Trial Search Results

PD-1 in Patients With Advanced Basal Cell Carcinoma Who Experienced Progression of Disease on Hedgehog Pathway Inhibitor Therapy, or Were Intolerant of Prior Hedgehog Pathway Inhibitor Therapy

This study is being done to test effects of REGN2810, a monoclonal antibody directed to PD-1, in people with advanced BCC. These effects could be good (for example, shrinking of tumors) or bad (side effects). Researchers will study the effects and how long they last to understand if REGN2810 could be used for treatment of advanced basal cell carcinoma (BCC). Researchers will also study the amount of REGN2810 in the blood and if the body creates antibodies against the REGN2810. There are two groups of participants in this study. Group 1 is for participants with skin cancer that has spread to other parts of the body (such as lung, liver, bone or lymph nodes). Group 2 is for participants with cancer that has remained localized in the skin. Participants in both groups will receive the same treatment.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Regeneron Pharmaceuticals

Collaborator: Sanofi

Stanford Investigator(s):


  • Drug: cemiplimab


Phase 2


Key Inclusion Criteria:

   - Confirmed diagnosis of invasive BCC

   - Progression of disease on hedgehog inhibitor (HHI) therapy or intolerance of prior HHI

   - At least 1 measurable lesion

   - ≥18 years of age

   - Hepatic function, renal function, bone marrow function in defined lab-value-ranges

   - Anticipated life expectancy >12 weeks

   - Consent to provide archived tumor biopsy material (all patients)

   - Group 2: consent to undergo research biopsies

   - Group 2: must not be a candidate for radiation therapy or surgery

   - Comply with study procedures and site visits

   - Sign Subject Information Sheet and Informed Consent Form

Key Exclusion Criteria:

   - Ongoing or recent significant autoimmune disease

   - Prior treatment with specific pathway-blockers (PD-1/PD-L1)

   - Prior treatment with immune-modulating agents within 28 days before cemiplimab

   - Untreated brain metastasis that may be considered active

   - Immunosuppressive corticosteroid doses (>10mg prednisone) within 28 days prior to
   treatment with cemiplimab

   - Active infections requiring therapy, including HIV, hepatitis

   - Pneumonitis within the last 5 years

   - Cancer treatment other than radiation therapy, including investigational or standard
   of care, within 30 days prior to treatment with cemiplimab

   - Documented allergic reactions or similar to antibody treatments

   - Concurrent malignancies other than BCC, other than those with negligible risk of
   metastases or death

   - Any acute or chronic psychiatric problems

   - Having received a solid organ transplantation

   - Inability to undergo contrast radiological assessments

   - Breastfeeding, pregnant, women of childbearing potential not using contraception

Note: Other protocol-defined inclusion/exclusion criteria apply

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Alexander Ayon Valencia
Not Recruiting