CD24Fc With Ipilimumab and Nivolumab to Decrease irAE (CINDI)

NCT04060407 | Withdrawn Phase 1 DMC FDA Drug

• 3 other identifiers: 7110-004R44CA250889CD24-004-CINDI
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metastatic Melanoma

Outcome Measures

Primary Outcomes (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.

  4 weeks

Secondary Outcomes (4)

• Profile of treatment related adverse events

  1 year

• The Objective Response Rate (OPR)

  1 year

• The Progression Free Survival (PFS)

  1 year

• The Overall Survival (OS)

  1 year

Study Arms (1)

Advanced Melanoma

EXPERIMENTAL

Patients with advanced melanoma.

Drug: CD24Fc; Drug: Ipilimumab; Drug: Nivolumab

Interventions

CD24Fc DRUG

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

Also known as: Human CD24 and human IgG Fc Fusion Protein

Advanced Melanoma

Ipilimumab DRUG

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

Also known as: Yervoy, MDX-010.

Advanced Melanoma

Nivolumab DRUG

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.

Also known as: Opdivo, MDX-1106, BMS-936558

Advanced Melanoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oncoimmune, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA): lead
• Huntsman Cancer Institute: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

Ipilimumab; Nivolumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open Label

Study Record Dates

• First Submitted: August 15, 2019
• First Posted: August 19, 2019
• Study Start: June 15, 2021
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2023
• Last Updated: June 1, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)