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

• Sponsor: Corvus Pharmaceuticals, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04280328
• Collaborator: (none)
• Enrollment: 7
• Location: 1
• Arm: 1
• Actual Duration (Months): 24.3
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 7 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: Feb 20, 2020
• Actual Primary Completion Date: Sep 21, 2021
• Actual Study Completion Date: Mar 1, 2022

Arms and Interventions

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 Names: 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

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

1. 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]).

2. 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.

3. Disease control rate. [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. [Up to 2 years after end of treatment.]

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

5. Progression free survival. [Up to 2 years after end of treatment.]

   Proportion of participants remaining progression free or surviving at a given time.

6. Minimal Residual Disease. [From start of treatment to end of treatment, up to 24 months]

   Rate of molecular minimal residual disease (MRD) negativity.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland	United States	21231

Sponsors and Collaborators

• Corvus Pharmaceuticals, Inc.

Investigators

• Study Director: Deborah Strahs, Corvus Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Corvus Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT04280328
• Other Study ID Numbers: CPI-444-003
• First Posted: Feb 21, 2020
• Last Update Posted: Mar 11, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Daratumumab

Study Results

No Results Posted as of Mar 11, 2022