Phase 1b/2 Trial of Ipilimumab, Nivolumab, and Ciforadenant (Adenosine A2a Receptor Antagonist) in First-line Advanced Renal Cell Carcinoma.
2 other identifiers
interventional
50
1 country
3
Brief Summary
To learn if the combination of ciforadenant, ipilimumab, and nivolumab can help to control advanced renal cell carcinoma
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Feb 2023
Typical duration for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2022
CompletedFirst Posted
Study publicly available on registry
August 15, 2022
CompletedStudy Start
First participant enrolled
February 9, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
January 14, 2026
January 1, 2026
3.7 years
August 10, 2022
January 13, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
To establish the objective response rate (ORR)
through study completion and average of 1 year.
Study Arms (1)
Ipilimumab, Nivolumab, and Ciforadenant
EXPERIMENTALTo help control advanced renal cell carcinoma.
Interventions
Given by IV (vein)
Given by IV (vein)
Eligibility Criteria
You may qualify if:
- Willing and able to provide a signed and dated written informed consent
- Male or female ≥ 18 years of age
- Confirmed diagnosis of clear cell RCC
- Stage IV metastatic renal cell carcinoma per American Joint Committee on Cancer
- No prior systemic therapy for advanced RCC
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Appendix 2)
- At least one measureable lesion as defined by RECIST 1.1
- A tumor lesion situated in a previously irradiated area is considered a measureable/target lesion only if subsequent disease progression has been documented in the lesion
- Has submitted an archival tumor tissue sample or newly obtained core or incisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed parrafin-embedded tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue but not necessary. Details pertaining to tumor tissue submission can be found in the Lab Procedures Manual
- Willing and able to under go bone and brain scans at baseline and continue to have scans performed if positive at screening.
- Adequate organ function within 21 days prior to first dose of protocol-indicated treatment, including:
- White blood cell (WBC) ≥ 2,000 /µL
- Absolute neutrophil count (ANC) ≥ 1,500/µL
- Platelets ≥ 100,000/µL
- Hemoglobin (Hgb) ≥ 9.0 g/d without requirement for transfusion in prior 4 weeks
- +10 more criteria
You may not qualify if:
- Patients meeting any of the following criteria will be excluded from the trial:
- Prior systemic treatment including neoadjuvant or adjuvant therapy \<6 months from protocol initiation is not allowed including an immune checkpoint inhibitor or TKI
- ≤ 28 days before first dose of protocol-indicated treatment:
- Major surgery requiring general anesthesia
- Suspected or confirmed SARS-CoV-2 infection
- ≤ 14 days before first dose of protocol-indicated treatment:
- Radiosurgery or radiotherapy
- Minor surgery. (Note: Placement of a vascular access device is not considered minor or major surgery)
- Active infection requiring infusional treatment
- Known or suspected clinically significant active bleeding including active hemoptysis
- Inability to swallow oral medication; or the presence of a poorly controlled gastrointestinal disorder that could significantly affect the absorption of oral study drug - e.g. Crohn's disease, ulcerative colitis, chronic diarrhea (defined as \> 4 loose stools per day), malabsorption, or bowel obstruction
- Central nervous system (CNS) metastasis, unless asymptomatic and stable with imaging of the head by MRI unless contraindicated for the patient in which case CT is acceptable showing no change in CNS disease status for at least two (2) weeks prior to initiating protocol-indicated treatment
- Any condition requiring systemic treatment with either corticosteroids (\> 10 mg/day prednisone or equivalent daily) or other immunosuppressive medications within 14 days prior to initiating protocol-indicated treatment
- In the absence of active autoimmune disease: Subjects are permitted the use of corticosteroids with minimal systemic absorption (e.g. topical, ocular, intra-articular, intranasal, and inhalational) ≤ 10 mg/day prednisone or equivalent daily; and physiologic replacement doses of systemic corticosteroids ≤ 10 mg/day prednisone or equivalent daily (e.g. hormone replacement therapy needed in patients with hypophysitis)
- Active, known or suspected autoimmune disease
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Duke Cancer Institute
Durham, North Carolina, 27710, United States
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Jonasch, MD
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2022
First Posted
August 15, 2022
Study Start
February 9, 2023
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
November 1, 2026
Last Updated
January 14, 2026
Record last verified: 2026-01