Trial · NCT01835145

Cabozantinib-S-Malate Compared With Temozolomide or Dacarbazine in Treating Patients With Metastatic Melanoma of the Eye That Cannot Be Removed by Surgery

NCT01835145, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2019-04-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Cabozantinib-S-Malate Compared With Temozolomide or Dacarbazine in Treating Patients With Metastatic Melanoma of the Eye That Cannot Be Removed by Surgery. Trials, record NCT01835145. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01835145

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Cabozantinib-S-Malate Compared With Temozolomide or Dacarbazine in Treating Patients With Metastatic Melanoma of the Eye That Cannot Be Removed by Surgery
NCT number: NCT01835145
Status: Completed
Phases: Phase 2
Enrollment: 47 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Recurrent Uveal Melanoma, Stage III Uveal Melanoma AJCC v7, Stage IIIA Uveal Melanoma AJCC v7, Stage IIIB Uveal Melanoma AJCC v7, Stage IIIC Uveal Melanoma AJCC v7, Stage IV Uveal Melanoma AJCC v7
Interventions: Cabozantinib S-malate, Dacarbazine, Laboratory Biomarker Analysis, Temozolomide
First posted: 2013-04-18
Last updated: 2022-08-04
Results first posted: 2019-04-26

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Proportion of Patients Without a Progression Free Survival Event at 4 Months (PFS4)	At 4 months	A patient will be declared a PFS4 success if they are on study and progression free for at least 4 months. Progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study, with an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. The success for each arm will be calculated independently as the number of successes divided by the total number of evaluable patients. A one-sided chi-squared test for a difference in PFS4 proportions will be used to test for a difference between arms.
Secondary	Confirmed Response Rate as Determined by the RECIST Criteria (Version 1.1)	Up to 2 years	The confirmed response rates will be estimated by dividing the number of confirmed responders by the number of evaluable patients. 95% confidence intervals will be calculated.
Secondary	Percentage of Patients Who Experienced Grade 3+ Adverse Events Regardless of Attribution	Up to 2 years	percentage of patients who experienced grade 3+ adverse events regardless of attribution, graded according to the National Cancer Institute CTCAE version 4.0
Secondary	Overall Survival (OS)	Number of days from registration until death, assessed up to 2 years	The distribution of OS time will be estimated using the method of Kaplan Meier.
Secondary	PFS	Number of days from registration until disease progression (or death), assessed up to 2 years	The distribution of PFS time will be estimated using the method of Kaplan Meier and is defined as the number of days from registration until disease progression (or death). Progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study, with an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
Other	Pre-treatment GNAQ/GNA11 and Potentially Other Mutations in Tissue	Baseline	The proportions of patients within these groups pre-treatment will be presented with 90% exact binomial confidence intervals. These findings will be correlated with overall survival using a Student's T-test.
Other	Pre-treatment Immune Gene Expression in Tissue Defined as T Cell-inflamed, Intermediate and Non-T Cell-inflamed	Baseline	The proportions of patients within these groups pre-treatment will be presented with 90% exact binomial confidence intervals. These findings will be correlated with overall survival using a Student's T-test.

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Proportion of Patients Without a Progression Free Survival Event at 4 Months (PFS4)	At 4 months	All patients that began protocol treatment were included in this analysis.	proportion of participants	NUMBER
SECONDARY	Confirmed Response Rate as Determined by the RECIST Criteria (Version 1.1)	Up to 2 years		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Percentage of Patients Who Experienced Grade 3+ Adverse Events Regardless of Attribution	Up to 2 years		percentage of patients	NUMBER
SECONDARY	Overall Survival (OS)	Number of days from registration until death, assessed up to 2 years		months	MEDIAN
SECONDARY	PFS	Number of days from registration until disease progression (or death), assessed up to 2 years		months	MEDIAN
OTHER_PRE_SPECIFIED	Pre-treatment GNAQ/GNA11 and Potentially Other Mutations in Tissue	Baseline
OTHER_PRE_SPECIFIED	Pre-treatment Immune Gene Expression in Tissue Defined as T Cell-inflamed, Intermediate and Non-T Cell-inflamed	Baseline

Source ClinicalTrials.gov

Results by group10

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Proportion of Patients Without a Progression Free Survival Event at 4 Months (PFS4)	Arm I (Cabozantinib-s-malate)	.323	95% Confidence Interval .167 to .514	proportion of participants
Proportion of Patients Without a Progression Free Survival Event at 4 Months (PFS4)	Arm II (Temozolomide or Dacarbazine)	.267	95% Confidence Interval .078 to .551	proportion of participants
Confirmed Response Rate as Determined by the RECIST Criteria (Version 1.1)	Arm I (Cabozantinib-s-malate)	0		Participants
Confirmed Response Rate as Determined by the RECIST Criteria (Version 1.1)	Arm II (Temozolomide or Dacarbazine)	0		Participants
Percentage of Patients Who Experienced Grade 3+ Adverse Events Regardless of Attribution	Arm I (Cabozantinib-s-malate)	51.6		percentage of patients
Percentage of Patients Who Experienced Grade 3+ Adverse Events Regardless of Attribution	Arm II (Temozolomide or Dacarbazine)	20		percentage of patients
Overall Survival (OS)	Arm I (Cabozantinib-s-malate)	6.3	95% Confidence Interval 5.5 to 10.3	months
Overall Survival (OS)	Arm II (Temozolomide or Dacarbazine)	7.2	95% Confidence Interval 5.6 to NA	months
PFS	Arm I (Cabozantinib-s-malate)	2.0	95% Confidence Interval 1.8 to 5.3	months
PFS	Arm II (Temozolomide or Dacarbazine)	1.9	95% Confidence Interval 1.8 to 5.0	months

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm I (Cabozantinib-s-malate)	32
Overall Study	STARTED	Arm II (Temozolomide or Dacarbazine)	15
Overall Study	COMPLETED	Arm I (Cabozantinib-s-malate)	31
Overall Study	COMPLETED	Arm II (Temozolomide or Dacarbazine)	15
Overall Study	NOT COMPLETED	Arm I (Cabozantinib-s-malate)	1
Overall Study	NOT COMPLETED	Arm II (Temozolomide or Dacarbazine)	0

Source ClinicalTrials.gov

Adverse events381

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	Arm I (Cabozantinib-s-malate)	2	31	4
other	Anemia	Blood and lymphatic system disorders	Arm II (Temozolomide)	6	11	9
other	Anemia	Blood and lymphatic system disorders	Arm II (Dacarbazine)	0	4	0
other	Cardiac disorders - Other, specify	Cardiac disorders	Arm I (Cabozantinib-s-malate)	1	31	1
other	Cardiac disorders - Other, specify	Cardiac disorders	Arm II (Temozolomide)	0	11	0
other	Cardiac disorders - Other, specify	Cardiac disorders	Arm II (Dacarbazine)	0	4	0
other	Left ventricular systolic dysfunction	Cardiac disorders	Arm I (Cabozantinib-s-malate)	1	31	1
other	Left ventricular systolic dysfunction	Cardiac disorders	Arm II (Temozolomide)	0	11	0
other	Left ventricular systolic dysfunction	Cardiac disorders	Arm II (Dacarbazine)	0	4	0
other	Palpitations	Cardiac disorders	Arm I (Cabozantinib-s-malate)	2	31	3

1 to 10 of 381Source ClinicalTrials.gov

See all 381 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm I (Cabozantinib-s-malate)	2	31
Total, all-cause mortality	Arm II (Temozolomide)	1	11
Total, all-cause mortality	Arm II (Dacarbazine)	0	4
Total, other adverse events	Arm I (Cabozantinib-s-malate)	30	31
Total, other adverse events	Arm II (Temozolomide)	11	11
Total, other adverse events	Arm II (Dacarbazine)	4	4
Total, serious adverse events	Arm I (Cabozantinib-s-malate)	15	31
Total, serious adverse events	Arm II (Temozolomide)	6	11
Total, serious adverse events	Arm II (Dacarbazine)	2	4

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
33170593	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
U10CA180821	Alliance for Clinical Trials in Oncology Operations Center	Galanis, Evanthia; Hahn, Olwen; Kozono, David	ALLIANCE NCTN FOUNDATION	NATIONAL CANCER INSTITUTE	2014 to 2026	NIH RePORTER
U10CA031946	Cancer and Leukemia Group B	BERTAGNOLLI, MONICA M	BRIGHAM AND WOMEN'S HOSPITAL	NATIONAL CANCER INSTITUTE	1985 to 2013	NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Arm I (Cabozantinib-s-malate) vs Arm II (Temozolomide or Dacarbazine): Confirmed Response Rate as Determined by the RECIST Criteria (Version 1.1)

Source Trial comparisons

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT01835145

GET https://conductscience.org/api/trials/v1/NCT01835145/events?page=2

API reference For AI assistants