Pembrolizumab With Chemotherapy in Metastatic or Unresectable High Grade Gastroenteropancreatic o… (NCT03901378) | Clinical Trial Compass
WithdrawnPhase 2
Pembrolizumab With Chemotherapy in Metastatic or Unresectable High Grade Gastroenteropancreatic or Lung Neuroendocrine Carcinoma
Stopped: Lack of accrual
United States0Started 2019-10-02
Plain-language summary
The purpose of this study is to test the efficacy, safety, and tolerability of the combination of chemotherapy treatment, which could be either Cisplatin or carboplatin and etoposide, and the research study drug, Pembrolizumab (also known as MK-3475) in patients with high grade neuroendocrine carcinomas of the gastroenteropancreatic system or lung who are chemotherapy naïve. The chemotherapy treatment you receive will be either Cisplatin or carboplatin and etoposide. the participant's doctor will discuss this choice with you and determined which chemotherapy treatment is best for you.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Be willing and able to provide written informed consent/assent for the trial.
✓. Be 18 years of age on day of signing informed consent.
✓. Must have cytologically or histologically proven high grade neuroendocrine carcinoma of the gastroenteropancreatic system or large cell neuroendocrine carcinoma as defined by the 2010 WHO classification.
✓. Have metastatic or unresectable disease.
✓. No prior systemic chemotherapy or immunotherapy for metastatic disease allowed.
✓. Concurrent use of somatostatin analogs is allowed for symptom control.
✓. Life expectancy greater than 12 weeks.
✓. Have measurable disease based on RECIST 1.1.
Exclusion criteria
✕. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
✕. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
✕. Has a known history of active TB (Bacillus Tuberculosis)
✕. Hypersensitivity to pembrolizumab or any of its excipients.
✕. Has had prior systemic anti-cancer therapy for metastatic or unresectable neuroendocrine tumors other than somatostatin analogs.
✕. Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
✕. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
✕. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.