A Study to Evaluate Safety/Tolerability of Immunotherapy Combinations in Participants With Triple-Negative Breast Cancer or Gynecologic Malignancies
NCT ID: NCT03719326
Last Updated: 2024-05-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
35 participants
INTERVENTIONAL
2018-10-15
2021-07-02
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation-Arm A
Dose escalation is a 3+3 design, including a Dose Limiting Toxicity (DLT) evaluation period.
Etrumadenant
Etrumadenant is an A2aR and A2bR antagonist for oral use
Pegylated liposomal doxorubicin (PLD)
Doxil is an anthracycline topoisomerase II inhibitor that is encapsulated in liposomes for intravenous (IV) use
Dose Escalation-Arm B
Dose escalation is a 3+3 design, including a Dose Limiting Toxicity (DLT) evaluation period.
Etrumadenant
Etrumadenant is an A2aR and A2bR antagonist for oral use
nanoparticle albumin-bound paclitaxel (NP)
NP is a microtubule inhibitor for intravenous (IV) use
Dose Escalation-Arm C
Dose escalation is a 3+3 design, including a Dose Limiting Toxicity (DLT) evaluation period.
Etrumadenant
Etrumadenant is an A2aR and A2bR antagonist for oral use
IPI-549
IPI-549 is a phosphoinositide-3-kinase-gamma inhibitor for oral use
Pegylated liposomal doxorubicin (PLD)
Doxil is an anthracycline topoisomerase II inhibitor that is encapsulated in liposomes for intravenous (IV) use
Dose Expansion-TNBC-Arm 1
The dose given will be determined from the dose escalation part (Arm A).
Etrumadenant
Etrumadenant is an A2aR and A2bR antagonist for oral use
Pegylated liposomal doxorubicin (PLD)
Doxil is an anthracycline topoisomerase II inhibitor that is encapsulated in liposomes for intravenous (IV) use
Dose Expansion-Ovarian Cancer-Arm 2
The dose given will be determined from the dose escalation part (Arm A).
Etrumadenant
Etrumadenant is an A2aR and A2bR antagonist for oral use
Pegylated liposomal doxorubicin (PLD)
Doxil is an anthracycline topoisomerase II inhibitor that is encapsulated in liposomes for intravenous (IV) use
Dose Expansion-TNBC-Arm 3
The dose given will be determined from the dose escalation part (Arm B). .
Etrumadenant
Etrumadenant is an A2aR and A2bR antagonist for oral use
nanoparticle albumin-bound paclitaxel (NP)
NP is a microtubule inhibitor for intravenous (IV) use
Dose Expansion-TNBC-Arm 4
The dose expansion will be determined from the dose escalation part (Arm C).
Etrumadenant
Etrumadenant is an A2aR and A2bR antagonist for oral use
IPI-549
IPI-549 is a phosphoinositide-3-kinase-gamma inhibitor for oral use
Pegylated liposomal doxorubicin (PLD)
Doxil is an anthracycline topoisomerase II inhibitor that is encapsulated in liposomes for intravenous (IV) use
Interventions
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Etrumadenant
Etrumadenant is an A2aR and A2bR antagonist for oral use
IPI-549
IPI-549 is a phosphoinositide-3-kinase-gamma inhibitor for oral use
Pegylated liposomal doxorubicin (PLD)
Doxil is an anthracycline topoisomerase II inhibitor that is encapsulated in liposomes for intravenous (IV) use
nanoparticle albumin-bound paclitaxel (NP)
NP is a microtubule inhibitor for intravenous (IV) use
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Measurable disease per radiographic evaluation
* Performance status 0 or 1
* Available archival tissue sample (within 2 years) or a fresh tumor biopsy may be required
* Adequate organ, cardiac, and bone marrow function
* Dose escalation
* Participants with breast cancer:
* Locally advanced or metastatic triple negative breast cancer (ER-negative, PgR-negative, and HER2-negative according to ASCO/CAP guidelines) with disease progression
* No available alternative or curative therapy
* Participants may have received any number of prior therapies for advanced/recurrent and progressive disease
* Participants with ovarian cancer:
* Locally advanced or metastatic ovarian cancer with disease progression
* No available alternative or curative therapy
* Participants may have received any number of prior therapies for advanced/recurrent and progressive disease
* Dose expansion
* Participants with breast cancer:
* Locally advanced or metastatic triple negative breast cancer (ER-negative, PgR-negative, and HER2-negative according to ASCO/CAP guidelines)
* Disease progression after no more than 3 prior lines of therapy
* Participants with ovarian cancer:
* Locally advanced or metastatic ovarian cancer that is platinum-resistant
* Disease progression after no more than 3 prior lines of therapy
Exclusion Criteria
* Prior anticancer treatment including approved agents, systemic radiotherapy, or investigational therapy within 4 weeks prior first study treatment
* Cancer other than the disease under study within 2 years prior to study entry, except for some cancers with a low risk of spreading like non-melanoma skin cancers
* Inability to swallow oral medications
* Participant is breastfeeding, pregnant, or expects to become pregnant during the study
* Active autoimmune disease or documented history of autoimmune disease within 2 years prior to first study treatment
* History of peptic ulcer or stomach bleeding within 6 months prior to first study treatment
* Use of drugs contraindicated by the protocol within 4 weeks prior to and during study treatment
* Prior treatment with drugs that suppress the immune system within 2 weeks prior to first study treatment
* Presence of metastases in the brain or cancer spreading into the cerebrospinal fluid - CSF (leptomeningeal disease)
* HIV, Hepatitis B, and C test results negative prior to first study treatment
* Major surgery within 4 weeks prior to first study treatment
* Participants who have previously received maximum cumulative lifetime anthracycline dosage or baseline ejection fraction \<50% (on heart echography)
18 Years
FEMALE
No
Sponsors
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Infinity Pharmaceuticals, Inc.
INDUSTRY
Arcus Biosciences, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Arcus Biosciences, Inc.
Locations
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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
Countries
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Related Links
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ARC-2 - Lay Summary (English Version)
Other Identifiers
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ARC-2 (AB928CSP0002)
Identifier Type: -
Identifier Source: org_study_id
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