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BRIEF TITLE: Pharmacokinetic Multi-tumor Study of Subcutaneous Formulation of Ipilimumab Monotherapy and in Combination With Subcutaneous Nivolumab

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


  • Org Study ID: CA209-76U
  • Secondary ID:
  • NCT ID: NCT04311710
  • NCT Alias:
  • Sponsor: Bristol-Myers Squibb - Industry
  • Source: 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

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

Primary Outcomes:

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

Condition:

  • Tumor

Eligibility

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

Official Information

Name: Bristol-Myers Squibb

Role: Study Director

Affiliation: Bristol-Myers Squibb

Overall Contact

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

Locations

Facility Status Contact
Local Institution
San Francisco, California 94158
United States
Not yet recruiting Site 0001

Hartford Hospital
Hartford, Connecticut 06102
United States
Recruiting Omar Eton, Site 0020
860-972-5371
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana 46804
United States
Recruiting Sunil Babu, Site 0013
260-436-0800
Local Institution
Malvern, Victoria 3144
Australia
Not yet recruiting Site 0008

Local Institution
S?o Paulo, SAO Paulo 05653120
Brazil
Not yet recruiting Site 0022

Local Institution
Sao Paulo, 01246000
Brazil
Not yet recruiting Site 0021

Local Institution
Lyon, 69008
France
Not yet recruiting Site 0012

Local Institution
Marseille, 13385
France
Not yet recruiting Site 0014

Local Institution
Saint Herblain, 44805
France
Not yet recruiting Site 0011

Local Institution
Toulouse, 31059
France
Not yet recruiting Site 0019

Local Institution
Milano, 20133
Italy
Not yet recruiting Site 0003

Local Institution
Napoli, 80131
Italy
Not yet recruiting Site 0002

Humanitas-U.O di Oncologia medica ed Ematologia
Rozzano, 20089
Italy
Recruiting Matteo Simonelli, Site 0004
+39022244559
ospedale le scotte-U.O.C. Immunoterapia Oncologica
Siena, 53100
Italy
Recruiting Michele Maio, Site 0005
+390577586335 0000 000000
Local Institution
Maastricht, Limburg 6229 HX
Netherlands
Not yet recruiting Site 0023

Local Institution
Auckland, 1023
New Zealand
Recruiting Site 0010

Local Institution
Madrid, 28050
Spain
Not yet recruiting Site 0027

Local Institution
Pamplona, 31008
Spain
Not yet recruiting Site 0026

Local Institution
Liverpool, L7 8YA
United Kingdom
Not yet recruiting Site 0028