Clinical trial NCT04280328: Study of Ciforadenant in Combination With Daratumumab in Patients With Relapsed or Refractory Multiple Myeloma
Official title: An Open-Label Study of Ciforadenant in Combination With Daratumumab in Patients With Relapsed or Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Myeloma
Lead sponsor: Corvus Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2020-02-21
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Safety and tolerability of ciforadenant in combination with daratumumab relapsed / refractory multiple myeloma.
timeFrame: From start of treatment to end of treatment, up to 24 months
measure: Safety and tolerability of ciforadenant in combination with daratumumab relapsed / refractory multiple myeloma.
timeFrame: 28 days following first administration of ciforadnenat in combination with daratumumab
Secondary outcomes:
measure: Overall response rate.
timeFrame: From start of treatment to end of treatment, up to 24 months
measure: Duration of response.
timeFrame: From start of treatment to end of treatment, up to 24 months
measure: Disease control rate.
timeFrame: From start of treatment to end of treatment, up to 24 months
measure: Time to next therapy.
timeFrame: Up to 2 years after end of treatment.
measure: Progression free survival.
timeFrame: Up to 2 years after end of treatment.
measure: Minimal Residual Disease.
timeFrame: From start of treatment to end of treatment, up to 24 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
Study officials:
affiliation: Corvus Pharmaceuticals
name: Deborah Strahs
role: STUDY_DIRECTOR
References: