Trial Search Results
Pembrolizumab With or Without Vismodegib in Treating Metastatic or Unresectable Basal Cell Skin Cancer
This phase 1-2 trial studies how well pembrolizumab with or without vismodegib works in treating patients with skin basal cell cancer that has spread to other places in the body or cannot be removed by surgery. Monoclonal antibodies, such as pembrolizumab, are checkpoint inhibitors that stimulate immune response. Vismodegib may stop the growth of tumor cells by blocking signals needed for cell growth.
Stanford is currently not accepting patients for this trial.
Collaborator: Merck Sharp & Dohme Corp.
- Biological: Pembrolizumab
- Drug: Vismodegib
Phase 1/Phase 2
- Histologically-proven basal cell carcinoma (BCC) in which curative resection is
unlikely without significant morbidity, or have nodal or distantly metastatic disease
which has progressed on vismodegib (Arm 1) or has achieved partial response or stable
disease on smoothened inhibitor (Arm 2). Individuals who are intolerant or have a
medical contra-indication to smoothened inhibitor will be enrolled into Arm 1.
- Have measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST)
- ≥ 18 years of age on day of consent.
- Willing to provide tissue from a core or excisional biopsy of a tumor lesion up to 6
weeks (42 days) prior to initiation of treatment on Day 1, or availability of adequate
- Eastern Cooperative Oncology Group (ECOG) Performance Status = 0 or 1
- Absolute neutrophil count (ANC) ≥ 1,500/mcL
- Platelets ≥ 100,000/mcL
- Hemoglobin ≥ 9 g/dL, or ≥ 5.6 mmol/L, without transfusion or EPO dependency (within 7
days of assessment)
- Serum creatinine ≤ 1.5 x upper limit of normal (ULN) OR measured or calculated
creatinine clearance ≥ 60 mL/min for subject(s) with creatinine levels > 1.5 x ULN
- Serum total bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ ULN for subjects with total
bilirubin levels > 1.5 x ULN
- Aspartate aminotransferase (AST) ≤ 2.5 x ULN, OR ≤ 5 x ULN for subjects with liver
- alanine aminotransferase (ALT) ≤ 2.5 x ULN, OR ≤ 5 x ULN for subjects with liver
- Albumin ≥ 2.5 mg/dL
- International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 x ULN unless
subject is receiving anticoagulant therapy, in which case PT/INR must be within
therapeutic range of intended use of anticoagulants
- Activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN unless subject is receiving
anticoagulant therapy, in which case PTT must be within therapeutic range of intended
use of anticoagulants
- Female subject of childbearing potential should have a negative urine or serum
pregnancy within 72 hours prior to receiving the first dose of study medication. If
the urine test is positive or cannot be confirmed as negative, a serum pregnancy test
will be required.
- Female subjects of childbearing potential should be willing to use 2 methods of birth
control or be surgically sterile, or be willing to abstain from heterosexual activity
for the course of the study through 120 days after the last dose of study medication.
Subjects of childbearing potential are those who have not been surgically sterilized
or have not been free from menses for > 1 year.
- If female, is postmenopausal; is surgically sterile; or agrees to use 2 acceptable
methods of birth control throughout the trial, until 120 days after the last dose of
- If female, agree to use an adequate method of contraception starting with the first
dose of study therapy through 120 days after the last dose of study therapy
- Male with female partner of childbearing potential agrees to use adequate method of
contraception throughout study, until 120 days after last dose of treatment or last
- Willing and able to provide written informed consent/assent for the trial. Consent may
be obtained by legally-authorized representative (LAR).
- Currently receiving investigational study therapy, or has received investigational
study therapy, or used an investigational device, within 4 weeks of the first dose of
- Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other
form of immunosuppressive therapy within 7 days prior to the first dose of trial
treatment (EXCEPTIONS: topical, intraarticular, intralesional, and inhaled steroids)
- Known history of active Bacillus Tuberculosis (TB) infection
- Hypersensitivity to pembrolizumab or any of its excipients.
- Has received an anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study
Day 1, or who has not recovered (ie, ≤ Grade 1 or at baseline) from adverse events due
to agents administered more than 4 weeks earlier.
- Has received chemotherapy, targeted small molecule therapy, or radiation therapy
within 2 weeks prior to study Day 1, or who has not recovered (ie, ≤ Grade 1 or at
baseline) from adverse events due to a previously administered agent. (EXCEPTION:
Subjects with ≤ Grade 2 neuropathy may qualify for the study).
- If subject received major surgery, they must have recovered adequately from the
toxicity and/or complications from the intervention prior to starting therapy.
- Known additional malignancy that is progressing or requires active treatment.
(EXCEPTIONS: basal cell carcinoma of the skin or squamous cell carcinoma of the skin
that has undergone potentially curative therapy, or in situ cervical cancer)
- Carcinomatous meningitis without consideration of clinical stability
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Subjects with previously treated brain metastases may participate provided they are
stable (without evidence of progression by imaging for at least four weeks prior to
the first dose of trial treatment and any neurologic symptoms have returned to
baseline), have no evidence of new or enlarging brain metastases, and are not using
steroids for at least 7 days prior to trial treatment.
- Active autoimmune disease that has required systemic treatment in the past 2 years
(ie, with use of disease modifying agents, corticosteroids or immunosuppressive
drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid
replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a
form of systemic treatment. Intraarticular, inhaled, and intralesional doses of
steroids are allowed at screening and during the study.
- Known history of, or any evidence of active, non-infectious pneumonitis that required
steroids or current pneumonitis.
- Active infection requiring systemic therapy.
- History or current evidence of any condition, therapy, or laboratory abnormality that
might confound the results of the trial, interfere with the subject's participation
for the full duration of the trial, or is not in the best interest of the subject to
participate, in the opinion of the treating investigator.
- Has known psychiatric or substance abuse disorders that would interfere with
cooperation with the requirements of the trial.
- Is pregnant or breastfeeding
- Expecting to conceive or father children within the projected duration of the trial,
starting with the pre-screening or screening visit through 120 days after the last
dose of trial treatment.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
- Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1-2 antibodies).
- Has known active Hepatitis B (eg, HBsAg reactive) or Hepatitis C (eg, HCV RNA
[qualitative] is detected).
- Has received a live vaccine within 30 days of planned start of study therapy. Note:
Seasonal influenza vaccines for injection are generally inactivated flu vaccines and
are allowed; however intranasal influenza vaccines (eg, Flu-Mist) are live attenuated
vaccines, and are not allowed.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study