A Study Evaluating the Drug Levels of Iplimumab Given Under the Skin Alone and in Combination With Nivolumab in Multiple Tumor Types (CheckMate 76U)

February 23, 2023 updated by: Bristol-Myers Squibb

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
No longer available

No longer available

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Napoli, Italy, 80131
        • Istituto Nazionale Tumori IRCCS Fondazione Pascale-s.c. melanoma, immunoterapia oncologica e terapie
      • Rozzano, Italy, 20089
        • Humanitas-U.O di Oncologia medica ed Ematologia
      • Siena, Italy, 53100
        • ospedale le scotte-U.O.C. Immunoterapia Oncologica
  • New Zealand
      • Auckland, New Zealand, 1023
        • Local Institution - 0010
  • United States
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Local Institution - 0020
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Local Institution - 0013

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part 1 Arm A: mM, mUC, HCC
metastatic Melanoma (mM), metastatic Urothelial Carcinoma (mUC), and advanced Heptocellular Carcinoma (HCC)
Drug: ipilimumab
Specified Dose on Specified Days
Other Names:
  • (BMS-734016)
Drug: nivolumab
Specified Dose on Specified Days
Other Names:
  • (BMS-986298)
Drug: ENHANZE (rHuPH20)
Specified Dose on Specified Days
Experimental: Part 1: Arm B: mM
metastatic Melanoma (mM)
Drug: ipilimumab
Specified Dose on Specified Days
Other Names:
  • (BMS-734016)
Drug: nivolumab
Specified Dose on Specified Days
Other Names:
  • (BMS-986298)
Experimental: Part 2: Arm A: NSCLC
metastatic non small cell lung cancer (NSCLC)
Drug: ipilimumab
Specified Dose on Specified Days
Other Names:
  • (BMS-734016)
Drug: nivolumab
Specified Dose on Specified Days
Other Names:
  • (BMS-986298)
Drug: ENHANZE (rHuPH20)
Specified Dose on Specified Days
Experimental: Part 2: Arm B: RCC
advanced or metastatic renal cell carcinoma (RCC)
Drug: ipilimumab
Specified Dose on Specified Days
Other Names:
  • (BMS-734016)
Drug: nivolumab
Specified Dose on Specified Days
Other Names:
  • (BMS-986298)
Drug: ENHANZE (rHuPH20)
Specified Dose on Specified Days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Part 1 Arm A: Average concentration of ipilimumab (Cavg21d)
Time Frame: Day 21
Day 21
Part 1 Arm A: Area under the concentration in ipilimumab AUC(0-21d)
Time Frame: Day 21
Day 21
Part 1 Arm A: Maximum observed serum concentration of ipilimumab (Cmax)
Time Frame: Up to 21 days
Up to 21 days
Part 1 Arm A: Observed concentration of ipilimumab at 21 days post dose (C21d)
Time Frame: Day 21
Day 21
Part 1 Arm A: Time of maximum observed concentration in ipilimumab (Tmax)
Time Frame: Up to 21 days
Up to 21 days
Part 2 Arm A: Average concentration in ipilimumab (Cavg42d)
Time Frame: Day 42
Day 42
Part 2 Arm A: Area under the concentration in ipilimumab AUC(0-42d)
Time Frame: Day 42
Day 42
Part 2 Arm A: Maximum observed serum Concentration of Ipilimumab (Cmax)
Time Frame: Up to 42 days
Up to 42 days
Part 2 Arm A: Observed concentration in ipilimumab (C42d)
Time Frame: Day 42
Day 42
Part 2 Arm A: Time of maximum observed concentration in ipilimumab (Tmax)
Time Frame: Up to 42 days
Up to 42 days
Part 2 Arm B: Average concentration of Ipilimumab at 21 days post dose (Cavg21d)
Time Frame: Day 21
Day 21
Part 2 Arm B: Area Under the Concentration in Ipilimumab AUC(0-21d)
Time Frame: Day 21
Day 21
Part 2 Arm B: Maximum observed serum Concentration in Ipilimumab (Cmax)
Time Frame: Up to 21 days
Up to 21 days
Part 2 Arm B: Observed concentration of ipilimumab at 21 days post dose (C21d)
Time Frame: Day 21
Day 21
Part 2 Arm B: Time of maximum observed concentration in Ipilimumab (Tmax)
Time Frame: Up to 21 days
Up to 21 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Part 1 Arm B: Average concentration of ipilimumab without rHuPH20 (Cavg21d)
Time Frame: Day 21
Day 21
Part 1 Arm B: Area under the concentration in ipilimumab without rHuPH20 AUC(0-21d)
Time Frame: Day 21
Day 21
Part 1 Arm B: Maximum observed serum concentration of ipilimumab without rHuPH20 (Cmax)
Time Frame: Up to 21 days
Up to 21 days
Part 1 Arm B: Observed concentration of ipilimumab without rHuPH20 at 21 days post dose (C21d)
Time Frame: Day 21
Day 21
Part 1 Arm B: Time of maximum observed concentration in ipilimumab without rHuPH20 (Tmax)
Time Frame: Up to 21 days
Up to 21 days
Incidence of adverse events (AE's)
Time Frame: Up to 2.5 years
Up to 2.5 years
Incidence of serious adverse events (SAEs)
Time Frame: Up to 5 years
Up to 5 years
Incidence of AE's leading to discontinuation
Time Frame: Up to 2.5 years
Up to 2.5 years
Incidence of death
Time Frame: Up to 2.5 years
Up to 2.5 years
Incidence of laboratory abnormalities
Time Frame: Up to 2.5 years
Up to 2.5 years
Instance of Anaphylactic occurring within 2 days of study drug administration
Time Frame: Up to 2.5 years
Up to 2.5 years
Instance of hypersensitivity occurring within 2 days of study drug administration
Time Frame: Up to 2.5 years
Up to 2.5 years
Incidence of hypersensitivity occurring within 2 days of study drug administration
Time Frame: Up to 2.5 years
Up to 2.5 years
Incidence of infusion reactions occurring within 2 days of study drug administration
Time Frame: Up to 2.5 years
Up to 2.5 years
Incidence of injection occurring within 2 days of study drug administration
Time Frame: Up to 2.5 years
Up to 2.5 years
Percentage of participants who develop anti-ipilimumab antibodies
Time Frame: Up to 2.5 years
Up to 2.5 years
Percentage of participants who develop anti-nivolumab antibodies
Time Frame: Up to 2.5 years
Up to 2.5 years
Percentage of participants who have developed neutralizing antibodies
Time Frame: Up to 2.5 years
Up to 2.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 25, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 14, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 18, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 16, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 17, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 24, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CA209-76U

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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