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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04311710
Ethics application status
Date submitted
16/03/2020
Date registered
17/03/2020
Date last updated
27/10/2020

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
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
Gender
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/Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Local Institution - Malvern
Recruitment postcode(s) [1] 0 0
3144 - Malvern
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
Brazil
State/province [4] 0 0
SAO Paulo
Country [5] 0 0
Brazil
State/province [5] 0 0
Sao Paulo
Country [6] 0 0
France
State/province [6] 0 0
Lyon
Country [7] 0 0
France
State/province [7] 0 0
Marseille
Country [8] 0 0
France
State/province [8] 0 0
Saint Herblain
Country [9] 0 0
France
State/province [9] 0 0
Toulouse
Country [10] 0 0
Italy
State/province [10] 0 0
Milano
Country [11] 0 0
Italy
State/province [11] 0 0
Napoli
Country [12] 0 0
Italy
State/province [12] 0 0
Rozzano
Country [13] 0 0
Italy
State/province [13] 0 0
Siena
Country [14] 0 0
Netherlands
State/province [14] 0 0
Limburg
Country [15] 0 0
New Zealand
State/province [15] 0 0
Auckland
Country [16] 0 0
Spain
State/province [16] 0 0
Madrid
Country [17] 0 0
Spain
State/province [17] 0 0
Pamplona
Country [18] 0 0
United Kingdom
State/province [18] 0 0
Liverpool

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/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
Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
Address 0 0
Country 0 0
Phone 0 0
please email:
Fax 0 0
Email 0 0
Clinical.Trials@bms.com
Contact person for scientific queries

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