Brief Title: A Study Evaluating the Drug Levels of Iplimumab Given Under the Skin Alone and in Combination With Nivolumab in Multiple Tumor Types

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Part 1 Arm A: Average concentration of ipilimumab (Cavg21d)

Primary Outcome 1 - Timeframe: Day 21

Primary Outcome 2 - Measure: Part 1 Arm A: Area under the concentration in ipilimumab AUC(0-21d)

Primary Outcome 2 - Timeframe: Day 21

Primary Outcome 3 - Measure: Part 1 Arm A: Maximum observed serum concentration of ipilimumab (Cmax)

Primary Outcome 3 - Timeframe: 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 - Timeframe: Day 21

Primary Outcome 5 - Measure: Part 1 Arm A: Time of maximum observed concentration in ipilimumab (Tmax)

Primary Outcome 5 - Timeframe: Up to 21 days

Primary Outcome 6 - Measure: Part 2 Arm A: Average concentration in ipilimumab (Cavg42d)

Primary Outcome 6 - Timeframe: Day 42

Primary Outcome 7 - Measure: Part 2 Arm A: Area under the concentration in ipilimumab AUC(0-42d)

Primary Outcome 7 - Timeframe: Day 42

Primary Outcome 8 - Measure: Part 2 Arm A: Maximum observed serum Concentration of Ipilimumab (Cmax)

Primary Outcome 8 - Timeframe: Up to 42 days

Primary Outcome 9 - Measure: Part 2 Arm A: Observed concentration in ipilimumab (C42d)

Primary Outcome 9 - Timeframe: Day 42

Primary Outcome 10 - Measure: Part 2 Arm A: Time of maximum observed concentration in ipilimumab (Tmax)

Primary Outcome 10 - Timeframe: 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 - Timeframe: Day 21

Primary Outcome 12 - Measure: Part 2 Arm B: Area Under the Concentration in Ipilimumab AUC(0-21d)

Primary Outcome 12 - Timeframe: Day 21

Primary Outcome 13 - Measure: Part 2 Arm B: Maximum observed serum Concentration in Ipilimumab (Cmax)

Primary Outcome 13 - Timeframe: 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 - Timeframe: Day 21

Primary Outcome 15 - Measure: Part 2 Arm B: Time of maximum observed concentration in Ipilimumab (Tmax)

Primary Outcome 15 - Timeframe: Up to 21 days

CONDITION

• Tumor

ELIGIBILITY

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Bristol-Myers Squibb

Role: Study Director

Affiliation: Bristol-Myers Squibb

Overall Contact

Name: N/A

Phone: N/A

Email: N/A

LOCATION