Trial Search Results

Pembrolizumab Compared to Standard of Care Observation in Treating Patients With Completely Resected Stage I-III Merkel Cell Cancer, STAMP Study

This phase III trial studies how well pembrolizumab works compared to standard of care observation in treating patients with stage I-III Merkel cell cancer that has been completely removed by surgery (resected). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

National Cancer Institute (NCI)

Stanford Investigator(s):

Intervention(s):

  • Other: Best Practice
  • Biological: Pembrolizumab
  • Radiation: Radiation Therapy

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   - Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status: 0,
   1, or 2 (However, those patients with a performance state of 3 because they are wheel
   chair bound due to congenital or traumatic events more than one year before the
   diagnosis of Merkel cell carcinoma are eligible).

   - Women must not be pregnant or breast-feeding due to the unknown effects of the study
   drug in this setting. All women of childbearing potential must have a blood test or
   urine study within 2 weeks prior to registration to rule out pregnancy. A female of
   childbearing potential is any woman, regardless of sexual orientation or whether they
   have undergone tubal ligation, who meets the following criteria: 1) has achieved
   menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy;
   or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does
   not rule out childbearing potential) for at least 24 consecutive months (i.e., has had
   menses at any time in the preceding 24 consecutive months).

   - Women of childbearing potential, and sexually active males, on Arm A MK-3475
   (pembrolizumab must use accepted and effective method(s) of contraception or abstain
   from sex from time of registration, while on study treatment, and continue for 120
   days after the last dose of study treatment. For patients on Arm B only receiving
   radiation therapy, contraception use should be per institutional standard.

   - Patient must have a histological confirmation of diagnosis of Merkel cell carcinoma
   (MCC), pathologic stages (American Joint Committee on Cancer [AJCC] version 8) I-IIIb.

      - Stage I patients with negative sentinel lymph node biopsy are ineligible.
      Patients who have a positive biopsy or for whom no biopsy was done are eligible.

      - Patients with distant metastatic disease (stage IV) are not eligible.

      - The primary tumor must have grossly negative margins. (Microscopically positive
      margins are allowed).

      - Cancers of unknown primary that have regional disease only can be included.

      - Complete nodal dissection is not required for eligibility.

   - Patients with all macroscopic Merkel cell carcinoma (either identified by physical
   exam or imaging) have been completely resected by surgery within 16 weeks before
   registration.

   - All patients must have disease-free status documented by a complete physical
   examination and conventional imaging studies within 8 weeks prior to registration.

   - Patient may not have a history of distant metastatic disease.

      - NOTE: Loco-regional recurrent disease is acceptable, as long as this is not
      metastatic (prior surgery with or without radiation therapy is acceptable).

   - For patients with initial presentation of Merkel cell carcinoma, patient must have no
   previous systemic therapy or radiation therapy prior to surgery for Merkel cell
   carcinoma and cannot have completed adjuvant radiation therapy for Merkel cell
   carcinoma more than 6 weeks prior to registration. Patients actively undergoing
   radiation therapy or having completed adjuvant radiation therapy within 6 weeks of
   registration are eligible, as long as resection date is within 16 weeks of
   registration.

   - White blood count >= 2000/uL (within 4 weeks prior to randomization).

   - Absolute neutrophil count (ANC) >= 1000/uL (within 4 weeks prior to randomization).

   - Platelets >= 75 x 10^3/uL (within 4 weeks prior to randomization).

   - Hemoglobin >= 8 g/dL (>= 80 g/L; may be transfused) (within 4 weeks prior to
   randomization).

   - Creatinine =< 2.0 x upper limit of normal (ULN) (within 4 weeks prior to
   randomization).

   - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN
   (within 4 weeks prior to randomization).

   - Total bilirubin =< 2.0 x ULN, (except patients with Gilbert's syndrome, who must have
   a total bilirubin less than 3.0 mg/dL) (within 4 weeks prior to randomization).

   - Patients who are human immunodeficiency virus (HIV)+ with undetectable HIV viral load
   are eligible provided they meet all other protocol criteria for participation.

   - Patients with hepatitis B virus (HBV) or hepatitis C virus (HCV) infection are
   eligible provided viral loads are undetectable. Patients on suppressive therapy are
   eligible.

   - Patients must not be on active immunosuppression, have a history of life threatening
   virus, have had other (beside non-melanoma skin cancers, or recent indolent cancers
   e.g.: resected low grade prostate cancer) invasive cancer diagnoses in the last two
   years, or have had immunotherapy of any kind within the last 2 years.

   - Patients must not have a history of (non-infectious) pneumonitis that required
   steroids or has current pneumonitis.

   - Operative notes from patient's surgical resection must be accessible.

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
Lisa Zhou
650-736-4112
Recruiting