This study is designed to determine the efficacy and safety of durvalumab in combination with novel oncology therapies with or without paclitaxel and durvalumab + paclitaxel for first-line metastatic triple negative breast cancer
This is a Phase IB/II, 2-stage, open-label, multicenter study to determine the efficacy and safety of durvalumab in combination with novel oncology therapies (i.e. therapies designed for immune modulation) with or without paclitaxel and durvalumab + paclitaxel as first-line treatment in patients with metastatic triple negative breast cancer (TNBC). The study is designed to concurrently evaluate potential novel treatment combinations with clinical promise using a 2-stage approach. The study will use a Simon 2-Stage design to evaluate which cohorts may proceed to expansion. Part 1 is a Phase IB study of safety and initial efficacy, and Part 2 may expand patient enrollment if adequate efficacy signal is observed in Part 1. The treatment regimens evaluated in Part 2 will depend on the evaluation of safety and efficacy outcomes in Part 1.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
243
Durvalumab iv Every 4 weeks (q4w) or 3 weeks (q3w) Arm 6, 7 and 8
Capivasertib oral bid 4-week cycles; 3 weeks on (dosing on days 2,3,4 and 5) and 1 week off
Oleclumab iv Every 2 weeks (q2w) for first 2 cycles (days 1 and 15 in cycles 1 and 2), then every 4 weeks (q4w) starting at cycle 3 day 1
Research Site
Tucson, Arizona, United States
Dose Limiting Toxicity (DLT) Events
The occurrence of a severe adverse event (meeting pre-specified criteria) that is at least possibly related to durvalumab and/or the novel oncology therapy in 6 DLT-evaluable patients
Time frame: From the time of first dose until completion of the first cycle (28 days for Arms 2-5, 21 days for Arms 6-7 (no safety run-in for Arms 1 and 8))
Objective Response Rate (ORR)
Percentage of evaluable patients with a confirmed Investigator-assessed response of CR (complete response) or PR (partial response). Confirmed response is defined as at least one visit response of CR or PR confirmed by a follow-up scan at least 4 weeks later showing CR or PR.
Time frame: Tumor assessments: every 8 wks (Arms 1-5) or every 6 wks (Arms 6-8) until wk 48, then every 12 wks from first IP dose until radiologic progression, death, withdrawal of consent, or study completion; up to max 54 mos (observed longest duration in Arm 1)
Progression-free Survival (PFS)
Time from date of first dose (at least one study intervention \[durvalumab, paclitxel or novel oncology therapy\]) until the date of objective radiological disease progression using RECIST 1.1 or death (by any cause in the absence of progression)
Time frame: Tumor assessments: every 8 wks (Arms 1-5) or every 6 wks (Arms 6-8) until wk 48, then every 12 wks from first IP dose until radiologic progression, death, withdrawal of consent, or study completion; up to max 54 mos (observed longest duration in Arm 1)
Duration of Response (DoR)
Time from the date of first documented response (which is subsequently confirmed) until the first date of documented progression (PD) or death in the absence of PD (ie, date of PFS event or censoring - date of first response + 1). If a patient does not progress following a response, then their DoR will be censored at the last evaluable disease assessment date
Time frame: Tumor assessments: every 8 wks (Arms 1-5) or every 6 wks (Arms 6-8) until wk 48, then every 12 wks from first IP dose until radiologic progression, death, withdrawal of consent, or study completion; up to max 54 mos (observed longest duration in Arm 1)
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Paclitaxel iv 4-week cycles: 3 weeks once weekly (q1w) and 1 week off
Trastuzumab deruxtecan iv 3-week cycles (once weekly) q3w
Datopotamab deruxtecan iv 3-week cycles (once weekly) q3w
Research Site
Columbia, Maryland, United States
Research Site
Boston, Massachusetts, United States
Research Site
Boston, Massachusetts, United States
Research Site
Grand Rapids, Michigan, United States
Research Site
St Louis, Missouri, United States
Research Site
Dallas, Texas, United States
Research Site
Williamsburg, Virginia, United States
Research Site
Kelowna, British Columbia, Canada
Research Site
London, Ontario, Canada
...and 22 more locations
Overall Survival (Count)
Number of patients with overall survival, the time from date of first dose (at least one study intervention \[durvalumab, paclitxel or novel oncology therapy\]) until the date of death by any cause
Time frame: From date of first dose until date of death due to any cause; up to the maximum of 54 months (observed longest duration in Arm 1)
Overall Survival (Duration)
Time from date of first dose (at least one study intervention \[durvalumab, paclitxel or novel oncology therapy\]) until the date of death by any cause
Time frame: From date of first dose of IP until date of death due to any cause; up to the maximum of 54 months (observed longest duration in Arm 1)
Progression-free Survival at 6 Months (PFS6)
Percentage of patients alive and progression-free at 6 months following date of first dose (at least one study intervention \[durvalumab, paclitxel or novel oncology therapy\])
Time frame: 6 months following date of first dose