Trial · NCT02496208
Cabozantinib S-malate and Nivolumab With or Without Ipilimumab in Treating Patients With Metastatic Genitourinary Tumors
NCT02496208, Phase 1, Active not recruiting, National Cancer Institute (NCI)
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Cabozantinib S-malate and Nivolumab With or Without Ipilimumab in Treating Patients With Metastatic Genitourinary Tumors. Trials, record NCT02496208. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02496208
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cabozantinib S-malate and Nivolumab With or Without Ipilimumab in Treating Patients With Metastatic Genitourinary Tumors
- NCT number
- NCT02496208
- Status
- Active not recruiting
- Phases
- Phase 1
- Enrollment
- 152 participants, estimated
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Bladder Small Cell Neuroendocrine Carcinoma, Bladder Squamous Cell Carcinoma, Bladder Urothelial Carcinoma, Clear Cell Renal Cell Carcinoma, Invasive Bladder Plasmacytoid Urothelial Carcinoma, Invasive Bladder Sarcomatoid Urothelial Carcinoma, Invasive Sarcomatoid Urothelial Carcinoma, Kidney Medullary Carcinoma, Malignant Genitourinary System Neoplasm, Malignant Solid Neoplasm, Penile Carcinoma, Penile Squamous Cell Carcinoma, Renal Cell Carcinoma, Renal Pelvis Urothelial Carcinoma, Sarcomatoid Renal Cell Carcinoma, Stage III Bladder Cancer AJCC v8, Stage III Penile Cancer AJCC v8, Stage III Renal Cell Cancer AJCC v8, Stage III Renal Pelvis and Ureter Cancer AJCC v8, Stage III Renal Pelvis Cancer AJCC v8, Stage III Ureter Cancer AJCC v8, Stage III Urethral Cancer AJCC v8, Stage IV Bladder Cancer AJCC v8, Stage IV Penile Cancer AJCC v8, Stage IV Renal Cell Cancer AJCC v8, Stage IV Renal Pelvis and Ureter Cancer AJCC v8, Stage IV Ureter Cancer AJCC v8, Stage IV Urethral Cancer AJCC v8, Ureter Urothelial Carcinoma, Urethral Urothelial Carcinoma
- Interventions
- Biopsy Procedure, Biospecimen Collection, Cabozantinib S-malate, Computed Tomography, Echocardiography Test, Ipilimumab, Magnetic Resonance Imaging, Nivolumab
- First posted
- 2015-07-14
- Last updated
- 2026-11-12
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recommended phase II dose (Phase I) | Up to 4-6 weeks | Will be defined as the highest dose for which no more than 1/6 patients experience a dose limiting toxicity evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. The safe dose level of cabozantinib and nivolumab, as well as of cabozantinib, nivolumab, and ipilimumab will be established. |
| Primary | Incidence of adverse events (Phase I) | Up to 30 days post treatment | Will be evaluated according National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. The safety and tolerability of a novel dose of cabozantinib, nivolumab and ipilimumab in patients with genitourinary cancer will be assessed. |
| Secondary | Clinical response rate | Up to 3 years | Will be assessed by Response Evaluation Criteria in Solid Tumors 1.1 and Immune-Related Response Criteria. The response rate may be used to guide the further development of the combinations. |
| Secondary | Fraction of patients who have been identified as being alive and progression free at two months | At 2 months | May be determined as well and reported on both arms. This fraction will be considered as a secondary endpoint for the expansion cohorts as well, and this information may be used to guide the further development of the combinations. A Kaplan-Meier curve for progression free survival will also be presented as a secondary endpoint, in addition to reporting the fraction without progression at two months. |
| Secondary | PDL-1 and MET expression | Up to day 1 of final cycle | PDL-1 and MET expression data will be obtained in patients with urothelial carcinoma checkpoint inhibition naive, clear cell renal cell carcinoma, adenocarcinoma of the bladder, squamous cell carcinoma of the bladder, urothelial carcinoma with prior checkpoint inhibition therapy, and penile cancer. Data will be obtained in pre- and post-treatment biopsies and analyze, in at least an exploratory fashion, their association to response or clinical benefit. |
| Other | Overall response rate in patients receiving ipilimumab challenge/re-challenge | Up to 3 years | The overall response rates determined at this time point will be combined and reported along with 95% confidence intervals. |
| Other | Progression free survival in bone-only urothelial carcinoma | Up to 3 years | Patients with bone-only disease will be enrolled and evaluated using progression free survival for a descriptive analysis of the effect of treatment. In addition, if PDL-1 or MET data are obtained in this small cohort, exploratory and descriptive analyses may be done as appropriate. |
Source ClinicalTrials.gov
Outcomes0
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.
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants4
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| UM1CA186712 | The Ohio State University as a Lead Academic Organization (LAO) for the Experimental Therapeutics Clinical Trials Network | CARSON, WILLIAM E.; ARNOLD, SUSANNE M; EPPERLA, NARENDRANATH | OHIO STATE UNIVERSITY | NATIONAL CANCER INSTITUTE | 2014 to 2025 | NIH RePORTER |
| UM1CA186717 | Phase 1 and 2 Molecular and Clinical Pharmacodynamic Trials ETCTN | DANILOV, ALEXEY V.; COLEVAS, A. DIMITRIOS; LARA, PRIMO N.; LENZ, HEINZ JOSEF | BECKMAN RESEARCH INSTITUTE/CITY OF HOPE | NATIONAL CANCER INSTITUTE | 2014 to 2025 | NIH RePORTER |
| ZIABC011078 | Phase 0-1 Clinical Trials | DOROSHOW, JAMES | DIVISION OF BASIC SCIENCES - NCI | NATIONAL CANCER INSTITUTE | 2009 to 2025 | NIH RePORTER |
| UM1CA186716 | Wisconsin and New Jersey Alliance in Precision Experimental Therapeutics | JABBOUR, SALMA; LIU, GLENN | RBHS -CANCER INSTITUTE OF NEW JERSEY | NATIONAL CANCER INSTITUTE | 2014 to 2019 | NIH RePORTER |
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/NCT02496208
GET https://conductscience.org/api/trials/v1/NCT02496208/registered