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Disease

Basal cell carcinoma

Late-stage therapeutic development

Also known as basal cell cancer, epithelioma, basal cell, malignant basal cell neoplasm.

20
Clinical trials
12
Associated genes
8
Related proteins
Current focus
Smoothened biologyTherapeutic developmentToll-like 7 biologyInflammation & immunityMetabolic & lifestyle factors

What's happening now

An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.

Executive briefingUpdating summary…Momentum: Moderate
Key developments
  • 6 clinical trials expected to report results, the earliest in Q2 2027.
Upcoming Milestones
Clinical Milestones7View
Results expected 5
Recently completed 1
Activity timeline7

Therapeutic landscape

Therapies with a regulatory footing for this condition, alongside the wider set of agents co-studied with it in the literature.

Approved & established therapies
Cemiplimabapproved

Approval — Cutaneous Squamous Cell Carcinoma Libtayo as monotherapy is indicated for the treatment… (2019)

Vismodegibapproved

Approval — Erivedge is indicated for the treatment of adult patients with:- symptomatic metastatic b… (2013)

Clinical trials

18 sponsors · 2 new · 1 completed in the last 12 months (net +2)

The current development programme across all trial phases.

Clinical programme
20
All trials
6
Active
8
Late-stage
6
Completed
Late-stage studies

Combination of 5-Fluorouracil and Calcipotriene in the Treatment of Superficial Basal Cell Carcinomas and Squamous Cell Carcinomas in Situ

Phase 2/3 · Recruiting · Boston University

Study of the Relationship Between the Pharmacokinetics of Vismodegib and Safety Data: a Pilot Study to Therapeutic Optimization in Patients With Basal Cell Carcinoma - OPTIVISMO-1

Phase 4 · Completed · University Hospital, Bordeaux

A Randomized, Observer Blind, Multinational Phase III Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) in Comparison to Metvix® in the Treatment of Non-aggressive Basal Cell Carcinoma (BCC) With Photodynamic Therapy (PDT)

Phase 3 · Completed · Biofrontera Bioscience GmbH

An Open-label Study to Evaluate the Safety and Long-Term Clinical Efficacy of Imiquimod 5% Cream Applied Once Daily 7 Days Per Week for 6 Weeks in the Treatment of Superficial Basal Cell Carcinoma

Phase 3 · Completed · Graceway Pharmaceuticals, LLC

Intron-A/Aldara Combination Therapy for BCC Excluding the Face and Scalp

Phase 4 · Completed · The University of Texas Health Science Center, Houston

An Open-Label Study to Evaluate the Safety and Long-Term Clinical Efficacy of Imiquimod 5% Cream Applied Once Daily 5 Days Per Week for 6 Weeks in the Treatment of Superficial Basal Cell Carcinoma

Phase 3 · Completed · MEDA Pharma GmbH & Co. KG
Recruiting

Combination of 5-Fluorouracil and Calcipotriene in the Treatment of Superficial Basal Cell Carcinomas and Squamous Cell Carcinomas in Situ

Phase 2/3 · Recruiting · Boston University

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

Phase 2 · Recruiting · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

A Phase 2 Controlled Randomized Study of the Efficacy of L19IL2 or L19TNF or L19IL2/L19TNF Intralesional Injections for the Treatment of Locally Advanced Basal Cell Carcinoma (LaBCC)

Phase 2 · Recruiting · Philogen S.p.A.

Evaluation of Efficacy and Safety of Cemiplimab as First Line Treatment for Advanced Basal Cell Carcinoma (CEMI-first) - An Open Label, Single Arm, Prospective Phase II Trial of the DeCOG Network

Phase 2 · Recruiting · Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Phase Ib/II Study Of The Combination Of Cemiplimab Plus Imiquimod and Laser Therapy As Neoadjuvant Treatment In Cutaneous Basal Cell Carcinoma

Phase 1/2 · Recruiting · Instituto Oncológico Dr Rosell

Evaluation of Radiotherapy After Complete Response to Sonic Hedgehog Pathway Inhibitors in Patients With Locally Advanced Basal Cell Carcinoma: a Prospective Multicenter Study

Phase 2 · Recruiting · University Hospital, Lille
Recently completed

A Randomized, Double-blind, Three-arm Phase 2 Study Evaluating Two Dose Levels of Microneedle-mediated Delivery of Doxorubicin Compared With a Device-only Control in Patients With Nodular Basal Cell Carcinoma.

Phase 2 · Completed · SkinJect, Inc.

Study of the Relationship Between the Pharmacokinetics of Vismodegib and Safety Data: a Pilot Study to Therapeutic Optimization in Patients With Basal Cell Carcinoma - OPTIVISMO-1

Phase 4 · Completed · University Hospital, Bordeaux

A Randomized, Observer Blind, Multinational Phase III Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) in Comparison to Metvix® in the Treatment of Non-aggressive Basal Cell Carcinoma (BCC) With Photodynamic Therapy (PDT)

Phase 3 · Completed · Biofrontera Bioscience GmbH

Intron-A/Aldara Combination Therapy for BCC Excluding the Face and Scalp

Phase 4 · Completed · The University of Texas Health Science Center, Houston

An Open-label Study to Evaluate the Safety and Long-Term Clinical Efficacy of Imiquimod 5% Cream Applied Once Daily 7 Days Per Week for 6 Weeks in the Treatment of Superficial Basal Cell Carcinoma

Phase 3 · Completed · Graceway Pharmaceuticals, LLC

An Open-Label Study to Evaluate the Safety and Long-Term Clinical Efficacy of Imiquimod 5% Cream Applied Once Daily 5 Days Per Week for 6 Weeks in the Treatment of Superficial Basal Cell Carcinoma

Phase 3 · Completed · MEDA Pharma GmbH & Co. KG

Regulatory timeline

Drug regulatory events matched to this condition by indication — EMA.

First approvals
2019emaApproval — Cemiplimab· Cutaneous Squamous Cell Carcinoma Libtayo as monotherapy is indicated for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (mCSCC or laCSCC) who are not candidates for curative surgery or curative radiation. Libtayo as monotherapy is indicated for the adjuvant treatment of adult patients with CSCC at high risk of recurrence after surgery and radiation (see section 5.1 for selection criteria).  Basal Cell Carcinoma Libtayo as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic basal cell carcinoma (laBCC or mBCC) who have progressed on or are intolerant to a hedgehog pathway inhibitor (HHI). Non-Small Cell Lung Cancer Libtayo as monotherapy is indicated for the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) expressing PD-L1 (in ? 50% tumour cells), with no EGFR, ALK or ROS1 aberrations, who have: locally advanced NSCLC who are not candidates for definitive chemoradiation, or metastatic NSCLC. Libtayo in combination with platinum?based chemotherapy is indicated for the first?line treatment of adult patients with NSCLC expressing PD-L1 (in ? 1% of tumour cells), with no EGFR, ALK or ROS1 aberrations, who have: locally advanced NSCLC who are not candidates for definitive chemoradiation, or metastatic NSCLC. Cervical Cancer Libtayo as monotherapy is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy. source ↗
2013emaApproval — Vismodegib· Erivedge is indicated for the treatment of adult patients with:- symptomatic metastatic basal cell carcinoma- locally advanced basal cell carcinoma inappropriate for surgery or radiotherapy source ↗

European Medicines Agency (CC BY 4.0). Events are matched to this condition by drug indication text — approvals/updates for drugs indicated for it, not disease-specific acts.

Associated genes

12 matches

Genes associated with this disease in the canonical knowledge graph (Open Targets evidence). Number shows the association score.

SMO0.74PTCH10.68XPA0.59TLR70.57MYCN0.56CPVL0.55CYP1B10.55OCA20.54LPP0.53BACH20.53TGM30.52BNC20.52

Disease biology

8 matches

Proteins whose encoding gene is associated with this disease, reached through the canonical gene→disease graph. Number shows the gene's association score.

Protein smoothenedvia SMO0.74Toll-like receptor 7via TLR70.57Melanocyte-stimulating hormone receptorvia MC1R0.51Toll-like receptor 3via TLR30.36Interferon regulatory factor 3via IRF30.28Phospholipid hydroperoxide glutathione peroxidase GPX4via GPX40.28Interleukin-7via IL70.26Protein-arginine deiminase type-4via PADI40.15

Reference

Authoritative identity, definition & identifiers.

Synonyms

basal cell cancer, epithelioma, basal cell, malignant basal cell neoplasm

References & data sources
  • Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
  • Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
  • Related entities are derived from literature co-mention (studied together) — associative, not causal.