Spots Global Cancer Trial Database for A Study to Evaluate Safety/Tolerability of Immunotherapy Combinations in Participants With Triple-Negative Breast Cancer or Gynecologic Malignancies
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Trial Identification
Brief Title: A Study to Evaluate Safety/Tolerability of Immunotherapy Combinations in Participants With Triple-Negative Breast Cancer or Gynecologic Malignancies
Official Title: A Phase 1/1b Study to Evaluate the Safety and Tolerability of Immunotherapy Combinations in Participants With Breast or Gynecologic Malignancies
Study ID: NCT03719326
Study Description
Brief Summary: This is a Phase 1/1b, open-label, dose-escalation, and dose-expansion study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and clinical activity of etrumadenant (AB928) in combination with pegylated liposomal doxorubicin (PLD) with or without IPI-549 in participants with advanced metastatic triple-negative breast cancer (TNBC) or ovarian cancer, and etrumadenant in combination with nanoparticle albumin-bound-paclitaxel (NP) in participants with advanced metastatic TNBC.
Detailed Description: In the dose escalation phase, the following will be assessed: * Arm A: escalating doses of etrumadenant in combination with PLD at standard doses will be assessed in participants with advanced metastatic triple-negative breast cancer or ovarian cancer. Eligible participants will receive oral administration of etrumadenant as well as intravenous (IV) infusion of PLD. The recommended dose (RDE) for expansion Arms 1 and 2 and escalation Arm C will be determined upon completion of this dose escalation arm. * Arm B: escalating doses of etrumadenant in combination with the NP at standard doses will also be assessed in participants with advanced metastatic TNBC. Eligible participants will receive oral administration of etrumadenant as well as NP infusion. The RDE of etrumadenant will be determined upon completion of this dose escalation arm. * Arm C: escalating doses of IPI-549 in combination with the RDE of etrumadenant (from Arm A) and PLD at standard doses will be assessed in participants with advanced metastatic TNBC or ovarian cancer. Eligible participants will receive oral administration of both etrumadenant and IPI-549 as well as IV infusion of PLD. The RDE of IPI-549 for expansion Arm 4 will be determined upon completion of this dose escalation arm. In the dose expansion phase, the following will be assessed: * Arms 1 and 2: Etrumadenant at the RDE in combination with PLD at standard doses may be assessed in participants with advanced metastatic TNBC or ovarian cancer. * Arm 3: Etrumadenant at the RDE in combination with NP at standard doses may be assessed in participants with advanced metastatic TNBC. * Arm 4: Etrumadenant and IPI-549 at the RDE in combination with PLD at standard doses may be assessed in participants with advanced metastatic TNBC. Overall duration of treatment will depend on how well the treatment is tolerated. Treatment may continue until unacceptable toxicity or progressive disease or other reasons specified in the protocol.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Scottsdale Healthcare Hospitals dba Honor Health Research Institute, Scottsdale, Arizona, United States
Arizona Clinical Research Center, Tucson, Arizona, United States
University of California, Los Angeles, Los Angeles, California, United States
Rocky Mountain Cancer Centers (Aurora), Aurora, Colorado, United States
Miami Cancer Institute at Baptist Health, Miami, Florida, United States
Maryland Oncology Hematology, PA, Rockville, Maryland, United States
HealthPartners Institute Cancer Care Center, Saint Paul, Minnesota, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
Carolina BioOncology Institute, Huntersville, North Carolina, United States
Willamette Valley Cancer Institute and Research Center, Eugene, Oregon, United States
Texas Oncology, P.A. - Austin (Midtown), Austin, Texas, United States
Texas Oncology, P.A. - Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
Texas Oncology, P.A. - Fort Worth Cancer Center, Fort Worth, Texas, United States
Texas Oncology, P.A. - San Antonio Northeast, San Antonio, Texas, United States
Texas Oncology, P.A. - San Antonio Medical Center, San Antonio, Texas, United States
Texas Oncology, P.A. - Tyler, Tyler, Texas, United States
Virginia Cancer Specialists, PC, Fairfax, Virginia, United States
Virginia Oncology Associates, Norfolk, Virginia, United States
Medical Oncology Associates dba Summit Cancer Centers, Spokane, Washington, United States
MultiCare Regional Cancer Center, Tacoma, Washington, United States
Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia
The Kinghorn Cancer Centre, Darlinghurst, New South Wales, Australia
St. George Private Hospital, Kogarah, New South Wales, Australia
Macquarie University, Macquarie, New South Wales, Australia
Pindara Private Hospital, Benowa, Queensland, Australia
Peninsula & South Eastern Haematology and Oncology Group, Frankston, Victoria, Australia
Cabrini Hospital, Malvern, Victoria, Australia
Contact Details
Name: Medical Director
Affiliation: Arcus Biosciences, Inc.
Role: STUDY_DIRECTOR
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