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

A Phase 1/2 Pharmacokinetic Multi-tumor Study of Subcutaneous Formulation of Ipilimumab Monotherapy and in Combination With Subcutaneous Nivolumab

INTRODUCTION

  • Org Study ID: CA209-76U
  • Secondary ID: N/A
  • NTC ID: NCT04311710
  • Sponsor: Bristol-Myers Squibb

BRIEF SUMMARY


A study evaluating the drug levels of ipilimumab alone and in combination with nivolumab
applied under the skin in various tumor types


  • Overall Status
    Recruiting
  • Start Date
    June 22, 2020
  • Phase
    Phase 1/Phase 2
  • Study Type
    Interventional

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: N/A

Maximum Age: 18 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Bristol-Myers Squibb

Role: Study Director

Affiliation: Bristol-Myers Squibb

Overall Contact

Name: Bristol-Myers Squibb

Phone: please email:

Email: Clinical.Trials@bms.com

LOCATION

Facility Status Contact
Facility: Hartford Hospital
Hartford, Connecticut 06102
United States 		Status: Recruiting Contact:
Omar Eton, Site 0020
860-972-5371
Facility: Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana 46804
United States 		Status: Recruiting Contact:
Sunil Babu, Site 0013
260-436-0800
Facility: Humanitas-U.O di Oncologia medica ed Ematologia
Rozzano, 20089
Italy 		Status: Recruiting Contact:
Matteo Simonelli, Site 0004
+39022244559
Facility: ospedale le scotte-U.O.C. Immunoterapia Oncologica
Siena, 53100
Italy 		Status: Recruiting Contact:
Michele Maio, Site 0005
+390577586335 0000 000000
Facility: Local Institution
Auckland, 1023
New Zealand 		Status: Recruiting Contact:
Site 0010

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