A Study to Evaluate Immunotherapy Combinations in Participants With Gastrointestinal Malignancies
NCT ID: NCT03720678
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
44 participants
INTERVENTIONAL
2018-11-18
2021-06-25
Brief Summary
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Detailed Description
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In the dose expansion phase, etrumadenant at the RDE in combination with mFOLFOX at standard doses may be assessed in participants with advanced metastatic GEC or CRC.
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
Dose escalation is a 3+3 design, including a Dose Limiting Toxicity (DLT) evaluation period. The RDE of etrumadenant will be determined in this part with escalating doses of etrumadenant in combination with the standard mFOLFOX chemotherapy regimen in participants with gastroesophageal or colorectal cancer.
etrumadenant
Etrumadenant is an A2aR and A2bR antagonist.
mFOLFOX
Oxaliplatin, Leucovorin and 5-fluorouracil given as part of standard mFOLFOX chemotherapy regimen
Dose Expansion-GE
The RDE of etrumadenant will be determined from the dose escalation part. Etrumadenant will be given in combination with the standard mFOLFOX chemotherapy regimen in participants with gastroesophageal cancer
etrumadenant
Etrumadenant is an A2aR and A2bR antagonist.
mFOLFOX
Oxaliplatin, Leucovorin and 5-fluorouracil given as part of standard mFOLFOX chemotherapy regimen
Dose Expansion-CRC
The RDE of etrumadenant will be determined from the dose escalation part. Etrumadenant will be given in combination with the standard mFOLFOX chemotherapy regimen in participants with colorectal cancer
etrumadenant
Etrumadenant is an A2aR and A2bR antagonist.
mFOLFOX
Oxaliplatin, Leucovorin and 5-fluorouracil given as part of standard mFOLFOX chemotherapy regimen
Interventions
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etrumadenant
Etrumadenant is an A2aR and A2bR antagonist.
mFOLFOX
Oxaliplatin, Leucovorin and 5-fluorouracil given as part of standard mFOLFOX chemotherapy regimen
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed gastroesophageal cancer or colorectal cancer that is metastatic, advanced or recurrent with progression
* Participants for whom mFOLFOX is considered appropriate therapy
* Must have at least 1 measurable lesion per RECIST v1.1.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
* Must have received standard of care, including potentially curative available therapies or interventions.
* Confirm that an archival tissue sample is available and ≤ 24 months old; if not, a new biopsy of a tumor lesion must be obtained.
* Adequate organ and marrow function
* Previously treated central nervous system metastases, meeting the following criteria:
* No evidence of progression by magnetic resonance imaging for at least 4 weeks prior to first dose.
* Neurologic symptoms returned to baseline.
* No immunosuppressive doses of systemic corticosteroids for at least 2 weeks before investigational product administration.
* No carcinomatous meningitis.
Exclusion Criteria
* Underlying medical conditions that, in the Investigator's or Sponsor's opinion, will make the administration of investigational product hazardous (eg interstitial lung disease, active infections requiring antibiotics, recent hospitalization with unresolved symptoms) or obscure the interpretation of toxicity determination or AEs, or concurrent medical condition requiring the use of immunosuppressive medications or immunosuppressive doses of systemic or absorbable topical corticosteroids.
* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the pre-screening or screening visit through 30 days after the last dose of etrumadenant in combination with mFOLFOX.
* Any active autoimmune disease or a documented history of autoimmune disease or syndrome that required systemic treatment in past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs), except for vitiligo or resolved childhood asthma/atopy.
* Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
* Participants with asthma who require intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroid injections will not be excluded from this study. Participants on chronic systemic corticosteroids will be excluded from the study.
* Prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix, breast, or prostate.
* Prior chemotherapy, targeted small-molecule therapy, or radiation therapy within 4 weeks prior to Day 1 or has not recovered (ie, ≥ Grade 1 or baseline) from AEs due to a previously administered agent, except ≤ Grade 2 alopecia or ≤ Grade 2 neuropathy and other AEs ≤ Grade 2 considered not clinically significant by the Medical Monitor and Investigator.
* Use of other investigational drugs (drugs not marketed for any indication) within 28 days of investigational product administration.
18 Years
ALL
No
Sponsors
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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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Arizona Clinical Research Center
Tucson, Arizona, United States
Rocky Mountain Cancer Centers
Denver, Colorado, United States
Yale Cancer Center
New Haven, Connecticut, United States
Maryland Oncology Hematology
Rockville, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
QUEST Research Institute
Farmington Hills, Michigan, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Carolina BioOncology Institute
Huntersville, North Carolina, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Prisma Health
Greenville, South Carolina, United States
Texas Oncology - Austin Midtown
Austin, Texas, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
Texas Oncology - Fort Worth Cancer Center
Fort Worth, Texas, United States
Texas Oncology - San Antonio Northeast
San Antonio, Texas, United States
Texas Oncology - San Antonio Medical Center
San Antonio, Texas, United States
Texas Oncology - Tyler
Tyler, Texas, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States
Border Medical Oncology
Albury, New South Wales, Australia
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 Hospital
Macquarie Park, New South Wales, 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-3 - Lay Summary (English Version)
Other Identifiers
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ARC-3 (AB928CSP0003)
Identifier Type: -
Identifier Source: org_study_id
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