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TumorPhase 1CheckMate 76UNCT04311710

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

A Phase 1 study testing ipilimumab, nivolumab and ENHANZE (rHuPH20) in people with Tumor, run by Bristol-Myers Squibb at 6 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Tumor
What is being tested?
ipilimumab, nivolumab and ENHANZE (rHuPH20)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
6 sitesin 3 countries
Study dates
25 Jun 2020to 18 Jan 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 11Show fewer
  • 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%

Who cannot join

  • 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.

Trial locations and contacts

6 sites in 3 countries.

6 sites in 3 countries

Italy3 sites

  • Istituto Nazionale Tumori IRCCS Fondazione Pascale-s.c. melanoma, immunoterapia oncologica e terapie

    Naples, 80131

  • Humanitas-U.O di Oncologia medica ed Ematologia

    Rozzano, 20089

  • ospedale le scotte-U.O.C. Immunoterapia Oncologica

    Siena, 53100

Other trials in Italy

United States2 sites

  • Local Institution - 0013

    Fort Wayne, Indiana, 46804

  • Local Institution - 0020

    Hartford, Connecticut, 06106

Other trials in United States

New Zealand1 site

  • Local Institution - 0010

    Auckland, 1023

Other trials in New Zealand

About this study

Official title: 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

Conditions
Tumor
Being tested
ipilimumab, nivolumab, ENHANZE (rHuPH20)
Keywords
lung cancer, renal cancer, bladder cancer, skin cancer, liver cancer
Medical subject headings
Neoplasms, Lung Neoplasms, Kidney Neoplasms, Urinary Bladder Neoplasms, Skin Neoplasms, Liver Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ipilimumabDrug

    Also called (BMS-734016)

    Specified Dose on Specified Days

  • nivolumabDrug

    Also called (BMS-936558)

    Specified Dose on Specified Days

  • ENHANZE (rHuPH20)Drug

    Specified Dose on Specified Days

  • nivolumabDrug

    Also called (BMS-986298)

    Specified Dose on Specified Days

Study groups in NCT04311710
Study groupRoleWhat they receive
Part 1 Arm A: mM, mUC, HCCExperimentalmetastatic Melanoma (mM), metastatic Urothelial Carcinoma (mUC), and advanced Heptocellular Carcinoma (HCC)
Receives: Drug: ipilimumab; Drug: nivolumab; Drug: ENHANZE (rHuPH20)
Part 1: Arm B: mMExperimentalmetastatic Melanoma (mM)
Receives: Drug: ipilimumab; Drug: nivolumab
Part 2: Arm A: NSCLCExperimentalmetastatic non small cell lung cancer (NSCLC)
Receives: Drug: ipilimumab; Drug: ENHANZE (rHuPH20); Drug: nivolumab
Part 2: Arm B: RCCExperimentaladvanced or metastatic renal cell carcinoma (RCC)
Receives: Drug: ipilimumab; Drug: ENHANZE (rHuPH20); Drug: nivolumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1 Arm A: Average concentration of ipilimumab (Cavg21d)

    Measured: Day 21

  2. Part 1 Arm A: Area under the concentration in ipilimumab AUC(0-21d)

    Measured: Day 21

  3. Part 1 Arm A: Maximum observed serum concentration of ipilimumab (Cmax)

    Measured: Up to 21 days

  4. Part 1 Arm A: Observed concentration of ipilimumab at 21 days post dose (C21d)

    Measured: Day 21

  5. Part 1 Arm A: Time of maximum observed concentration in ipilimumab (Tmax)

    Measured: Up to 21 days

  6. Part 2 Arm A: Average concentration in ipilimumab (Cavg42d)

    Measured: Day 42

  7. Part 2 Arm A: Area under the concentration in ipilimumab AUC(0-42d)

    Measured: Day 42

  8. Part 2 Arm A: Maximum observed serum Concentration of Ipilimumab (Cmax)

    Measured: Up to 42 days

  9. Part 2 Arm A: Observed concentration in ipilimumab (C42d)

    Measured: Day 42

  10. Part 2 Arm A: Time of maximum observed concentration in ipilimumab (Tmax)

    Measured: Up to 42 days

  11. Part 2 Arm B: Average concentration of Ipilimumab at 21 days post dose (Cavg21d)

    Measured: Day 21

  12. Part 2 Arm B: Area Under the Concentration in Ipilimumab AUC(0-21d)

    Measured: Day 21

  13. Part 2 Arm B: Maximum observed serum Concentration in Ipilimumab (Cmax)

    Measured: Up to 21 days

  14. Part 2 Arm B: Observed concentration of ipilimumab at 21 days post dose (C21d)

    Measured: Day 21

  15. Part 2 Arm B: Time of maximum observed concentration in Ipilimumab (Tmax)

    Measured: Up to 21 days

Secondary outcomes (18)

  1. Part 1 Arm B: Average concentration of ipilimumab without rHuPH20 (Cavg21d)

    Measured: Day 21

  2. Part 1 Arm B: Area under the concentration in ipilimumab without rHuPH20 AUC(0-21d)

    Measured: Day 21

  3. Part 1 Arm B: Maximum observed serum concentration of ipilimumab without rHuPH20 (Cmax)

    Measured: Up to 21 days

  4. Part 1 Arm B: Observed concentration of ipilimumab without rHuPH20 at 21 days post dose (C21d)

    Measured: Day 21

  5. Part 1 Arm B: Time of maximum observed concentration in ipilimumab without rHuPH20 (Tmax)

    Measured: Up to 21 days

  6. Incidence of adverse events (AE's)

    Measured: Up to 2.5 years

  7. Incidence of serious adverse events (SAEs)

    Measured: Up to 5 years

  8. Incidence of AE's leading to discontinuation

    Measured: Up to 2.5 years

  9. Incidence of death

    Measured: Up to 2.5 years

  10. Incidence of laboratory abnormalities

    Measured: Up to 2.5 years

  11. Instance of Anaphylactic occurring within 2 days of study drug administration

    Measured: Up to 2.5 years

  12. Instance of hypersensitivity occurring within 2 days of study drug administration

    Measured: Up to 2.5 years

  13. Incidence of hypersensitivity occurring within 2 days of study drug administration

    Measured: Up to 2.5 years

  14. Incidence of infusion reactions occurring within 2 days of study drug administration

    Measured: Up to 2.5 years

  15. Incidence of injection occurring within 2 days of study drug administration

    Measured: Up to 2.5 years

  16. Percentage of participants who develop anti-ipilimumab antibodies

    Measured: Up to 2.5 years

  17. Percentage of participants who develop anti-nivolumab antibodies

    Measured: Up to 2.5 years

  18. Percentage of participants who have developed neutralizing antibodies

    Measured: Up to 2.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2020
  2. Study start25 Jun 2020
  3. Primary completion14 Jan 2021
  4. Study completion18 Jan 2023

Why it stopped: Business objectives have changed

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04311710
Sponsor's protocol ID
CA209-76U
Acronym
CheckMate 76U
Status last verified
Feb 2023
First submitted
16 Mar 2020
Last updated
24 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ipilimumab, nivolumab and ENHANZE (rHuPH20) in people with Tumor, run by Bristol-Myers Squibb at 6 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Italy, United States, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Business objectives have changed). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1 Arm A: Average concentration of ipilimumab (Cavg21d) (time frame: Day 21). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04311710.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2023.

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