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CD24Fc With Ipilimumab and Nivolumab to Decrease irAE (CINDI) (CINDI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04060407
Recruitment Status : Not yet recruiting
First Posted : August 19, 2019
Last Update Posted : June 4, 2020
Sponsor:
Collaborator:
Huntsman Cancer Institute
Information provided by (Responsible Party):
OncoImmune, Inc.

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.

Condition or disease Intervention/treatment Phase
Metastatic Melanoma Renal Cell Carcinoma Colon Cancer With MSI-H or dMMR Drug: CD24Fc Drug: Ipilimumab Drug: Nivolumab Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Open Label
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase Ib/II Study Combining CD24Fc With Checkpoint Inhibitors for Patients With Advanced Solid Tumors
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : December 30, 2023


Arm Intervention/treatment
Experimental: Advanced Melanoma
Patients with advanced melanoma.
Drug: CD24Fc
CD24Fc will be administrated as IV infusion in a dose of 480 mg, q3w x 4, then q4w for up to 1 year.
Other Name: Human CD24 and human IgG Fc Fusion Protein

Drug: Ipilimumab
Ipilimumab will be administrated as IV infusion, q3w x 4. For metastatic melanoma, the dose will be 3mg/kg, q3w x4. For renal cell carcinoma and colon cancer, the dose will be 1mg/kg, q3w x 4.
Other Name: Yervoy, MDX-010.

Drug: Nivolumab

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.

For renal cell carcinoma or colon cancer, the dose will be 3mg/kg, q3w x 4, then 480 mg, q4w for up to 1 year.

Other Name: Opdivo, MDX-1106, BMS-936558

Experimental: Renal Cell Carcinoma
Patients with advanced renal cell carcinoma.
Drug: CD24Fc
CD24Fc will be administrated as IV infusion in a dose of 480 mg, q3w x 4, then q4w for up to 1 year.
Other Name: Human CD24 and human IgG Fc Fusion Protein

Drug: Ipilimumab
Ipilimumab will be administrated as IV infusion, q3w x 4. For metastatic melanoma, the dose will be 3mg/kg, q3w x4. For renal cell carcinoma and colon cancer, the dose will be 1mg/kg, q3w x 4.
Other Name: Yervoy, MDX-010.

Drug: Nivolumab

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.

For renal cell carcinoma or colon cancer, the dose will be 3mg/kg, q3w x 4, then 480 mg, q4w for up to 1 year.

Other Name: Opdivo, MDX-1106, BMS-936558

Experimental: Colon cancer
Patients with colon cancer carrying MSI-high or dMMR.
Drug: CD24Fc
CD24Fc will be administrated as IV infusion in a dose of 480 mg, q3w x 4, then q4w for up to 1 year.
Other Name: Human CD24 and human IgG Fc Fusion Protein

Drug: Ipilimumab
Ipilimumab will be administrated as IV infusion, q3w x 4. For metastatic melanoma, the dose will be 3mg/kg, q3w x4. For renal cell carcinoma and colon cancer, the dose will be 1mg/kg, q3w x 4.
Other Name: Yervoy, MDX-010.

Drug: Nivolumab

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.

For renal cell carcinoma or colon cancer, the dose will be 3mg/kg, q3w x 4, then 480 mg, q4w for up to 1 year.

Other Name: Opdivo, MDX-1106, BMS-936558




Primary Outcome Measures :
  1. Safety and tolerability of combination of CD24Fc with Ipilimumab and Nivolumab [ Time Frame: 4 weeks ]
    The rate of Grade 3 or above treatment-related adverse events (TRAE) at 4 weeks after first dosing of drugs.


Secondary Outcome Measures :
  1. Profile of treatment related adverse events [ Time Frame: 1 year ]
    To tabulate the treatment related adverse events in 1 year

  2. The Objective Response Rate (OPR) [ Time Frame: 1 year ]
    The rate of objective response with CD24Fc, Ipilimumab, Nivolumab combination therapy at 1 year

  3. The Progression Free Survival (PFS) [ Time Frame: 1 year ]
    The rate of Progression Free Survival with CD24Fc, Ipilimumab, Nivolumab combination therapy at 1 year.

  4. The Overall Survival (OS) [ Time Frame: 1 year ]
    The rate of Overall Survival with CD24Fc, Ipilimumab, Nivolumab combination therapy at 1 year.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04060407


Contacts
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Contact: Pan Zheng, MD, PhD 202-7516823 pzheng@oncoimmune.com

Locations
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United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
OncoImmune, Inc.
Huntsman Cancer Institute
Investigators
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Principal Investigator: Siwen Hu-Lieskovan, MD, PhD Huntsman Cancer Institute/ University of Utah
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Responsible Party: OncoImmune, Inc.
ClinicalTrials.gov Identifier: NCT04060407    
Other Study ID Numbers: CD24-004-CINDI
First Posted: August 19, 2019    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Kidney Diseases
Urologic Diseases
Nivolumab
Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents