ACTIVE_NOT_RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2023-02-09

Study Completion:2026-11-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05501054

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
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 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	1. Prior systemic treatment including neoadjuvant or adjuvant therapy \<6 months from protocol initiation is not allowed including an immune checkpoint inhibitor or TKI 2. ≤ 28 days before first dose of protocol-indicated treatment: * Major surgery requiring general anesthesia * Suspected or confirmed SARS-CoV-2 infection 3. ≤ 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 4. Known or suspected clinically significant active bleeding including active hemoptysis 5. 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 6. 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 7. 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 8. Active, known or suspected autoimmune disease 9. Known psychiatric condition, social circumstance, or other medical condition reasonably judged by the investigator to unacceptably increase the risk of study participation; or to prohibit the understanding or rendering of informed consent or anticipated compliance with and interpretation of scheduled visits, treatment schedule, laboratory tests and other study requirements

Inclusion Criteria

Exclusion Criteria

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
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

1. Prior systemic treatment including neoadjuvant or adjuvant therapy \<6 months from protocol initiation is not allowed including an immune checkpoint inhibitor or TKI
2. ≤ 28 days before first dose of protocol-indicated treatment:
* Major surgery requiring general anesthesia
* Suspected or confirmed SARS-CoV-2 infection
3. ≤ 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
4. Known or suspected clinically significant active bleeding including active hemoptysis
5. 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
6. 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
7. 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
8. Active, known or suspected autoimmune disease
9. Known psychiatric condition, social circumstance, or other medical condition reasonably judged by the investigator to unacceptably increase the risk of study participation; or to prohibit the understanding or rendering of informed consent or anticipated compliance with and interpretation of scheduled visits, treatment schedule, laboratory tests and other study requirements

Contacts and Locations

Principal Investigator

Eric Jonasch, MD

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Eric Jonasch, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-09

Study Completion Date2026-11-01

Study Record Updates

Study Start Date2023-02-09

Study Completion Date2026-11-01

Terms related to this study

Additional Relevant MeSH Terms

Renal Cell Carcinoma