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

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ClinicalTrials.gov Identifier: NCT04280328
Recruitment Status : Recruiting
First Posted : February 21, 2020
Last Update Posted : September 28, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Ciforadenant Drug: daratumumab Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study of Ciforadenant in Combination With Daratumumab in Patients With Relapsed or Refractory Multiple Myeloma
Actual Study Start Date : February 20, 2020
Estimated Primary Completion Date : February 7, 2023
Estimated Study Completion Date : July 15, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Daratumumab

Arm Intervention/treatment
Experimental: Ciforadenant in combination with daratumumab
Ciforadenant 100 mg orally twice daily in combination with daratumumab IV 16 mg/kg.
Drug: Ciforadenant
100 mg orally twice daily for 28-day cycles
Other Name: CPI-444

Drug: 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




Primary Outcome Measures :
  1. Safety and tolerability of ciforadenant in combination with daratumumab relapsed / refractory multiple myeloma. [ Time Frame: 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

  2. Safety and tolerability of ciforadenant in combination with daratumumab relapsed / refractory multiple myeloma. [ Time Frame: 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 :
  1. Overall response rate. [ Time Frame: 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]).

  2. Duration of response. [ Time Frame: 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.

  3. Disease control rate. [ Time Frame: From start of treatment to end of treatment, up to 24 months ]
    Proportion of participants achieving disease control for ≥ 3 months.

  4. Time to next therapy. [ Time Frame: Up to 2 years after end of treatment. ]
    Time from end of treatment to starting next anti-myeloma therapy.

  5. Progression free survival. [ Time Frame: Up to 2 years after end of treatment. ]
    Proportion of participants remaining progression free or surviving at a given time.

  6. Minimal Residual Disease. [ Time Frame: From start of treatment to end of treatment, up to 24 months ]
    Rate of molecular minimal residual disease (MRD) negativity.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04280328


Contacts
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Contact: Clinical Operations 650-900-4520 CPI444003inquiry@corvuspharma.com

Locations
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United States, Maryland
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21231
Contact: J Law    650-900-4558    CPI444003inquiry@corvuspharma.com   
Principal Investigator: Philip Imus, MD         
Sponsors and Collaborators
Corvus Pharmaceuticals, Inc.
Investigators
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Study Director: M Mobasher, MD, MPH Corvus Pharmaceuticals
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Responsible Party: Corvus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT04280328    
Other Study ID Numbers: CPI-444-003
First Posted: February 21, 2020    Key Record Dates
Last Update Posted: September 28, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Daratumumab
Antineoplastic Agents