NCT01603212 is a Phase 1 clinical trial of Vemurafenib in Melanoma, sponsored by M.D. Anderson Cancer Center.

Who is sponsoring NCT01603212?

NCT01603212 is sponsored by M.D. Anderson Cancer Center.

What drugs are being tested in NCT01603212?

Interventions in NCT01603212: Vemurafenib, IL-2, Interferon Alpha-2b.

Is NCT01603212 still recruiting?

NCT01603212 is currently completed. Last updated 21 May 2019.

Last reviewed 2019-05-21 · How we verify

NCT01603212

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

Systemic Therapy With Interferon, Interleukin-2 and BRAF Inhibitor

Completed Phase 1 Last updated 21 May 2019

What this trial tests

Phase 1 trial testing Vemurafenib in Melanoma in 6 participants. Completed in 5 July 2017.

Timeline

18 July 2013

Primary endpoint
5 July 2017

5 July 2017

Quick facts

Lead sponsor	M.D. Anderson Cancer Center
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	6
Start date	18 July 2013
Primary completion	5 July 2017
Estimated completion	5 July 2017
Sites	1 location across United States

Drugs / interventions tested

Vemurafenib (vemurafenib) — full drug profile →
IL-2 — full drug profile →
Interferon Alpha-2b — full drug profile →

Conditions studied

Melanoma — all drugs for Melanoma →

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

Adults 18 to 65, any sex, with Melanoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of the Phase I part of this clinical research study is to find the highest tolerable dose of vemurafenib and Aldesleukin (interleukin-2) that can be given in combination with interferon alfa-2b in patients with advanced or metastatic melanoma. The safety of this combination will also be studied. The goal of Phase II is to learn if this study drug combination can help to control advanced or metastatic melanoma.

Publications & conference data

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

Combining targeted therapy with immunotherapy in BRAF-mutant melanoma: promise and challenges.
Hu-Lieskovan S, Robert L, Homet Moreno B, Ribas A. · · 2014 · cited 150× · PMID 24958825 · DOI 10.1200/jco.2013.52.1377
Immune Effects of Chemotherapy, Radiation, and Targeted Therapy and Opportunities for Combination With Immunotherapy.
Wargo JA, Reuben A, Cooper ZA, Oh KS, et al · · 2015 · cited 127× · PMID 26320064 · DOI 10.1053/j.seminoncol.2015.05.007
BRAF-mutant melanoma: treatment approaches, resistance mechanisms, and diagnostic strategies.
Spagnolo F, Ghiorzo P, Orgiano L, Pastorino L, et al · · 2015 · cited 115× · PMID 25653539 · DOI 10.2147/ott.s39096
Overcoming resistance to BRAF inhibition in BRAF-mutated metastatic melanoma.
Spagnolo F, Ghiorzo P, Queirolo P. · · 2014 · cited 92× · PMID 25344914 · DOI 10.18632/oncotarget.2602
Combination of Immunotherapy With Targeted Therapy: Theory and Practice in Metastatic Melanoma.
Yu C, Liu X, Yang J, Zhang M, et al · · 2019 · cited 86× · PMID 31134073 · DOI 10.3389/fimmu.2019.00990
Chemotherapy Resistance Mechanisms in Advanced Skin Cancer.
Kalal BS, Upadhya D, Pai VR. · · 2017 · cited 80× · PMID 28382191 · DOI 10.4081/oncol.2017.326
Effects of BRAF mutations and BRAF inhibition on immune responses to melanoma.
Ilieva KM, Correa I, Josephs DH, Karagiannis P, et al · · 2014 · cited 72× · PMID 25385327 · DOI 10.1158/1535-7163.mct-14-0290
Combining targeted therapy and immune checkpoint inhibitors in the treatment of metastatic melanoma.
Kim T, Amaria RN, Spencer C, Reuben A, et al · · 2014 · cited 57× · PMID 25610709 · DOI 10.7497/j.issn.2095-3941.2014.04.002

Verify or expand the search:

Other trials of Vemurafenib

Trials testing the same drug.

NCT06692491 — Study of Precision Treatment for Rare Tumours in China Guided by PDO and NGS · Phase 2 · not yet recruiting
NCT06561360 — A Study of Vemurafenib and Obinutuzumab Compared to Cladribine and Rituximab in People With Hairy Cell Leukemia (HCL) · Phase 2 · recruiting
NCT06440850 — Vemurafenib and Cobimetinib for the Treatment of Patients With High Risk Differentiated Thyroid Carcinoma With BRAFV600E · Phase 2 · recruiting
NCT05238831 — SMMART Adaptive Clinical Treatment (ACT) Trial · EARLY_PHASE1 · withdrawn
NCT05233332 — Study of HL-085 and Vemurafinib in Metastatic Colorectal Cancer (mCRC) · Phase 2 · unknown

Other recruiting trials for Melanoma

Currently open trials in the same condition.

NCT07524114 — Study of High-Precision Evaluation of Molecular ResiduaL Disease Through a PlatfOrm for Cancer TracKing and Interception · recruiting
NCT07224425 — A Study in People With Advanced Cancer (Solid Tumours) to Test Different Doses of BI 3810944 and to Find Out Whether it · Phase 1 · recruiting
NCT07285044 — The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Tr · Phase 2 · recruiting
NCT07225036 — Promoting Immunotherapy Efficacy With Low-Dose Liver RT · NA · recruiting
NCT07379138 — Studying Quality of Life Inclusive of Mental Health and Cognitive Behavioral Therapy for Cancer Distress for the Improve · NA · recruiting

Other M.D. Anderson Cancer Center trials

Trials by the same sponsor.

NCT07053020 — A Phase 1b/2 Open-label, Dose-ranging Safety and Efficacy Study of Oral Cladribine in Patients With Acute Myeloid Leukem · Phase 1, PHASE2 · not yet recruiting
NCT07052994 — A Phase Ia/Ib Trial of Revumenib Combined With Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin (GO) in Frontline and · Phase 1 · not yet recruiting
NCT07137481 — Phase II Study of CD5 CAR Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Che · Phase 2 · not yet recruiting
NCT07162480 — Phase II Trial of Puxitatug Samrotecan (AZD8205) in Advanced, Recurrent or Metastatic (R/M) Aggressive Adenoid Cystic Ca · Phase 2 · not yet recruiting
NCT07076498 — Engineered HSV-1 M032 for the Treatment of Children and Adults With Newly Diagnosed Diffuse Midline Glioma After Standar · Phase 1 · 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 NCT01603212 (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 M.D. Anderson Cancer Center
Last refreshed: 21 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/NCT01603212.

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