Immunotherapy combo before kidney surgery shows promise in small trial
NCT ID NCT04028245
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tested two immunotherapy drugs (spartalizumab and canakinumab) given before surgery to 17 people with localized clear cell kidney cancer. The main goal was to see if this approach was safe and did not delay surgery. The study also looked at how the drugs affected the immune system and tumor shrinkage.
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
-
Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
-
17 people
The number who actually took part.
- Started
-
Aug 2019
- Finished
-
Mar 2026
- 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 to 99 years
- 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 Hide 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: * Radiographically consistent with or histologically confirmed clear cell RCC or predominantly clear cell RCC * Localized non-metastatic RCC T1b-T4NanyM0 or TanyN1M0) * Schedule to undergo either partial or radical nephrectomy as part of the treatment plan * Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 * Age ≥ 18 years old at time of consent * HIV-infected patients who are healthy and have a low risk of AIDS-related outcomes as defined by the following * Cluster of differentiation 4 (CD4+) T cell counts ≥ 350 cells/microliter OR undetectable HIV viral load * no history of AIDS-defining opportunistic infection in the last year * Normal organ and marrow function as defined below: * White blood cell count (WBC) \> 3.0 K/mm3 * Absolute neutrophil count (ANC) ≥ 1.5 K/mm3 * Platelets ≥ 100 K/mm3 * Hemoglobin (Hgb) ≥ 9 g/dL * Serum total bilirubin: ≤ 1.5 x upper limit of normal (ULN) * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 x ULN * Serum creatinine ≤ 1.5 x ULN or serum creatinine \> 1.5 - 3 x ULN if calculated * creatinine clearance (CrCl) is ≥ 30 mL/min * For patients with known chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated * For patients with a history of hepatitis C virus (HCV) infection, the infection must be treated and cured * Willingness to provide written informed consent and HIPAA authorization for the release of personal health information, and the ability to comply with the study requirements (note: HIPAA authorization will be included in the informed consent) * Willingness to use barrier contraception from the time of first dose of canakinumab and spartalizumab until 120 days after surgical intervention Exclusion Criteria: * Presence of distant metastases * Presence of active, known or suspected autoimmune disease. * No patients with documented, active infections, treated or untreated, may be included in this study * Use of any live vaccines against infectious disease within 4 weeks of initiation ot study treatment. * Prior therapy with experimental anti-tumor vaccines; any T cell co-stimulation or checkpoint pathways * Prior treatment for RCC including surgery, radiation, thermoablation, or systemic therapy * Surgery within 28 days of starting study treatment * Prior treatment with any antibody or drug targeting T cell costimulation or immune checkpoint pathways (anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, etc) * Systemic chronic steroid therapy (≥ 10mg/day prednisone or equivalent) or any immunosuppressive therapy 7 days prior to planned date of first dose of study treatment. Note: Topical, inhaled, nasal and ophthalmic steroids are allowed * Allogenic bone marrow or solid organ transplant * History of severe hypersensitivity reactions to other monoclonal antibodies, which in the opinion of the investigator may pose an increased risk of serious infusion reaction * History or current interstitial lung disease or non-infectious pneumonitis requiring the use of home oxygen * History of severe hypersensitivity reaction to other monoclonal antibodies * Current signs or symptoms of severe progressive or uncontrolled, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, or cardiac disease other than directly related to RCC * Positive tests for hepatitis B surface antigen or hepatitis C ribonucleic acid (RNA) * History of known or suspected autoimmune disease with the following exceptions: * Vitiligo * Resolved childhood atopic dermatitis * Psoriasis (with exception of psoriatic arthritis) not requiring systemic treatment (within the past 2 years). * Patients with Grave's disease or Hashimoto's thyroiditis that are now euthyroid clinically and by laboratory testing. * History of malignancy within the last 2 years, with the exception of non-melanoma skin cancers and superficial bladder cancer * Uncontrolled major active infectious, cardiovascular, pulmonary, hematologic, or psychiatric illnesses that would make the patient a poor study candidate
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Carcinoma, renal cell are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Columbia University Irving Medical Center
New York, New York, 10032, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A simple blood draw may spot kidney cancer early
- Personalized vaccine trains immune system to attack kidney cancer blood vessels
- New kidney cancer drug shows promise in early trial
- New hope for advanced kidney cancer: belzutifan takes on everolimus in major trial
- New hope for advanced kidney cancer: Triple-Drug combo shows promise
- New drug cocktail aims to fight advanced cancers