Study of Ciforadenant in Combination With Daratumumab in Patients With Relapsed or Refractory Multiple Myeloma
- Registration Number
- NCT04280328
- Lead Sponsor
- Corvus Pharmaceuticals, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ciforadenant in combination with daratumumab daratumumab Ciforadenant 100 mg orally twice daily in combination with daratumumab IV 16 mg/kg. Ciforadenant in combination with daratumumab Ciforadenant Ciforadenant 100 mg orally twice daily in combination with daratumumab IV 16 mg/kg.
- Primary Outcome Measures
Name Time Method Safety and tolerability of ciforadenant in combination with daratumumab relapsed / refractory multiple myeloma. 28 days following first administration of ciforadnenat in combination with daratumumab Incidence of dose-limiting toxicities (DLTs) of CPI-444 in combination with daratumumab
- Secondary Outcome Measures
Name Time Method Overall response rate. From start of treatment to end of treatment, up to 24 months According to international myeloma working group guidelines (including stringent complete response \[sCR\], complete response \[CR\], very good partial response \[VGPR\], partial response \[PR\]).
Minimal Residual Disease. From start of treatment to end of treatment, up to 24 months Rate of molecular minimal residual disease (MRD) negativity.
Progression free survival. Up to 2 years after end of treatment. Proportion of participants remaining progression free or surviving at a given time.
Disease control rate. From start of treatment to end of treatment, up to 24 months Proportion of participants achieving disease control for ≥ 3 months.
Time to next therapy. Up to 2 years after end of treatment. Time from end of treatment to starting next anti-myeloma therapy.
Duration of response. From start of treatment to end of treatment, up to 24 months Time from the first assessment showing objective response to the date of documented disease progression.
Trial Locations
- Locations (1)
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States