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Renal Cell CarcinomaPhase 1/2NCT05501054

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

A Phase 1/2 study testing Ipilimumab, Nivolumab and Ciforadenant in people with Renal Cell Carcinoma, run by M.D. Anderson Cancer Center at 3 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

To learn if the combination of ciforadenant, ipilimumab, and nivolumab can help to control advanced renal cell carcinoma Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Cell Carcinoma
What is being tested?
Ipilimumab, Nivolumab and Ciforadenant
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
3 sitesUnited States
Study dates
9 Feb 2023to 1 Nov 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study:
  • 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
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  • 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
  • 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
  • Women must not be breastfeeding while taking the study drug and for up to five months after the last dose of study drug
  • 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
  • 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
  • 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

Who cannot join

  • 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:
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  • 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
  • Subjects with type I diabetes mellitus; hypothyroidism only requiring hormone replacement; skin disorders such as vitiligo, psoriasis or alopecia not requiring systemic treatment; or conditions not expected by the investigator to recur in the absence of an external trigger are permitted to enroll
  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Duke Cancer Institute

    Durham, North Carolina, 27710

  • M D Anderson Cancer Center

    Houston, Texas, 77030

  • Abramson Cancer Center of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

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

Read the detailed description

Primary Objectives:

  • To determine the safety and tolerability of ipilimumab, nivolumab, and ciforadenant in patients with untreated advanced renal cell carcinoma (RCC).
  • To assess the depth of responsein patients with untreated advanced renal cell carcinoma treated with ipilimumab, nivolumab, and ciforadenant.

Secondary Objectives:

  • To estimate the objective response rate (ORR), duration of response (DOR) progression free survival (PFS), progressive disease (PD) rate, and irAE rate of ipilimumab, niovlumab, and Ciforadenant combination in untreated advanced RCC.

Exploratory Objectives:

  • To assess association of gene expression signatures and pharmacodynamic parameters with outcome.
Being tested
Ipilimumab, Nivolumab, Ciforadenant
Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IpilimumabDrug

    Also called Yervoy, BMS-734016, MDX010

    Given by IV (vein)

  • NivolumabDrug

    Also called BMS-936558, Opdivo

    Given by IV (vein)

  • CiforadenantDrug

    Given by PO

Study groups in NCT05501054
Study groupRoleWhat they receive
Ipilimumab, Nivolumab, and CiforadenantExperimentalTo help control advanced renal cell carcinoma.
Receives: Drug: Ipilimumab; Drug: Nivolumab; Drug: Ciforadenant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To establish the objective response rate (ORR)

    Measured: through study completion and average of 1 year.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2022
  2. Study start9 Feb 2023
  3. Primary completion1 Nov 2028 (estimated)
  4. Study completion1 Nov 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05501054
Sponsor's protocol ID
2022-0093
Other IDs
NCI-2022-06736
Status last verified
Nov 2026
First submitted
10 Aug 2022
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Ipilimumab, Nivolumab and Ciforadenant in people with Renal Cell Carcinoma, run by M.D. Anderson Cancer Center at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To establish the objective response rate (ORR) (time frame: through study completion and average of 1 year.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05501054.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.

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