Trial · NCT04079712
Testing the Combination of XL184 (Cabozantinib), Nivolumab, and Ipilimumab for Poorly Differentiated Neuroendocrine Tumors
NCT04079712, Phase 2, Active not recruiting, National Cancer Institute (NCI); results first posted 2025-12-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Testing the Combination of XL184 (Cabozantinib), Nivolumab, and Ipilimumab for Poorly Differentiated Neuroendocrine Tumors. Trials, record NCT04079712. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04079712
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Testing the Combination of XL184 (Cabozantinib), Nivolumab, and Ipilimumab for Poorly Differentiated Neuroendocrine Tumors
- NCT number
- NCT04079712
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 17 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Metastatic Large Cell Neuroendocrine Carcinoma, Metastatic Neuroendocrine Carcinoma, Metastatic Neuroendocrine Neoplasm, Metastatic Small Cell Neuroendocrine Carcinoma
- Interventions
- Cabozantinib S-malate, Ipilimumab, Nivolumab
- First posted
- 2019-09-06
- Last updated
- 2026-09-22
- Results first posted
- 2025-12-12
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With a Response | Up to 3.5 years | Participants who are considered to have a response are those with either a complete response (CR) (disappearance of all target lesions) or a partial response (PR) (\>=30% decrease in the sum of the longest diameter of target lesions) using Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 and assessed by CT or MRI scan. |
| Secondary | Progression Free Survival (PFS) | Up to 3.5 years | Progression is defined as a \>= 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) and assessed by CT or MRI scan. The duration is from the date of registration to the time of progression or death, whichever occurs first. |
| Secondary | Number of Participants Reporting Adverse Events | Up to 3.5 years | Adverse events will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) 5.0 criteria. The population is defined as all patients who have received the study treatment. The highest grade is reported. |
| Secondary | Disease Control Rate (DCR) | Up to 3.5 years | DCR will be defined as the achievement of Complete Response (CR) (disappearance of all target lesions), Partial Response (PR) (\>=30% decrease in the sum of the longest diameter of target lesions), or Stable Disease (SD) (between \< 30% decrease and \>20% increase in the sum of the longest diameter of target lesions) using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI scan. |
| Secondary | Duration of Response (DOR) | Up to 3.5 years | The time when measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. |
| Other | CD8+ T Lymphocytes | Up to Day 35 | Expression of CD8+ T lymphocytes in the tumor tissue at baseline and during treatment. |
| Other | Myeloid-Derived Suppressor Cells | Up to Day 35 | Presence of myeloid derived suppressor cells in the tumor before and during treatment. |
| Other | Tumor-associated Macrophages | Up to Day 35 | Presence of tumor-associated macrophages in the tumor at baseline and during treatment. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With a Response | Up to 3.5 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Progression Free Survival (PFS) | Up to 3.5 years | Days | MEDIAN | |
| SECONDARY | Number of Participants Reporting Adverse Events | Up to 3.5 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Disease Control Rate (DCR) | Up to 3.5 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Duration of Response (DOR) | Up to 3.5 years | Days | MEDIAN | |
| OTHER_PRE_SPECIFIED | CD8+ T Lymphocytes | Up to Day 35 | This biomarker assay was not performed as there were insufficient samples available to interpret the planned correlative studies. | ||
| OTHER_PRE_SPECIFIED | Myeloid-Derived Suppressor Cells | Up to Day 35 | This biomarker assay was not performed as there were insufficient samples available to interpret the planned correlative studies. | ||
| OTHER_PRE_SPECIFIED | Tumor-associated Macrophages | Up to Day 35 | This biomarker assay was not performed as there were insufficient samples available to interpret the planned correlative studies. |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With a Response | Treatment (Cabozantinib S-malate, Nivolumab, Ipilimumab) | Response | 2 | Participants | |
| Number of Participants With a Response | Treatment (Cabozantinib S-malate, Nivolumab, Ipilimumab) | No Response | 14 | Participants | |
| Progression Free Survival (PFS) | Treatment (Cabozantinib S-malate, Nivolumab, Ipilimumab) | 85 | Full Range 23 to 902 | Days | |
| Number of Participants Reporting Adverse Events | Treatment (Cabozantinib S-malate, Nivolumab, Ipilimumab) | Grade 5 | 0 | Participants | |
| Number of Participants Reporting Adverse Events | Treatment (Cabozantinib S-malate, Nivolumab, Ipilimumab) | Grade 4 | 3 | Participants | |
| Number of Participants Reporting Adverse Events | Treatment (Cabozantinib S-malate, Nivolumab, Ipilimumab) | Grade 3 | 7 | Participants | |
| Number of Participants Reporting Adverse Events | Treatment (Cabozantinib S-malate, Nivolumab, Ipilimumab) | Grades 1-2 | 6 | Participants | |
| Disease Control Rate (DCR) | Treatment (Cabozantinib S-malate, Nivolumab, Ipilimumab) | Achieved disease control | 9 | Participants | |
| Disease Control Rate (DCR) | Treatment (Cabozantinib S-malate, Nivolumab, Ipilimumab) | Did not achieve disease control | 7 | Participants | |
| Duration of Response (DOR) | Treatment (Cabozantinib S-malate, Nivolumab, Ipilimumab) | 664 | Full Range 504 to 824 | Days |
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 | Treatment (Cabozantinib S-malate, Nivolumab, Ipilimumab) | 17 | |
| Overall Study | COMPLETED | Treatment (Cabozantinib S-malate, Nivolumab, Ipilimumab) | 16 | |
| Overall Study | NOT COMPLETED | Treatment (Cabozantinib S-malate, Nivolumab, Ipilimumab) | 1 |
Source ClinicalTrials.gov
Adverse events129
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 | Anemia | Blood and lymphatic system disorders | Treatment (Cabozantinib S-malate, Nivolumab, Ipilimumab) | 6 | 17 | |
| other | Sinus bradycardia | Cardiac disorders | Treatment (Cabozantinib S-malate, Nivolumab, Ipilimumab) | 3 | 17 | |
| other | Sinus tachycardia | Cardiac disorders | Treatment (Cabozantinib S-malate, Nivolumab, Ipilimumab) | 1 | 17 | |
| other | Hearing impaired | Ear and labyrinth disorders | Treatment (Cabozantinib S-malate, Nivolumab, Ipilimumab) | 1 | 17 | |
| other | Adrenal insufficiency | Endocrine disorders | Treatment (Cabozantinib S-malate, Nivolumab, Ipilimumab) | 1 | 17 | |
| other | Hyperthyroidism | Endocrine disorders | Treatment (Cabozantinib S-malate, Nivolumab, Ipilimumab) | 3 | 17 | |
| other | Hypothyroidism | Endocrine disorders | Treatment (Cabozantinib S-malate, Nivolumab, Ipilimumab) | 5 | 17 | |
| other | Dry eye | Eye disorders | Treatment (Cabozantinib S-malate, Nivolumab, Ipilimumab) | 1 | 17 | |
| other | Vision Changes | Eye disorders | Treatment (Cabozantinib S-malate, Nivolumab, Ipilimumab) | 1 | 17 | |
| other | Abdominal distension | Gastrointestinal disorders | Treatment (Cabozantinib S-malate, Nivolumab, Ipilimumab) | 1 | 17 |
1 to 10 of 129Source ClinicalTrials.gov
See all 129 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Cabozantinib S-malate, Nivolumab, Ipilimumab) | 13 | 17 |
| Total, other adverse events | Treatment (Cabozantinib S-malate, Nivolumab, Ipilimumab) | 16 | 17 |
| Total, serious adverse events | Treatment (Cabozantinib S-malate, Nivolumab, Ipilimumab) | 10 | 17 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41968073 | DERIVED |
Source PubMed
Grants2
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 |
|---|---|---|---|---|---|---|
| UM1CA186689 | VICKtOrY Early Clinical Trials Consortium | LORUSSO, PATRICIA M. | YALE UNIVERSITY | NATIONAL CANCER INSTITUTE | 2014 to 2025 | NIH RePORTER |
| UM1CA186691 | The Johns Hopkins Translational Science Team and Consortium for ETCTN Studies | CARDUCCI, MICHAEL A; BEUMER, JAN HENDRIK; GENTZLER, RYAN; LIU, GLENN; MESSERSMITH, WELLS A.; RUIZ, JIMMY | JOHNS HOPKINS UNIVERSITY | NATIONAL CANCER INSTITUTE | 2014 to 2025 | 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/NCT04079712
GET https://conductscience.org/api/trials/v1/NCT04079712/events?page=2