Clinical trial information: NCT03170960.NEWS RELEASE: DCCA Disciplinary Actions (Through February 2023) Posted on in News Releases, OAHĭEPARTMENT OF COMMERCE AND CONSUMER AFFAIRS Given the encouraging activity in these pts, especially in those with visceral and/or extra pelvic lymph node metastases, further evaluation of C+A in men with mCRPC is being pursued. Conclusions: The combination of C+A had a tolerable safety profile and demonstrated clinically meaningful activity with durable responses in men with mCRPC. In 12 responders with at least 1 post-baseline PSA evaluation, 8 (67%) had a PSA decline ≥50%. Median DOR for all pts with response per RECIST 1.1 was 8.3 mo (range 1.38+, 9.76+). ORR per RECIST 1.1 was 33% in 36 pts with high-risk clinical features (visceral and/or extrapelvic lymph node metastases). One pt with initial PD per RECIST 1.1 had an irPR per irRECIST. The ORR per RECIST 1.1 among all pts was 32% (2 CRs and 12 PRs ) 21 (48%) pts had SD giving a disease control rate of 80% in all pts. One Grade 5 TRAE of dehydration was reported in a 90 y/o. The most common any grade TEAEs were fatigue (57%), nausea (48%), decreased appetite (45%), diarrhea (39%), PPE (32%), and vomiting (32%). 27% of pts had prior docetaxel and 52% had ≥2 prior novel hormonal therapies. Median age was 70 y (range 49, 90), 50% had ECOG PS 1, 34% had visceral metastases, and 61% had extrapelvic lymph node metastases. Results: As of Oct 2019, 44 mCRPC pts were enrolled with a median follow-up of 10.6 mo (range 3.4+, 17.9).
Other endpoints include safety, ORR per irRECIST, duration of response (DOR), PFS, and OS.
The primary endpoint is ORR per RECIST 1.1. CT/MRI scans were performed q6w for 52w and q12w thereafter. Pts received C 40 mg PO qd and A 1200 mg IV q3w. Prior chemotherapy for mCSPC was permitted. Methods: Eligible pts were required to have radiographic progression in soft tissue after enzalutamide and/or abiraterone, measurable disease, and an ECOG PS of 0 or 1. We report interim results from Cohort 6 in mCRPC. COSMIC-021 (NCT03170960), a multinational phase 1b study, is evaluating the combination of C with A in various solid tumors. Background: C may enhance response to immune checkpoint inhibitors by promoting an immune-permissive microenvironment.
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