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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04280328
Other study ID # CPI-444-003
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date February 20, 2020
Est. completion date March 1, 2022

Study information

Verified date March 2022
Source Corvus Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a Phase 1b open-label study of ciforadenant, an oral, small molecule inhibitor targeting adenosine-2A receptors (A2AR), on safety/tolerability and efficacy in combination with daratumumab, a monoclonal antibody targeting CD38, in relapsed or refractory multiple myeloma.


Recruitment information / eligibility

Status Completed
Enrollment 7
Est. completion date March 1, 2022
Est. primary completion date September 21, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Relapsed or refractory myeloma. - Must have been exposed to at least 2 cycles of an IMiD containing regimen and PI containing regimen and must be refractory to at least one of the two. - Must have completed and tolerated 2 cycles of daratumumab or other anti-CD38 targeting antibodies. - Active myeloma requiring systemic treatment. - Measurable disease per protocol. - ECOG performance status of 0 - 2. - Life expectancy of at least 3 months. Exclusion Criteria: - POEMS syndrome; non-secretory myeloma (no measurable protein on sFLC assay); amyloidosis. - History of select prior malignancies. - Previous intolerance to daratumumab or any study drug. - Received an allogeneic stem cell transplant within 12 months, or an autologous stem cell transplant within 6 months, or have ongoing toxicity related to transplant. - Have an active infection or serious comorbid medical condition. - Any live attenuated vaccination against infectious diseases (e.g., influenza, varicella) within 4 weeks of initiation of study treatment; uncontrolled human immunodeficiency virus, or positive tests for hepatitis B or hepatitis C. - Female participants pregnant or breast-feeding. - Screening chemistry and blood counts within protocol limits - Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment or anticipation of need for systemic immunosuppressant medication during study treatment.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ciforadenant
100 mg orally twice daily for 28-day cycles
daratumumab
16 mg/kg administered intravenously as follows based on 28-day cycles: Cycles 1 - 2: Days 1, 8, 15, and 22 Cycles 3 - 6: Days 1 and 15 Cycles 7 - 24: Day 1

Locations

Country Name City State
United States The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland

Sponsors (1)

Lead Sponsor Collaborator
Corvus Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety and tolerability of ciforadenant in combination with daratumumab relapsed / refractory multiple myeloma. Incidence of treatment-emergent adverse events, as assessed by NCI CTCAE v.5 From start of treatment to end of treatment, up to 24 months
Primary Safety and tolerability of ciforadenant in combination with daratumumab relapsed / refractory multiple myeloma. Incidence of dose-limiting toxicities (DLTs) of CPI-444 in combination with daratumumab 28 days following first administration of ciforadnenat in combination with daratumumab
Secondary Overall response rate. According to international myeloma working group guidelines (including stringent complete response [sCR], complete response [CR], very good partial response [VGPR], partial response [PR]). From start of treatment to end of treatment, up to 24 months
Secondary Duration of response. Time from the first assessment showing objective response to the date of documented disease progression. From start of treatment to end of treatment, up to 24 months
Secondary Disease control rate. Proportion of participants achieving disease control for = 3 months. From start of treatment to end of treatment, up to 24 months
Secondary Time to next therapy. Time from end of treatment to starting next anti-myeloma therapy. Up to 2 years after end of treatment.
Secondary Progression free survival. Proportion of participants remaining progression free or surviving at a given time. Up to 2 years after end of treatment.
Secondary Minimal Residual Disease. Rate of molecular minimal residual disease (MRD) negativity. From start of treatment to end of treatment, up to 24 months
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