CD24Fc With Ipilimumab and Nivolumab to Decrease irAE (CINDI)

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
Oncoimmune, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Study ID
NCT04060407
Phase
PHASE1/PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
Jun 15, 2021
Status verified
May 2021
Primary completion
Dec 30, 2022
Completion
Dec 30, 2023

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Advanced Melanoma
    Patients with advanced melanoma.

Primary Outcome Measure

Safety and tolerability of combination of CD24Fc with Ipilimumab and Nivolumab [ Time Frame: 4 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Huntsman Cancer InstituteSalt Lake CityUtah84112-

Find similar trials in Salt Lake City, UT

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Huntsman Cancer Institute· Salt Lake City, UT

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