New drug cocktail aims to shrink kidney tumors after first treatment fails

NCT ID NCT07277972

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Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

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Status unknown
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First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a combination of two immunotherapy drugs (iparomlimab and tuvonralimab) plus a targeted therapy (lenvatinib or axitinib) in 36 adults with advanced clear cell kidney cancer that has worsened after initial treatment. The main goal is to see if the combination can shrink tumors. Participants must be in good overall health and have measurable tumors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 36 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Aug 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age at Diagnosis: ≥18 years. * Histologically confirmed locally advanced or metastatic clear cell renal cell carcinoma. * Disease progression or intolerance during or following first-line systemic therapy. * ECOG Performance Status: 0-1. * At least one measurable lesion as defined by RECIST v1.1. * Life expectancy ≥12 weeks. * Adequate bone marrow function: White blood cell count \> 4.0×10⁹/L, Hemoglobin \> 90 g/L, Platelet count \> 100×10⁹/L. * Adequate hepatic and renal function: Total bilirubin ≤ 1.5 × ULN; Aspartate aminotransferase and/or Alanine aminotransferase ≤ 2.5 × ULN; Alkaline phosphatase ≤ 2.5 × ULN; Serum creatinine ≤ 1.5 × ULN. * Adequate coagulation function: International Normalized Ratio (INR) ≤1.5 × ULN, Activated Partial Thromboplastin Time (APTT) ≤1.5 × ULN. * The patient must provide signed informed consent and be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures as specified in the study protocol. * Female subjects of childbearing potential must agree to use reliable contraceptive methods (e.g., condoms, prescribed oral contraceptives taken regularly) from screening until 1 year after the end of treatment. Exclusion Criteria: * Allergy to any component of macromolecular protein preparations; contraindications or hypersensitivity to any ingredient of Iparomlimab and Tuvonralimab Injection, Lenvatinib, or Axitinib. * Major surgery within 28 days prior to the first dose (excluding diagnostic laparoscopy; local surgery for isolated lesions is acceptable). * Positive Hepatitis B surface antigen (HBsAg) with HBV DNA \>1×10³ copies/mL, or positive anti-Hepatitis C virus (HCV) antibody. * Positive anti-HIV antibody or a diagnosis of Acquired Immunodeficiency Syndrome (AIDS). * Active, known, or suspected autoimmune disease (including but not limited to uveitis, enteritis, hepatitis, pituitary disorders, nephritis, vasculitis, systemic lupus erythematosus, hyperthyroidism, hypothyroidism, asthma requiring bronchodilator therapy). Exceptions include type I diabetes mellitus, hypothyroidism requiring hormone replacement therapy only, and skin disorders not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia). * Renal failure requiring hemodialysis or peritoneal dialysis. * History of interstitial lung disease (ILD) or pneumonitis requiring oral or intravenous steroids within the past year; administration of Vancomycin within the past month. * Chronic systemic glucocorticoid therapy (at a dose equivalent to ≥10 mg prednisone daily) or any other form of immunosuppressive therapy. Subjects using inhaled or topical corticosteroids are eligible. * Uncontrolled cardiac disease, such as: 1) Heart failure, NYHA class ≥ II; 2) Unstable angina; 3) Myocardial infarction within the past year; 4) Supraventricular or ventricular arrhythmia requiring treatment or intervention. * Thromboembolic events within 6 months prior to the start of study treatment, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), or pulmonary embolism, etc. * Known central nervous system metastases. * Urinalysis indicating urine protein ≥ +++ and confirmed 24-hour urinary protein \>1.0 g. * Pregnant or lactating women (a pregnancy test should be considered for sexually active women of childbearing potential). * Prior or concurrent other malignancies, except for adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, and papillary carcinoma of the thyroid. * Active infection requiring systemic therapy within one week. * Administration of a live vaccine within 30 days prior to the first dose of Iparomlimab and Tuvonralimab Injection. * History of organ transplantation or hematopoietic stem cell transplantation. * Any other condition that, in the investigator's assessment, may compromise patient safety or compliance, such as severe concomitant illnesses (including psychiatric disorders) requiring prompt treatment, severely abnormal laboratory test results, or the presence of other psychological, familial, or sociogeographic factors posing high-risk.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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