Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Stopped early
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT04311710