Phase 1b/2 Trial of Ipilimumab, Nivolumab, and Ciforadenant (Adenosine A2a Receptor Antagonist) in First-line Advanced Renal Cell Carcinoma.

Introduction

• Org Study ID: 2022-0093
• NTC ID: NCT05501054
• Lead Sponsor Name: M.D. Anderson Cancer Center
• Status: RECRUITING

Conditions

• Clear Cell Renal Cell Carcinoma

Brief Summary

To learn if the combination of ciforadenant, ipilimumab, and nivolumab can help to control advanced renal cell carcinoma

Eligibility Criteria

Inclusion Criteria:

Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study:

1. Willing and able to provide a signed and dated written informed consent
2. Male or female ≥ 18 years of age
3. Confirmed diagnosis of clear cell RCC
4. Stage IV metastatic renal cell carcinoma per American Joint Committee on Cancer
5. No prior systemic therapy for advanced RCC
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Appendix 2)
7. 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
8. 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
9. Willing and able to under go bone and brain scans at baseline and continue to have scans performed if positive at screening.
10. 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
* Serum creatinine ≤ 2 times institutional upper limit of normal (ULN), or calculated creatinine clearance ≥ 40 mL/min (per the Cockcroft-Gault formula, Appendix 3)
* Total bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who must have total bilirubin < 3.0 mg/dL)
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN
11. Women must not be breastfeeding while taking the study drug and for up to five months after the last dose of study drug
12. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 24 hours prior to receiving first dose of protocol-indicated treatment

* "Women of childbearing potential" (WOCBP) is defined as any female who has experienced menarche who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or is not postmenopausal
* Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 years of age in the absence of other biological or physiological causes
* If menopausal status is considered for the purpose of evaluating childbearing potential, women < 62 years of age must have a documented serum follicle stimulating hormone (FSH) level within laboratory reference range for postmenopausal women, in order to be considered postmenopausal and not of childbearing potential
13. Women of childbearing potential (WOCBP) must agree to follow instructions for acceptable contraception Appendix 4 from the time of signing consent, and for 23 weeks after their last dose of protocol-indicated treatment
14. Men not azoospermic who are sexually active with WOCBP must agree to follow instructions for acceptable contraception (Appendix 4), from the time of signing consent, and for 31 weeks after their last dose of protocol-indicated treatment

Exclusion Criteria:

Patients meeting any of the following criteria will be excluded from the trial:

1. Prior systemic treatment including neoadjuvant or adjuvant therapy