NCT01258855 is a Phase 2 clinical trial of Aldesleukin in Metastatic Melanoma, sponsored by National Cancer Institute (NCI).

Who is sponsoring NCT01258855?

NCT01258855 is sponsored by National Cancer Institute (NCI).

What drugs are being tested in NCT01258855?

Interventions in NCT01258855: Aldesleukin, Laboratory Biomarker Analysis, Ziv-Aflibercept.

What condition does NCT01258855 study?

NCT01258855 studies Metastatic Melanoma, Recurrent Melanoma, Stage III Cutaneous Melanoma AJCC v7, Stage IIIA Cutaneous Melanoma AJCC v7, Stage IIIB Cutaneous Melanoma AJCC v7, Stage IIIC Cutaneous Melanoma AJCC v7, Stage IV Cutaneous Melanoma AJCC v6 and v7.

Is NCT01258855 still recruiting?

NCT01258855 is currently completed. Last updated 10 May 2019.

Are results published for NCT01258855?

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

Last reviewed 2019-05-10 · How we verify

NCT01258855

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

Aldesleukin With or Without Ziv-Aflibercept in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed by Surgery

Completed Phase 2 Results posted Last updated 10 May 2019

What this trial tests

Phase 2 trial testing Aldesleukin in Metastatic Melanoma in 84 participants. Completed in 29 March 2018.

Timeline

18 January 2011

Primary endpoint
29 March 2018

29 March 2018

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	84
Start date	18 January 2011
Primary completion	29 March 2018
Estimated completion	29 March 2018
Sites	21 locations across United States

Drugs / interventions tested

Aldesleukin (ALDESLEUKIN) — full drug profile →
Laboratory Biomarker Analysis — full drug profile →
Ziv-Aflibercept

Conditions studied

Metastatic Melanoma — all drugs for Metastatic Melanoma →
Recurrent Melanoma — all drugs for Recurrent Melanoma →
Stage III Cutaneous Melanoma AJCC v7 — all drugs for Stage III Cutaneous Melanoma AJCC v7 →
Stage IIIA Cutaneous Melanoma AJCC v7 — all drugs for Stage IIIA Cutaneous Melanoma AJCC v7 →

Sponsor

National Cancer Institute (NCI)

Who can join

17 and older, any sex, with Metastatic Melanoma or Recurrent Melanoma. 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.

Progression-free Survival Primary · The time from the date of randomization until date of progression, death, or recurrence, assessed up to 5 years

Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), 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.

Group	Value	95% CI
Combination Arm (Ziv-Afilbercept+HD IL2)	6.9	4.1 – 8.7
Mono-therapy Arm (HD IL2 Alone)	2.3	1.6 – 3.5

Overall Survival Secondary · Until Death from any cause, up to 5 years

Estimated using the product-limit method of Kaplan and Meier.

Group	Value	95% CI
Combination Arm (Ziv-Afilbercept+HD IL2)	26.9	14.4 – 63.6
Mono-therapy Arm (HD IL2 Alone)	24.2	11.3 – 36.4

Response Rate Secondary · Up to 5 years

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (RR) = CR + PR.

Group	Value	95% CI
Combination Arm (Ziv-Afilbercept+HD IL2)	22
Mono-therapy Arm (HD IL2 Alone)	17

Count of Participants With Adverse Events Secondary · Up to 5 years

Count of the number of participants with grade 3 \& 4 adverse events attributed to treatment agents. Events are graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.

Anemia

Group	Value	95% CI
Combination Arm (Ziv-Afilbercept+HD IL2)	2
Mono-therapy Arm (HD IL2 Alone)	0

Leukocytosis

Group	Value	95% CI
Combination Arm (Ziv-Afilbercept+HD IL2)	1
Mono-therapy Arm (HD IL2 Alone)	0

Lymphocyte count decreased

Group	Value	95% CI
Combination Arm (Ziv-Afilbercept+HD IL2)	41
Mono-therapy Arm (HD IL2 Alone)	20

Neutrophil count decreased

Group	Value	95% CI
Combination Arm (Ziv-Afilbercept+HD IL2)	2
Mono-therapy Arm (HD IL2 Alone)	0

Platelet count decreased

Group	Value	95% CI
Combination Arm (Ziv-Afilbercept+HD IL2)	11
Mono-therapy Arm (HD IL2 Alone)	9

Left ventricular systolic

Group	Value	95% CI
Combination Arm (Ziv-Afilbercept+HD IL2)	1
Mono-therapy Arm (HD IL2 Alone)	0

Sinus tachycardia

Group	Value	95% CI
Combination Arm (Ziv-Afilbercept+HD IL2)	0
Mono-therapy Arm (HD IL2 Alone)	1

Supraventricular tachycardia

Group	Value	95% CI
Combination Arm (Ziv-Afilbercept+HD IL2)	1
Mono-therapy Arm (HD IL2 Alone)	1

Progression-free Survival for Patients With High Vascular Endothelial Growth Factor (VEGF) Levels Secondary · Up to 5 years

Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), 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. Median baseline measure for VEGF were used as the cut point for "low" vs "high" VEGF groups.

Group	Value	95% CI
Combination Arm (Ziv-Afilbercept+HD IL2)	8.7	6.1 – 16.2
Mono-therapy Arm (HD IL2 Alone)	3.1	1.5 – 7.4

Progression-free Survival for Patients With Low VEGF Levels Secondary · Up to 5 years

Group	Value	95% CI
Combination Arm (Ziv-Afilbercept+HD IL2)	6.9	4.4 – 11.6
Mono-therapy Arm (HD IL2 Alone)	4.0	1.2 – 6.9

1-year Overall Survival Rate Secondary · Until Death from any cause, up to 1 year

Estimated using the product-limit method of Kaplan and Meier.

Group	Value	95% CI
Combination Arm (Ziv-Afilbercept+HD IL2)	75.6	64.5 – 88.6
Mono-therapy Arm (HD IL2 Alone)	66.8	51.5 – 86.5

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were recorded and graded throughout the study and until 30 days following the last dose of treatment agent.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Combination Arm (Ziv-Afilbercept+HD IL2)

Serious: 28/55 (51%)

Deaths: 37/55

Mono-therapy Arm (HD IL2 Alone)

Serious: 7/29 (24%)

Deaths: 20/29

Serious adverse events (41 terms)

Reaction	System	Combination Arm (Ziv-Afilb…	Mono-therapy Arm (HD IL2 A…
Lymphocyte count decreased	Investigations	—	—
Hypophosphatemia	Metabolism and nutrition disorders	—	—
Platelet count decreased	Investigations	—	—
Hypoalbuminemia	Metabolism and nutrition disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Oral pain	Gastrointestinal disorders	—	—
Lipase increased	Investigations	—	—
Dry skin	Skin and subcutaneous tissue disorders	—	—
Skin ulceration	Skin and subcutaneous tissue disorders	—	—
Hypertension	Vascular disorders	—	—
Sinus bradycardia	Cardiac disorders	—	—
Abdominal distension	Gastrointestinal disorders	—	—
Abdominal pain	Gastrointestinal disorders	—	—
Colitis	Gastrointestinal disorders	—	—
Colonic hemorrhage	Gastrointestinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Fatigue	General disorders	—	—
Fever	General disorders	—	—
Infusion related reaction	General disorders	—	—
Choledocholithiasis	Hepatobiliary disorders	—	—
Portal vein thrombosis	Hepatobiliary disorders	—	—
Skin infection	Infections and infestations	—	—
Soft tissue infection	Infections and infestations	—	—
Alanine aminotransferase increased	Investigations	—	—
Aspartate aminotransferase increased	Investigations	—	—

Other adverse events (353 terms — click to expand)

Reaction	System	Combination Arm (Ziv-Afilb…	Mono-therapy Arm (HD IL2 A…
Hypoalbuminemia	Metabolism and nutrition disorders	—	—
Platelet count decreased	Investigations	—	—
Aspartate aminotransferase increased	Investigations	—	—
Hyponatremia	Metabolism and nutrition disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Hypomagnesemia	Metabolism and nutrition disorders	—	—
Anemia	Blood and lymphatic system disorders	—	—
Diarrhea	Gastrointestinal disorders	—	—
Chills	General disorders	—	—
Sinus tachycardia	Cardiac disorders	—	—
Fatigue	General disorders	—	—
Blood bilirubin increased	Investigations	—	—
Hypophosphatemia	Metabolism and nutrition disorders	—	—
Lymphocyte count decreased	Investigations	—	—
Alkaline phosphatase increased	Investigations	—	—
Weight gain	Investigations	—	—
Alanine aminotransferase increased	Investigations	—	—
Vomiting	Gastrointestinal disorders	—	—
Hypertension	Vascular disorders	—	—
Fever	General disorders	—	—
Anxiety	Psychiatric disorders	—	—
Edema limbs	General disorders	—	—
Creatinine increased	Investigations	—	—
Hypocalcemia	Metabolism and nutrition disorders	—	—
Proteinuria	Renal and urinary disorders	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—
Hypotension	Vascular disorders	—	—
White blood cell decreased	Investigations	—	—
Headache	Nervous system disorders	—	—
Dry skin	Skin and subcutaneous tissue disorders	—	—
Hyperkalemia	Metabolism and nutrition disorders	—	—
Hypokalemia	Metabolism and nutrition disorders	—	—
Dyspnea	Respiratory, thoracic and mediastinal disorders	—	—
Mucositis oral	Gastrointestinal disorders	—	—
Hoarseness	Respiratory, thoracic and mediastinal disorders	—	—
Anorexia	Metabolism and nutrition disorders	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—
Neutrophil count decreased	Investigations	—	—
Hypermagnesemia	Metabolism and nutrition disorders	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—

Most-reported serious reactions: Lymphocyte count decreased, Hypophosphatemia, Platelet count decreased, Hypoalbuminemia, Nausea, Oral pain, Lipase increased, Dry skin.

Data from ClinicalTrials.gov NCT01258855 adverse events section.

Sponsor's own description

This randomized phase II trial studies how well aldesleukin with or without ziv-aflibercept works in treating patients with stage III-IV melanoma that cannot be removed by surgery. Aldesleukin may stimulate the white blood cells to kill cancer. Ziv-aflibercept may stop the growth of melanoma by blocking blood flow to the tumor. It is not yet known whether aldesleukin is more effective with or without ziv-aflibercept in treating melanoma.

Publications & conference data

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

Hypoxia-dependent drivers of melanoma progression.
D'Aguanno S, Mallone F, Marenco M, Del Bufalo D, et al · · 2021 · cited 67× · PMID 33964953 · DOI 10.1186/s13046-021-01926-6
Update on use of aldesleukin for treatment of high-risk metastatic melanoma.
Amaria RN, Reuben A, Cooper ZA, Wargo JA. · · 2015 · cited 30× · PMID 27471714 · DOI 10.2147/itt.s61590
State of melanoma: an historic overview of a field in transition.
Gorantla VC, Kirkwood JM. · · 2014 · cited 24× · PMID 24880939 · DOI 10.1016/j.hoc.2014.02.010
34th Annual Meeting & Pre-Conference Programs of the Society for Immunotherapy of Cancer (SITC 2019): part 1 : National Harbor, MD, USA. 6-10 November 2019.
· 2019 · cited 19× · PMID 31694725 · DOI 10.1186/s40425-019-0763-1
New therapies in the treatment of melanoma.
Davar D, Kirkwood JM. · · 2012 · cited 7× · PMID 22876817 · DOI 10.1517/13543784.2012.713938

Verify or expand the search:

Other trials of Aldesleukin

Trials testing the same drug.

NCT07389239 — A Study Evaluating the Immunotherapy Treatment for Ovarian Cancer and Other Advanced Malignancies. · Phase 1, PHASE2 · not yet recruiting
NCT06626256 — STIL101 for Injection for the Treatment of Locally Advanced, Metastatic or Unresectable Pancreatic Cancer, Colorectal Ca · Phase 1 · withdrawn
NCT06690281 — A Phase II Study of Adjuvant Immunotherapy Targeting KRAS G12D, KRAS G12V, or TP53 R175H for Participants With Advanced · Phase 2 · withdrawn
NCT05639972 — E7 T-cell Receptor (TCR) -T Cell Induction Therapy for Locoregionally Advanced HPV-associated Cancers · Phase 1, PHASE2 · recruiting
NCT05989828 — A2-ESO-1 TCR-Engineered T Cells for Relapsed/Refractory Advanced or Metastatic NY-ESO-1 Overexpression Positive Triple N · Phase 1 · suspended

Other recruiting trials for Metastatic Melanoma

Currently open trials in the same condition.

NCT06066138 — A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing · Phase 1 · recruiting
NCT07237100 — Mirdametinib in Patients With Advanced NF1-mutant Melanoma · Phase 2 · recruiting
NCT07086105 — A Study to Evaluate Adze1.C in Participants With Metastatic Melanoma · Phase 1 · recruiting
NCT07112170 — Consolidative Use of Radiotherapy to Block Oligoprogression in Patients With Metastatic Melanoma · NA · recruiting
NCT06488365 — In Vivo Liquid Biopsy of Melanoma (Cytophone) · NA · 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 NCT01258855 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 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: 10 May 2019

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/NCT01258855.

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