Trial Search Results

Pembrolizumab Versus Placebo Following Surgery and Radiation in Participants With Locally Advanced Cutaneous Squamous Cell Carcinoma (MK-3475-630/KEYNOTE-630)

The purpose of this study is to:-See how well the study drug, pembrolizumab, keeps cutaneous squamous cellcarcinoma (cSCC) from coming back or spreading compared to placebo. A placebolooks like the study drug but has no medicine in it.-See if giving pembrolizumab after surgery and radiation helps patients with cSCC live longer.-Test the safety of the study drug and see how patients' bodies handle it.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Merck Sharp & Dohme Corp.

Stanford Investigator(s):

Intervention(s):

  • Biological: Pembrolizumab 400 mg
  • Drug: Placebo

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   - Has histologically confirmed cutaneous squamous cell carcinoma (cSCC) as the primary
   site of malignancy (metastatic skin involvement from another primary cancer or from an
   unknown primary cancer is not permitted)

   - Has histologically confirmed LA cSCC with ≥1 high-risk feature(s) as the primary site
   of malignancy

   - Has undergone complete macroscopic resection of all known cSCC disease with or without
   microscopic positive margins. For those participants with residual microscopic
   positive margin involvement, confirmation that additional re-excision is not possible
   must be provided

   - Has completed adjuvant radiotherapy (RT) for LA cSCC with last dose of RT ≥4 weeks and
   ≤16 weeks from randomization

   - Has completed at least 45 Gray (Gy) of adjuvant RT for LA cSCC prior to study entry

   - Is disease free as assessed by the investigator with complete radiographic staging
   assessment ≤28 days from randomization

   - Is not pregnant or breastfeeding

   - Is not a woman of childbearing potential (WOCBP)

   - Has a negative pregnancy test ≤72 hours before the first dose of study intervention

   - Has provided an archival or newly-obtained tumor tissue sample adequate for Programmed
   Cell Death Ligand 1 (PD-L1) testing as determined by central laboratory testing

   - Has a life expectancy of >3 months

   - Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 ≤10 days
   prior to the first dose of study intervention

Exclusion Criteria:

   - Has macroscopic residual cSCC after surgery and/or recurrence with active cSCC disease
   before randomization

   - Has any other histologic type of skin cancer other than invasive cSCC (eg, basal cell
   carcinoma) that has not been definitively treated with surgery or radiation; Bowen's
   disease; Merkel cell carcinoma; or melanoma

   - Has received prior therapy with an anti-programmed cell death receptor 1(PD-1), anti-
   PD-L1, or anti-programmed cell death receptor ligand 2 (PD-L2) agent or with an agent
   directed to another co-stimulatory or co-inhibitory T-cell receptor (eg, cytotoxic
   T-lymphocyte-associated protein 4 [CTLA-4], OX-40, CD137)

   - Has received prior systemic anticancer therapy including investigational agents for
   cSCC ≤4 weeks prior to randomization

   - Has not recovered from all radiation-related toxicities and has not had radiation
   pneumonitis

   - Has received a live vaccine ≤30 days prior to the first dose of study intervention

   - Is currently participating in or has participated in a study of an investigational
   agent or has used an investigational device ≤4 weeks prior to the first dose of study
   intervention

   - Has an active autoimmune disease that has required systemic treatment in past 2 years
   (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs)

   - Has a history of (non-infectious) pneumonitis that required steroids or has current
   pneumonitis

   - Has an active infection requiring systemic therapy

   - Has a known history of human immunodeficiency virus (HIV) infection

   - Has a known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg]
   reactive) or known active hepatitis C virus (HCV; defined as HCV RNA [qualitative] is
   detected) infection

   - Is pregnant or breastfeeding or expecting to conceive or father children within the
   projected duration of the study, starting with the screening visit through 120 days
   after the last dose of study intervention

   - Has had an allogeneic tissue/solid organ transplant

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Alexander Valencia
650-498-5185
Not Recruiting