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Metastatic MelanomaPhase 1/2CINDINCT04060407

CD24Fc With Ipilimumab and Nivolumab to Decrease irAE (CINDI)

A Phase 1/2 study testing CD24Fc, Ipilimumab and Nivolumab in people with Metastatic Melanoma, run by Oncoimmune, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is a phase Ib/II clinical trial to test safety and efficacy of combining CD24Fc with ipilimumab and nivolumab to decrease irAE, with built-in interim analyses, and safety and response stopping rules. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Melanoma
What is being tested?
CD24Fc, Ipilimumab and Nivolumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
15 Jun 2021to 30 Dec 2023
Phase
Phase 1/2
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

  • Male or female ≥18 years old.
  • Patients with histologically confirmed unresectable Stage III or Stage IV metastatic melanoma who have not been previously treated with a CD24Fc, anti-CTLA4 and anti-PD1/PDL1 inhibitors with documented progression.
  • Measurable disease per RECIST v1.1 criteria using imaging scans, or peripheral lesions that can be adequately documented with a picture and a ruler even if they do not meet RECIST criteria.
  • Patients must have lesion accessible for sequential biopsy (core needle biopsy or excision preferred, fine needle aspiration not eligible).
  • ECOG performance status 0 or 1.
  • Women of child-bearing potential must have a negative serum pregnancy test within 24 hour of initiation of dosing and must agree to use an effective form of contraception during the study from the time of the negative pregnancy test up to 6 months after the last dose of study drug. Effective forms of contraception include abstinence, hormonal contraceptive in conjunction with a barrier method, or a double barrier method. Women of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for ≥1 year. Fertile men must also agree to use an effective method of birth control while on study drug and up to 6 months after the last dose of study drug.
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  • Patients must have fully recovered from the effects of any major surgery or significant traumatic injury within 14 days of C1D1.
  • Adequate hematologic, hepatic, and renal function, as defined below:
  • Absolute neutrophil count ≥1 X 109/L,
  • Hgb > 8 g/dL
  • Platelet count ≥ 75 X 109/L,
  • AST/ALT/bilirubin ≤3X ULN (patients with Gilbert syndrome can have higher bilirubin levels).
  • Creatinine ≤ 3 X ULN or calculated CrCl > 30 mL/min using Cockcroft- Gault formula.
  • Willing and able to provide written informed consent prior to any study related procedures and to comply with all study requirements.

Who cannot join

  • Active secondary malignancy, unless the malignancy is not expected to interfere with the evaluation of safety and is approved by the Medical Monitor.
  • Investigational drug use within 28 days of C1D1.
  • Chemotherapy, targeted therapy, growth factors or radiation therapy within 14 days of C1D1.
  • Systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to C1D1.
  • Patients with known active CNS lesions are excluded (i.e., those with radiographically unstable, symptomatic lesions). However, patients treated with stereotactic therapy or surgery are eligible if they remain without clinical evidence of disease progression in the brain.
  • Has received a live vaccine within 28 days prior to C1D1.
  • A known active and clinically significant bacterial, fungal, or viral infection.
  • Active hepatitis B (HBV), hepatitis C (HCV), or human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness, including patients who have an active infection requiring systemic therapy.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

Other trials in United States

About this study

Official title: Phase Ib/II Study Combining CD24Fc With Checkpoint Inhibitors for Patients With Metastatic Melanoma

This is a phase Ib/II clinical trial to test safety and efficacy of combining CD24Fc with ipilimumab and nivolumab to decrease irAE, with built-in interim analyses, and safety and response stopping rules.

Read the detailed description

This is a phase 1b/II clinical trial using a fixed recommended phase 2 dose (RP2D) of CD24Fc to explore the safety and efficacy of combining CD24Fc with ipilimumab and nivolumab to reduce the toxicity of immunotherapy combination, in patients who are naïve to anti-PD1/L1 based checkpoint inhibitors. The dosing of nivolumab and ipilimumab will be fixed at FDA approved levels for each indication. Dosing of the drugs will continue until disease progression, unacceptable toxicity, or any other discontinuation criterion is met. Patients who complete 12 months on study treatment and demonstrate clinical benefit with manageable toxicity will be given the opportunity to continue treatment for another 12 months upon agreement between investigator and drug manufacturers.

Being tested
CD24Fc, Ipilimumab, Nivolumab
Medical subject headings
Melanoma

What participants receive

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

  • CD24FcDrug

    Also called Human CD24 and human IgG Fc Fusion Protein

    CD24Fc will be administrated as IV infusion in a dose of 480 mg, q3w x 4, then q4w for up to 6 times.

  • IpilimumabDrug

    Also called Yervoy, MDX-010.

    Ipilimumab will be administrated as IV infusion, q3w x 4. For metastatic melanoma, the dose will be 3mg/kg, q3w x4.

  • NivolumabDrug

    Also called Opdivo, MDX-1106, BMS-936558

    Nivolumab will be administrated as IV infusion. For metastatic melanoma, the dose will be 1mg/kg, q3w x 4, then 480 mg, q4w for up to 1 year.

Study groups in NCT04060407
Study groupRoleWhat they receive
Advanced MelanomaExperimentalPatients with advanced melanoma.
Receives: Drug: CD24Fc; Drug: Ipilimumab; Drug: Nivolumab

What is being measured

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

  1. Safety and tolerability of combination of CD24Fc with Ipilimumab and Nivolumab

    The rate of Grade 3 or above treatment-related adverse events (TRAE) at 4 weeks after first dosing of drugs.

    Measured: 4 weeks

Secondary outcomes (4)

  1. Profile of treatment related adverse events

    To tabulate the treatment related adverse events in 1 year

    Measured: 1 year

  2. The Objective Response Rate (OPR)

    The rate of objective response with CD24Fc, Ipilimumab, Nivolumab combination therapy at 1 year

    Measured: 1 year

  3. The Progression Free Survival (PFS)

    The rate of Progression Free Survival with CD24Fc, Ipilimumab, Nivolumab combination therapy at 1 year.

    Measured: 1 year

  4. The Overall Survival (OS)

    The rate of Overall Survival with CD24Fc, Ipilimumab, Nivolumab combination therapy at 1 year.

    Measured: 1 year

Timeline

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

  1. First posted19 Aug 2019
  2. Study start15 Jun 2021 (estimated)
  3. Primary completion30 Dec 2022 (estimated)
  4. Study completion30 Dec 2023 (estimated)

Why it stopped: Business Reasons

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Open Label
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04060407
Sponsor's protocol ID
7110-004
Other IDs
R44CA250889, CD24-004-CINDI
Acronym
CINDI
Status last verified
May 2021
First submitted
15 Aug 2019
Last updated
1 Jun 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CD24Fc, Ipilimumab and Nivolumab in people with Metastatic Melanoma, run by Oncoimmune, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 1 site in United States.

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 14 inclusion and 8 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: withdrawn, as of the sponsor's last update on 1 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 withdrawn before enrolling participants, so there are no results.

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?

Safety and tolerability of combination of CD24Fc with Ipilimumab and Nivolumab (time frame: 4 weeks). 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 NCT04060407.

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 1 Jun 2021; AzTrials last refreshed its copy on 27 Oct 2026.

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