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Brief Title: Evaluation of IPI-549 Combined With Front-line Treatments in Pts. With Triple-Negative Breast Cancer or Renal Cell Carcinoma
Official Title: Ph 2, Multi-arm, Multicenter, Open-label Study to Evaluate Efficacy and Safety of IPI-549 Administered in Combo With Front-line Treatment Regimens in Pts With Locally Advanced and/or Metastatic Triple-Negative Breast Cancer or Renal Cell Carcinoma
Study ID: NCT03961698
Brief Summary: MARIO-3 is a Phase 2 multi-arm combination cohort study designed to evaluate IPI-549, Infinity Pharmaceutical's first-in-class, oral immuno-oncology product candidate targeting immune-suppressive tumor-associated myeloid cells through selective inhibition of phosphoinositide-3-kinase (PI3K)-gamma, in combinations with Tecentriq and Abraxane (nab-paclitaxel) in front-line triple negative breast cancer (TNBC) and in combination with Tecentriq and Avastin (bevacizumab) in front-line renal cell cancer (RCC).
Detailed Description: MARIO-3 (Macrophage Reprogramming in Immuno-Oncology) is a prospective Phase 2 multi-arm, multicenter, open-label, combination cohort study designed to evaluate IPI-549, Infinity Pharmaceutical's first-in-class, oral immuno-oncology product candidate targeting immune-suppressive tumor-associated myeloid cells through selective inhibition of phosphoinositide-3-kinase (PI3K)-gamma. IPI-549 will be administered in combinations with Tecentriq and Abraxane (nab-paclitaxel) in front-line triple negative breast cancer (TNBC) and in combination with Tecentriq and Avastin (bevacizumab) in front-line renal cell cancer (RCC). This study will enroll approximately 90 treatment-naïve patients across the following disease cohorts. Cohort A will be composed of patients with locally advanced and/or metastatic triple-negative breast cancer (TNBC). Cohort B will be composed of patients with locally advanced and/or metastatic renal cell carcinoma (RCC). The primary objective of MARIO-3 is to evaluate the complete response (CR) rate per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 following combination treatment with IPI-549 and front-line treatment in patients with TNBC and RCC. Its secondary objectives include evaluation of the safety, objective response rate (ORR), time to CR (TTCR), time to response (TTR), duration of CR (DOCR), duration of response (DOR), and progression-free survival (PFS).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Ironwood Cancer and Research Center, Chandler, Arizona, United States
Arizona Oncology Associates, Tucson, Arizona, United States
Arizona Clinical Research Center, Tucson, Arizona, United States
St. Joseph Heritage Healthcare, Fullerton, California, United States
Cancer & Blood Specialty Clinic, Los Alamitos, California, United States
Sharp Memorial Hospital, San Diego, California, United States
Samsum Clinic, Santa Barbara, California, United States
UCLA, Santa Monica, California, United States
Olive View - UCLA Medical Center, Sylmar, California, United States
Valley Breast Cancer Care and Women's Health Center, Van Nuys, California, United States
University of Colorado, Aurora, Colorado, United States
Orlando Health, Orlando, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
University Cancer & Blood Center, Athens, Georgia, United States
Rush University Medical Center, Chicago, Illinois, United States
Fort Wayne Medical Oncology and Hematology, Fort Wayne, Indiana, United States
Cancer Center of Kansas, Wichita, Kansas, United States
Norton Cancer Institute, Louisville, Kentucky, United States
University of Maryland, Baltimore, Maryland, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Tennessee Oncology, Nashville, Tennessee, United States
MD Anderson Cancer Center, Houston, Texas, United States
UT Health East Texas HOPE Cancer Center, Tyler, Texas, United States
Utah Cancer Specialists, Salt Lake City, Utah, United States
Name: Feng Chi, PhD, RN
Affiliation: Medical Lead
Role: STUDY_DIRECTOR