Who is sponsoring NCT01835145?

NCT01835145 is sponsored by National Cancer Institute (NCI).

What drugs are being tested in NCT01835145?

Interventions in NCT01835145: Cabozantinib S-malate, Dacarbazine, Laboratory Biomarker Analysis, Temozolomide.

What condition does NCT01835145 study?

NCT01835145 studies 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.

Is NCT01835145 still recruiting?

NCT01835145 is currently completed. Last updated 4 August 2022.

Are results published for NCT01835145?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-08-04 · How we verify

NCT01835145

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2 Results posted Last updated 4 August 2022

What this trial tests

Phase 2 trial testing Cabozantinib S-malate in Recurrent Uveal Melanoma in 47 participants. Completed in 1 November 2019.

Timeline

31 July 2013

Primary endpoint
21 October 2016

1 November 2019

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	47
Start date	31 July 2013
Primary completion	21 October 2016
Estimated completion	1 November 2019
Sites	228 locations across Canada, United States

Drugs / interventions tested

Cabozantinib S-malate — full drug profile →
Dacarbazine (dacarbazine) — full drug profile →
Laboratory Biomarker Analysis — full drug profile →
Temozolomide (temozolomide) — full drug profile →

Conditions studied

Recurrent Uveal Melanoma — all drugs for Recurrent Uveal Melanoma →
Stage III Uveal Melanoma AJCC v7 — all drugs for Stage III Uveal Melanoma AJCC v7 →
Stage IIIA Uveal Melanoma AJCC v7 — all drugs for Stage IIIA Uveal Melanoma AJCC v7 →
Stage IIIB Uveal Melanoma AJCC v7 — all drugs for Stage IIIB Uveal Melanoma AJCC v7 →

Sponsor

National Cancer Institute (NCI)

Who can join

18 and older, any sex, with Recurrent Uveal Melanoma or Stage III Uveal Melanoma AJCC v7. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Proportion of Patients Without a Progression Free Survival Event at 4 Months (PFS4) Primary · 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 di

Group	Value	95% CI
Arm I (Cabozantinib-s-malate)	.323	.167 – .514
Arm II (Temozolomide or Dacarbazine)	.267	.078 – .551

Confirmed Response Rate as Determined by the RECIST Criteria (Version 1.1) Secondary · 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.

Group	Value	95% CI
Arm I (Cabozantinib-s-malate)	0
Arm II (Temozolomide or Dacarbazine)	0

Percentage of Patients Who Experienced Grade 3+ Adverse Events Regardless of Attribution Secondary · 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

Group	Value	95% CI
Arm I (Cabozantinib-s-malate)	51.6
Arm II (Temozolomide or Dacarbazine)	20

Overall Survival (OS) Secondary · 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.

Group	Value	95% CI
Arm I (Cabozantinib-s-malate)	6.3	5.5 – 10.3
Arm II (Temozolomide or Dacarbazine)	7.2	5.6 – NA

PFS Secondary · 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.

Group	Value	95% CI
Arm I (Cabozantinib-s-malate)	2.0	1.8 – 5.3
Arm II (Temozolomide or Dacarbazine)	1.9	1.8 – 5.0

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Arm I (Cabozantinib-s-malate)

Serious: 15/31 (48%)

Deaths: 2/31

Arm II (Temozolomide)

Serious: 6/11 (55%)

Deaths: 1/11

Arm II (Dacarbazine)

Serious: 2/4 (50%)

Deaths: 0/4

Serious adverse events (35 terms)

Reaction	System	Arm I (Cabozantinib-s-mala…	Arm II (Temozolomide)	Arm II (Dacarbazine)
Alanine aminotransferase increased	Investigations	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—
Thromboembolic event	Vascular disorders	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—
Diarrhea	Gastrointestinal disorders	—	—	—
Death NOS	General disorders	—	—	—
Fatigue	General disorders	—	—	—
Hepatobiliary disorders - Other, specify	Hepatobiliary disorders	—	—	—
Alkaline phosphatase increased	Investigations	—	—	—
Blood bilirubin increased	Investigations	—	—	—
Hyponatremia	Metabolism and nutrition disorders	—	—	—
Hypertension	Vascular disorders	—	—	—
Hyperthyroidism	Endocrine disorders	—	—	—
Nausea	Gastrointestinal disorders	—	—	—
Oral pain	Gastrointestinal disorders	—	—	—
Portal vein thrombosis	Hepatobiliary disorders	—	—	—
Anaphylaxis	Immune system disorders	—	—	—
Appendicitis perforated	Infections and infestations	—	—	—
Enterocolitis infectious	Infections and infestations	—	—	—
Lung infection	Infections and infestations	—	—	—
Creatinine increased	Investigations	—	—	—
Ejection fraction decreased	Investigations	—	—	—
Lipase increased	Investigations	—	—	—
Neutrophil count decreased	Investigations	—	—	—
Platelet count decreased	Investigations	—	—	—

Other adverse events (92 terms — click to expand)

Reaction	System	Arm I (Cabozantinib-s-mala…	Arm II (Temozolomide)	Arm II (Dacarbazine)
Aspartate aminotransferase increased	Investigations	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—
Fatigue	General disorders	—	—	—
Hypertension	Vascular disorders	—	—	—
Diarrhea	Gastrointestinal disorders	—	—	—
Platelet count decreased	Investigations	—	—	—
Nausea	Gastrointestinal disorders	—	—	—
Neutrophil count decreased	Investigations	—	—	—
Anorexia	Metabolism and nutrition disorders	—	—	—
Anemia	Blood and lymphatic system disorders	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—
Blood bilirubin increased	Investigations	—	—	—
Weight loss	Investigations	—	—	—
Proteinuria	Renal and urinary disorders	—	—	—
Alkaline phosphatase increased	Investigations	—	—	—
Dry mouth	Gastrointestinal disorders	—	—	—
Mucositis oral	Gastrointestinal disorders	—	—	—
White blood cell decreased	Investigations	—	—	—
Hyperglycemia	Metabolism and nutrition disorders	—	—	—
Hypoalbuminemia	Metabolism and nutrition disorders	—	—	—
Dysgeusia	Nervous system disorders	—	—	—
Hypothyroidism	Endocrine disorders	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—
Constipation	Gastrointestinal disorders	—	—	—
Pain	General disorders	—	—	—
Lymphocyte count decreased	Investigations	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—
Hyponatremia	Metabolism and nutrition disorders	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—
Dry skin	Skin and subcutaneous tissue disorders	—	—	—
Skin and subcutaneous tissue disorders - Other, specify	Skin and subcutaneous tissue disorders	—	—	—
Palpitations	Cardiac disorders	—	—	—
Hyperthyroidism	Endocrine disorders	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—
Dysphagia	Gastrointestinal disorders	—	—	—
Oral pain	Gastrointestinal disorders	—	—	—
Creatinine increased	Investigations	—	—	—
Investigations - Other, specify	Investigations	—	—	—
Hypokalemia	Metabolism and nutrition disorders	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—

Most-reported serious reactions: Alanine aminotransferase increased, Aspartate aminotransferase increased, Thromboembolic event, Abdominal pain, Diarrhea, Death NOS, Fatigue, Hepatobiliary disorders - Other, specify.

Data from ClinicalTrials.gov NCT01835145 adverse events section.

Sponsor's own description

This randomized phase II trial studies how well cabozantinib-s-malate works compared with temozolomide or dacarbazine in treating patients with melanoma of the eye (ocular melanoma) that has spread to other parts of the body and cannot be removed by surgery. Cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide and dacarbazine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether cabozantinib-s-malate works better than temozolomide or dacarbazine in treating patients with melanoma of the eye.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Metastatic disease from uveal melanoma: treatment options and future prospects.
Carvajal RD, Schwartz GK, Tezel T, Marr B, et al · · 2017 · cited 304× · PMID 27574175 · DOI 10.1136/bjophthalmol-2016-309034
Treatment of uveal melanoma: where are we now?
Yang J, Manson DK, Marr BP, Carvajal RD. · · 2018 · cited 229× · PMID 29497459 · DOI 10.1177/1758834018757175
Phase II DeCOG-study of ipilimumab in pretreated and treatment-naïve patients with metastatic uveal melanoma.
Zimmer L, Vaubel J, Mohr P, Hauschild A, et al · · 2015 · cited 192× · PMID 25761109 · DOI 10.1371/journal.pone.0118564
Systemic treatment of metastatic uveal melanoma: review of literature and future perspectives.
Buder K, Gesierich A, Gelbrich G, Goebeler M. · · 2013 · cited 89× · PMID 24403233 · DOI 10.1002/cam4.133
<i>GNAQ</i> and <i>GNA11</i> Genes: A Comprehensive Review on Oncogenesis, Prognosis and Therapeutic Opportunities in Uveal Melanoma.
Silva-Rodríguez P, Fernández-Díaz D, Bande M, Pardo M, et al · · 2022 · cited 80× · PMID 35804836 · DOI 10.3390/cancers14133066
Biology of advanced uveal melanoma and next steps for clinical therapeutics.
Luke JJ, Triozzi PL, McKenna KC, Van Meir EG, et al · · 2015 · cited 69× · PMID 25113308 · DOI 10.1111/pcmr.12304
Targeted Therapy of Uveal Melanoma: Recent Failures and New Perspectives.
Croce M, Ferrini S, Pfeffer U, Gangemi R. · · 2019 · cited 68× · PMID 31216772 · DOI 10.3390/cancers11060846
A molecular revolution in uveal melanoma: implications for patient care and targeted therapy.
Harbour JW, Chao DL. · · 2014 · cited 51× · PMID 24480708 · DOI 10.1016/j.ophtha.2013.12.014

Verify or expand the search:

Other trials of Cabozantinib S-malate

Trials testing the same drug.

NCT06811116 — Testing the Addition of an Anti-cancer Drug, Sapanisertib, to the Usual Chemotherapy Treatment (Cabozantinib) in Metasta · Phase 1, PHASE2 · recruiting
NCT06006013 — Cabozantinib in Combination With Pembrolizumab for the Treatment of Patients With Locally Advanced, Metastatic, or Unres · Phase 2 · recruiting
NCT05904080 — Testing Nivolumab and Ipilimumab Immunotherapy With or Without the Targeted Drug Cabozantinib in Recurrent, Metastatic, · Phase 2 · recruiting
NCT05411081 — Testing Cabozantinib With or Without Atezolizumab in Patients With Advanced Papillary Kidney Cancer, PAPMET2 Trial · Phase 2 · active not recruiting
NCT05691478 — A Study to Test the Addition of the Drug Cabozantinib to Chemotherapy in Patients With Newly Diagnosed Osteosarcoma · Phase 2, PHASE3 · recruiting

Other recruiting trials for Recurrent Uveal Melanoma

Currently open trials in the same condition.

NCT01979523 — Trametinib With or Without GSK2141795 in Treating Patients With Metastatic Uveal Melanoma · Phase 2 · active not recruiting

Other National Cancer Institute (NCI) trials

Trials by the same sponsor.

NCT07147231 — Testing the Effectiveness of the Anti-cancer Drug Pidnarulex (CX-5461), in Combination With Another Anti-cancer Drug Cem · Phase 1, PHASE2 · recruiting
NCT07572123 — Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem · Phase 2, PHASE3 · not yet recruiting
NCT07281417 — Testing the Addition of Cemiplimab (REGN2810) to Chemotherapy Treatment Given Prior to Surgery in Patients With Sinonasa · Phase 2 · recruiting
NCT07012044 — A Study to Find the Highest Dose of Cedazuridine and Decitabine Combination With Filgrastim as a Treatment Option After · Phase 1 · not yet recruiting
NCT07437950 — Comparing Different Treatment Lengths for Venetoclax in Older People With Newly Diagnosed Acute Myeloid Leukemia (A Myel · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01835145 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
Last refreshed: 4 August 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01835145.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing