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

Tumor Clinical Trial

— CheckMate 76U  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04311710
• Other study ID #: CA209-76U
• Status: Terminated
• Phase: Phase 1
• Start date: June 25, 2020
• Est. completion date: January 18, 2023

Study information

• Verified date: February 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: January 18, 2023
• Est. primary completion date: January 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Tumor

Intervention

Drug:
• ipilimumab
Specified Dose on Specified Days
• nivolumab
Specified Dose on Specified Days
• ENHANZE (rHuPH20)
Specified Dose on Specified Days
• nivolumab
Specified Dose on Specified Days

Locations

Country	Name	City	State
Italy	Istituto Nazionale Tumori IRCCS Fondazione Pascale-s.c. melanoma, immunoterapia oncologica e terapie	Napoli
Italy	Humanitas-U.O di Oncologia medica ed Ematologia	Rozzano
Italy	ospedale le scotte-U.O.C. Immunoterapia Oncologica	Siena
New Zealand	Local Institution - 0010	Auckland
United States	Local Institution - 0013	Fort Wayne	Indiana
United States	Local Institution - 0020	Hartford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Italy,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 1 Arm A: Average concentration of ipilimumab (Cavg21d)		Day 21
Primary	Part 1 Arm A: Area under the concentration in ipilimumab AUC(0-21d)		Day 21
Primary	Part 1 Arm A: Maximum observed serum concentration of ipilimumab (Cmax)		Up to 21 days
Primary	Part 1 Arm A: Observed concentration of ipilimumab at 21 days post dose (C21d)		Day 21
Primary	Part 1 Arm A: Time of maximum observed concentration in ipilimumab (Tmax)		Up to 21 days
Primary	Part 2 Arm A: Average concentration in ipilimumab (Cavg42d)		Day 42
Primary	Part 2 Arm A: Area under the concentration in ipilimumab AUC(0-42d)		Day 42
Primary	Part 2 Arm A: Maximum observed serum Concentration of Ipilimumab (Cmax)		Up to 42 days
Primary	Part 2 Arm A: Observed concentration in ipilimumab (C42d)		Day 42
Primary	Part 2 Arm A: Time of maximum observed concentration in ipilimumab (Tmax)		Up to 42 days
Primary	Part 2 Arm B: Average concentration of Ipilimumab at 21 days post dose (Cavg21d)		Day 21
Primary	Part 2 Arm B: Area Under the Concentration in Ipilimumab AUC(0-21d)		Day 21
Primary	Part 2 Arm B: Maximum observed serum Concentration in Ipilimumab (Cmax)		Up to 21 days
Primary	Part 2 Arm B: Observed concentration of ipilimumab at 21 days post dose (C21d)		Day 21
Primary	Part 2 Arm B: Time of maximum observed concentration in Ipilimumab (Tmax)		Up to 21 days
Secondary	Part 1 Arm B: Average concentration of ipilimumab without rHuPH20 (Cavg21d)		Day 21
Secondary	Part 1 Arm B: Area under the concentration in ipilimumab without rHuPH20 AUC(0-21d)		Day 21
Secondary	Part 1 Arm B: Maximum observed serum concentration of ipilimumab without rHuPH20 (Cmax)		Up to 21 days
Secondary	Part 1 Arm B: Observed concentration of ipilimumab without rHuPH20 at 21 days post dose (C21d)		Day 21
Secondary	Part 1 Arm B: Time of maximum observed concentration in ipilimumab without rHuPH20 (Tmax)		Up to 21 days
Secondary	Incidence of adverse events (AE's)		Up to 2.5 years
Secondary	Incidence of serious adverse events (SAEs)		Up to 5 years
Secondary	Incidence of AE's leading to discontinuation		Up to 2.5 years
Secondary	Incidence of death		Up to 2.5 years
Secondary	Incidence of laboratory abnormalities		Up to 2.5 years
Secondary	Instance of Anaphylactic occurring within 2 days of study drug administration		Up to 2.5 years
Secondary	Instance of hypersensitivity occurring within 2 days of study drug administration		Up to 2.5 years
Secondary	Incidence of hypersensitivity occurring within 2 days of study drug administration		Up to 2.5 years
Secondary	Incidence of infusion reactions occurring within 2 days of study drug administration		Up to 2.5 years
Secondary	Incidence of injection occurring within 2 days of study drug administration		Up to 2.5 years
Secondary	Percentage of participants who develop anti-ipilimumab antibodies		Up to 2.5 years
Secondary	Percentage of participants who develop anti-nivolumab antibodies		Up to 2.5 years
Secondary	Percentage of participants who have developed neutralizing antibodies		Up to 2.5 years

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls