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Kidney cancer trial pulled before it even started

NCT ID NCT05487859

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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 This study
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.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Summary

This study planned to test whether adding acarbose, a drug normally used for diabetes, could improve standard immunotherapy for advanced kidney cancer. The goal was to see if the combination was safe and affected gut bacteria. However, the trial was withdrawn before enrolling any participants, so no results are available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Acarbose (a diabetes drug that may affect the immune system)
What this could lead to
If it had worked, this could have pointed toward a new way to boost standard immunotherapy for advanced kidney cancer.
What could go wrong
The trial was withdrawn before any patients enrolled, so we have no data on safety or effectiveness. Acarbose is not a standard cancer treatment, and its benefits in this setting are entirely unknown.

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.

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

Dec 2026

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: 1. Histologically confirmed diagnosis of clear cell or non-clear cell carcinoma of the kidney, except for medullary carcinoma, collecting duct carcinoma, lymphoma and sarcoma. Sarcomatoid features of any degree are allowed 2. Must have locally advanced or unresectable metastatic disease (i.e., newly diagnosed Stage IV RCC per American Joint Committee on Cancer) or has recurrent disease. 3. Has measurable disease per RECIST 1.1 as assessed by the investigator/site radiologist. 4. Has received no prior systemic therapy for advanced RCC in the past 3 weeks. 5. Has Karnofsky performance status (KPS) ≥ 60% as assessed within 10 days prior to randomization. 6. If receiving bone resorptive therapy (including but not limited to bisphosphonate or RANK-L inhibitor) must have therapy initiated at least 2 weeks prior to randomization. 7. Demonstrates adequate organ function defined as follows 1. Liver function liver function (bilirubin \< 3mg/dL, AST and/or ALT \<3 x ULN) 2. Kidney function (CrCL \>=15ml/min using cockroft-gault method) 3. ANC \>= 500/microliter, Hemoglobin \> 8 mg/dL, platelet count \> 50,000/microliter 8. CNS metastasis is allowed if has been treated \>3 weeks and patient has achieved clinical stability with no new neurologic deficits in the interim 9. Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study drugs. Male participants of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study drug through 120 days after the last dose of study drug. Exclusion Criteria: * 1\. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to randomization. 2\. Has had major surgery within 4 weeks, received radiation therapy within 2 weeks prior to randomization, or has not recovered (i.e., ≤ Grade 1 or at baseline) from AEs due to prior treatment. 3\. Has a history of severe hypersensitivity reaction (e.g., generalized rash/erythema, hypotension, bronchospasm, angioedema or anaphylaxis) to acarbose or investigators choice of standard of care therapy. 4\. Has a diagnosis of immunodeficiency OR is receiving a systemic steroid therapy exceeding physiologic corticosteroid dose or any other form of immunosuppressive therapy within 7 days prior to randomization, except in the case of central nervous system (CNS) metastases. 5\. Has an active autoimmune disease requiring systemic treatment with in the past 2 years OR a documented history of clinically severe autoimmune disease. Note: Participants with vitiligo, Sjøgren's syndrome, Type 1 diabetes, resolved childhood asthma/atopy, hypothyroidism or adrenal or pituitary insufficiency who are stable on hormone replacement, are not excluded. 6\. Has a known additional malignancy that has progressed or has required active treatment in the last 3 years. Note: Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ such as breast cancer in situ are acceptable if they have undergone potentially curative therapy. Low grade prostate cancer with gleason score 6 or lower which is not under active therapy will be acceptable if in investigator judgement it is likely not a competing risk to patient's life expectancy. 7\. Has known active untreated CNS metastases and/or carcinomatous meningitis. 8. Has an active infection requiring systemic therapy. 9. Has received a live virus vaccine within 30 days of randomization. 10. Has a clinically significant gastrointestinal (GI) abnormality including Malabsorption, total gastric resection or any condition that might affect the absorption of orally taken medication. 11\. Active GI bleeding, as evidenced by hematemesis, hematochezia or melena in the past 3 months without evidence of resolution documented by endoscopy or colonoscopy 12. Has QT interval corrected for heart rate (QTc) ≥480 msec. 13. Has a history of any of the following cardiovascular conditions within 6 months of randomization: Myocardial infarction, Unstable angina pectoris Cardiac angioplasty or stenting, Coronary/peripheral artery bypass graft, Class III or IV congestive heart failure per New York Heart Association and Cerebrovascular accident or transient ischemic attack. 14\. Has poorly controlled hypertension defined as systolic blood pressure (SBP) ≥150 mm Hg and/or diastolic blood pressure (DBP) ≥90 mm Hg measured two times a day - despite the use of 3 or more antihypertensive medications. 15\. Has recorded hypoglycemic episodes with blood glucose \<60 mg/dL documented within the last 12 months. 16\. Has medication treated diabetes and HbA1c \< 8 gm/dL 17. Has hemoptysis within 6 weeks prior to randomization. 18. Has current use (within 7 days of randomization) or anticipated need for treatment with drugs or foods that are known strong cytochrome P450 (CYP3A4/5) inhibitors. 19\. Has current use (within 7 days of randomization) or anticipated need for treatment with drugs that are known strong CYP3A4/5 inducers, including but not limited to carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, and St. John's wort; or drugs that are known with proarrhythmic potential. 20\. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study. 21\. Has had a prior solid organ transplant. 22. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study drug.

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Conditions

The condition(s) this trial relates to.

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