Clinical Trials /

CD24Fc With Ipilimumab and Nivolumab to Decrease irAE (CINDI)

NCT04060407

Description:

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.

Related Conditions:
  • Colorectal Carcinoma
  • Melanoma
  • Renal Cell Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: CD24Fc With Ipilimumab and Nivolumab to Decrease irAE (CINDI)
  • Official Title: Phase Ib/II Study Combining CD24Fc With Checkpoint Inhibitors for Patients With Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: CD24-004-CINDI
  • NCT ID: NCT04060407

Conditions

  • Metastatic Melanoma
  • Renal Cell Carcinoma
  • Colon Cancer With MSI-H or dMMR

Interventions

DrugSynonymsArms
CD24FcHuman CD24 and human IgG Fc Fusion ProteinCD24Fc, Ipilimumab, Nivolumab combination
IpilimumabYervoy, MDX-010.CD24Fc, Ipilimumab, Nivolumab combination
NivolumabOpdivo, MDX-1106, BMS-936558CD24Fc, Ipilimumab, Nivolumab combination

Purpose

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.

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.
    

Trial Arms

NameTypeDescriptionInterventions
CD24Fc, Ipilimumab, Nivolumab combinationExperimentalThis is an open label single arm study.
  • CD24Fc
  • Ipilimumab
  • Nivolumab

Eligibility Criteria

        Inclusion Criteria

          1. Male or female ≥18 years old.

          2. Patients with histologically confirmed unresectable Stage III or Stage IV metastatic
             melanoma, renal cell carcinoma, or MSI-high or dMMR colorectal carcinoma, who have not
             been previously treated with a CD24Fc, anti-CTLA4 and anti-PD1/PDL1 inhibitors with
             documented progression.

          3. 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.

          4. Patients must have lesion accessible for sequential biopsy (core needle biopsy or
             excision preferred, fine needle aspiration not eligible).

          5. ECOG performance status 0 or 1.

          6. 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.

          7. Patients must have fully recovered from the effects of any major surgery or
             significant traumatic injury within 14 days of C1D1.

          8. 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.

          9. Willing and able to provide written informed consent prior to any study related
             procedures and to comply with all study requirements.

        Exclusion Criteria

          1. Active secondary malignancy, unless the malignancy is not expected to interfere with
             the evaluation of safety and is approved by the Medical Monitor.

          2. Investigational drug use within 28 days of C1D1.

          3. Chemotherapy, targeted therapy, growth factors or radiation therapy within 14 days of
             C1D1.

          4. Systemic steroid therapy or any other form of immunosuppressive therapy within 7 days
             prior to C1D1.

          5. 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.

          6. Has received a live vaccine within 28 days prior to C1D1.

          7. A known active and clinically significant bacterial, fungal, or viral infection.

          8. 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Safety and tolerability of combination of CD24Fc with Ipilimumab and Nivolumab
Time Frame:4 weeks
Safety Issue:
Description:The rate of Grade 3 or above treatment-related adverse events (TRAE) at 4 weeks after first dosing of drugs.

Secondary Outcome Measures

Measure:Profile of treatment related adverse events
Time Frame:1 year
Safety Issue:
Description:To tabulate the treatment related adverse events in 1 year
Measure:The Objective Response Rate (OPR)
Time Frame:1 year
Safety Issue:
Description:The rate of objective response with CD24Fc, Ipilimumab, Nivolumab combination therapy at 1 year
Measure:The Progression Free Survival (PFS)
Time Frame:1 year
Safety Issue:
Description:The rate of Progression Free Survival with CD24Fc, Ipilimumab, Nivolumab combination therapy at 1 year.
Measure:The Overall Survival (OS)
Time Frame:1 year
Safety Issue:
Description:The rate of Overall Survival with CD24Fc, Ipilimumab, Nivolumab combination therapy at 1 year.

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:OncoImmune, Inc.

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