A Study to Evaluate the Safety and Tolerability of Immunotherapy Combinations in Participants With Advanced Malignancies
NCT ID: NCT03629756
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
48 participants
INTERVENTIONAL
2018-07-24
2021-09-03
Brief Summary
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Detailed Description
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In the dose-expansion phase, etrumadenant at RP2D in combination with zimberelimab may be assessed in participants with advanced clear-cell renal cell carcinoma (RCC) or metastatic castrate-resistant adenocarcinoma of the prostate (mCRPC).
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
3+3 design, including a DLT evaluation period. Etrumadenant RP2D will be determined in this part with escalating doses of oral etrumadenant in combination with a fixed dose of IV zimberelimab.
Etrumadenant
Etrumadenant is an A2aR and A2bR antagonist.
Zimberelimab
Zimberelimab is a fully human anti-PD-1 monoclonal antibody.
Dose Expansion-advanced clear-cell RCC
Etrumadenant at RP2D + zimberelimab
Etrumadenant
Etrumadenant is an A2aR and A2bR antagonist.
Zimberelimab
Zimberelimab is a fully human anti-PD-1 monoclonal antibody.
Dose Expansion-mCRPC
Etrumadenant at RP2D + zimberelimab
Etrumadenant
Etrumadenant is an A2aR and A2bR antagonist.
Zimberelimab
Zimberelimab is a fully human anti-PD-1 monoclonal antibody.
Interventions
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Etrumadenant
Etrumadenant is an A2aR and A2bR antagonist.
Zimberelimab
Zimberelimab is a fully human anti-PD-1 monoclonal antibody.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Must have at least 1 measurable lesion per RECIST v1.1.
3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
4. Must have received standard of care, including potentially curative available therapies or interventions.
5. Confirm that an archival tissue sample is available and ≤ 6 months old; if not, a new biopsy of a tumor lesion must be obtained. Biopsy must not put participant at undue risk and the procedure must not be more invasive than a core biopsy.
6. Adequate organ and marrow function
Dose escalation only:
7. Pathologically confirmed non-small cell lung cancer, squamous cell carcinoma of the head and neck, renal cell carcinoma, breast cancer, colorectal cancer, melanoma, bladder cancer, ovarian cancer, endometrial cancer, Merkel cell carcinoma, or gastroesophageal cancer that is metastatic, advanced or recurrent with progression for which no alternative or curative therapy exists or standard therapy is not considered appropriate by the participant and treating physician (reason must be documented in medical records).
Dose expansion only:
8. Participants with advanced clear-cell RCC or mCRPC.9. Clear-cell RCC participants may have received up to 2 prior lines of therapy, one of which must have included an anti-PD-(L)1 based therapy and must not have progressed within 16 weeks during an anti-PD-(L)1 therapy.
9. mCRPC participants must have progressed during or following treatment with an androgen synthesis inhibitor, and have also had one prior line of a taxane-containing regimen or the physician and participant consider the taxane-containing regimen to be inappropriate.
10. mCRPC participants must be naive to any immunotherapy (including but not limited to anti-PD-(L)1 or anti-CTLA-4 antagonists, sipuleucel-T, etc.).
Exclusion Criteria
2. 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.
3. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
4. 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 90 days after the last dose of etrumadenant in combination with zimberelimab.
5. Any active or documented history of autoimmune disease, or history of a syndrome that required systemic steroids or immunosuppressive medications, except for vitiligo or resolved childhood asthma/atopy. Participants with asthma who require intermittent use of bronchodilators (such as albuterol) will not be excluded from this study.
6. Prior malignancy active within the previous year 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 cancer.
7. Dose escalation: Prior treatment with an anti-PD-L1, anti-PD-1, anti-CTLA-4, or other immune checkpoint inhibitor or agonist as a monotherapy or in combination;
8. Use of other investigational drugs (drugs not marketed for any indication) within 28 days or at least 5 half-lives (whichever is longer) before 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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Scottsdale Healthcare Hospitals dba HonorHealth
Scottsdale, Arizona, United States
University of California, Los Angeles
Los Angeles, California, United States
The Angeles Clinic and Research Institute
Los Angeles, California, United States
Rocky Mountain Cancer Centers (Midtown)
Denver, Colorado, United States
University of Michigan
Ann Arbor, Michigan, United States
QUEST Research Institute
Royal Oak, Michigan, United States
Carolina BioOncology Institute
Huntersville, North Carolina, United States
Prisma Health
Greenville, South Carolina, United States
Texas Oncology, P.A. - Fort Worth Cancer Center
Fort Worth, 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
Medical Oncology Associates dba Summit Cancer Centers
Spokane, Washington, United States
St. George Private Hospital
Kogarah, New South Wales, Australia
Gallipoli Medical Research Foundation
Greenslopes, Queensland, Australia
Cabrini Health Limited
Malvern, , Australia
Countries
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Related Links
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ARC-5 - Lay Summary (English Version)
Other Identifiers
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ARC-5 (AB928CSP0005)
Identifier Type: -
Identifier Source: org_study_id
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