Kidney CancerPhase 2NCT02964078
Interleukin-2 and Pembrolizumab for Metastatic Kidney Cancer
A Phase 2 study testing Pembrolizumab and Interleukin-2 in people with Kidney Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
The main purpose of this study is to evaluate the effects of the interleukin-2 given in combination with pembrolizumab. Interleukin-2 (IL-2) is also called aldesleukin, or Proleukin™. Pembrolizumab is also called Keytruda™, or anti-PD-1 antibody. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Cancer
- What is being tested?
- Pembrolizumab and Interleukin-2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2017to 30 Oct 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Diagnosis/Condition for Entry into the Trial: Metastatic kidney cancer. Clear cell histology component from primary or metastatic lesion.
- Willing and able to provide written informed consent for the trial.
- Age over 18 on day of signing informed consent.
- Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
- Willing to provide tissue from a newly obtained or archival tissue, if available.
- Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
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- Demonstrate adequate organ function, as outlined in Table 1 of study protocol document.
- Females of childbearing potential must have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Females of childbearing potential must agree to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication.
- Males must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.
- Cardiac testing with either exercise stress test or thallium stress test, within 3 months of start of the first treatment day. Atrial fibrillation that is rate controlled is allowed. Note - the first treatment day is about 9 weeks before the first IL-2 treatment day. If a cardiologist's evaluation determines that this is superfluous based on other assessments, then this may be omitted.
- Pulmonary function test is required, within 3 months of start.
Who cannot join
- Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
- Has a known history of active Bacillus Tuberculosis (TB).
- Has hypersensitivity to pembrolizumab or any of its excipients.
- The number of prior therapies is restricted as follows: (a) Zero or one prior therapies during the preceding one year. This serves to limit the treatment cohort to patients with either only slowly progressive disease, or up to one prior therapy. (b) No prior PD-1 or PD-L1 antibody therapies are allowed. (c) Prior IL-2 is allowed, if it finished more than 1 year prior. (d) The following are not counted as medical therapies: nephrectomy, radiation therapy, other energy-ablative techniques, or metastasectomy.
- Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
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- Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent. - Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study. - Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Potential participants with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment that would be exclusionary.
- Has known history of, or any evidence of active, non-infectious pneumonitis.
- Has an active infection requiring systemic therapy.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
- Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
- Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., hepatitis C virus (HCV) RNA [qualitative] is detected).
- Has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
- Myocardial infarction, stroke, coronary artery bypass surgery, coronary stent, or unstable angina within one year.
Trial locations and contacts
1 site in 1 country.
United States1 site
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
Official title: Coordinated High Dose Interleukin-2 (Aldesleukin, Proleukin™) and Pembrolizumab (Anti-PD1, Keytruda™) for Therapy of Metastatic Kidney Cancer
The main purpose of this study is to evaluate the effects of the interleukin-2 given in combination with pembrolizumab.
Interleukin-2 (IL-2) is also called aldesleukin, or Proleukin™.
Pembrolizumab is also called Keytruda™, or anti-PD-1 antibody.
Read the detailed description
The treatment is organized into blocks of 9 weeks, with pembrolizumab treatment planned for weeks 1, 4 and 7. On the second and third blocks, interleukin-2 is added, for 5 doses at a time, one dose every 8 hours, on a weekly schedule on the two weeks after the week 1 and the week 4 pembrolizumab doses.
There is no dose escalation portion: The dose and schedule of IL-2 is fixed, 600,000 IU/kg/dose, with a cap of 66 mIU/dose. Doses may be omitted for safety. The dose of pembrolizumab is fixed, flat dose 200 mg/dose.
- Conditions
- Kidney Cancer
- Being tested
- Pembrolizumab, Interleukin-2
- Keywords
- Kidney Disease, Metastatic, Antibody
- Medical subject headings
- Kidney Neoplasms, Kidney Diseases, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Also called anti-PD-1 antibody, Keytruda™
Pembrolizumab: 200 mg every 3 weeks, 12 doses planned. This is considered the investigational part of the combination. The infusion time is 1 hour.
Interleukin-2Drug
Also called aldesleukin, Proleukin™, IL-2
Interleukin-2: 8 admissions to hospital, each with 5 doses planned. This is considered the standard part of the combination. The standard interleukin-2 dose is 600,000 international units per kilogram per dose, with a maximum of 66,000,000 (for patients over 110 kg, which is 242 pounds). The dose is usually set at the start of the treatment and not adjusted. The infusion time is 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Pembrolizumab and Interleukin-2 | Experimental | Outpatient Intravenous (IV) infusion of Pembrolizumab and Inpatient IV infusion of Interleukin-2. Receives: Drug: Pembrolizumab; Drug: Interleukin-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
Overall Response According to Immune-related response criteria (irRC). Overall response rate ORR is defined with confirmation of the response status Complete Response (CR) or Partial Response (PR) among the combination treatment population patients; the binomial estimate and its one-sided 95% confidence interval will be reported. CR: Disappearance of all lesions in two consecutive observation not less than 4 weeks apart. PR: ≥50% decrease in tumor burden compared with baseline in two observations at least 4 weeks apart.
Measured: Up to 24 months
Secondary outcomes (2)
Overall Survival (OS) of Intent to Treat (ITT) Population
Analysis: Overall Survival (OS) of ITT patients using Kaplan-Meier estimate, counting from the eligible date to death from any cause, or censored on end of known follow up, either within this study or in the Prometheus Laboratories sponsored PROCLAIM registry (PROCLAIM Registry to Evaluate the Treatment Patterns and Clinical Response in Malignancy, NCT01415167).
Measured: Up to 24 months
Progression Free Survival (PFS)
Progression-free survival (PFS) of ITT patients using Kaplan Meier estimate, from the confirmed eligible date to the first occurrence of disease progression or death, from any cause, or lost to follow up, whichever is earliest; or censored at last follow-up during study. Progressive Disease (PD): At least 25% increase in tumor burden compared with nadir (at any single time point) in two consecutive observations at least 4 weeks apart.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2016 (estimated)
- Study start25 Apr 2017
- Primary completion26 Mar 2019
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Prometheus Laboratories
- Responsible party
- Sponsor
- Investigators
- Jon Chatzkel, MD, Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02964078
- Sponsor's protocol ID
- MCC-18536
- Other IDs
- MISP# 52587, IIT15PLK02
- Status last verified
- Jun 2026
- First submitted
- 11 Nov 2016
- Last updated
- 2 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Johnson JS, Miller JW, Hatoum F, Schell MJ, Yu X, Roman Souza G, Mizelle S, Gullapalli K, Fazili A, Jain R, Chatzkel J, Cen L, Dhillon J, Cubitt C, Yao J, Whiting J, Li J, Swank J, Jameel G, Zhang J, Wang X, Spiess PE, Fishman M, Chahoud J. Pembrolizumab plus high-dose IL-2 in advanced clear cell renal cell carcinoma: six-year survival outcomes and molecular signatures from a phase 2 trial. Nat Commun. 2026 May 25;17(1):6788. doi: 10.1038/s41467-026-73336-1.
PubMed 42185255
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coordinated High Dose Interleukin-2 (Aldesleukin, Proleukin™) and Pembrolizumab (Anti-PD1, Keytruda™) for Therapy of Metastatic Kidney Cancer
- ClinicalTrials.gov ID
- NCT02964078
- Acronym / sponsor ID
- MCC-18536
- Conditions
- Kidney Cancer
- Keywords
- Kidney Disease, Metastatic, Antibody
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Prometheus Laboratories
- Study start
- 25 Apr 2017 (actual)
- Primary completion
- 26 Mar 2019 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 15 Nov 2016 (estimated)
- Results
- Posted 1 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to evaluate the effects of the interleukin-2 given in combination with pembrolizumab.
Interleukin-2 (IL-2) is also called aldesleukin, or Proleukin™.
Pembrolizumab is also called Keytruda™, or anti-PD-1 antibody.
Detailed description
The treatment is organized into blocks of 9 weeks, with pembrolizumab treatment planned for weeks 1, 4 and 7. On the second and third blocks, interleukin-2 is added, for 5 doses at a time, one dose every 8 hours, on a weekly schedule on the two weeks after the week 1 and the week 4 pembrolizumab doses.
There is no dose escalation portion: The dose and schedule of IL-2 is fixed, 600,000 IU/kg/dose, with a cap of 66 mIU/dose. Doses may be omitted for safety. The dose of pembrolizumab is fixed, flat dose 200 mg/dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pembrolizumab and Interleukin-2 | Experimental | Drug: Pembrolizumab, Drug: Interleukin-2Outpatient Intravenous (IV) infusion of Pembrolizumab and Inpatient IV infusion of Interleukin-2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Diagnosis/Condition for Entry into the Trial: Metastatic kidney cancer. Clear cell histology component from primary or metastatic lesion.
- Willing and able to provide written informed consent for the trial.
- Age over 18 on day of signing informed consent.
- Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
- Willing to provide tissue from a newly obtained or archival tissue, if available.
Key exclusion criteria (20 listed)
- Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
- Has a known history of active Bacillus Tuberculosis (TB).
- Has hypersensitivity to pembrolizumab or any of its excipients.
- The number of prior therapies is restricted as follows: (a) Zero or one prior therapies during the preceding one year. This serves to limit the treatment cohort to patients with either only slowly progressive disease, or up to one prior therapy. (b) No prior PD-1 or PD-L1 antibody therapies are allowed. (c) Prior IL-2 is allowed, if it finished more than 1 year prior. (d) The following are not counted as medical therapies: nephrectomy, radiation therapy, other energy-ablative techniques, or metastasectomy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PembrolizumabAlso: anti-PD-1 antibody, Keytruda™Pembrolizumab: 200 mg every 3 weeks, 12 doses planned. This is considered the investigational part of the combination. The infusion time is 1 hour. | Drug | Pembrolizumab and Interleukin-2 |
| Interleukin-2Also: aldesleukin, Proleukin™, IL-2Interleukin-2: 8 admissions to hospital, each with 5 doses planned. This is considered the standard part of the combination. The standard interleukin-2 dose is 600,000 international units per kilogram per dose, with a maximum of 66,000,000 (for patients over 110 kg, which is 242 pounds). The dose is usually set at the start of the treatment and not adjusted. The infusion time is 15 minutes. | Drug | Pembrolizumab and Interleukin-2 |
Primary outcome
Overall Response Rate (ORR)
Time frame: Up to 24 months
Overall Response According to Immune-related response criteria (irRC). Overall response rate ORR is defined with confirmation of the response status Complete Response (CR) or Partial Response (PR) among the combination treatment population patients; the binomial estimate and its one-sided 95% confidence interval will be reported. CR: Disappearance of all lesions in two consecutive observation not less than 4 weeks apart. PR: ≥50% decrease in tumor burden compared with baseline in two observations at least 4 weeks apart.
2 secondary outcomes
Overall Survival (OS) of Intent to Treat (ITT) Population
Time frame: Up to 24 months
Progression Free Survival (PFS)
Time frame: Up to 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42185255Johnson JS, Miller JW, Hatoum F, Schell MJ, Yu X, Roman Souza G, Mizelle S, Gullapalli K, Fazili A, Jain R, Chatzkel J, Cen L, Dhillon J, Cubitt C, Yao J, Whiting J, Li J, Swank J, Jameel G, Zhang J, Wang X, Spiess PE, Fishman M, Chahoud J. Pembrolizumab plus high-dose IL-2 in advanced clear cell renal cell carcinoma: six-year survival outcomes and molecular signatures from a phase 2 trial. Nat Commun. 2026 May 25;17(1):6788. doi: 10.1038/s41467-026-73336-1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jon Chatzkel, MD principal investigator
H. Lee Moffitt Cancer Center and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab and Interleukin-2 in people with Kidney Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site 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 12 inclusion and 20 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: finished, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 phase mean?
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?
Yes. Results are posted in the registry (first posted 1 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Response Rate (ORR) (time frame: Up to 24 months). 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 NCT02964078, which also lists 1 linked publication.
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 2 Jul 2026.