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How Do I Find a Clinical Trial for Advanced BCC?

Where to look, what the phases mean, and questions to ask

Medically reviewed by Dr. Steven Q. Wang, MDLast reviewed

Bring a printable list of questions to your appointment, or share this page with someone who needs it.

Download printable checklist (PDF)

Introduction

Most basal cell carcinomas (BCCs) are cured with a single procedure and never need anything more. Advanced BCC is different: when a tumor is too large or deep for surgery, keeps coming back, or has spread, treatment relies on a small number of systemic medications, and each of them can eventually stop working or become hard to tolerate. Clinical trials are how the current options — hedgehog pathway inhibitors and, more recently, immunotherapy — became available in the first place, and they remain one of the main ways to reach newer drugs and combinations.

This guide explains what a trial actually involves, what the phase numbers mean, who might qualify, and the specific places to search for a study that fits advanced BCC. For background on the disease itself, see what "advanced" basal cell carcinoma means.

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Why a Trial Is Worth Considering in Advanced BCC

A few features of advanced BCC make trials especially relevant:

  • •The approved menu is short. Two hedgehog pathway inhibitors (vismodegib, sonidegib) and one immunotherapy (cemiplimab) carry most of the weight. Trials are testing additional drug classes and smarter sequencing.
  • •Resistance is common. Many locally advanced and metastatic BCCs develop acquired resistance to hedgehog inhibitors after a year or two, so second-line and combination strategies are an active research question.
  • •Timing options are being studied. Trials are looking at medication before surgery (neoadjuvant) to shrink a tumor and spare tissue, and at combining systemic drugs with radiation.
  • •Rare disease, concentrated expertise. Because advanced BCC is uncommon, the physicians running trials are usually the same specialists with the most experience managing it.

A trial is not a last resort or a sign your team has run out of ideas. It is often a way to access tomorrow's treatment under close supervision, and it is worth raising early — during your initial multidisciplinary workup, not only after a drug fails.

What the Trial Phases Mean

A clinical trial is a research study that follows a written protocol spelling out who can enroll, what treatment participants receive, and what will be measured. Cancer treatment trials move through four phases, each answering a different question:

  • •Phase I — Is it safe, and what is the right dose? Small studies (often a few dozen people), frequently open to patients whose BCC has progressed on standard therapy. Some Phase I trials for advanced BCC are "basket" studies that enroll several cancer types sharing a genetic feature.
  • •Phase II — Does it work? Researchers look for early evidence of tumor shrinkage in a specific setting (for example, hedgehog-inhibitor-resistant locally advanced BCC) while continuing to track safety.
  • •Phase III — Is it better than, or as good as, the current standard? Larger, often randomized trials comparing the new approach directly against an approved drug. Fewer of these exist in advanced BCC because the disease is rare.
  • •Phase IV — What happens over the long run? Conducted after approval, to follow long-term safety and effectiveness in a broader group of patients.

Earlier-phase trials generally carry more unknowns about benefit and side effects; later-phase trials test drugs whose safety is already better understood. Neither is automatically "better" — the right fit depends on your situation.

Where to Look

  • •ClinicalTrials.gov— the federal registry of essentially every U.S. trial and many international sites. Filter by basal cell carcinoma, recruitment status, and distance from your ZIP code. Read the "Eligibility" section of any study that looks relevant; it lists the exact requirements. The language is technical, so bring promising study numbers (they start with "NCT") to your oncologist.
  • •National Cancer Institute (NCI) trial search— pulls from the same underlying data with a more patient-friendly interface, and NCI's Steps to Find a Clinical Trial walks through the process one step at a time. NCI's Cancer Information Service (1-800-4-CANCER) will also run a search for you by phone.
  • •NCI-Designated Cancer Centers and academic dermatology / head-and-neck programs— these institutions run their own advanced-BCC trial portfolios and often have studies that never fully populate the public registries. They are usually the fastest route to learning what is enrolling near you. Ask your dermatologist or oncologist for a referral if your community practice has nothing open.
  • •Your own care team— the multidisciplinary tumor board reviewing your case may already know of a suitable study, including trials at partner hospitals. If you have Gorlin syndrome, ask specifically about trials for people who develop many BCCs, which sometimes test prevention or topical approaches rather than treatment of a single tumor.

Who Might Be Eligible

Every trial sets its own criteria, but eligibility for an advanced BCC study commonly turns on:

  • •Disease category — most trials specify locally advanced BCC not suitable for surgery or radiation, or metastatic BCC. A pathology report and recent imaging are used to confirm which applies.
  • •Prior treatment — some studies require that you have already received a hedgehog pathway inhibitor (and had it stop working or cause intolerable side effects); others enroll only patients who have not yet had systemic therapy.
  • •Measurable disease — there usually has to be a tumor that can be measured on exam or a scan, so response to the study drug can be tracked.
  • •Overall health and organ function — adequate blood counts, kidney and liver function, and a performance status showing you can manage daily activities. Autoimmune conditions or certain medications can exclude some immunotherapy trials.
  • •A washout period — a set gap since your last treatment, radiation, or major surgery.

There is no single profile of who qualifies. The only reliable way to know is to compare a specific study's eligibility list against your records with your oncologist's help.

Clearing Up Common Worries

"A trial means my doctors have given up."

Research on cancer trial enrollment consistently finds that patients are far more likely than physicians and research staff to see trials as an option only when a case is "hopeless." Many advanced BCC trials are for people earlier in their care, including as a first systemic treatment or before surgery.

"I might get a placebo instead of real treatment."

Placebo-only arms are rare in cancer research and considered unethical when an effective standard treatment exists. Advanced BCC trials typically compare a new drug against an approved one, or add it on top of standard care.

"Once I enroll, I am locked in."

Participation is voluntary. You can withdraw at any time, for any reason, and still receive standard care. Every U.S. trial is reviewed by an independent Institutional Review Board before it opens, and you go through an informed-consent process that you can take home to discuss with family.

"I cannot afford it."

The study sponsor generally covers the investigational drug and trial-specific tests. Routine care costs are usually billed to insurance, and many trials help with travel and lodging. Ask the study coordinator for a written breakdown of what you would owe.

What to Ask Your Care Team

Download printable checklist (PDF)
  • •Is there a clinical trial that fits my specific type of advanced BCC and my treatment history?
  • •What phase is it, and how much is already known about the study drug's safety and benefit?
  • •Would the trial replace my standard treatment, add to it, or be a next step if my current drug stops working?
  • •What extra visits, scans, biopsies, or travel would it involve compared with standard care?
  • •What are the known and possible side effects, and how would they be monitored?
  • •What happens if the trial treatment does not work for me, or if I decide to stop?
  • •Which costs are covered by the sponsor, and what would my insurance still be billed for?

Our companion article on questions to ask your care team has more on organizing these conversations.

Conclusion

Because advanced BCC is rare and its approved treatments are few, clinical trials play an outsized role in what care can look like. Searching ClinicalTrials.gov and the NCI tools is a reasonable place to start, but the most efficient path is usually a referral to an NCI-Designated Cancer Center or academic program that manages advanced BCC regularly and runs its own studies.

Whether or not a trial turns out to be right for you, ask about it early — alongside surgery, radiation, and standard systemic therapy — so you understand the full range of options for your specific tumor.

Sources

Clinical Guidelines & Peer-Reviewed Literature

  • Schmults CD, Blitzblau R, Aasi SZ, et al. Basal Cell Skin Cancer, Version 2.2024, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2023;21(11):1181-1203. PubMed
  • Niebel D, Sirokay J, Hoffmann F, Fröhlich A, Bieber T, Landsberg J. Clinical management of locally advanced basal-cell carcinomas and future therapeutic directions. Dermatol Ther (Heidelb). 2020;10(4):835-846. PubMed
  • Hillyer GC, Beauchemin M, Hershman DL, et al. Discordant attitudes and beliefs about cancer clinical trial participation between physicians, research staff, and cancer patients. Clin Trials. 2020;17(2):184-194. PubMed

Patient Resources

Disclaimer: This article is for educational purposes only and is not a substitute for professional medical advice. Always consult a qualified dermatologist or oncologist about your diagnosis, treatment plan, and whether a clinical trial is appropriate for you.

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