RECRUITING

A Randomized Phase 2 Trial of Nivolumab, Relatlimab Plus Ipilimumab vs. Nivolumab Plus Ipilimumab in First-line Advanced Renal Cell Carcinoma (RCC)

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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

This is a phase 2 stratified, randomized, multicenter, study investigating the efficacy of a triplet arm treating with nivolumab 480 mg every 4 weeks (Q4W), relatlimab 160 mg Q4W and ipilimumab 1 mg/kg every 8 weeks (Q8W) intravenous (IV) versus a doublet arm treating with nivolumab 480 mg Q3W and ipilimumab 1mg/kg Q3W IV in first-line advanced RCC.

Official Title

A Randomized Phase 2 Trial of Nivolumab, Relatlimab Plus Ipilimumab vs. Nivolumab Plus Ipilimumab in First-line Advanced Renal Cell Carcinoma (RCC)

Quick Facts

Study Start:2025-03-20

Study Completion:2028-12-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06708949

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. ≥ 18 years of age 3. Confirmed diagnosis of RCC with a clear cell component 4. Stage IV metastatic renal cell carcinoma per American Joint Committee on Cancer 5. No prior systemic therapy for RCC. Prior neo/adjuvant systemic therapy is not allowed. 6. Karnofsky performance status ≥ 70%. 7. At least one measurable lesion as defined by RECIST 1.1 (Appendix 3) 8. Adequate organ function within 28 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 * Serum creatinine \< 1.5 x upper limit of normal (ULN) or creatinine clearance \> 30 mL/min (measured or calculated by Cockroft-Gault formula) * 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) ≤ 3 x ULN 9. Women must not be breastfeeding while taking the study drug and for up to five months after the last dose of study drug 10. 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. An extension up to 72 hours prior to the start of study treatment is permissible in situations where results cannot be obtained within the standard 24-hour window. * "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. 11. Women of childbearing potential (WOCBP) must agree to follow instructions for acceptable contraception Appendix 5 from the time of signing consent, and for 23 weeks after their last dose of protocol-indicated treatment.	1. Prior systemic treatment for RCC of any type including neoadjuvant or adjuvant therapy is not allowed. 2. ≤ 28 days before first dose of protocol-indicated treatment: 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 infusion treatment. 4. Any history of or current CNS metastases 5. 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. 6. Active, known or suspected autoimmune disease (see Appendix 1 for a comprehensive list of autoimmune diseases and immune deficiencies). 7. 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. 8. History of myocarditis, regardless of etiology 9. Troponin T (TnT) or I (TnI) \> 2× institutional upper limit of normal (ULN) 10. Treatment with any live/attenuated vaccine within 30 days of first study treatment

Inclusion Criteria

Exclusion Criteria

1. Willing and able to provide a signed and dated written informed consent.
2. ≥ 18 years of age
3. Confirmed diagnosis of RCC with a clear cell component
4. Stage IV metastatic renal cell carcinoma per American Joint Committee on Cancer
5. No prior systemic therapy for RCC. Prior neo/adjuvant systemic therapy is not allowed.
6. Karnofsky performance status ≥ 70%.
7. At least one measurable lesion as defined by RECIST 1.1 (Appendix 3)
8. Adequate organ function within 28 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
* Serum creatinine \< 1.5 x upper limit of normal (ULN) or creatinine clearance \> 30 mL/min (measured or calculated by Cockroft-Gault formula)
* 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) ≤ 3 x ULN
9. Women must not be breastfeeding while taking the study drug and for up to five months after the last dose of study drug
10. 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. An extension up to 72 hours prior to the start of study treatment is permissible in situations where results cannot be obtained within the standard 24-hour window.
* "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.
11. Women of childbearing potential (WOCBP) must agree to follow instructions for acceptable contraception Appendix 5 from the time of signing consent, and for 23 weeks after their last dose of protocol-indicated treatment.

1. Prior systemic treatment for RCC of any type including neoadjuvant or adjuvant therapy is not allowed.
2. ≤ 28 days before first dose of protocol-indicated treatment:
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 infusion treatment.
4. Any history of or current CNS metastases
5. 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.
6. Active, known or suspected autoimmune disease (see Appendix 1 for a comprehensive list of autoimmune diseases and immune deficiencies).
7. 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.
8. History of myocarditis, regardless of etiology
9. Troponin T (TnT) or I (TnI) \> 2× institutional upper limit of normal (ULN)
10. Treatment with any live/attenuated vaccine within 30 days of first study treatment

Contacts and Locations

Study Contact

Eric Jonasch, MD

CONTACT

(713) 563-7232

ejonasch@mdanderson.org

Principal Investigator

Eric Jonasch, MD

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

The University of Texas 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 Date2025-03-20

Study Completion Date2028-12-15

Study Record Updates

Study Start Date2025-03-20

Study Completion Date2028-12-15

Terms related to this study

Additional Relevant MeSH Terms

Renal Cell Carcinoma, Clear Cell