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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04311710




Registration number
NCT04311710
Ethics application status
Date submitted
16/03/2020
Date registered
17/03/2020
Date last updated
24/02/2023

Titles & IDs
Public title
A Study Evaluating the Drug Levels of Iplimumab Given Under the Skin Alone and in Combination With Nivolumab in Multiple Tumor Types
Scientific title
A Phase 1/2 Pharmacokinetic Multi-tumor Study of Subcutaneous Formulation of Ipilimumab Monotherapy and in Combination With Subcutaneous Nivolumab
Secondary ID [1] 0 0
CA209-76U
Universal Trial Number (UTN)
Trial acronym
CheckMate 76U
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tumor 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - ipilimumab
Treatment: Drugs - nivolumab
Treatment: Drugs - ENHANZE (rHuPH20)
Treatment: Drugs - nivolumab

Experimental: Part 1 Arm A: mM, mUC, HCC - metastatic Melanoma (mM), metastatic Urothelial Carcinoma (mUC), and advanced Heptocellular Carcinoma (HCC)

Experimental: Part 1: Arm B: mM - metastatic Melanoma (mM)

Experimental: Part 2: Arm A: NSCLC - metastatic non small cell lung cancer (NSCLC)

Experimental: Part 2: Arm B: RCC - advanced or metastatic renal cell carcinoma (RCC)


Treatment: Drugs: ipilimumab
Specified Dose on Specified Days

Treatment: Drugs: nivolumab
Specified Dose on Specified Days

Treatment: Drugs: ENHANZE (rHuPH20)
Specified Dose on Specified Days

Treatment: Drugs: nivolumab
Specified Dose on Specified Days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part 1 Arm A: Average concentration of ipilimumab (Cavg21d)
Timepoint [1] 0 0
Day 21
Primary outcome [2] 0 0
Part 1 Arm A: Area under the concentration in ipilimumab AUC(0-21d)
Timepoint [2] 0 0
Day 21
Primary outcome [3] 0 0
Part 1 Arm A: Maximum observed serum concentration of ipilimumab (Cmax)
Timepoint [3] 0 0
Up to 21 days
Primary outcome [4] 0 0
Part 1 Arm A: Observed concentration of ipilimumab at 21 days post dose (C21d)
Timepoint [4] 0 0
Day 21
Primary outcome [5] 0 0
Part 1 Arm A: Time of maximum observed concentration in ipilimumab (Tmax)
Timepoint [5] 0 0
Up to 21 days
Primary outcome [6] 0 0
Part 2 Arm A: Average concentration in ipilimumab (Cavg42d)
Timepoint [6] 0 0
Day 42
Primary outcome [7] 0 0
Part 2 Arm A: Area under the concentration in ipilimumab AUC(0-42d)
Timepoint [7] 0 0
Day 42
Primary outcome [8] 0 0
Part 2 Arm A: Maximum observed serum Concentration of Ipilimumab (Cmax)
Timepoint [8] 0 0
Up to 42 days
Primary outcome [9] 0 0
Part 2 Arm A: Observed concentration in ipilimumab (C42d)
Timepoint [9] 0 0
Day 42
Primary outcome [10] 0 0
Part 2 Arm A: Time of maximum observed concentration in ipilimumab (Tmax)
Timepoint [10] 0 0
Up to 42 days
Primary outcome [11] 0 0
Part 2 Arm B: Average concentration of Ipilimumab at 21 days post dose (Cavg21d)
Timepoint [11] 0 0
Day 21
Primary outcome [12] 0 0
Part 2 Arm B: Area Under the Concentration in Ipilimumab AUC(0-21d)
Timepoint [12] 0 0
Day 21
Primary outcome [13] 0 0
Part 2 Arm B: Maximum observed serum Concentration in Ipilimumab (Cmax)
Timepoint [13] 0 0
Up to 21 days
Primary outcome [14] 0 0
Part 2 Arm B: Observed concentration of ipilimumab at 21 days post dose (C21d)
Timepoint [14] 0 0
Day 21
Primary outcome [15] 0 0
Part 2 Arm B: Time of maximum observed concentration in Ipilimumab (Tmax)
Timepoint [15] 0 0
Up to 21 days
Secondary outcome [1] 0 0
Part 1 Arm B: Average concentration of ipilimumab without rHuPH20 (Cavg21d)
Timepoint [1] 0 0
Day 21
Secondary outcome [2] 0 0
Part 1 Arm B: Area under the concentration in ipilimumab without rHuPH20 AUC(0-21d)
Timepoint [2] 0 0
Day 21
Secondary outcome [3] 0 0
Part 1 Arm B: Maximum observed serum concentration of ipilimumab without rHuPH20 (Cmax)
Timepoint [3] 0 0
Up to 21 days
Secondary outcome [4] 0 0
Part 1 Arm B: Observed concentration of ipilimumab without rHuPH20 at 21 days post dose (C21d)
Timepoint [4] 0 0
Day 21
Secondary outcome [5] 0 0
Part 1 Arm B: Time of maximum observed concentration in ipilimumab without rHuPH20 (Tmax)
Timepoint [5] 0 0
Up to 21 days
Secondary outcome [6] 0 0
Incidence of adverse events (AE's)
Timepoint [6] 0 0
Up to 2.5 years
Secondary outcome [7] 0 0
Incidence of serious adverse events (SAEs)
Timepoint [7] 0 0
Up to 5 years
Secondary outcome [8] 0 0
Incidence of AE's leading to discontinuation
Timepoint [8] 0 0
Up to 2.5 years
Secondary outcome [9] 0 0
Incidence of death
Timepoint [9] 0 0
Up to 2.5 years
Secondary outcome [10] 0 0
Incidence of laboratory abnormalities
Timepoint [10] 0 0
Up to 2.5 years
Secondary outcome [11] 0 0
Instance of Anaphylactic occurring within 2 days of study drug administration
Timepoint [11] 0 0
Up to 2.5 years
Secondary outcome [12] 0 0
Instance of hypersensitivity occurring within 2 days of study drug administration
Timepoint [12] 0 0
Up to 2.5 years
Secondary outcome [13] 0 0
Incidence of hypersensitivity occurring within 2 days of study drug administration
Timepoint [13] 0 0
Up to 2.5 years
Secondary outcome [14] 0 0
Incidence of infusion reactions occurring within 2 days of study drug administration
Timepoint [14] 0 0
Up to 2.5 years
Secondary outcome [15] 0 0
Incidence of injection occurring within 2 days of study drug administration
Timepoint [15] 0 0
Up to 2.5 years
Secondary outcome [16] 0 0
Percentage of participants who develop anti-ipilimumab antibodies
Timepoint [16] 0 0
Up to 2.5 years
Secondary outcome [17] 0 0
Percentage of participants who develop anti-nivolumab antibodies
Timepoint [17] 0 0
Up to 2.5 years
Secondary outcome [18] 0 0
Percentage of participants who have developed neutralizing antibodies
Timepoint [18] 0 0
Up to 2.5 years

Eligibility
Key inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com.



- 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%
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/06/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/01/2023
Sample size
Target
Accrual to date
Final
21
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Connecticut
Country [2] 0 0
United States of America
State/province [2] 0 0
Indiana
Country [3] 0 0
Italy
State/province [3] 0 0
Napoli
Country [4] 0 0
Italy
State/province [4] 0 0
Rozzano
Country [5] 0 0
Italy
State/province [5] 0 0
Siena
Country [6] 0 0
New Zealand
State/province [6] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
A study evaluating the drug levels of ipilimumab alone and in combination with nivolumab
applied under the skin in various tumor types
Trial website
https://clinicaltrials.gov/ct2/show/NCT04311710
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04311710