Phase 1b/2 Trial of Ipilimumab, Nivolumab, and Ciforadenant (Adenosine A2a Receptor Antagonist) in First-line Advanced Renal Cell Carcinoma.
- Conditions
- Renal Cell Carcinoma
- Registration Number
- NCT05501054
- Lead Sponsor
- M.D. Anderson Cancer Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br>Patients must meet all of the following inclusion criteria to be eligible for enrollment<br>into the study:<br><br> 1. Willing and able to provide a signed and dated written informed consent<br><br> 2. Male or female = 18 years of age<br><br> 3. Confirmed diagnosis of clear cell RCC<br><br> 4. Stage IV metastatic renal cell carcinoma per American Joint Committee on Cancer<br><br> 5. No prior systemic therapy for advanced RCC<br><br> 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Appendix 2)<br><br> 7. At least one measureable lesion as defined by RECIST 1.1<br><br> • A tumor lesion situated in a previously irradiated area is considered a<br> measureable/target lesion only if subsequent disease progression has been documented<br> in the lesion<br><br> 8. Has submitted an archival tumor tissue sample or newly obtained core or incisional<br> biopsy of a tumor lesion not previously irradiated. Formalin-fixed parrafin-embedded<br> tissue blocks are preferred to slides. Newly obtained biopsies are preferred to<br> archived tissue but not necessary. Details pertaining to tumor tissue submission can<br> be found in the Lab Procedures Manual<br><br> 9. Willing and able to under go bone and brain scans at baseline and continue to have<br> scans performed if positive at screening.<br><br> 10. Adequate organ function within 21 days prior to first dose of protocol-indicated<br> treatment, including:<br><br> - White blood cell (WBC) = 2,000 /µL<br><br> - Absolute neutrophil count (ANC) = 1,500/µL<br><br> - Platelets = 100,000/µL<br><br> - Hemoglobin (Hgb) = 9.0 g/d without requirement for transfusion in prior 4 weeks<br><br> - Serum creatinine = 2 times institutional upper limit of normal (ULN), or<br> calculated creatinine clearance = 40 mL/min (per the Cockcroft-Gault formula,<br> Appendix 3)<br><br> - Total bilirubin = 1.5 x ULN (except subjects with Gilbert Syndrome, who must<br> have total bilirubin < 3.0 mg/dL)<br><br> - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 2.5 x ULN<br><br> 11. Women must not be breastfeeding while taking the study drug and for up to five<br> months after the last dose of study drug<br><br> 12. Women of childbearing potential (WOCBP) must have a negative serum or urine<br> pregnancy test within 24 hours prior to receiving first dose of protocol-indicated<br> treatment<br><br> - Women of childbearing potential (WOCBP) is defined as any female who has<br> experienced menarche who has not undergone surgical sterilization (hysterectomy<br> or bilateral oophorectomy) or is not postmenopausal<br><br> - Menopause is defined clinically as 12 months of amenorrhea in a woman over 45<br> years of age in the absence of other biological or physiological causes<br><br> - If menopausal status is considered for the purpose of evaluating childbearing<br> potential, women < 62 years of age must have a documented serum follicle<br> stimulating hormone (FSH) level within laboratory reference range for<br> postmenopausal women, in order to be considered postmenopausal and not of<br> childbearing potential<br><br> 13. Women of childbearing potential (WOCBP) must agree to follow instructions for<br> acceptable contraception Appendix 4 from the time of signing consent, and for 23<br> weeks after their last dose of protocol-indicated treatment<br><br> 14. Men not azoospermic who are sexually active with WOCBP must agree to follow<br> instructions for acceptable contraception (Appendix 4), from the time of signing<br> consent, and for 31 weeks after their last dose of protocol-indicated treatment<br><br>Exclusion Criteria:<br><br>Patients meeting any of the following criteria will be excluded from the trial:<br><br> 1. Prior systemic treatment including neoadjuvant or adjuvant therapy <6 months from<br> protocol initiation is not allowed including an immune checkpoint inhibitor or TKI<br><br> 2. = 28 days before first dose of protocol-indicated treatment:<br><br> - Major surgery requiring general anesthesia<br><br> - Suspected or confirmed SARS-CoV-2 infection<br><br> 3. = 14 days before first dose of protocol-indicated treatment:<br><br> - Radiosurgery or radiotherapy<br><br> - Minor surgery. (Note: Placement of a vascular access device is not considered<br> minor or major surgery)<br><br> - Active infection requiring infusional treatment<br><br> 4. Known or suspected clinically significant active bleeding including active<br> hemoptysis<br><br> 5. Inability to swallow oral medication; or the presence of a poorly controlled<br> gastrointestinal disorder that could significantly affect the absorption of oral<br> study drug - e.g. Crohn's disease, ulcerative colitis, chronic diarrhea (defined as<br> > 4 loose stools per day), malabsorption, or bowel obstruction<br><br> 6. Central nervous system (CNS) metastasis, unless asymptomatic and stable with imaging<br> of the head by MRI unless contraindicated for the patient in which case CT is<br> acceptable showing no change in CNS disease status for at least two (2) weeks prior<br> to initiating protocol-indicated treatment<br><br> 7. Any condition requiring systemic treatment with either corticosteroids (> 10 mg/day<br> prednisone or equivalent daily) or other immunosuppressive medications within 14<br> days prior to initiating protocol-indicated treatment<br><br> • In the absence of active autoimmune disease: Subjects are permitted the use of<br> corticosteroids with minimal systemic absorption (e.g. topical, ocular,<br> intra-articular, intranasal, and inhalational) = 10 mg/day prednisone or equivalent<br> daily; and physiologic replacement doses of systemic corticosteroids = 10 mg/day<br> prednisone or equivalent daily (e.g. hormone replacement therapy needed in patients<br> with hypophysitis)<br><br> 8. Active, known or suspected autoimmune disease<br><br> • Subjects with type I diabetes mellitus; hypothyroidism only requiring hormone<br> replacement; skin disorders such as vitiligo, psoriasis or alopecia not requiring<br> systemic treatment; or conditions not expected by the investigator to recur in the<br> absence of an external trigger are permitted to enroll<br><br> 9. Known psychiatric condition, social circumstance, or other medical condition<br> reasonably judged by the investigator to unacceptably increase the risk of study<br> participation; or to prohibit the understanding or rendering of informed consent or<br> anticipated compliance with and interpretation of scheduled visits, treatment<br> schedule, laboratory tests and other study requirements
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To establish the objective response rate (ORR)
- Secondary Outcome Measures
Name Time Method