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MEDI4736-MM-005 (FUSION MM-005): A Phase 2, Multicenter, Single-Arm, Study to Determine the Efficacy for the Combination of Durvalumab (DURVA) Plus Daratumumab (DARA) (D2) in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM) That Have Progressed While on Current Treatment Regimen Containing Daratumumab.

Primary: To determine the efficacy of DARA plus durvalumab (DURVA) in subjects with RRMM who have progressed on DARA while on a DARA-containing regimen as the most recent MM treatment. Secondary: Determine the safety of DARA plus DURVA in subjects with RRMM who have progressed on DARA while on a DARA-containing regimen as the most recent MM treatment. Further evaluate the efficacy of the combination of DARA plus DURVA in subjects with RRMM who have progressed on DARA while on a DARA-containing regimen as the most recent MM treatment. Key efficacy measures include time-to-response [TTR], duration of response [DOR], progression-free survival [PFS], and overall survival [OS]. Evaluate the pharmacokinetics (PK) of DARA and DURVA in subjects with RRMM who have progressed on DARA while on a DARA-containing regimen as the most recent MM treatment. Exploratory: Determine the immunogenicity of the combination of DARA plus DURVA in subjects with RRMM who have progressed on DARA while on a DARA-containing regimen as the most recent MM treatment. Evaluate the dynamic changes in the microenvironment of the tumor and in peripheral immune cell subsets in subjects prior to DURVA treatment and while on DURVA/DARA combination therapy to investigate whether DURVA can restore the immune defects associated with DARA resistance. Explore the pharmacodynamics (Pd), mechanistic, and predictive biomarkers of DARA and DURVA when given in combination to subjects with RRMM. Evaluate minimal residual disease (MRD) negativity and its correlation to key clinical outcome measures.

Primary: To determine the efficacy of DARA plus durvalumab (DURVA) in subjects with RRMM who have progressed on DARA while on a DARA-containing regimen as the most recent MM treatment. Secondary: Determine the safety of DARA plus DURVA in subjects with RRMM who have progressed on DARA while on a DARA-containing regimen as the most recent MM treatment. Further evaluate the efficacy of the combination of DARA plus DURVA in subjects with RRMM who have progressed on DARA while on a DARA-containing regimen as the most recent MM treatment. Key efficacy measures include time-to-response [TTR], duration of response [DOR], progression-free survival [PFS], and overall survival [OS]. Evaluate the pharmacokinetics (PK) of DARA and DURVA in subjects with RRMM who have progressed on DARA while on a DARA-containing regimen as the most recent MM treatment. Exploratory: Determine the immunogenicity of the combination of DARA plus DURVA in subjects with RRMM who have progressed on DARA while on a DARA-containing regimen as the most recent MM treatment. Evaluate the dynamic changes in the microenvironment of the tumor and in peripheral immune cell subsets in subjects prior to DURVA treatment and while on DURVA/DARA combination therapy to investigate whether DURVA can restore the immune defects associated with DARA resistance. Explore the pharmacodynamics (Pd), mechanistic, and predictive biomarkers of DARA and DURVA when given in combination to subjects with RRMM. Evaluate minimal residual disease (MRD) negativity and its correlation to key clinical outcome measures.