⭐️⭐️⭐️⭐️⭐️ "A total no brainer"

⭐️⭐️⭐️⭐️⭐️ "Love this, so easy."

Spots is the easy way to track your skin, mole and cancer changes.

Spots Global Cancer Trial Database for Evaluation of IPI-549 Combined With Front-line Treatments in Pts. With Triple-Negative Breast Cancer or Renal Cell Carcinoma

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

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

Study Description

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).

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Feng Chi, PhD, RN

Affiliation: Medical Lead

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

Logo

Take Control of Your Skin and Body Changes Today.

Try out Spots for free, set up only takes 2 mins.

spots app storespots app store

Join others from around the world: