NCI Community Oncology Research Program - Protocol Summary
Alliance A091605 - "A RANDOMIZED PHASE II STUDY OF ANTI-PD1 ANTIBODY [MK-3475 (PEMBROLIZUMAB)] ALONE VERSUS ANTI-PD1 ANTIBODY PLUS STEREOTACTIC BODY RADIATION THERAPY IN ADVANCED MERKEL CELL CARCINOMA"
The summary below serves as a brief review of the treatment plan and eligibility for the protocol.
This summary is not intended to be used in place of the full eligibility & treatment information in the protocol.
Please contact NCORP-KC for complete protocol information.
Skin Clinical Trial
CANCER TYPE: Merkel Cell Carcinoma
RESEARCH BASE: Alliance
NCT NUMBER: NCT03304639
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UPDATED ON 06/04/2019 (16:09:44)
Advanced or metastatic MCC, ≥ 2 cancerous deposits, MK-3475 (pembrolizumab) vs. MK-3475 (pembrolizumab) + SBRT
To determine whether your institution needs to complete any further credentialing requirements, please complete the “Credentialing Status Inquiry Form” found under credentialing on the IROC Houston QA Center website (http://irochouston.mdanderson.org)
Treatment must begin ≤ 21 days of registration
Supplied Drug: MK-3475 (Pembrolizumab)
MK-3475 200mg IV on day 1, every 3 weeks until progression or toxicity
MK-3475 200mg IV on day 1, every 3 weeks until progression or toxicity + SBRT (three 8 Gy doses to single metastasis)
- Patients must have pathologically (histologically or cytologically) proven diagnosis of MCC by local pathology review.
- Have measurable disease based on RECIST 1.1 including at least two cancerous deposits. At least one deposit must be RECIST measurable while at least one deposit must meet criteria for SBRT (See Section 7.1). Non-radiated tumor will be identified prior to randomization on the protocol. Non-radiated tumor will be identified prior to randomization on the protocol.
- Patients must have advanced or metastatic MCC defined as evidence of distant metastasis(es) on imaging.
- No prior immunotherapy for advanced/metastatic MCC
- Patients with known or suspected CNS metastases, untreated CNS metastases, or with the CNS as the only site of disease are excluded. However, subjects with controlled brain metastases will be allowed to enroll. Controlled brain metastases are defined as no radiographic progression for at least 4 weeks following radiation and/or surgical treatment (or 4 weeks of observation if no intervention is clinically indicated), and off of steroids for at least 2 weeks, and no new or progressive neurological signs and symptoms
- Patients having received palliative radiotherapy for extracranial metastasis(es) are eligible as long as there are 2 cancerous deposits that have not received prior RT and No prior radiation therapy (>5 Gy) to the metastasis intended to be treated with SBRT.
- No History of:
- Autoimmunity requiring systemic immunosuppression within 2 years
- Patients known to be HIV positive are eligible if they meet the following:
- CD4 counts ≥ 350 mm3
- Serum HIV viral load of <25,000 IU/ml.
- No other active malignancy that the investigator determines would interfere with the treatment and safety analysis.
- Not pregnant and not nursing
- Age ≥ 18 years
- ECOG Performance Status 0-2
- Required Initial Laboratory Values:
- Absolute Neutrophil Count (ANC) ≥ 1,500/mm3
- Platelet Count ≥ 100,000/mm3
- Hemoglobin ≥ 9.0g/dl
- Total Bilirubin ≤ 2.0 mg/dl
- AST / ALT ≤ 3.0 x ULN
- Systolic BP ≤150 mg HG
- Diastolic BP ≤ 90 mg HG
- Albumin >3mg/dl
- BUN ≤30 mg/dl
- Creatinine ≤1.7 mg/dl
- The following imaging workup to document metastases within 45 days prior to study registration are required: CT scans of the chest, abdomen and pelvis with radionuclide bone scan OR whole body (at least skullbase to midthigh) PET/CT.