Study of Ciforadenant in Combination With Daratumumab in Patients With Relapsed or Refractory Multiple Myeloma

Corvus Pharmaceuticals, Inc.7 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Multiple Myeloma

Interventions

CiforadenantDRUG

100 mg orally twice daily for 28-day cycles

daratumumabDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

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

Time frame: From start of treatment to end of treatment, up to 24 months

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

Time frame: 28 days following first administration of ciforadnenat in combination with daratumumab

Secondary Outcomes

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 \[PR\]).

Time frame: From start of treatment to end of treatment, up to 24 months

Duration of response.

Time from the first assessment showing objective response to the date of documented disease progression.

Time frame: From start of treatment to end of treatment, up to 24 months

Disease control rate.

Proportion of participants achieving disease control for ≥ 3 months.

Time frame: From start of treatment to end of treatment, up to 24 months

Time to next therapy.

Time from end of treatment to starting next anti-myeloma therapy.

Time frame: Up to 2 years after end of treatment.

Progression free survival.

Data from ClinicalTrials.gov

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