frame: Up to 42 days
Primary Outcome 11 - Measure: Part 2 Arm B: Average concentration of Ipilimumab at 21 days post dose (Cavg21d)
Primary Outcome 11 - Time Frame: Day 21
Primary Outcome 12 - Measure: Part 2 Arm B: Area Under the Concentration in Ipilimumab AUC(0-21d)
Primary Outcome 12 - Time Frame: Day 21
Primary Outcome 13 - Measure: Part 2 Arm B: Maximum observed serum Concentration in Ipilimumab (Cmax)
Primary Outcome 13 - Time Frame: Up to 21 days
Primary Outcome 14 - Measure: Part 2 Arm B: Observed concentration of ipilimumab at 21 days post dose (C21d)
Primary Outcome 14 - Time Frame: Day 21
Primary Outcome 15 - Measure: Part 2 Arm B: Time of maximum observed concentration in Ipilimumab (Tmax)
Primary Outcome 15 - Time Frame: Up to 21 days
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/exclusion criteria apply.
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Gender: All
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
Name: Bristol-Myers Squibb
Role: Study Director
Affiliation: Bristol-Myers Squibb
Name: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
Phone: please email:
Email: Clinical.Trials@bms.com
Link: BMS Clinical Trial Information
