Trial · NCT02964078
Interleukin-2 and Pembrolizumab for Metastatic Kidney Cancer
NCT02964078, Phase 2, Completed, H. Lee Moffitt Cancer Center and Research Institute; results first posted 2020-04-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Interleukin-2 and Pembrolizumab for Metastatic Kidney Cancer. Trials, record NCT02964078. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02964078
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Interleukin-2 and Pembrolizumab for Metastatic Kidney Cancer
- NCT number
- NCT02964078
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 27 participants, actual
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Conditions
- Kidney Cancer
- Interventions
- Pembrolizumab, Interleukin-2
- First posted
- 2016-11-15
- Last updated
- 2026-07-02
- Results first posted
- 2020-04-01
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) | 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. |
| Secondary | Overall Survival (OS) of Intent to Treat (ITT) Population | Up to 24 months | 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). |
| Secondary | Progression Free Survival (PFS) | Up to 24 months | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate (ORR) | Up to 24 months | percentage of participants | MEDIAN | |
| SECONDARY | Overall Survival (OS) of Intent to Treat (ITT) Population | Up to 24 months | proportion of participants | NUMBER | |
| SECONDARY | Progression Free Survival (PFS) | Up to 24 months | proportion of participants | NUMBER |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate (ORR) | Pembrolizumab and Interleukin-2 | 70.4 | 90% Confidence Interval 54.6 to 100 | percentage of participants | |
| Overall Survival (OS) of Intent to Treat (ITT) Population | Pembrolizumab and Interleukin-2 | 1 | 95% Confidence Interval .871 to 1 | proportion of participants | |
| Progression Free Survival (PFS) | Pembrolizumab and Interleukin-2 | .630 | 95% Confidence Interval .421 to .781 | proportion of participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pembrolizumab and Interleukin-2 | 27 | |
| Overall Study | COMPLETED | Pembrolizumab and Interleukin-2 | 27 | |
| Overall Study | NOT COMPLETED | Pembrolizumab and Interleukin-2 | 0 |
Source ClinicalTrials.gov
Adverse events124
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Creatinine increased | Investigations | Pembrolizumab and Interleukin-2 | 7 | 27 | 12 |
| other | Lymphocyte count decreased | Investigations | Pembrolizumab and Interleukin-2 | 7 | 27 | 19 |
| other | Blood bilirubin increased | Investigations | Pembrolizumab and Interleukin-2 | 5 | 27 | 6 |
| other | Urine output decreased | Investigations | Pembrolizumab and Interleukin-2 | 3 | 27 | 4 |
| other | Alanine aminotransferase increased | Investigations | Pembrolizumab and Interleukin-2 | 2 | 27 | 2 |
| other | Electrocardiogram QT corrected interval prolonged | Investigations | Pembrolizumab and Interleukin-2 | 2 | 27 | 2 |
| other | Investigations - Other | Investigations | Pembrolizumab and Interleukin-2 | 2 | 27 | 2 |
| other | Aspartate aminotransferase increased | Investigations | Pembrolizumab and Interleukin-2 | 1 | 27 | 1 |
| other | Weight gain | Investigations | Pembrolizumab and Interleukin-2 | 1 | 27 | 1 |
| other | Hypophosphatemia | Metabolism and nutrition disorders | Pembrolizumab and Interleukin-2 | 8 | 27 | 14 |
1 to 10 of 124Source ClinicalTrials.gov
See all 124 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pembrolizumab and Interleukin-2 | 0 | 27 |
| Total, other adverse events | Pembrolizumab and Interleukin-2 | 25 | 27 |
| Total, serious adverse events | Pembrolizumab and Interleukin-2 | 17 | 27 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42185255 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02964078
GET https://conductscience.org/api/trials/v1/NCT02964078/events?page=2