Basal Cell Carcinoma

Oncology
11
Pipeline Programs
7
Companies
40
Clinical Trials
2 recruiting
1
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
9
0
1
1
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Monoclonal Antibody
2100%
+ 9 programs with unclassified modality

On Market (1)

Approved therapies currently available

Roche
ERIVEDGEApproved
vismodegib
Roche
Hedgehog Pathway Inhibitor [EPC]oral2012

Competitive Landscape

7 companies ranked by most advanced pipeline stage

Roche
RocheSTAVANGER NORWAY, Norway
2 programs
1
1
ERIVEDGE(Vismodegib)Phase 25 trials
An Analysis of Treatment Patterns and Outcomes for Basal Cell Carcinoma (BCC) Cancer ParticipantsN/A1 trial
Active Trials
NCT02100111Completed134Est. Dec 2011
NCT02648048Completed21Est. Nov 2016
NCT02438644Completed75Est. Jul 2017
+3 more trials
Novartis
NovartisBASEL, Switzerland
2 programs
1
1
verteporfin PDTPhase 31 trial
LDE225Phase 25 trials
Active Trials
NCT03070691Withdrawn0
NCT02358161Completed78Est. Jan 2019
NCT02138929Completed25Est. Jun 2020
+3 more trials
Bristol Myers Squibb
2 programs
2
NivolumabPhase 2Monoclonal Antibody1 trial
NivolumabPhase 2Monoclonal Antibody1 trial
Active Trials
NCT03521830Recruiting57Est. Mar 2027
NCT06624475Recruiting30Est. May 2028
Genentech
GenentechCA - Oceanside
2 programs
2
VismodegibPhase 21 trial
vismodegibPhase 21 trial
Active Trials
NCT01201915Completed74Est. May 2013
NCT01700049Completed28Est. Jul 2018
AT
1 program
1
ASN-002Phase 21 trial
Active Trials
NCT04416516CompletedEst. Feb 2024
Highlight Therapeutics
Highlight TherapeuticsSpain - Valencia
1 program
1
BO-112Phase 21 trial
Active Trials
NCT06422936Active Not Recruiting60Est. Jun 2028
Design Therapeutics
1 program
1
PHITAHPhase 21 trial
Active Trials
NCT05234658UnknownEst. Dec 2024

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
Novartisverteporfin PDT
Bristol Myers SquibbNivolumab
Highlight TherapeuticsBO-112
Design TherapeuticsPHITAH
Ascend TherapeuticsASN-002
Bristol Myers SquibbNivolumab
RocheVismodegib
NovartisLDE225
RocheVismodegib
NovartisLDE225
NovartisLDE225
RocheVismodegib
Genentechvismodegib
NovartisLDE225
NovartisLDE225

Showing 15 of 39 trials with date data

Clinical Trials (40)

Total enrollment: 1,928 patients across 40 trials

NCT00049959Novartisverteporfin PDT

Two Studies to Determine if Verteporfin PDT is Effective & Safe in Treating Multiple Basal Cell Carcinoma of the Skin.

Est. completion: Mar 2004
Phase 3Terminated
NCT03070691NovartisLDE225

Efficacy, Safety and Tolerability of Topically Applied LDE225 Cream (Hedgehog Pathway Inhibitor) in Adult Patients With Nevoid Basal Cell Carcinoma Syndrome (NBCCS)

0
Phase 2/3Withdrawn
NCT06624475Bristol Myers SquibbNivolumab

Neoadjuvant Nivolumab + Relatlimab (Opdualag) Versus Nivolumab for Resectable High-Risk Basal Cell Carcinoma

Start: Aug 2025Est. completion: May 202830 patients
Phase 2Recruiting
NCT06422936Highlight TherapeuticsBO-112

Clinical Trial to Evaluate BO-112 in Patients With Basal Cell Carcinoma (BCC)

Start: May 2024Est. completion: Jun 202860 patients
Phase 2Active Not Recruiting
NCT05234658Design TherapeuticsPHITAH

Study of an Artificial Human Skin Medicine for Patients With Basal Cell Carcinoma Undergoing Reconstructive Surgery

Start: Jan 2022Est. completion: Dec 2024
Phase 2Unknown
NCT04416516Ascend TherapeuticsASN-002

Safety and Efficacy of ASN-002 Combined With a Hedgehog Pathway Inhibitor

Start: Jul 2020Est. completion: Feb 2024
Phase 2Completed
NCT03521830Bristol Myers SquibbNivolumab

Nivolumab Alone or Plus Relatlimab or Ipilimumab for Patients With Locally-Advanced Unresectable or Metastatic Basal Cell Carcinoma

Start: Nov 2018Est. completion: Mar 202757 patients
Phase 2Recruiting
NCT02667574RocheVismodegib

Study Evaluating the Interest of Vismodegib as Neo-adjuvant Treatment of Basal Cell Carcinoma (BCC)

Start: Nov 2014Est. completion: Jul 202055 patients
Phase 2Completed
NCT02002689NovartisLDE225

LDE225 for Patients With PTCH1 or SMO Mutated Tumors

Start: Feb 2014Est. completion: Mar 201510 patients
Phase 2Terminated
NCT01880437RocheVismodegib

A Study of Vismodegib in Patients With Relapsed/Refractory Acute Myelogenous Leukemia and Relapsed Refractory High-Risk Myelodysplastic Syndrome

Start: Sep 2013Est. completion: Nov 201438 patients
Phase 2Terminated
NCT01708174NovartisLDE225

A Phase II Study of Oral LDE225 in Patients With Hedge-Hog (Hh)-Pathway Activated Relapsed Medulloblastoma (MB)

Start: May 2013Est. completion: Oct 201622 patients
Phase 2Completed
NCT01826214NovartisLDE225

Study of Efficacy and Safety of LDE225 in Adult Patients With Relapsed/Refractory Acute Leukemia

Start: May 2013Est. completion: May 201570 patients
Phase 2Completed
NCT01815840RocheVismodegib

A Study of Two Vismodegib Regimens in Participants With Multiple Basal Cell Carcinomas

Start: Apr 2013Est. completion: Aug 2016229 patients
Phase 2Completed
NCT01700049Genentechvismodegib

Study Evaluating the Efficacy of Oral Vismodegib in Various Histologic Subtypes

Start: Jan 2013Est. completion: Jul 201828 patients
Phase 2Completed
NCT01327053NovartisLDE225

A Phase II Study of Efficacy and Safety in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma

Start: Jun 2011Est. completion: Jun 2018230 patients
Phase 2Completed
NCT01350115NovartisLDE225

Efficacy, Safety and Pharmacokinetics of Oral LDE225 in Treatment of Patients With Nevoid Basal Cell Carcinoma Syndrome (NBCCS)

Start: Apr 2011Est. completion: Oct 201210 patients
Phase 2Completed
NCT01201915GenentechVismodegib

A Study Evaluating the Efficacy and Safety of Vismodegib (GDC-0449) in Operable Basal Cell Carcinoma

Start: Oct 2010Est. completion: May 201374 patients
Phase 2Completed
NCT01033019NovartisLDE225

To Evaluate the Safety, Local Tolerability, PK and PD of LDE225 on Sporadic Superficial and Nodular Skin Basal Cell Carcinomas (sBCC)

Start: Dec 2009Est. completion: Feb 201125 patients
Phase 2Terminated
NCT00961896NovartisLDE225

A Trial to Evaluate the Safety, Local Tolerability, Pharmacokinetics and Pharmacodynamics of LDE225 on Skin Basal Cell Carcinomas in Gorlin Syndrome Patients

Start: Jul 200918 patients
Phase 2Completed
NCT02358161NovartisLDE225

Phase I/II Study of LDE225 With Gemcitabine and Nab-paclitaxel in Patients With Pancreatic Cancer

Start: Sep 2015Est. completion: Jan 201978 patients
Phase 1/2Completed
NCT01787552NovartisLDE225

A Phase Ib/II Dose-finding Study to Assess the Safety and Efficacy of LDE225 + INC424 in Patients With MF

Start: May 2013Est. completion: Apr 201850 patients
Phase 1/2Completed
NCT01431794NovartisLDE225

Gemcitabine + Nab-paclitaxel With LDE-225 (Hedgehog Inhibitor) as Neoadjuvant Therapy for Pancreatic Adenocarcinoma

Start: Dec 2011Est. completion: Nov 201823 patients
Phase 1/2Terminated
NCT02648048RocheVismodegib

A Study of Oral Vismodegib in Combination With Pirfenidone in Participants With Idiopathic Pulmonary Fibrosis

Start: Jan 2016Est. completion: Nov 201621 patients
Phase 1Completed
NCT02138929NovartisLDE225

LDE225 + Everolimus in Advanced Gastroesophageal Adenocarcinoma

Start: Nov 2014Est. completion: Jun 202025 patients
Phase 1Completed
NCT02195973NovartisLDE225

Phase IB Trial of LDE225 and Paclitaxel in Recurrent Ovarian Cancer

Start: Sep 2014Est. completion: Sep 201715 patients
Phase 1Completed
NCT02182622NovartisLDE225

LDE225 + Docetaxel/Prednisone for Adv/Met Castrate Resistant Prostate Cancer w/ Disease Progression After Docetaxel

Start: Jul 2014Est. completion: Dec 20150
Phase 1Withdrawn
NCT02151864NovartisLDE225

LDE225 in Patients With Advanced or Metastatic Hepatocellular Carcinoma and Child-Pugh A/B7 Cirrhosis

Start: Jul 2014Est. completion: Sep 20179 patients
Phase 1Completed
NCT02027376NovartisLDE225

Study of LDE225 (Sonidegib) in Combination With Docetaxel in Triple Negative (TN) Advanced Breast Cancer (ABC) Patients

Start: May 2014Est. completion: Apr 201612 patients
Phase 1Completed
NCT02086513NovartisLDE225

Phase I Trial of LDE225 for Steroid-refractory Chronic GVHD After Allogeneic HSCT

Start: Apr 2014Est. completion: Dec 201617 patients
Phase 1Terminated
NCT01769768NovartisLDE225

Phase I Study to Evaluate the Effect of LDE225 on the Pharmacokinetics of Bupropion and Warfarin in Patients

Start: Apr 2013Est. completion: Aug 2016114 patients
Phase 1Completed
NCT01764776NovartisLDE225

Effect of Hepatic Impairment on LDE225..

Start: Mar 2013Est. completion: Mar 201533 patients
Phase 1Completed
NCT01576666NovartisLDE225

Phase Ib, Dose Escalation Study of Oral LDE225 in Combination With BKM120 in Patients With Advanced Solid Tumors

Start: Jul 2012Est. completion: Apr 2015120 patients
Phase 1Completed
NCT01579929NovartisLDE225

Combination of the Hedgehog Inhibitor, LDE225, With Etoposide and Cisplatin in the First-Line Treatment of Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Start: Apr 2012Est. completion: Aug 201719 patients
Phase 1Completed
NCT01487785NovartisLDE225

Dose-escalation, and Safety Study of LDE225 and Gemcitabine in Locally Advanced or Metastatic Pancreatic Cancer Patients

Start: Mar 2012Est. completion: Jul 201418 patients
Phase 1Completed
NCT01208831NovartisLDE225

An East Asian Study of LDE225

Start: Oct 2010Est. completion: Oct 201345 patients
Phase 1Completed
NCT00880308NovartisLDE225

Dose Finding and Safety of Oral LDE225 in Patients With Advanced Solid Tumors

Start: Mar 2009Est. completion: Jul 2013103 patients
Phase 1Completed
NCT02438644RocheVismodegib

Observational Study of Vismodegib (Erivedge) in Patients Treated in Argentina

Start: Jun 2015Est. completion: Jul 201775 patients
N/ACompleted
NCT02371967RocheVismodegib

A Study to Assess the Effectiveness and Safety of Vismodegib (Erivedge®) in Participants With Advanced Basal Cell Carcinoma (BCC)

Start: Apr 2015Est. completion: Aug 202050 patients
N/ACompleted
NCT01529450NovartisLDE225

Pilot LDE225 in Locally Advanced or Metastatic BCC + Previously Tx Non-LDE225 Smoothened Inhibitors

Start: Feb 2012Est. completion: Aug 201311 patients
N/ACompleted
NCT02100111RocheAn Analysis of Treatment Patterns and Outcomes for Basal Cell Carcinoma (BCC) Cancer Participants

An Analysis of Treatment Patterns and Outcomes for Basal Cell Carcinoma (BCC) Cancer Participants

Start: Jan 2005Est. completion: Dec 2011134 patients
N/ACompleted

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Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

1 late-stage (Phase 3) programs — potential near-term approvals
2 actively recruiting trials targeting 1,928 patients
7 companies competing in this space

Related Indications

Breast Cancer(530)Non-small Cell Lung Cancer(373)Prostate Cancer(371)Multiple Myeloma(244)Advanced Solid Tumors(221)Acute Myeloid Leukemia(204)Cancer(187)Neoplasms(173)Colorectal Cancer(166)Advanced Solid Tumor(165)