Trial · NCT02014636
Safety and Efficacy Study of Pazopanib and MK 3475 in Advanced Renal Cell Carcinoma (RCC; KEYNOTE-018)
NCT02014636, Phase 1, Completed, Novartis Pharmaceuticals
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy Study of Pazopanib and MK 3475 in Advanced Renal Cell Carcinoma (RCC; KEYNOTE-018). Trials, record NCT02014636. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02014636
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Study of Pazopanib and MK 3475 in Advanced Renal Cell Carcinoma (RCC; KEYNOTE-018)
- NCT number
- NCT02014636
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 42 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Carcinoma, Renal Cell
- Interventions
- Pazopanib, MK-3475
- First posted
- 2013-12-18
- Last updated
- 2020-03-03
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs ) | From the start of study treatment (first dose) and, until the post-treatment follow-up visit (at least 30 days after the last dose of investigational product) for AEs, and until 90 days after last dose for SAEs | |
| Primary | Part 1: To determine the dose limiting toxicity (DLT) and maximum tolerated regimen (MTR) | 8 weeks | MTR is defined as the highest dose of pazopanib in combination with the highest dose of MK 3475 at which no more than 1 of 6 subjects experiences a DLT after a minimum of 8 weeks of treatment. DLT is defined as a drug-related AE starting in the first 8 weeks of treatment |
| Primary | Part 1: Number of subjects with permanent discontinuation of treatment, dose reductions, interruptions, or delays | 24 months | |
| Primary | Part 1: Change from baseline in laboratory parameters | Average of 4 years | Laboratory assessments include haematology, clinical chemistry, urine, coagulation and thyroid function test |
| Primary | Part 1: Change from baseline in vital signs | 30 days after the last dose of study treatment | Vital sign measurements will include heart rate, temperature and blood pressure |
| Primary | Part 1: Change from baseline in cardiac parameters | 24 months | Cardiac assessments will include Electrocardiogram (ECG) and Echocardiograms (ECHOs) |
| Primary | Part 1: Incidence and titer of anti MK 3475 antibodies | 24 months | Subjects will be monitored for anti-MK 3475 antibodies throughout the study |
| Primary | Part 2: Progression-free survival (PFS) | Average of 4 years | PFS is defined as the interval between the date of randomization and the earlier date of disease progression (using RECIST v1.1) or death due to any cause. |
| Secondary | Part 1: Dose escalation cohorts: pazopanib plasma concentrations and serum MK 3475 concentrations. | For Pazopanib: before and after the 1st and 2nd dose of MK-3475. For MK-3475: Until 6 months after the last dose of MK-3475 | For analysis of plasma pazopanib and serum MK 3475 concentrations, blood samples will be collected from all subjects |
| Secondary | Part 1: Pharmacokinetic (PK) parameters in Expansion cohort | For Pazopanib: before and after the 1st and 2nd dose of MK-3475. For MK-3475: Until 6 months after the last dose of MK-3475 | Area under the plasma concentration-time curve from time 0 to 24 hrs (AUC\[0-24\], maximum observed concentration (Cmax), tmax, and concentration at 24 hours (C24) of pazopanib; Pre-dose (trough) concentration at the end of the dosing interval (Ctau), and apparent clearance following oral dosing CL/F of pazopanib will be determined if data permit. |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT02014636
GET https://conductscience.org/api/trials/v1/NCT02014636/registered?page=2