Multiple Myeloma
Conditions
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.
Interventions
DRUGCiforadenant
100 mg orally twice daily for 28-day cycles
DRUGdaratumumab
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
Sponsors
Corvus Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability of ciforadenant in combination with daratumumab relapsed / refractory multiple myeloma. | From start of treatment to end of treatment, up to 24 months | Incidence of treatment-emergent adverse events, as assessed by NCI CTCAE v.5 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Disease control rate. | From start of treatment to end of treatment, up to 24 months | Proportion of participants achieving disease control for ≥ 3 months. |
| 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 \[PR\]). |
| Progression free survival. | Up to 2 years after end of treatment. | Proportion of participants remaining progression free or surviving at a given time. |
| Minimal Residual Disease. | From start of treatment to end of treatment, up to 24 months | Rate of molecular minimal residual disease (MRD) negativity. |
| Time to next therapy. | Up to 2 years after end of treatment. | Time from end of treatment to starting next anti-myeloma therapy. |
Countries
United States
Outcome results
None listed